United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - ritlecitinib tosylate (unii: eag4t1459k) (ritlecitinib - unii:2oye00pc25) - litfulo is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. limitations of use : not recommended for use in combination with other jak inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. litfulo is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see warnings and precautions (5.6)] .       if a patient becomes pregnant while receiving litfulo, healthcare providers should report litfulo exposure by calling 1-877-390-2940. risk summary available data from clinical trials with litfulo use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparison, respectively (see animal data) . the background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. the estimated background risks in the u.s. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively. data animal data in an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the mrhd based on auc comparison). maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the mrhd based on auc comparison). there was no developmental toxicity at 75 mg/kg/day (16 times the mrhd based on auc comparison). in an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the mrhd based on auc comparison). there was no developmental toxicity at doses up to 25 mg/kg/day (12 times the mrhd based on auc comparison). in a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the mrhd based on auc comparison). at 175 mg/kg/day (41 times the mrhd based on auc comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. bred females in the f1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day. risk summary there are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. ritlecitinib is present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that it will be present in human milk. because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with litfulo and for approximately 14 hours after the last dose (approximately 6 elimination half-lives). data after a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. the mean milk to plasma auc ratio was 2.2. the safety and effectiveness of litfulo for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. a total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (trial aa-i). efficacy was consistent between the pediatric patients and adults [see clinical studies (14)] . the adverse reaction profile in the pediatric patients was similar to adults. the safety and efficacy of litfulo have not been established in pediatric patients under 12 years of age. no dose adjustment is required for patients ≥65 years of age. a total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. clinical trials of litfulo did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. as there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. no dose adjustment is required in patients with mild (child pugh a) or moderate (child pugh b) hepatic impairment. litfulo is not recommended in patients with severe (child pugh c) hepatic impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

ol pharma tech, llc drs pharmacy - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - anti-itch for temporary external feminine itching - you have a vaginal discharge. consult a physician. - condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.

New Zealand - English - Ministry for Primary Industries

new zealand equine health association - equine influenza vcp2242 alvac virus [ohio/03 (h3n8 american lineage strain)]; equine influenza vcp3011 alvac virus [richmond/1/07 (h3n8)]; tetanus toxoid - equine influenza vcp2242 alvac virus [ohio/03 (h3n8 american lineage strain)] 0 vaccine; equine influenza vcp3011 alvac virus [richmond/1/07 (h3n8)] 0 vaccine; tetanus toxoid 0 vaccine - vaccine

United States - English - NLM (National Library of Medicine)

