アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology (12.3) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data ]. at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by increased pre-

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

actavis pharma, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use (8.4 )]. propofol injectable emulsion is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use (8.4 )]. propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

cipla usa inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione injectable emulsion is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors ii, vii, ix and x when caused by vitamin k deficiency or interference with vitamin k activity: - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; - hypoprothrombinemia due to antibacterial therapy; - hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin k, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin k metabolism, e.g., salicylates. phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin k-deficiency bleeding in neonates. hypersensitivity to phytonadione or any other component of this medication [see warnings and precautions (5.1)] . risk summary phytonadione injectable emulsion contains benzyl alcohol, which has been associated with gasping syndrome in neonates. the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants. if phytonadione injectable emulsion is needed during pregnancy, consider using a benzyl alcohol-free formulation [see warnings and precautions (5.2), use in specific populations (8.4)] . published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see data] . there are maternal and fetal risks associated with vitamin k deficiency during pregnancy [see clinical considerations] . animal reproduction studies have not been conducted with phytonadione. the estimated background risk for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with vitamin k deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. subclinical maternal vitamin k deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. data human data phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. administration of vitamin k1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. however, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. animal data in pregnant rats receiving vitamin k1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. risk summary phytonadione injectable emulsion contains benzyl alcohol. if available, preservative-free phytonadione injectable emulsion is recommended when phytonadione injectable emulsion is needed during lactation [see warnings and precautions (5.2), use in specific populations (8.4)] . phytonadione is present in breastmilk. there are no data on the effects of phytonadione injectable emulsion on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the clinical need for phytonadione injectable emulsion and any potential adverse effects on the breastfed child from phytonadione injectable emulsion or from the underlying maternal condition. the safety and effectiveness of phytonadione injectable emulsion for prophylaxis and treatment of vitamin k deficiency have been established in neonates. use of phytonadione injection for prophylaxis and treatment of vitamin k deficiency is based on published clinical studies. serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. when prescribing phytonadione injectable emulsion in infants consider the combined daily metabolic load of benzyl alcohol from all sources including phytonadione injectable emulsion (phytonadione injectable emulsion contains 9 mg of benzyl alcohol per ml) and other drugs containing benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see warnings and precautions (5.2)] . whenever possible, use preservative-free phytonadione formulations in neonates. the preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. premature and low-birth weight infants may be more likely to develop toxicity.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

radius health, inc. - abaloparatide (unii: avk0i6hy2u) (abaloparatide - unii:avk0i6hy2u) - abaloparatide 2000 ug in 1 ml - tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, tymlos reduces the risk of vertebral fractures and nonvertebral fractures. tymlos is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. tymlos is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. reactions have included anaphylaxis, dyspnea, and urticaria [see adverse reactions (6.2)] . risk summary tymlos is not indicated for use in females of reproductive potential. there are no human data with tymlos use in pregnant women to inform any drug associated risks. animal reproduction studies with abaloparatide have not been conducted. risk summary tymlos is not indicated for use in females of reproductive potential. there is no information on the presence of abaloparatide in human milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness of tymlos have not been established in pediatric patients. tymlos is not recommended for use in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma [see warnings and precautions (5.1)] . of the total number of patients in the postmenopausal osteoporosis clinical studies of tymlos, 82% were age 65 years and over, and 19% were age 75 years and over. in the male osteoporosis study, 74% were age 65 years and over and 23% were age 75 years or over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is required for patients with mild, moderate, or severe renal impairment. a study of a single dose of tymlos 80 mcg given subcutaneously was conducted in subjects with normal renal function or mild, moderate, or severe renal impairment. the maximal concentration (cmax ) and area under the concentration-time curve (auc) of abaloparatide increased 1.4- and 2.1-fold, respectively, in subjects with severe renal impairment, compared to subjects with normal renal function. patients with severe renal impairment may have increased abaloparatide exposure that may increase the risk of adverse reactions; therefore, monitor for