Den europeiske union - latvisk - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumabs - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agents for dermatitis, excluding corticosteroids - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Den europeiske union - islandsk - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - umboðsmenn fyrir húðbólgu, að undanskildu barkstera - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Den europeiske union - dansk - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - midler til dermatitis, undtagen kortikosteroider - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Den europeiske union - svensk - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenter för dermatit, med undantag av kortikosteroider - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

USA - engelsk - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sarilumab (unii: nu90v55f8i) (sarilumab - unii:nu90v55f8i) - sarilumab 150 mg in 1.14 ml - kevzara® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (dmards). kevzara is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. kevzara is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients [see warnings and precautions (5.5) and adverse reactions (6.1)] . risk summary the limited human data with kevzara in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations) . from animal data, and consistent with the mechanism of ac

USA - engelsk - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - durvalumab (unii: 28x28x9okv) (durvalumab - unii:28x28x9okv) - durvalumab 120 mg in 2.4 ml - imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc). imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (btc). none. risk summary based on findings from animal studies and its mechanism of action, imfinzi can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of imfinzi in pregnant women. in animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the clinical dose of 10 mg/kg based on area under the curve (auc), resulted in an increase in premature delivery, fetal loss, and premature neonatal death (see data). human immunoglobulin g1 (igg1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. apprise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data as reported in the literature, the pd-1/pd-l1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the fetus. in mouse allogeneic pregnancy models, disruption of pd-l1 signaling was shown to result in an increase in fetal loss. the effects of durvalumab on prenatal and postnatal development were evaluated in reproduction studies in cynomolgus monkeys. durvalumab was administered from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at a clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth), and increase in neonatal deaths. durvalumab was detected in infant serum on postpartum day 1, indicating the presence of placental transfer of durvalumab. based on its mechanism of action, fetal exposure to durvalumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in pd-1 knockout mice. risk summary there are no data on the presence of durvalumab in human milk, its effects on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to imfinzi are unknown. durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death (see data ). because of the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with imfinzi and for 3 months after the last dose. refer to the prescribing information for the agents administered in combination with imfinzi for recommended duration to not breastfeed, as appropriate. data in lactating cynomolgus monkeys, durvalumab was present in breast milk at about 0.15% of maternal serum concentrations after administration of durvalumab from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature neonatal death. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating treatment with imfinzi. contraception females imfinzi can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with imfinzi and for 3 months following the last dose of imfinzi. refer to the prescribing information for the agents administered in combination with imfinzi for recommended contraception duration, as appropriate. the safety and effectiveness of imfinzi have not been established in pediatric patients. of the 476 patients treated with imfinzi in the pacific study, 45% were 65 years or older, while 7.6% were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. the pacific study did not include sufficient numbers of patients aged 75 years and over to determine whether they respond differently from younger patients. of the 265 patients with es-sclc treated with imfinzi in combination with chemotherapy 101 (38%) patients were 65 years or older and 19 (7.2%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 330 patients with metastatic nsclc treated with imfinzi in combination with tremelimumab-actl and platinum-based chemotherapy, 143 (43%) patients were 65 years or older and 35 (11%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 338 patients with btc treated with imfinzi in combination with chemotherapy in the topaz-1 study, 158 (47%) patients were 65 years or older and 38 (11%) patients were 75 years or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients. of the 393 patients with uhcc treated with imfinzi in combination with tremelimumab-actl, 50% of patients were 65 years of age or older and 13% of patients were 75 years of age or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients.