abbvie inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab 40 mg in 0.8 ml - humira 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. humira can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards).  humira is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. humira can be used alone or in combination with methotrexate. humira is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. humira can be used alone or in combination with non-biologic dmards. humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. humira is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. humira is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. limitations of use the effectiveness of humira has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies ( 14.7 , 14.8 )] . humira 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. humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions ( 5 ) ] . humira is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. humira is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. 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 humira pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd). 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 humira 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 humira, 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 humira was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 µg/ml in cord blood, 4.28-17.7 µg/ml in infant serum, and 0-16.1 µg/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 µg/ml), 7 weeks (1.31 µg/ml), 8 weeks (0.93 µg/ml), and 11 weeks (0.53 µg/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 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 humira and any potential adverse effects on the breastfed child from humira or from the underlying maternal condition. the safety and effectiveness of humira 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. - the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. - the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. - the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older. due to its inhibition of tnfα, humira administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to humira 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 humira [see warnings and precautions ( 5.2 ) ] . juvenile idiopathic arthritis in study jia-i, humira 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 ) ] . humira has 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 humira 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 humira have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of humira 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 humira 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 humira 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 humira have not been established in pediatric patients with crohn’s disease less than 6 years of age. pediatric ulcerative colitis the safety and effectiveness of humira for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients 5 years of age and older. use of humira 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 humira in 93 pediatric patients (5 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.3 ) , clinical studies ( 14.8 ) ] . the adverse reaction profile in patients 5 years to 17 years of age was similar to adults. the effectiveness of humira has not been established in patients who have lost response or were intolerant to tnf blockers. the safety and effectiveness of humira have not been established in pediatric patients with ulcerative colitis less than 5 years of age. pediatric uveitis the safety and effectiveness of humira for the treatment of non-infectious uveitis have been established in pediatric patients 2 years of age and older. the use of humira is supported by evidence from adequate and well-controlled studies of humira in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients [see clinical studies ( 14.12 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with uveitis less than 2 years of age. hidradenitis suppurativa use of humira in pediatric patients 12 years of age and older for hs is supported by evidence from adequate and well-controlled studies of humira in adult hs patients. additional population pharmacokinetic modeling and simulation predicted that weight-based dosing of humira in pediatric patients 12 years of age and older can provide generally similar exposure to adult hs patients. the course of hs is sufficiently similar in adult and adolescent patients to allow extrapolation of data from adult to adolescent patients. the recommended dosage in pediatric patients 12 years of age or older is based on body weight [see dosage and administration ( 2.6 ) , clinical pharmacology ( 12.3 ) , and clinical studies ( 14.10 ) ] . the safety and effectiveness of humira have not been established in patients less than 12 years of age with hs. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received humira 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 humira 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 humira in patients 65 years of age and older. in patients treated with humira, closely monitor for the development of infection or malignancy [see warnings and precautions ( 5.1 , 5.2 )] . instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml single-dose pen do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira.  important: - do not use humira if frozen, even if it has been thawed. - the humira pen contains glass. do not drop or crush the pen because the glass inside may break. - each humira pen has 2 caps on it. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) until right before your injection. - when the plum-colored button on the humira pen is pressed to give your dose of humira, you will hear a loud “click” sound. you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. the loud click sound means the start of the injection. you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. - you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. - the loud click sound means the start of the injection. - you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. see the section below called “prepar ing the humira pen” . gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. 1 alcohol swab 1 cotton ball or gauze pad (not included in your humira carton) 1 humira pen (see figure a) puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. - 1 alcohol swab - 1 cotton ball or gauze pad (not included in your humira carton) - 1 humira pen (see figure a) - puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. if more comfortable, take your humira pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what the humira pen looks like. see figure a. figure a check the carton, dose tray, and humira pen . 1. make sure the name humira appears on the carton, dose tray, and humira pen label. 2. do not use and do call your doctor or pharmacist if: - you drop or crush your humira pen. - the seals on the top or bottom of the carton are broken or missing. - the expiration date on the carton, dose tray, and pen has passed. - the humira pen has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). see the “how should i store humira?” section at the end of this instructions for use. 3. hold the pen with the gray cap (cap # 1) pointed down. 4. make sure the amount of liquid in the pen is at the fill line or close to the fill line seen through the window. this is the full dose of humira that you will inject. see figure b. 5. if the pen does not have the full amount of liquid, do not use that pen . call your pharmacist. figure b 6. turn the pen over and hold the pen with the gray cap (cap # 1) pointed up. see figure c. 7. check the solution through the windows on the side of the pen to make sure the liquid is clear and colorless. do not use your humira pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. call your pharmacist. it is normal to see one or more bubbles in the window. figure c choose the injection site 8. wash and dry your hands well. 9. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure d. figure d - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject humira into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 10. wipe the injection site with an alcohol prep (swab) using a circular motion. - do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. preparing the humira pen 11. do not remove the gray cap (cap # 1) or the plum-colored cap (cap # 2) until right before your injection. 12. hold the middle of the pen (gray body) with one hand so that you are not touching the gray cap (cap # 1) or the plum-colored cap (cap # 2). turn the pen so that the gray cap (cap # 1) is pointing up. see figure e. figure e 13. with your other hand, pull the gray cap (cap # 1) straight off (do not twist the cap). make sure the small needle cover of the syringe has come off with the gray cap (cap # 1). see figure f. 14. throw away the gray cap (cap # 1). figure f - do not put the gray cap (cap # 1) back on the pen. putting the gray cap (cap # 1) back on may damage the needle. - the white needle sleeve, which covers the needle, can now be seen. - do not touch the needle with your fingers or let the needle touch anything. - you may see a few drops of liquid come out of the needle. this is normal. 