adverse reactions [see clinical pharmacology (12.3)] . instructions for use tymlos® (tim lows') (abaloparatide) injection, for subcutaneous use instructions for use read and follow this instructions for use so that you inject tymlos pen the right way. call your healthcare provider if you have any questions about the right way to inject the tymlos pen. important information about your tymlos pen - do not try to inject tymlos yourself until you or your caregiver receive training from a healthcare provider on the right way to use tymlos pen. - do not share your tymlos pen or pen needles with other people, even if the needle has been changed. you may give other people a serious infection, or get a serious infection from them. - each tymlos pen is a prefilled pen containing 30 doses of tymlos. each dose will contain 80 mcg of tymlos. you do not have to measure your dose. the pen measures each dose of tymlos for you. - use a new pen needle for each injection. keep the cap on the tymlos pen when not using the pen. - before using the pen always check the label to be sure it is your tymlos pen. - do not use your tymlos pen if it looks damaged. if you drop your tymlos pen or it becomes damaged, call your healthcare provider or pharmacist or call 1-855-672-3487. - to clean your tymlos pen, wipe the outside of the pen with a clean, damp cloth, if needed. - the tymlos pen is not recommended for use by the blind or visually impaired without the help of a person trained in the right way to use the pen. pen needles to use with your tymlos pen - pen needles are not included with your tymlos pen. you will need a prescription from your healthcare provider to get pen needles from your pharmacy. - the correct needles to use with your tymlos pen are 5 to 8 mm, 31-gauge needles. compatible needles include clickfine®, bd ultra-fine™, medtfine®, easy comfort, clever choice™ comfort ez™, and surecomfort™. if you are not sure what type of needle to use, ask your healthcare provider or pharmacist. supplies you will need for each injection using your tymlos pen - 1 tymlos pen - 1 pen needle - 1 alcohol swab - 1 cotton ball or gauze pad - 1 sharps disposal container for pen needles and tymlos pens. see "how should i throw away (dispose) of the pen needles and tymlos pens? " in the far right column. how should i store the tymlos pen? - before first use, store tymlos pens in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not store pens with the needle attached. - do not freeze the tymlos pen or expose it to heat. during 30 days of use: - after first use, store the tymlos pen for up to 30 days at room temperature between 68°f to 77°f (20°c to 25°c). - keep the pen cap on your tymlos pen when storing. do not store the tymlos pen with needle attached. - use your tymlos pen for only 30 days. - write down the date of your first use of tymlos here: _____/_____/_____. throw away your tymlos pen 30 days after first opening it even if it still contains unused medicine. keep the tymlos pen, pen needles and all medicines out of the reach of children. how should i throw away (dispose) of the pen needles and tymlos pens? - throw away (dispose of) your tymlos pen, in a fda-cleared sharps disposal container or puncture resistant container, 30 days after first opening it even if it still contains unused medicine. - put your used pen needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) your used sharps disposal container in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to fda's website at: https://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information about the tymlos pen for more information, go to www.tymlos.com or call 1-855-672-3487. manufactured for: radius radius health, inc. 22 boston wharf road, 7th floor boston, ma 02210 tymlos is a registered trademark of radius health, inc. us-ifu-000001-v8.0 begin the injection. check the tymlos® pen step 1. wash and dry your hands. step 2. check the expiration date (exp.) on the tymlos pen. - do not use the pen if the expiration date has passed. - call your healthcare provider or pharmacist if the expiration date has passed. attach pen needle to your tymlos pen step 3. pull off the pen cap from your tymlos pen. (see figure d.) - check the tymlos cartridge. the liquid should be clear, colorless, and free of particles; if not, do not use. step 4. pull off the protective paper from the outer needle cap of your pen needle. (see figure e.) step 5. keep the needle straight and screw it onto the pen until fixed; a secure fit is ensured even if there is no noticeable stop. do not over-tighten. (see figure f.) step 6. pull off the outer pen needle cap from the pen needle and keep it to use after your injection. (see figure g.) step 7. carefully pull off the inner pen needle cap and dispose of it. (see figure h.) step 8. if you are using this pen for the first time, go to the "new pen setup - day 1 only" section to prime your pen. - if you have already used this pen before, go to step 13 for days 2 through 30. new pen setup – day 1 only (priming your tymlos pen) do not repeat new pen setup on days 2 through 30. step 9. the "new pen setup" removes air bubbles (primes your pen). you only need to prime your pen on day 1 for each new pen. otherwise, you will waste medicine. - skip steps 10 through 12 on days 2 through 30. step 10. turn the dose knob on your tymlos pen away from you (clockwise) until it stops. (see figure i.) note: you will see " • 80 " lined up in the dose display window. step 11. hold the tymlos pen with the pen needle pointing up. tap lightly with your finger on the cartridge holder to move any air bubbles in the cartridge to the top of the cartridge. (see figure j.) note: do step 11 even if you do not see air bubbles. step 12. press the green injection button until it will not go any further. (see figure k). note: you should see liquid come out of the needle tip. note: you will see "•0" lined up in the dose display window. what should i do if liquid does not come out of the needle tip? - if you do not see a drop of tymlos, repeat steps 10 through 12. a drop of