USA - engelsk - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - dupilumab (unii: 420k487fsg) (dupilumab - unii:420k487fsg) - dupilumab 300 mg in 2 ml - dupixent is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (ad) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. dupixent can be used with or without topical corticosteroids. dupixent is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma [see clinical studies (14)] . limitations of use dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus. dupixent is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (crswnp). dupixent is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (eoe). dupixent is indicated for the treatment of adult patients with prurigo nodularis (pn). dupixent is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of dupixent [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dupixent during pregnancy. healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or to obtain information about the registry. risk summary available data from case reports and case series with dupixent use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. human igg antibodies are known to cross the placental barrier; therefore, dupixent may be transmitted from the mother to the developing fetus. there are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy (see clinical considerations ). in an enhanced pre- and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha (il-4rα) during organogenesis through parturition at doses up to 10-times the maximum recommended human dose (mrhd) (see data ). the background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations 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 animal data in an enhanced pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of homologous antibody against il-4rα up to 10 times the mrhd (on a mg/kg basis of 100 mg/kg/week) from the beginning of organogenesis to parturition. no treatment-related adverse effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. risk summary there are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on the breastfed infant are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dupixent and any potential adverse effects on the breastfed child from dupixent or from the underlying maternal condition. atopic dermatitis the safety and effectiveness of dupixent have been established in pediatric patients 6 months of age and older with moderate-to-severe ad, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable [see clinical studies (14.1)] . use of dupixent in this age group is supported by data from the following clinical trials: - ad-1526 which included 251 pediatric subjects 12 to 17 years of age with moderate-to-severe ad. of the 251 subjects, 82 were treated with dupixent 200 mg q2w (<60 kg) or 300 mg q2w (≥60 kg) and 85 were treated with matching placebo - ad-1652 which included 367 pediatric subjects 6 to 11 years of age with severe ad. of the 367 subjects, 120 were treated with dupixent 300 mg q4w + tcs (15 to <30 kg) or 200 mg q2w + tcs (≥30 kg) and 123 were treated with matching placebo + tcs - ad-1539 which included 162 pediatric subjects 6 months to 5 years of age with moderate-to-severe ad. of the 162 subjects, 83 were treated with dupixent 200 mg q4w + tcs (5 to <15 kg) or 300 mg q4w + tcs (15 to <30 kg) and 79 subjects were assigned to be treated with matching placebo + tcs - ad-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with dupixent ± tcs, 368 pediatric subjects 6 to 11 years of age treated with dupixent ± tcs, and 180 pediatric subjects 6 months to 5 years of age treated with dupixent ± tcs - liberty-ad-haft which included 27 pediatric subjects 12 to 17 years of age with atopic dermatitis with moderate-to-severe hand and/or foot involvement treated with dupixent (n=14) or matching placebo (n=13) the safety and effectiveness were generally consistent between pediatric and adult patients [see adverse reactions (6.1) and clinical studies (14.1)] . in addition, hand-foot-and-mouth disease was reported in 9 (5%) pediatric subjects and skin papilloma was reported in 4 (2%) pediatric subjects 6 months to 5 years of age treated with dupixent ± tcs in ad-1434. these cases did not lead to study drug discontinuation [see adverse reactions (6.1)] . safety and effectiveness in pediatric patients younger than 6 months of age with ad have not been established. asthma the safety and effectiveness of dupixent for an add-on maintenance treatment in patients with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma have been established in pediatric patients 6 years of age and older. use of dupixent for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 6 years and older [see clinical studies (14.2)] . pediatric subjects 12 to 17 years of age : a total of 107 pediatric subjects 12 to 17 years of age with moderate-to-severe asthma were enrolled in quest and received either 200 mg (n=21) or 300 mg (n=18) dupixent (or matching placebo either 200 mg [n=34] or 300 mg [n=34]) q2w. asthma exacerbations and lung function were assessed in both pediatric subjects 12 to 17 years of age and adults. for both the 200 mg and 300 mg q2w doses, improvements in fev1 (ls mean change from baseline at