USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 150 mg - boniva is indicated for the treatment and prevention of osteoporosis in postmenopausal women. boniva increases bone mineral density (bmd) and reduces the incidence of vertebral fractures. the optimal duration of use has not been determined. the safety and effectiveness of boniva for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. boniva is contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1]) - inability to stand or sit upright for at least 60 minutes (see dosage and administration [2.2], and warnings and precautions [5.1]) - h

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - susvimo (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (amd) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (vegf) inhibitor medication. susvimo (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. susvimo (ranibizumab injection) is contraindicated in patients with active intraocular inflammation. susvimo (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in susvimo (ranibizumab injection). risk summary there are no adequate and well-controlled studies of susvimo (ranibizumab injection) administration in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses up to 41 times the human exposure (based on serum levels following the re

USA - engelsk - NLM (National Library of Medicine)

genentech inc. - risdiplam (unii: 76rs4s2et1) (risdiplam - unii:76rs4s2et1) - evrysdi is indicated for the treatment of spinal muscular atrophy (sma) in pediatric and adult patients. none. there is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to evrysdi during pregnancy. physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-760-1098 or visiting https://www.evrysdipregnancyregistry.com. risk summary there are no adequate data on the developmental risk associated with the use of evrysdi in pregnant women. in animal studies, administration of risdiplam during pregnancy or throughout pregnancy and lactation resulted in adverse effects on development (embryofetal mortality, malformations, decreased fetal body weights, and reproductive impairment in offspring) at or above clinically relevant drug exposures [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. based on animal data, advise pregnant women of the potential risk to the fetus. data animal data oral administration of risdiplam (0, 1, 3, or 7.5 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal structural variations at the highest dose tested, which was not associated with maternal toxicity. the no-effect level for adverse effects on embryofetal development (3 mg/kg/day) was associated with maternal plasma exposure (auc) approximately 2 times that in humans at the maximum recommended human dose (mrhd) of 5 mg. oral administration of risdiplam (0, 1, 4, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in embryofetal mortality, fetal malformations (hydrocephaly), and structural variations at the highest dose tested, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development (4 mg/kg/day) was associated with maternal plasma exposure (auc) approximately 4 times that in humans at the mrhd. when risdiplam (0, 0.75, 1.5, or 3 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, gestation was prolonged in the dams, and delayed sexual maturation (vaginal opening) and impaired reproductive function (decreased numbers of corpora lutea, implantation sites, and live embryos) were observed in female offspring at the highest dose. the no-effect dose for adverse effects on pre- and postnatal development in rats (1.5 mg/kg/day) was associated with maternal plasma exposure (auc) similar to that in humans at the mrhd. risk summary there are no data on the presence of risdiplam in human milk, the effects on the breastfed infant, or the effects on milk production. risdiplam was excreted in the milk of lactating rats orally administered risdiplam. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for evrysdi and any potential adverse effects on the breastfed infant from evrysdi or from the underlying maternal condition. studies of risdiplam in juvenile and adult rats and in monkeys demonstrated adverse effects on the reproductive organs, including germ cells, in males at clinically-relevant plasma exposures [see use in specific populations (8.4) and nonclinical toxicology (13.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating evrysdi [see use in specific populations (8.1)] . contraception evrysdi may cause embryofetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. female patients advise female patients of reproductive potential to use effective contraception during treatment with evrysdi and for at least 1 month after her last dose. infertility male patients male fertility may be compromised by treatment with evrysdi [see nonclinical toxicology (13.1)] . counsel male patients of reproductive potential receiving evrysdi about the potential effects on fertility. male patients may consider sperm preservation prior to treatment. the safety and effectiveness of evrysdi in pediatric patients (neonates and older) have been established. use of evrysdi for sma is supported by evidence from adequate and well-controlled studies of evrysdi in patients 2 months of age and older with sma. use of evrysdi for sma in patients 2 months of age and younger is supported by pharmacokinetic and safety data from pediatric patients 16 days and older, and pharmacokinetic modeling and simulation to identify the dosing regimen [see clinical pharmacology (12.3) and clinical studies (14)] . juvenile animal toxicity data oral administration of risdiplam (0, 0.75, 1.5, 2.5 mg/kg/day) to young rats from postnatal day (pnd) 4 through pnd 31 resulted in decreased growth (body weight, tibia length) and delayed sexual maturation in males at the mid and high dose. the skeletal and body weight deficits persisted after cessation of dosing. ophthalmic changes consisting of vacuoles in the anterior vitreous were seen at the high dose. decreases in absolute b lymphocyte counts were observed at all doses after cessation of