liquid should come out of the needle tip. - if you still do not see a drop of liquid call your healthcare provider or pharmacist and use a new tymlos pen. - when you are ready to use your new tymlos pen for the first time, remember to repeat all steps 9 through 12 to prime your new tymlos pen. set the dose on your tymlos pen do not push the green injection button while setting your dose. step 13. turn the dose knob on your pen away from you (clockwise) until the dose knob stops and "•80" is lined up in the dose display window. (see figure l.) if you set the dose before you are ready to give your injection, turn the dose knob toward you (counter-clockwise) until "•0" is in the dose display window. if you are not able to set the tymlos pen to "•80" , dispose of the pen and use a new tymlos pen for your injection, repeating steps 1 through 13. - if the pen cannot be set to "•80", there is not enough medicine in the tymlos pen for your full dose. see "how should i throw away (dispose) of the pen needles and tymlos pens? " on the other side. choose and clean your injection site step 14. injections should be given in the lower stomach area (abdomen). (see figure m.) avoid the 2-inch area around your belly button (navel). for each injection, change (rotate) your injection site around your abdomen. talk to your healthcare provider about how to change (rotate) your injection site for each injection. do not use the same injection area for each injection. do not inject into areas where the skin is tender, bruised, red, scaly, or hard. avoid areas with scars or stretch marks. step 15. wipe the injection site with an alcohol swab and allow it to dry. do not touch, fan, or blow on the injection site after you have cleaned it. giving your tymlos pen injection read step 16 and step 17 before you give your injection. inject your tymlos pen the way your healthcare provider has shown you. step 16. (see figure n.) - hold the pen so you can see the dose display window during the injection. - insert the pen needle straight into your skin. step 17. (see figure o.) - press the green injection button until it cannot go any further and "•0" is in the dose display window. do not move the tymlos pen after inserting the needle. - continue to press the green injection button while counting to 10. counting to 10 will allow the full dose of tymlos to be given. step 18. after counting to 10, release your finger from the green injection button and slowly remove the tymlos pen from the injection site by pulling the pen needle straight out. remove the pen needle step 19. carefully place the outer needle cap back on the pen needle. press on the outer needle cap until it snaps into place and is secure. (see figure p.) caution: to prevent needle stick injury, carefully follow step 20. step 20. unscrew the capped needle (like unscrewing a cap from a bottle). to unscrew the capped needle you may need to turn it 8 or more turns and then gently pull until the capped needle comes off. (see figure q.) note: do not push on the outer needle cap while unscrewing the needle. you should see a gap widening between the outer needle cap and the pen as you unscrew the needle. (see figure r.) replace pen cap step 21. firmly replace the pen cap onto the tymlos pen. (see figure s.) keep the pen cap on your tymlos pen between injections. after your injection step 22. press a cotton ball or gauze pad over the injection site and hold for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. you may cover the injection site with a small adhesive bandage, if needed. - dispose of the pen needle. see "how should i throw away (dispose) of the pen needles and tymlos pens?" . this instructions for use has been approved by the u.s. food and drug administration. issued:04/2021

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

liberty pharmaceuticals, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, proteus vulgaris, providencia stuartii, morganella morganii, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. ciprofloxacin is indicated in adult patients for treatment of i

アルメニア - 英語 - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

baxter sa. - alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil - emulsion for infusion - 1,83g+ 1,9g+ 1,37g+ 0,43g+ 2,29g+ 0,91g+ 0,87g+ 1,53g+ 2,29g+ 2,82g+ 0,55g+ 0,73g+ 0,96g+ 0,69g+ 0,91g+ 0,14g+ 0,85g+ 0,46g+ 0,18g+ 1,74g+ 1,79g+ 3,14g+ 0,56g+ 0,55g+ 2,21g+ 210,65+ 28,1g

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

novo nordisk - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - wegovy is indicated in combination with a reduced calorie diet and increased physical activity: limitations of use wegovy is contraindicated in the following conditions: pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. pregnant women exposed to wegovy and healthcare providers are encouraged to contact novo nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. risk summary based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. when a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue wegovy (see clinical considerations) . available pharmacovigilance data and data from clinical trials with wegovy use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (mrhd) based on auc. in rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the mrhd (rabbit) and greater than or equal to 2-fold the mrhd (monkey). these findings coincided with a marked maternal body weight loss in both animal species (see data).   