week 12) were observed (0.36 l and 0.27 l, respectively). for the 200 mg q2w dose, subjects had a reduction in the rate of severe exacerbations that was consistent with adults. dupilumab exposure was higher in pediatric subjects 12 to 17 years of age than that in adults at the respective dose level which was mainly accounted for by difference in body weight [see clinical pharmacology (12.3)] . the adverse event profile in pediatric subjects 12 to 17 years of age was generally similar to the adults [see adverse reactions (6.1)] . pediatric subjects 6 to 11 years of age : a total of 408 pediatric subjects 6 to 11 years of age with moderate-to-severe asthma were enrolled in voyage, which evaluated doses of 100 mg q2w or 200 mg q2w. improvement in asthma exacerbations and lung function were demonstrated [see clinical studies (14.2)] . the effectiveness of dupixent 300 mg q4w in subjects 6 to 11 years of age with body weight 15 to <30 kg was extrapolated from efficacy of 100 mg q2w in voyage with support from population pharmacokinetic analyses showing higher drug exposure levels with 300 mg q4w [see clinical pharmacology (12.3)] . subjects who completed the treatment period of the voyage study could participate in the open-label extension study (lts14424). eighteen subjects (≥15 to <30 kg) out of 365 subjects were exposed to 300 mg q4w in this study, and the safety profile in these eighteen subjects was consistent with that seen in voyage. additional safety for dupixent 300 mg q4w is based upon available safety information from the pediatric ad indication [see adverse reactions (6.1) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients younger than 6 years of age with asthma have not been established. crswnp safety and effectiveness in pediatric patients younger than 18 years of age with crswnp have not been established. eoe the safety and effectiveness of dupixent for the treatment of eoe have been established in pediatric subjects 1 year of age and older, weighing at least 15 kg. use of dupixent in this population is supported by an adequate well-controlled study in adults and 72 pediatric subjects 12 to 17 years of age (study eoe-1), a clinical study in 61 pediatric subjects 1 to 11 years of age (study eoe-2), and pharmacokinetic data in adult and pediatric subjects 1 to 17 years of age. the safety of dupixent in pediatric subjects 1 to 17 years of age was similar to adults [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.4)] . safety and effectiveness in pediatric patients younger than 1 year of age, or weighing less than 15 kg, with eoe have not been established. prurigo nodularis safety and effectiveness in pediatric patients younger than 18 years of age with pn have not been established. of the 1539 subjects with ad exposed to dupixent in a dose-ranging study and placebo-controlled trials, 70 subjects were 65 years or older. clinical trials of dupixent in ad did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects [see clinical pharmacology (12.3)] . of the 1977 subjects with asthma exposed to dupixent, a total of 240 subjects were 65 years or older. efficacy and safety in this age group was similar to the overall study population. of the 440 subjects with crswnp exposed to dupixent, a total of 79 subjects were 65 years or older. efficacy and safety in this age group were similar to the overall study population. clinical studies of dupixent in eoe did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects. of the 152 subjects with pn exposed to dupixent, a total of 37 were 65 years or older including 8 subjects 75 years or older. clinical trials did not include a sufficient number of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. read this instructions for use before using the dupixent pre-filled syringe. do not inject yourself or someone else until you have been shown how to inject dupixent. your healthcare provider can show you or your caregiver how to prepare and inject a dose of dupixent before you try to do it yourself the first time. keep these instructions for future use. call your healthcare provider if you have any questions. this device is a single-dose pre-filled syringe (called "dupixent syringe" in these instructions). it contains 300 mg of dupixent for injection under the skin (subcutaneous injection). the parts of the dupixent syringe are shown below: - read all of the instructions carefully before using the dupixent syringe. - ask your healthcare provider how often you will need to inject the medicine. - in children 12 years of age and older, it is recommended that dupixent be administered by or under supervision of an adult. - in children 6 months to less than 12 years of age, dupixent should be given by a caregiver. - rotate the injection site each time you inject. - do not use the dupixent syringe if it has been dropped on a hard surface or damaged. - do not use the dupixent syringe if the needle cap is missing or not securely attached. - do not touch the plunger rod until you are ready to inject. - do not inject through clothes. - do not get rid of any air bubble in the dupixent syringe. - to reduce the risk of accidental needle sticks, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given your injection. - do not pull