dosing. decreases in testis and epididymis weights, which correlated with degeneration of the seminiferous epithelium in the testis, occurred at the mid and high doses; the histopathology findings were reversible, but organ weight persisted after cessation of dosing. impaired female reproductive performance (decreased mating index, fertility index, and conception rate) was observed at the high dose. a no-effect dose for adverse developmental effects on preweaning rats was not identified. the lowest dose tested (0.75 mg/kg/day) was associated with plasma exposures (auc) lower than that in humans at the maximum recommended human dose (mrhd) of 5 mg/day. oral administration of risdiplam (0, 1, 3, or 7.5 mg/kg/day) to young rats from pnd 22 through pnd 112 produced a marked increase in micronuclei in the bone marrow, male reproductive organ histopathology (degeneration/necrosis of the seminiferous tubule epithelium, oligo/aspermia in the epididymis, spermatic granulomas), and adverse effects on sperm parameters (decreased sperm concentration and motility, increased sperm morphology abnormalities) at the highest dose tested. increases in t lymphocytes (total, helper, and cytotoxic) were observed at the mid and high doses. the reproductive and immune effects persisted after cessation of dosing. the no-effect dose (1 mg/kg/day) for adverse effects on postweaning juvenile rats was associated with plasma exposures (auc) lower than that in humans at the mrhd. clinical studies of evrysdi did not include patients aged 65 years and older to determine whether they respond differently from younger adult patients. instructions for use evrysdi® [ev-riz-dee] (risdiplam) for oral solution please read and understand this instructions for use and the patient information leaflet before you start taking evrysdi for information about evrysdi and how to prepare and give evrysdi through an oral syringe, gastrostomy tube (g-tube), or nasogastric tube (ng-tube). if you have any questions about how to take evrysdi, contact your healthcare provider. evrysdi should come as a liquid in a bottle when you receive it from the pharmacy. do not take evrysdi and contact your pharmacist if the medicine in the bottle is a powder. each evrysdi carton contains (see figure a): important information about evrysdi - ask your healthcare provider to show you the correct oral syringe you should use and how to measure your prescribed daily dose. - always use the reusable oral syringes that come with evrysdi to measure your prescribed daily dose. if your carton does not contain two identical syringes, contact your pharmacist. - always take evrysdi exactly as your healthcare provider tells you to take it. - take evrysdi 1 time daily after a meal at approximately the same time each day. - do not take evrysdi if the bottle adapter is not in the bottle. if the bottle adapter is not in the bottle, contact your pharmacist. - do not mix evrysdi into food or liquids. do not mix evrysdi with formula or milk. - do not take evrysdi if the bottle or oral syringes are damaged. - avoid getting evrysdi on your skin or in your eyes. if evrysdi gets on your skin, wash the area with soap and water. if evrysdi gets in your eyes, rinse your eyes with water. - if you spill evrysdi, dry the area with a dry paper towel and then clean with water. throw away the paper towel in the trash and wash your hands well with soap and water. - if there is not enough evrysdi left in the bottle for your prescribed dose, throw away (discard) the bottle with remaining evrysdi and used oral syringes according to your local requirements. - use a new bottle of evrysdi to get your prescribed dose. do not mix evrysdi from the new bottle with the bottle you are currently using. how to store evrysdi - store evrysdi in the refrigerator between 36°f to 46°f (2°c to 8°c). do not freeze. - if necessary, evrysdi can be kept at room temperature up to 104°f (up to 40°c) for a combined total of 5 days. evrysdi can be removed from, and returned to, a refrigerator. the total combined time out of refrigeration should not be more than 5 days. throw away evrysdi if it has been kept at room temperature for more than 5 days. - store evrysdi in the original amber bottle in an upright position with the cap tightly closed. - throw away (discard) any unused portion of evrysdi 64 days after mixed by the pharmacist (constitution) when stored in the refrigerator at 36°f to 46°f (2°c to 8°c). please see the discard after date written on the bottle label (see figure c). - ask your pharmacist for the discard after date if it is not written on the bottle label. - throw away any unused portion of evrysdi that has been kept above 104°f (40°c). - keep evrysdi, all medicines and syringes out of the reach of children. a) preparing and withdrawing your dose how to prepare your dose of evrysdi if you are taking your dose of evrysdi by mouth, follow the instructions in "b) how to take a dose of evrysdi by mouth ". if you are taking your dose of evrysdi through a gastrostomy tube, follow the instructions in "c) how to give a dose of evrysdi through a gastrostomy tube ". if you are taking your dose of evrysdi through a nasogastric tube, follow the instructions in "d) how to give a dose of evrysdi through a nasogastric tube ". b) how to take a dose of evrysdi by mouth sit upright when taking a dose of evrysdi by mouth. c) how to give a dose of evrysdi through a gastrostomy tube if you are giving evrysdi through a gastrostomy tube, ask your healthcare provider to show you how to inspect the gastrostomy tube before giving evrysdi. d) how to give a dose of evrysdi through a nasogastric tube if you are giving evrysdi through a nasogastric tube, ask your healthcare provider to show you how to inspect the nasogastric tube before giving evrysdi. e) how to clean the oral syringe after use evrysdi is a registered trademark of genentech, inc. distributed by: genentech, inc. 1 dna way south san francisco, ca 94080-4990 approved: 3/2023 this instructions for use has been approved by the u.s. food and drug administration. ©2023 genentech, inc. all rights reserved