15. remove the plum-colored cap (cap # 2) from the bottom of the pen by pulling it straight off (do not twist the cap). the pen is now activated. throw away the plum-colored cap (cap # 2). - do not put the plum-colored cap (cap # 2) back on the pen because it could cause medicine to come out of the syringe. the plum-colored activator button: - turn the pen so the plum-colored activator button is pointed up. see figure g. figure g - do not press the plum-colored activator button until you are ready to inject humira. pressing the plum-colored activator button will release the medicine from the pen. - hold the pen so that you can see the window. see figure h. it is normal to see one or more bubbles in the window. figure h position the pen and inject humira 16. position the pen: - squeeze the area of the cleaned skin and hold it firmly until the injection is complete. see figure i. you will inject into this raised area of skin. figure i 17. place the white end of the pen straight (at a 90º angle ) and flat against the raised area of your skin that you are squeezing. place the pen so that it will not inject the needle into your fingers that are holding the raised skin. see figure j. figure j 18. inject humira - it is important that you firmly push the pen down all the way against the injection site before starting the injection. - keep pushing down to prevent the pen from moving away from the skin during the injection. - press the plum-colored activator button with your thumb to begin the injection. try not to cover the window. see figure k. figure k - you will hear a loud ‘click’ when you press the plum-colored activator button. the loud click means the start of the injection. - keep pressing the plum-colored activator button and continue to push the pen against your squeezed, raised skin until all the medicine is injected. this can take up to 10 seconds, so count slowly to ten. keep pushing the pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine. - you will know that the injection has finished when the yellow indicator fully appears in the window view and stops moving. see figure l. figure l 19. when the injection is finished, slowly pull the pen from your skin. the white needle sleeve will move to cover the needle tip. see figure m. - do not touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure m - there may be a small amount of liquid on the injection site. this is normal. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 20. throw away (dispose of) your used humira pen in a sharps disposal container right away after use. see the section “how should i dispose of the used humira pen?” 21. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) the used humira pen? - put your pen in a fda-cleared sharps disposal container right away after use. see figure n. do not throw away the pen in your household trash.   - do not try to touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure n - 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. - 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. - for the safety and health of you and others, never re-use your humira pens. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - 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.   - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a pen if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066944 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the 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. - 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 10 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the 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. - 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 15 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml, 20 mg/0.4 ml and 10 mg/0.2 ml single-dose prefilled syringe do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject humira. gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. ● 1 alcohol swab ● 1 cotton ball or gauze pad (not included in your humira carton) ● 1 humira prefilled syringe (see figure a) ● puncture-resistant sharps disposal container for humira prefilled syringe disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used prefilled syringes and needles?” section at the end of this instructions for use. if more comfortable, take your humira prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the needle cover while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what a prefilled syringe looks like. see figure a. figure a check the carton, dose tray, and prefilled syringe 1. make sure the name humira appears on the dose tray and prefilled syringe label. 2. do not use and do call your doctor or pharmacist if: - the seals on top or bottom of the carton are broken or missing. - the humira labeling has an expired date. check the expiration date on your humira carton and do not use if the date has passed. - the prefilled syringe has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). - the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. make sure the liquid is clear and colorless. see the “how should i store humira?” section at the end of this instructions for use. choose the injection site 3. wash and dry your hands well. 4. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure b. figure b - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. prepare the injection site 5. wipe the injection site with an alcohol prep (swab) using a circular motion. 6. do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. prepare the syringe and needle 7. check the fluid level in the syringe: - hold the syringe with the covered needle pointing down. see figure c. figure c - hold the syringe at eye level. look closely to make sure that the amount of liquid in the syringe is the same or close to the: 0.8 ml line for the 40 mg prefilled syringe. see figure d. 0.4 ml line for the 20 mg prefilled syringe. see figure d. 0.2 ml line for the 10 mg prefilled syringe. see figure d. - 0.8 ml line for the 40 mg prefilled syringe. see figure d. - 0.4 ml line for the 20 mg prefilled syringe. see figure d. - 0.2 ml line for the 10 mg prefilled syringe. see figure d. figure d 8. the top of the liquid may be curved. if the syringe does not have the correct amount of liquid, do not use that syringe . call your pharmacist. 9. remove the needle cover: - hold the syringe in one hand. with the other hand gently remove the needle cover. see figure e. - throw away the needle cover. figure e - do not touch the needle with your fingers or let the needle touch anything. 10. turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. using your other hand, slowly push the plunger in to push the air out through the needle. see figure f. figure f - you may see a drop of liquid at the end of the needle. this is normal. position the prefilled syringe and inject humira position the syringe 11. hold the body of the prefilled syringe in one hand between the thumb and index finger. hold the syringe in your hand like a pencil. see figure g. figure g - do not pull back on the plunger at any time. - with your other hand, gently squeeze the area of the cleaned skin and hold it firmly. see figure h. figure h inject humira 12. using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle . see figure i. figure i - after the needle is in, let go of the skin. pull back gently on the plunger. if blood appears in the syringe: - it means that you have entered a blood vessel. - do not inject humira. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. see figure j. figure j - do not use the same syringe and needle again. throw away the needle and syringe in your sharps container. - do not rub the injection site. you may have slight bleeding. this is normal. - repeat steps 1 through 12 with a new prefilled syringe. if no blood appears in the syringe: - slowly push the plunger all the way in until all the liquid is injected and the syringe is empty. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 13. throw away the used prefilled syringe and needle in a sharps disposal container right away after use. see “how should i throw away ( dispose of ) used prefilled syringes and needles?” 14. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) used prefilled syringes and needles? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. see figure k. do not throw away (dispose of) loose needles and syringes in your household trash.   - do not try to touch the needle. figure k - 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. - 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. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - 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. - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. the prefilled syringe is glass. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066947 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the prefilled syringe has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the needle cover while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the prefilled syringe if liquid has been frozen (even if thawed) - 1 single-dose prefilled syringe and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your prefilled syringe - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - throw the needle cover away - do not touch the needle with your fingers or let the needle touch anything - hold the prefilled syringe at eye level with one hand so you can see the air in the prefilled syringe - using your other hand, slowly push the plunger in to push the air out through the needle. - you may see a drop of liquid at the end of the needle. this is normal. - after the needle is in, let go of the skin. - do not rub - slight bleeding at the injection site is normal - put your used needles, syringes, and sharps in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in the 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. - 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container