back on the plunger rod at any time. - do not remove the needle cap until just before you give the injection. - throw away (dispose of) the used dupixent single-dose pre-filled syringe right away after use. see "step 13: dispose" below. - do not re-use a dupixent single-dose pre-filled syringe . - keep dupixent syringes and all medicines out of the reach of children. - store dupixent syringes in the refrigerator between 36°f to 46°f (2°c to 8°c). - store dupixent syringes in the original carton to protect them from light. - dupixent syringes can be stored at room temperature up to 77°f (25°c) up to 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. - do not shake the dupixent syringe. - do not heat the dupixent syringe. - do not freeze the dupixent syringe. - do not put the dupixent syringe into direct sunlight. step 1: remove remove the dupixent syringe from the carton by holding the middle of the syringe body. do not pull off the needle cap until you are ready to inject. do not use the dupixent syringe if it has been dropped on a hard surface or damaged. step 2: prepare ensure you have the following: - the dupixent pre-filled syringe - 1 alcohol wipe* - 1 cotton ball or gauze* - a sharps disposal container* (see step 13) *items not included in the carton step 3: check when you receive your dupixent syringes, always check to see that: - you have the correct medicine and dose. - the expiration date on the single-dose pre-filled syringe has not passed. do not use the dupixent syringe if the expiration date has passed. step 4: inspect look at the medicine through the viewing window on the dupixent syringe: check to see if the liquid is clear and colorless to pale yellow. note: you may see an air bubble, this is normal. do not use the dupixent syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles. step 5: wait 45 minutes lay the dupixent syringe on a flat surface and let it naturally warm to room temperature for at least 45 minutes. do not heat the dupixent syringe. do not put the dupixent syringe into direct sunlight. do not keep dupixent syringes at room temperature for more than 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. step 6: choose your injection site - you can inject into your thigh or stomach, except for the 2 inches (5 cm) around your belly button (navel). - if a caregiver injects your dose, they can also use the outer area of the upper arm. - choose a different site each time you inject dupixent. do not inject into skin that is tender, damaged, bruised or scarred. step 7: clean wash your hands. clean the injection site with an alcohol wipe. let your skin dry before injecting. do not touch the injection site again or blow on it before the injection. step 8: remove needle cap hold the dupixent syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap. do not put the needle cap back on. do not touch the needle. inject your medicine right away after removing the needle cap. step 9: pinch pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around your belly button, or outer area of the upper arm if injected by your caregiver). the figure below shows an example of pinching a fold of skin on your stomach. step 10: insert insert the needle completely into the fold of the skin at about a 45° angle. step 11: push relax the pinch. push the plunger rod down slowly and steadily as far as it will go until the dupixent syringe is empty. note: you will feel some resistance. this is normal. step 12: release and remove lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site. lightly press a cotton ball or gauze on the injection site if you see any blood. do not put the needle cap back on. do not rub your skin after the injection. step 13: dispose put your used needles, dupixent syringes, and needle caps in a fda-cleared sharps disposal container right away after use. do not dispose of (throw away) needles, dupixent syringes, and needle caps in your household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container 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. do not put the needle cap back on. manufactured by: regeneron pharmaceuticals, inc. tarrytown, ny 10591 u.s. license no. 1760 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) dupixent® is a registered trademark of sanofi biotechnology © 2023 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 read this instructions for use before using the dupixent pre-filled syringe. do not inject yourself or someone else until you have been shown how to inject dupixent. your healthcare provider can show you or your caregiver how to prepare and inject a dose of dupixent before you try to do it yourself the first time. keep these instructions for future use. call your healthcare provider if you have any questions. this device is a single-dose pre-filled syringe (called "dupixent syringe" in these instructions). it contains 200 mg of dupixent for injection under the skin (subcutaneous injection). the parts of the dupixent syringe are shown below: - read all of the instructions carefully before using the dupixent syringe. - ask your healthcare provider how often you will need to inject the medicine. - in children 12 years of age and older, it is recommended that dupixent be administered by or