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - omalizumab (unii: 2p471x1z11) (omalizumab - unii:2p471x1z11) - omalizumab 202.5 mg in 1.4 ml - xolair is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. limitations of use: xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. xolair is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (crswnp) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. xolair is indicated for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with ige-mediated food allergy. xolair is to be used in conjunction with food allergen avoidance. limitations of use: xolair is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. xolair is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment. limitations of use: xolair is not indicated for treatment of other forms of urticaria. xolair is contraindicated in patients with severe hypersensitivity reaction to xolair or any ingredient of xolair [see warnings and precautions (5.1)] . risk summary a registry study of xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [see data] . there are risks associated with poorly or moderately controlled asthma in pregnancy [see clinical considerations ] . human igg antibodies are known to cross the placental barrier; therefore, xolair may be transmitted from the mother to the developing fetus. in animal reproduction studies, no evidence of fetal harm was observed in cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (mrhd) [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 us 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 disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. the level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. data human data a prospective cohort pregnancy exposure registry study conducted in the us from 2006 to 2018, included 250 pregnant women with asthma treated with xolair. of these, 246 patients were exposed to xolair in the first trimester of pregnancy, and the median exposure duration was 8.7 months. the registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to xolair) identified from healthcare databases of residents in the canadian province of quebec, and referred to as the quebec external comparator cohort ("comparator cohort"). among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%). among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. there was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking xolair during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. the registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort. animal data reproductive studies have been performed in cynomolgus monkeys. there was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the mrhd (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing. risk summary there is no information regarding the presence of omalizumab in human milk, or the effects on milk production. however, omalizumab is a human monoclonal antibody (igg1 kappa), and immunoglobulin (igg) is present in human milk in small amounts. the majority of infants (80.9%, 186/230) in the pregnancy exposure registry were breastfed. events categorized as "infections and infestations" were not significantly increased in infants who were exposed to xolair through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure to xolair. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition. asthma safety and effectiveness of xolair for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. use of xolair for this indication is supported by evidence from adequate and well-controlled studies. xolair was evaluated in 2 trials in 926 (xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. one trial was a pivotal trial of similar design and conduct to that of adult and adolescent asthma trials 1 and 2. the other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. in the pivotal trial, xolair-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ics dose) [see clinical studies (14.1)] . safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. chronic rhinosinusitis with nasal polyps safety and effectiveness in pediatric patients with chronic rhinosinusitis with nasal polyps (crswnp) below 18 years of age have not been established. ige-mediated food allergy the safety and effectiveness of xolair for the reduction of allergic reactions (type i), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with ige-mediated food allergy. use of xolair for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. a significantly greater percentage of xolair-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose- limiting symptoms [see clinical studies (14.3)]. safety and effectiveness in pediatric patients with ige-mediated food allergy below 1 year of age have not been established. chronic spontaneous urticaria the safety and effectiveness of xolair for chronic spontaneous urticaria (csu) who remain symptomatic despite h1 antihistamine treatment have been established in pediatric patients aged 12 years and older. use of xolair in this population is supported by evidence from adequate and well-controlled studies. adolescent patients with csu were evaluated in 39 patients 12 to 17 years of age (xolair 29, placebo 10) included in three randomized, placebo-controlled csu trials. a numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. safety and effectiveness in pediatric patients with csu below 12 years of age have not been established. in clinical studies, 134 asthma patients, 20 crswnp patients, 37 csu patients and no ige-mediated food allergy patients 65 years of age or older were treated with xolair. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. - xolair prefilled syringes (you may need more than 1 prefilled syringe for your prescribed dose). see "choose the correct prefilled syringe or combination of prefilled syringes" for more information. each xolair carton contains 1 prefilled syringe. - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14 "after the injection" ) choose the correct prefilled syringe or combination of prefilled syringes xolair prefilled syringes are available in 2 dose strengths. these instructions are to be used for both dose strengths. your prescribed dose may require more than 1 injection. the table below shows the combination of prefilled syringes needed to give your full dose. check the label on the xolair carton to make sure you have received the correct prefilled syringe or combination of prefilled syringes for your prescribed dose. if your dose requires more than 1 injection, inject the medicine from all of your prescribed prefilled syringes, immediately one after another. contact your healthcare provider if you have any questions. - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not exceed 2 days. if the prefilled syringe is exposed to temperatures above 77 °f (25 °c), do not use it and throw away in a sharps disposal container. - keep your xolair prefilled syringes out of direct sunlight. - do not freeze. do not use if the prefilled syringe has been frozen. - the needle cap contains a type of natural rubber latex. tell your healthcare provider if you have a latex allergy. - do not open the sealed carton until you are ready to inject xolair. - do not take the needle cap off until you are ready to inject xolair. - do not try to take the prefilled syringe apart at any time. - do not reuse the same prefilled syringe. - do not leave the prefilled syringe unattended. - if your dose requires you to give more than 1 injection, take all cartons out of the refrigerator at the same time. the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. this may damage the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe. when holding the prefilled syringe, make sure you always hold the prefilled syringe as shown. do not touch the needle-shield wings (see "prefilled syringe parts" ). - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine in the prefilled syringe should be clear and colorless to pale brownish-yellow. do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - do not use if the packaging or prefilled syringe appears damaged, tampered with, or has been dropped. - if you are giving yourself the injection, you can inject into the front and middle of the thighs and the stomach area (abdomen). the outer area of the upper arms may also be used if the injection is being given by a caregiver. do not try to inject into the upper arm area by yourself. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be exposed, clean skin. - if your prescribed dose requires more than 1 injection, choose a different injection site for each new injection, at least 1 inch from other injection sites. - do not touch the injection site again before giving the injection. - do not fan or blow on the cleaned skin. - do not twist the needle cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - throw away the needle cap in regular household trash. do not recap the needle. - there may be 1 or more small air bubbles in the prefilled syringe. this is normal, and you should not try to remove the air bubbles. - you may also see a drop of liquid at the end of the needle. this is also normal and will not affect the dose. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - do not insert the needle through clothing. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - you must press the plunger all the way down to make sure that the full dose of medicine gets injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - if needed, cover the injection site with a small bandage. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - choose a different injection site for each new injection at least 1 inch from other injection sites. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. 