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astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 2 mg in 0.65 ml - bydureon is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use : bydureon is contraindicated in patients with: limited data with exenatide, the active ingredient in bydureon, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be risks to the fetus from exposure to bydureon during pregnancy. bydureon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy, or from exposure to exenatide, during pregnancy and lactation, in associatio

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mhc pharma, llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 100 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae. - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent

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pfizer laboratories div pfizer inc - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg in 10 ml - inflectra is indicated for: inflectra is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active cd who have had an inadequate response to conventional therapy. inflectra is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to conventional therapy. inflectra is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active uc who have had an inadequate response to conventional therapy. inflectra, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderatel

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u.s. pharmaceuticals - tofacitinib citrate (unii: o1ff4div0d) (tofacitinib - unii:87la6fu830) - tofacitinib 5 mg - xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis (psa) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc), who have an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz oral solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcjia) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more tnf

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - tofacitinib citrate (unii: o1ff4div0d) (tofacitinib - unii:87la6fu830) - tofacitinib 5 mg - xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis (psa) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc), who have an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz oral solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcjia) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more tnf

United States - English - NLM (National Library of Medicine)

caraco pharmaceutical laboratories, ltd. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg in 5 ml - valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precautions (5.1) for statement regarding fatal hepatic dysfunction. valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see warnings and precautions (5.1)] . valproic acid is contraindicated in patients with known hypersensitivity to the drug [see warnings and precautions (5.