under supervision of an adult. - in children 6 months to less than 12 years of age, dupixent should be given by a caregiver. - rotate the injection site each time you inject. - do not use the dupixent syringe if it has been dropped on a hard surface or damaged. - do not use the dupixent syringe if the needle cap is missing or not securely attached. - do not touch the plunger rod until you are ready to inject. - do not inject through clothes. - do not get rid of any air bubble in the dupixent syringe. - to reduce the risk of accidental needle sticks, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given your injection. - do not pull back on the plunger rod at any time. - do not remove the needle cap until just before you give the injection. - throw away (dispose of) the used dupixent single-dose pre-filled syringe right away after use. see "step 13: dispose" below. - do not re-use a dupixent single-dose pre-filled syringe . - keep dupixent syringes and all medicines out of the reach of children. - store dupixent syringes in the refrigerator between 36°f to 46°f (2°c to 8°c). - store dupixent syringes in the original carton to protect them from light. - dupixent syringes can be stored at room temperature up to 77°f (25°c) up to 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. - do not shake the dupixent syringe. - do not heat the dupixent syringe. - do not freeze the dupixent syringe. - do not put the dupixent syringe into direct sunlight. step 1: remove remove the dupixent syringe from the carton by holding the middle of the syringe body. do not pull off the needle cap until you are ready to inject. do not use the dupixent syringe if it has been dropped on a hard surface or damaged. step 2: prepare ensure you have the following: - the dupixent pre-filled syringe - 1 alcohol wipe* - 1 cotton ball or gauze* - a sharps disposal container* (see step 13) *items not included in the carton step 3: check when you receive your dupixent syringes, always check to see that: - you have the correct medicine and dose. - the expiration date on the single-dose pre-filled syringe has not passed. do not use the dupixent syringe if the expiration date has passed. step 4: inspect look at the medicine through the viewing window on the dupixent syringe: check to see if the liquid is clear and colorless to pale yellow. note: you may see an air bubble, this is normal. do not use the dupixent syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles. step 5: wait 30 minutes lay the dupixent syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes. do not heat the dupixent syringe. do not put the dupixent syringe into direct sunlight. do not keep dupixent syringes at room temperature for more than 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. step 6: choose your injection site - you can inject into your thigh or stomach, except for the 2 inches (5 cm) around your belly button (navel). - if a caregiver injects your dose, they can also use the outer area of the upper arm. - choose a different site each time you inject dupixent. do not inject into skin that is tender, damaged, bruised or scarred. step 7: clean wash your hands. clean the injection site with an alcohol wipe. let your skin dry before injecting. do not touch the injection site again or blow on it before the injection. step 8: remove needle cap hold the dupixent syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap. do not put the needle cap back on. do not touch the needle. inject your medicine right away after removing the needle cap. step 9: pinch pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around your belly button, or outer area of the upper arm if injected by your caregiver). the figure below shows an example of pinching a fold of skin on your stomach. step 10: insert insert the needle completely into the fold of the skin at about a 45° angle. step 11: push relax the pinch. push the plunger rod down slowly and steadily as far as it will go until the dupixent syringe is empty. note: you will feel some resistance. this is normal. step 12: release and remove lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site. lightly press a cotton ball or gauze on the injection site if you see any blood. do not put the needle cap back on. do not rub your skin after the injection. step 13: dispose put your used needles, dupixent syringes, and needle caps in a fda-cleared sharps disposal container right away after use. do not dispose of (throw away) needles, dupixent syringes, and needle caps in your household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container 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. do not put the needle cap back on. manufactured by: regeneron pharmaceuticals, inc. tarrytown, ny 10591 u.s. license no. 1760 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) dupixent® is a registered trademark of sanofi biotechnology © 2023 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 instructions for use dupixent® (du-pix-ent) (dupilumab) injection, for subcutaneous use single-dose pre-filled pen (300 mg/2 ml) this instructions for use contains information on how to inject dupixent. read this instructions for use before using the dupixent pre-filled pen. do not inject yourself