14 throw away (dispose of) your used xolair prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away prefilled syringes in your household trash. - do not recap the needle. - 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 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 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. prefilled syringe parts - xolair prefilled syringe . - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 14) - keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). do not remove the prefilled syringe from its original carton during storage. - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the prefilled syringe is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - keep your prefilled syringes out of direct light. - do not freeze. do not use if the prefilled syringe has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the prefilled syringe is damaged or appears to be tampered with. - do not take the needle cap off until you are ready to inject. - do not use if the prefilled syringe has been dropped on a hard surface or dropped after removing the needle cap. - do not try to take apart the prefilled syringe at any time. - if you need more than 1 prefilled syringe to deliver your full dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 prefilled syringe). the following steps must be followed for each prefilled syringe. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the prefilled syringe can warm up on its own to room temperature. leave the prefilled syringe in the carton to protect it from light. - if the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the blister pack out of the carton. - check the expiration date on the blister pack. - do not use it if the expiration date has passed. if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - peel off the blister pack cover fully. be careful when taking out the prefilled syringe. - do not flip the blister pack upside down to take out the prefilled syringe. - take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe, as shown. - do not handle the prefilled syringe by holding the plunger or needle cap. - check the prefilled syringe. the medicine inside should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. do not try to remove the air bubbles. - do not use the prefilled syringe if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the prefilled syringe. do not use the prefilled syringe if the expiration date has passed. - do not use if the prefilled syringe appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh, or the stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the prefilled syringe firmly with 1 hand and pull the needle cap straight off with your other hand as shown. do not twist the cap. - do not hold, push or pull the plunger while you remove the needle cap. - do not touch the needle or let it touch any surfaces after removing the needle cap. - do not put the cap back on the prefilled syringe. throw away the needle cap in regular household trash. - you may see a drop of liquid at the end of the needle. this is normal. - use your other hand and gently pinch the area of skin that was cleaned. hold the pinched skin tightly until the injection is complete. - pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). - while holding the prefilled syringe by the center, insert the needle all the way into the pinched skin at an angle of about 45 degrees as shown. - it is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. - do not touch the plunger while inserting the needle into the skin. - hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted. - you should not move and should avoid sudden movements when giving the injection. - gently push the plunger all the way down until the plunger head is between the safety guard wings as shown. - you must press the plunger all the way down to make sure that the full dose of medicine is injected. if the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed. - release the plunger and allow the needle to be covered by the needle-shield. - if the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container (see step 14 ). - do not rub the injection site. - there may be a little bleeding or drop of liquid at the injection site. you can press a cotton ball or gauze over the injection site until the bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used prefilled syringe as described in step 14 . - repeat step 2 through step 13 for the next injection using a new prefilled syringe. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used prefilled syringes in an fda-cleared sharps disposal container right away after use. - the xolair prefilled syringe is a single-dose prefilled syringe and should not be used again. - do not throw away the prefilled syringes in your household trash. - do not recap the needle. - 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 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 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. - xolair autoinjector - alcohol swab - sterile cotton ball or gauze - small bandage - sharps disposal container (see step 15 ) - keep your unused autoinjectors in the original carton and store the carton in a refrigerator between 36°f to 46°f (2°c to 8°c). - before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. the total combined time out of the refrigerator may not be more than 2 days. if the autoinjector is left at temperatures above 77°f (25°c), do not use it and throw away in a sharps disposal container. - do not remove the autoinjector from its original carton during storage. - keep your autoinjectors out of direct light. - do not freeze. do not use if the autoinjector has been frozen. - do not use if the carton is damaged or appears to be tampered with. - do not open the carton until you are ready to inject. - do not use if the autoinjector has been damaged or appears to be tampered with. - do not take the cap off the autoinjector until you are ready to inject. - do not use if the autoinjector has been dropped on a hard surface or dropped after removing the needle cap. - do not take apart the autoinjector at any time. - do not clean or touch the needle guard. - if you need more than 1 autoinjector to deliver your prescribed dose (see dosing table ), take all cartons out of the refrigerator at the same time (each carton contains 1 autoinjector). the following steps must be followed for each autoinjector. - do not use if the expiration date has passed. - if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the autoinjector can warm up on its own to room temperature. leave the autoinjector in the carton to protect it from light. - if the autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable. - do not speed up the warming process using any heat sources such as warm water or a microwave. - wash your hands with soap and water. - take the autoinjector out of the carton as shown. - do not turn the carton upside down to take out the autoinjector, as this may damage the autoinjector. - do not hold the autoinjector by the cap. make sure you hold the autoinjector by the middle as shown. - do not remove the cap until you are ready to inject. - look through the viewing window of the autoinjector. the medicine in the autoinjector viewing window should be clear and colorless to pale brownish-yellow. you may see air bubbles in the medicine, which is normal. - do not use the autoinjector if the medicine contains particles, or if the medicine looks cloudy or brown. - check the expiration date on the autoinjector. do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if it appears to be damaged or tampered with. - if the medicine does not look as described or if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see step 15 ) and contact your healthcare provider. - if giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). if a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh or stomach area (abdomen). do not try to inject yourself in the upper arm. - do not inject within the 2-inch area directly around your belly button (navel). - do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin. - do not inject through clothing. the injection site should be uncovered, clean skin. - if your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other. - wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds. - do not fan or blow on the cleaned skin. - do not touch the injection site again before giving the injection. - hold the autoinjector firmly with 1 hand and pull the cap straight off with your other hand as shown. do not twist the cap. - do not put the cap back on the autoinjector. throw away the cap in regular household trash. - do not clean or touch the needle guard of the device. - hold the autoinjector comfortably with the needle guard directly against the skin. - the autoinjector should be at a 90-degree angle against the skin, as shown. - press straight down and hold the autoinjector firmly against the skin. the 1st click indicates that the injection has started. - hold the autoinjector tightly in place. do not change the angle of injection or remove the autoinjector until the injection is completed. - keep holding the autoinjector against the skin. the green indicator will move within the viewing window. - listen for the 2nd click . this indicates that the injection is almost complete. - hold the autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete. - after the green indicator has stopped moving and has completely filled the viewing window, lift the autoinjector straight up from the skin. the needle guard will automatically extend and lock over the needle. - if the green indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist. - do not rub the injection site. - there may be a little bleeding or a drop of liquid at the injection site. you can press a cotton ball or gauze pad over the injection site until any bleeding stops. - in case of skin contact with the medicine, wash the area that touched the medicine with water. - if needed, cover the injection site with a small bandage. - throw away the used autoinjector as described in step 15 . - repeat step 2 through step 14 for the next injection using a new autoinjector. - make sure each injection is at least 1 inch apart from each other. - complete all the required injections for your prescribed dose, immediately one after another. contact your healthcare provider if you have any questions. - put your used autoinjectors in an fda-cleared sharps disposal container right away after use. - the xolair autoinjector is a single-dose autoinjector and should not be used again. - do not throw away (dispose of) the autoinjectors in your household trash. - do not recap the autoinjector. - 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 autoinjectors. 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.