the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy. data animal data in a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.04-, 0.1-, and 0.4-fold the mrhd) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to gestation day 17. in parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. in the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. in an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.01-, 0.1-, and 0.9-fold the mrhd) were administered throughout organogenesis from gestation day 6 to 19. pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at greater than or equal to 0.0025 mg/kg/day, at clinically relevant exposures. in an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.4-, 2-, and 6-fold the mrhd) were administered throughout organogenesis, from gestation day 16 to 50. pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 2 times human exposure). in a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.2-, 1-, and 3-fold the mrhd) were administered from gestation day 16 to 140. pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 1-time human exposure). risk summary there are no data on the presence of semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. semaglutide was present in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for wegovy and any potential adverse effects on the breastfed infant from wegovy or from the underlying maternal condition. data in lactating rats, semaglutide was detected in milk at levels 3-12-fold lower than in maternal plasma. because of the potential for fetal harm, discontinue wegovy in patients at least 2 months before they plan to become pregnant to account for the long half-life of semaglutide [see use in specific populations (8.1 )] . the safety and effectiveness of wegovy as an adjunct to a reduced calorie diet and increased physical activity for weight reduction and long-term maintenance have been established in pediatric patients aged 12 years and older with obesity. use of wegovy for this indication is supported by a 68-week, double-blind, placebo-controlled clinical trial in 201 pediatric patients aged 12 years and older with a bmi corresponding to ≥95th percentile for age and sex and from studies in adult patients with obesity [see clinical studies (14.3) ] . adverse reactions with wegovy treatment in pediatric patients aged 12 years and older were generally similar to those reported in adults. pediatric patients aged 12 years and older treated with wegovy had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with wegovy [see adverse reactions (6.1)] . there are insufficient data in pediatric patients with type 2 diabetes treated with wegovy for obesity to determine if there is an increased risk of hypoglycemia with wegovy treatment similar to that reported in adults. inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. in pediatric patients aged 12 years and older with type 2 diabetes, monitor blood glucose prior to starting wegovy and during wegovy treatment. when initiating wegovy in pediatric patients aged 12 years and older with type 2 diabetes, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see warnings and precautions (5.4)] . the safety and effectiveness of wegovy have not been established in pediatric patients less than 12 years of age. in the wegovy clinical trials for weight reduction and long-term maintenance, 233 (9%) wegovy-treated patients were aged 65 to 75 years and 23 (1%) wegovy-treated patients were aged 75 years and older [see clinical studies (14.2)] . in a cardiovascular outcomes trial, 2656 (30%) wegovy-treated patients were aged 65 to 75 years and 703 (8%) wegovy-treated patients were aged 75 years and older [see clinical studies (14.1)] . no overall difference in effectiveness was observed between patients aged 65 years and older and younger adult patients. in the cardiovascular outcomes trial, patients aged 75 years and older reported more fractures of the hip and pelvis on wegovy than on placebo. patients aged 75 years and older (wegovy-treated and placebo-treated) reported more serious adverse reactions overall compared to younger adult patients [see adverse reactions (6.1)]. no dose adjustment of wegovy is recommended for patients with renal impairment. in a study in patients with renal impairment, including end-stage renal disease, no clinically relevant change in semaglutide pharmacokinetics was observed [see clinical pharmacology (12.3 )] . no dose adjustment of wegovy is recommended for patients with hepatic impairment. in a study in patients with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics was observed [see clinical pharmacology (12.3 )] . instructions for use wegovy® (semaglutide) injection wegovy comes in five strengths: before you use your wegovy pen for the first time, talk to your healthcare provider or your caregiver about how to prepare and inject wegovy correctly. important information read this instructions for use before you start using wegovy. this information does not replace talking to your healthcare provider about your medical condition or treatment. · your wegovy pen is for 1 time use only . the wegovy pen is for subcutaneous (under the skin) use only. · the dose of wegovy is already set on your pen. · the needle is covered by the needle cover and the needle will not be seen. · do not remove the pen cap until you are ready to inject. · do not touch or push on the needle cover. you could get a needle stick injury. · your wegovy injection will start when the needle cover is pressed firmly against your skin. · do not remove the pen from your skin before the yellow bar in the pen window has stopped moving. the medicine may appear on the skin or squirt from the needle and you may not get your full dose of wegovy if: · if the yellow bar does not start moving or stops during the injection, contact your healthcare provider or novo nordisk at startwegovy.com or call novo nordisk inc. at 1-833-934-6891. · the needle cover will lock when the pen is removed from your skin. you cannot stop the injection and restart it later. · people who are blind or have vision problems should not use the wegovy pen without help from a person trained to use the wegovy pen. how do i store wegovy? · store the wegovy pen in the refrigerator between 36°f to 46°f (2°c to 8°c). · if needed, before removing the pen cap, wegovy can be stored from 46°f to 86°f (8°c to 30°c) in the original carton for up to 28 days. · keep wegovy in the original carton to protect it from light. · do not freeze . · throw away the pen if wegovy has been frozen, has been exposed to light or temperatures above 86°f (30°c), or has been out of the refrigerator for 28 days or longer. keep wegovy