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - methoxy polyethylene glycol-epoetin beta (unii: lr3uxn0193) (methoxy polyethylene glycol-epoetin beta - unii:lr3uxn0193) - methoxy polyethylene glycol-epoetin beta 50 ug in 0.3 ml - mircera is indicated for the treatment of anemia associated with chronic kidney disease (ckd) in adult patients on dialysis and patients not on dialysis. mircera is not indicated and is not recommended: - in the treatment of anemia due to cancer chemotherapy [see warnings and precautions (5.2)] - as a substitute for rbc transfusions in patients who require immediate correction of anemia [see clinical pharmacology (12.2)] mircera has not been shown to improve symptoms, physical functioning or health-related quality of life. mircera is contraindicated in patients with: - uncontrolled hypertension [see warnings and precautions (5.3)] - pure red cell aplasia (prca) that begins after treatment with mircera or other erythropoietin protein drugs [see warnings and precautions (5.6)] - history of serious or severe allergic reactions to mircera (e.g. anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria). risk summary there are no adequate and well-controlled studies in pregnant women. mircera

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - peginterferon alfa-2a (unii: q46947fe7k) (peginterferon alfa-2a - unii:q46947fe7k) - peginterferon alfa-2a 180 ug in 1 ml - adult patients: pegasys, as part of a combination regimen with other hepatitis c virus (hcv) antiviral drugs, is indicated for the treatment of adults with chc and compensated liver disease. for information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys, refer to their prescribing information. pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. pediatric patients: pegasys in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with chc and compensated liver disease. limitations of use : - pegasys alone or in combination with ribavirin without additional hcv antiviral drugs is not recommended for treatment of patients with chc who previously failed therapy with an interferon-alfa. - pegasys is not recommended for treatment of patients with chc who have had solid