and all medicines out of the reach of children. how to use your wegovy pen do not use your wegovy pen without receiving training from your healthcare provider. make sure that you or your caregiver know how to give an injection with the pen before you start your treatment. read and follow the instructions so that you use your wegovy pen correctly: preparation step 1. prepare for your injection. contact novo nordisk at 1-833-934-6891 if your wegovy pen fails any of these checks. step 2. choose your injection site. • your healthcare provider can help you choose the injection site that is best for you • do not inject into an area where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. • you may inject in the same body area each week, but make sure it is not in the same spot each time. clean the injection site with an alcohol swab or soap and water. do not touch the injection site after cleaning. allow the skin to dry before injecting. injection step 3. remove pen cap. • pull the pen cap straight off your pen. step 4. inject wegovy. • push the pen firmly against your skin and keep applying pressure until the yellow bar has stopped moving. if the yellow bar does not start moving, press the pen more firmly against your skin. throw away pen step 5. throw away (dispose of) pen. safely dispose of the wegovy pen right away after each use. see “how do i throw away (dispose of) wegovy pens?” • what if blood appears after injection? if blood appears at the injection site, press the site lightly with a gauze pad or cotton ball. how do i throw away (dispose of) wegovy pens? put the used wegovy pen in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the pen in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific sharps disposal in the state that you live in, go to the fda’s website at http://www.fda.gov/safesharpsdisposal. important: keep your wegovy pen, sharps disposal container and all medicines out of the reach of children. how do i care for my pen? protect your pen manufactured by: novo nordisk a/s novo allé dk-2880 bagsvaerd, denmark for information about wegovy, go to startwegovy.com or contact: novo nordisk inc. 800 scudders mill road plainsboro, nj 08536 1-833-wegovy-1 version: 2 wegovy ® is a registered trademark of novo nordisk a/s. patent information: http://novonordisk-us.com/products/product-patents.html © 2022 novo nordisk this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

torrent pharmaceuticals limited - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: • treatment of adult and adolescent patients (13 to 17 years) patients with schizophrenia [see clinical studies ( 14.1)] . • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • known hypersensitivity to lurasidone hcl or any components in the formulation.  angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john's wort, phenytoin, carbamazepine, etc.) [see drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride tablets during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery  [see clinical considerations] . there are no studies of lurasidone hydrochloride tablets use in pregnant women. the limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. in animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5- and 6-times, the maximum recommended human dose (mrhd) of 160 mg/day, respectively based on mg/m 2 body surface area  [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data pregnant rats were treated with oral lurasidone at doses of 3, 10, and 25 mg/kg/day during the period of organogenesis. these doses are 0.2, 0.6, and 1.5 times the mrhd of 160 mg/day based on mg/m2 body surface area. no teratogenic or embryo-fetal effects were observed up to 1.5 times the mhrd of 160 mg/day, based on mg/m 2 . pregnant rabbits were treated with oral lurasidone at doses of 2, 10, and 50 mg/kg/day during the period of organogenesis. these doses are 0.2, 1.2 and 6 times the mrhd of 160 mg/day based on mg/m2. no teratogenic or embryo-fetal effects were observed up to 6 times the mhrd of 160 mg/day based on mg/m 2 . pregnant rats were treated with oral lurasidone at doses of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation. these doses are 0.02, 0.1 and 0.6 times the mrhd of 160 mg/day based on mg/m2. no pre- and postnatal developmental effects were observed up to 0.6 times the mrhd of 160 mg/day, based on mg/m 2 . risk summary lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production. lurasidone is present in rat milk. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for lurasidone hydrochloride and any potential adverse effects on the breastfed infant from lurasidone hydrochloride or from the underlying maternal condition. schizophrenia the safety and effectiveness of lurasidone hydrochloride tablets 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see dosage and administration (2.1), adverse reactions (6.1), and clinical studies (14.1)]. the safety and effectiveness of lurasidone hydrochloride have not been established in pediatric patients less than 13 years of age with schizophrenia.  bipolar depression the safety and effectiveness of lurasidone hydrochloride tablets 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)]. the safety and effectiveness of lurasidone hydrochloride have not been established in pediatric patients less than 10 years of age with bipolar depression.   irritability associated with autistic disorder the effectiveness of lurasidone hydrochloride in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder diagnosed by diagnostic and statistical manual of mental disorders, 4th ed., text revision [dsm-iv-tr] criteria. the primary objective of the study as measured by improvement from baseline in the irritability subscale of the aberrant behavior checklist (abc) at endpoint (week 6) was not met. a total of 149 patients were randomized to lurasidone hydrochloride or placebo. vomiting occurred at a higher rate than reported in other lurasidone hydrochloride studies (4/49 or 8% for 20mg, 14/51 or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on lurasidone hydrochloride with vomiting). in a long-term, open-label study that enrolled pediatric patients (age 6 to 17 years) with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. there was one adverse event in this trial that was considered possibly drug-related and has not been reported in adults receiving lurasidone: a 10 year old male experienced a prolonged, painful erection, consistent with priapism, that led to treatment discontinuation. in this trial, the mean increase in height from open-label baseline to week 104 was 4.94 cm. to adjust for normal growth, z-scores were derived (measured in standard deviations [sd]), which normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. a z-score change <0.5 sd is considered not clinically significant. in this trial, the mean change in height z-score from open-label baseline to week 104 was +0.05 sd, indicating minimal deviation from the normal growth curve. juvenile animal studies adverse effects were seen on growth, physical and neurobehavioral development at doses as low as 0.2 times the mrhd based on mg/m 2 . lurasidone was orally administered to rats from postnatal days 21 through 91 (this period corresponds to childhood, adolescence, and young adulthood in humans) at doses of 3, 30, and 150 (males) or 300 (females) mg/kg/day which are 0.2 to 10 times (males) and 20 times (females) the maximum recommended adult human dose (mrhd) of 160 mg/day based on mg/m 2 . the adverse effects included dose-dependent decreases in femoral length, bone mineral content, body and brain weights at 2 times the mrhd in both sexes, and motor hyperactivity at 0.2 and 2 times the mrhd in both sexes based on mg/m 2 . in females, there was a delay in attainment of sexual maturity at 2 times the mrhd, associated with decreased serum estradiol. mortality occurred in both sexes during early post- weaning period and some of the male weanlings died after only 4 treatments at doses as low as 2 times the mrhd based on mg/m 2 . histopathological findings included increased colloid in the thyroids and inflammation of the prostate in males at 10 times mrhd based on mg/m 2  and mammary gland hyperplasia, increased vaginal mucification, and increased ovarian atretic follicles at doses as low as 0.2 times the mrhd based on mg/m 2 . some of these findings were attributed to transiently elevated serum prolactin which was seen in both sexes at all doses. however, there were no changes at any dose level in reproductive parameters (fertility, conception indices, spermatogenesis, estrous cycle, gestation length, parturition, number of pups born). the no effect dose for neurobehavioral changes in males is 0.2 times the mhrd based on mg/m 2  and could not be determined in females. the no effect dose for growth and physical development in both sexes is 0.2 times the mrhd based on mg/m 2 . clinical studies with lurasidone hydrochloride did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. in elderly patients with psychosis (65 to 85), lurasidone hydrochloride concentrations (20 mg/day) were similar to those in young subjects. it is unknown whether dose adjustment is necessary on the basis of age alone. elderly patients with dementia-related psychosis treated with lurasidone hydrochloride are at an increased risk of death compared to placebo. lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis  [see boxed warning, warnings and precautions ( 5.1,  5.3)]. reduce the maximum recommended dosage in patients with moderate or severe renal impairment (clcr<50 ml/minute). patients with impaired renal function (clcr<50 ml/minute) had higher exposure to lurasidone than patients with normal renal function [ see clinical pharmacology ( 12.3) ]. greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [ see dosage and administration ( 2.4) ] reduce the maximum recommended dosage in patients with moderate to severe hepatic impairment (child-pugh score ≥7). patients with moderate to severe hepatic impairment (child-pugh score ≥7) generally had higher exposure to lurasidone than patients with normal hepatic function [ see clinical pharmacology ( 12.3) ]. greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [ see dosage and administration ( 2.5) ]. no dosage adjustment for lurasidone hydrochloride is required on the basis of a patient's sex, race, or smoking status [ see clinical pharmacology ( 12.3) ]. lurasidone hydrochloride is not a controlled substance. lurasidone hydrochloride has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. while clinical studies with lurasidone hydrochloride did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a cns-active drug will be misused, diverted and/or abused once it is marketed. patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of lurasidone hydrochloride misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

plum valleypharma llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine and prilocaine cream, 2.5%/2.5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

amgen inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. amjevita is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning and warnings and precautions (5)] . amjevita is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. amjevita is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data ]. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n = 10) and infant serum (n = 8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amjevita and any potential adverse effects on the breastfed child from amjevita or from the underlying maternal condition. the safety and effectiveness of amjevita have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for amjevita demonstrate that amjevita is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, amjevita is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of amjevita in patients 65 years of age and older. in patients treated with amjevita, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . instructions for use welcome! the amjevita™ sureclick® autoinjector is a single-dose prefilled autoinjector. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita sureclick autoinjector for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using amjevita sureclick autoinjector. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™(am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled sureclick® autoinjector guide to parts important: needle is inside important before you use an amjevita sureclick autoinjector, read this important information: storing your amjevita sureclick autoinjectors - keep the amjevita sureclick autoinjector and all medicines out of the reach of children. - keep the amjevita sureclick autoinjector in the original carton to protect from light or physical damage. - the amjevita sureclick autoinjector should be kept in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, you may store the amjevita sureclick autoinjector at room temperature up to 77°f (25°c) for up to 14 days. throw away amjevita if it has been kept at room temperature and not been used within 14 days. - do not store the amjevita sureclick autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita sureclick autoinjector - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita sureclick autoinjector after the expiration date on the label. - do not shake the amjevita sureclick autoinjector. - do not remove the yellow cap from the amjevita sureclick autoinjector until you are ready to inject. - do not use the amjevita sureclick autoinjector if it has been frozen. - do not use the amjevita sureclick autoinjector if it has been dropped on a hard surface. part of the amjevita sureclick autoinjector may be broken even if you cannot see the break. use a new amjevita sureclick autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the amjevita sureclick autoinjector is not made with natural rubber latex. for more information or help or call 1-800-77-amgen (1-800-772-6436). step 1: prepare a remove 1 amjevita sureclick autoinjector from the package. carefully lift the autoinjector straight up out of the box. put the original package with any unused autoinjectors back in the refrigerator. for a more comfortable injection, leave the autoinjector at room temperature for 15 to 30 minutes before injecting. - do not put the autoinjector back in the refrigerator once it has reached room temperature. - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector yet. b inspect the amjevita sureclick autoinjector. make sure the medicine in the window is clear and colorless to slightly yellow. - do not use the autoinjector if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the autoinjector has been dropped. the yellow cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the autoinjector has been dropped. - the yellow cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). c gather all materials needed for your injection. wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new autoinjector - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d prepare and clean your injection site. you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e pull yellow cap straight off, only when you are ready to inject. it is normal to see a drop of liquid at the end of the needle or yellow safety guard. - do not twist or bend the yellow cap. - do not put the yellow cap back onto the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. f stretch or pinch your injection site to create a firm surface. stretch method stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. pinch method pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin stretched or pinched while injecting. step 3: inject g hold the stretch or pinch. with the yellow cap off, place the autoinjector on your skin at 90 degrees. h firmly push the autoinjector down onto skin until it stops moving. push down important: you must push all the way down but do not touch blue start button until you are ready to inject. i when you are ready to inject, press the blue start button. j keep pushing down on your skin. your injection could take about 10 seconds. window turns yellow when injection is done important: when you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. step 4: finish k discard (throw away) the used autoinjector and the yellow cap. - put the used sureclick autoinjector in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the sureclick autoinjector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the autoinjector. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. l examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. commonly asked questions what will happen if i press the blue start button before i am ready to do the injection on my skin? can i move the autoinjector around on my skin while i am choosing an injection site? can i release the blue start button after i start my injection? will the blue start button pop up after i release my thumb? what do i do if i didn't hear a click after pushing the device down on my skin for 10 seconds? whom do i contact if i need help with the autoinjector or my injection? this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 07/2022 v2 turn over to continue……… welcome! amjevita™ is supplied as a single-dose prefilled syringe. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita prefilled syringe for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using the amjevita prefilled syringe. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled amjevita syringe guide to parts important: the needle is covered by the needle cap before use. important before you use an amjevita prefilled syringe, read this important information: storing your amjevita prefilled syringes - keep the amjevita prefilled syringe and all medicines out of the reach of children. - keep the amjevita prefilled syringe in the original carton to protect from light or physical damage. - the amjevita prefilled syringe should be kept in the refrigerator at 36° f to 46° f (2° c to 8° c). - if needed, you may store the amjevita prefilled syringe at room temperature up to 77° f (25° c) for up to 14 days. throw away amjevita if it has been kept at room temperature and has not been used within 14 days. - do not store the amjevita prefilled syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita prefilled syringe - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita prefilled syringe after the expiration date on the label. - do not shake the amjevita prefilled syringe. - do not remove the needle cap from the amjevita prefilled syringe until you are ready to inject. - do not use the amjevita prefilled syringe if it has been frozen. - do not use the amjevita prefilled syringe if it has been dropped on a hard surface. part of the amjevita prefilled syringe may be broken even if you cannot see the break. use a new amjevita prefilled syringe, and call 1-800-77-amgen (1-800-772-6436). - the amjevita prefilled syringe is not made with natural rubber latex. - for more information or help call 1-800-77-amgen (1-800-772-6436). step 1: prepare a   remove the prefilled syringe carton from the refrigerator. remove the number of amjevita prefilled syringes you need for your injection from the carton. grab the syringe barrel to remove the prefilled syringe from the tray as shown. put the original carton with any unused prefilled syringes back in the refrigerator. for safety reasons: - do not grab the plunger rod. - do not grab the needle cap. - do not remove the needle cap until you are ready to inject. - do not remove the finger flange. the finger flange is part of the syringe. for a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting. - do not put the syringe back in the refrigerator once it has reached room temperature. - do not try to warm the syringe by using a heat source such as hot water or microwave. - do not leave the syringe in direct sunlight. - do not shake the syringe. important: always hold the prefilled syringe by the syringe barrel. b   inspect the amjevita prefilled syringe. always hold the syringe by the syringe barrel. make sure the medicine in the syringe is clear and colorless to slightly yellow. - do not use the syringe if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new syringe, and call 1-800-77-amgen (1-800-772-6436). c   gather all materials needed for your injection(s). wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new syringe(s) - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d   prepare and clean your injection site(s).          you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e   hold the prefilled syringe by the syringe barrel with the needle cap pointing up. carefully pull the needle cap straight off and away from your body when you are ready to inject. it is normal to see a drop of liquid at the end of the needle. - do not twist or bend the needle cap. - do not put the needle cap back onto the syringe. - do not remove the needle cap from the syringe until you are ready to inject. important: throw the needle cap into the sharps disposal container provided. f   pinch your injection site to create a firm surface. pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin pinched while injecting. step 3: inject g   hold the pinch. with the needle cap off, insert the syringe into your skin at 45 to 90 degrees. do not place your finger on the plunger rod while inserting the needle. h   using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. do not pull back the plunger rod while the needle is inserted. i   when done, release your thumb, and gently pull the syringe off of your skin. step 4: finish j   discard (throw away) the used prefilled syringe and the needle cap. do not use any medicine that is left in the used syringe. - put the used amjevita prefilled syringe in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the syringe. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. k   examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. this instructions for use has been approved by the u.s. food and drug administration. manufactured by : amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 7/2022 v2 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) 10 mg/0.2 ml injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that a caregiver may be able to give your injections of amjevita at home, they should receive training on the right way to prepare and inject amjevita. do not try to inject until they have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex.   important: keep the syringe and sharps disposal container out of the sight and reach of children. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com, or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. important: keep the syringe out of the sight and reach of children. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68° f to 77° f (20° c to 25° c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68° f to 77° f (20° c to 25° c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored or has flakes. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at about a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on the injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the us food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 04/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 40 mg/0.4 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 10 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 80 mg/0.8 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 15 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita dosing: - amjevita comes in 3 different doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml. check your prescription to make sure you have the correct dose. - the color and look of the prefilled syringe will be different for each dose. the amount of medicine in the syringe will also be different for each dose. - for example, it is okay for the 20 mg/0.2 ml dose to have a small amount of medicine and the 80 mg/0.8 ml to have a large amount of medicine. check the illustrations below to see what your dose looks like in the syringe. 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave, or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for the injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023