USA - engelsk - NLM (National Library of Medicine)

genentech inc. - satralizumab (unii: yb18nf020m) (satralizumab - unii:yb18nf020m) - enspryng is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. enspryng is contraindicated in patients with: - a known hypersensitivity to satralizumab or any of the inactive ingredients [see warnings and precautions (5.4)] - active hepatitis b infection [see warnings and precautions (5.1)] - active or untreated latent tuberculosis [see warnings and precautions (5.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to enspryng during pregnancy. healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338. risk summary there are no adequate data on the developmental risk associated with the use of enspryng in pregnant women. in an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring,

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - mosunetuzumab (unii: ldj89ss0yg) (mosunetuzumab - unii:ldj89ss0yg) - lunsumio is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on the mechanism of action, lunsumio may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of lunsumio in pregnant women to evaluate for a drug-associated risk. no animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb. mosunetuzumab-axgb causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. in addition, based on expression of cd20 on b-cells and the finding of b-cell depletion in non-pregnant animals, mosunetuzumab-axgb c

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - atezolizumab (unii: 52cmi0wc3y) (atezolizumab - unii:52cmi0wc3y) - atezolizumab 1200 mg in 20 ml - - tecentriq, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ii to iiia [see clinical studies (14.1)] non-small cell lung cancer (nsclc) whose tumors have pd-l1 expression on ≥ 1% of tumor cells, as determined by an fda-approved test [see dosage and administration (2.1)]. - tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an fda-approved test, with no egfr or alk genomic tumor aberrations [see dosage and administration (2.1)]. - tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous nsclc with no egfr or alk genomic tumor abe

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - carefully consider the potential benefits and risks of naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension and other treatment options before deciding to use naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen as naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension is indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen as naprosyn suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naprosyn, anaprox, anaprox ds and naprosyn suspension is also indicated: - for relief of the signs and symptoms of tendonitis - for r