or someone else until you have been shown how to inject dupixent. your healthcare provider can show you or your caregiver how to prepare and inject a dose of dupixent before you try to do it yourself for the first time. keep this instructions for use. call your healthcare provider if you have any questions. this dupixent pre-filled pen is only for use in adults and children aged 2 years and older. this dupixent pre-filled pen is a single-dose device. it contains 300 mg of dupixent for injection under the skin (subcutaneous injection). the parts of the dupixent pre-filled pen are shown below: - read all of the instructions carefully before using the dupixent pre-filled pen. - ask your healthcare provider how often you will need to inject the medicine. - in children 12 years of age and older, it is recommended that dupixent be administered by or under supervision of an adult. - in children 2 years to less than 12 years of age, dupixent should be given by a caregiver. - choose a different injection site for each injection. - do not press or touch the yellow needle cover with your fingers. - do not inject through clothes. - do not remove the green cap until just before you give the injection. - do not try to put the green cap back on the dupixent pre-filled pen. - throw away (dispose of) the used dupixent pre-filled pen right away after use. - do not re-use a dupixent pre-filled pen. - store unused dupixent pre-filled pens in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). - store dupixent pre-filled pens in the original carton to protect from light. - if necessary, you may keep dupixent pre-filled pens at room temperature up to 77ºf (25ºc) for up to 14 days . - do not store dupixent pre-filled pens at room temperature more than 77ºf (25ºc). - after removing a dupixent pre-filled pen from the refrigerator, it must be used within 14 days or thrown away (disposed of). - do not shake the dupixent pre-filled pen at any time. - do not heat the dupixent pre-filled pen. - do not freeze the dupixent pre-filled pen. - do not put the dupixent pre-filled pen into direct sunlight. - keep dupixent pre-filled pens and all medicines out of the reach of children. - do not use the dupixent pre-filled pen if it has been damaged. - do not use the dupixent pre-filled pen if the green cap is missing or not securely attached. - do not use the dupixent pre-filled pen if the window is yellow before use. - check to be sure that you have the correct medicine and dose. - check the expiration date. - do not use the dupixent pre-filled pen if the expiration date has passed. do not use the dupixent pre-filled pen if the expiration date has passed. - look at the medicine through the window: it should be clear and colorless to pale yellow. - note: you may see an air bubble, this is normal. - do not use the dupixent pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles. do not use the dupixent pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles. - lay the dupixent pre-filled pen on a flat surface and let it warm up at room temperature less than 77ºf (25ºc) for at least 45 minutes. - do not heat the dupixent pre-filled pen in a microwave, hot water or direct sunlight. do not heat the dupixent pre-filled pen in a microwave, hot water or direct sunlight. - thigh - stomach except for the 2 inches (5 cm) around your belly button (navel). - a caregiver can also inject in the outer area of the upper arm . - choose a different site for each injection. - do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins. do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins. - do not inject through clothes. do not inject through clothes. - clean the injection site with an alcohol wipe. - let the skin dry before injecting. - do not touch the injection site again or blow on it before the injection. do not touch the injection site again or blow on it before the injection. - remove the green cap by pulling it straight off, as shown. do not twist the green cap off. - do not remove the green cap until you are ready to inject. - do not press or touch the yellow needle cover with your fingers. the needle is inside. - do not put the green cap back on the dupixent pre-filled pen after you have removed it. do not put the green cap back on the dupixent pre-filled pen after you have removed it. - hold the dupixent pre-filled pen as shown so that you can see the window. place the yellow needle cover on the skin. - place the yellow needle cover on the skin at approximately a 90-degree angle. - pinching is not needed for adults and children aged 12 years and older. - there will be a "click" when the injection starts, and - the window will start to turn yellow. - keep pressing the dupixent pre-filled pen against the skin. - the window will turn completely yellow, and - you will hear a 2nd "click" . - keep pressing the dupixent pre-filled pen against the skin. - after you have completed the injection pull straight up to remove dupixent pre-filled pen from the skin. the yellow needle cover will cover the needle. - if you see any blood at the site, lightly dab a cotton ball or gauze pad. - do not rub the skin after the injection. do not rub the skin after the injection. - if the window does not turn completely yellow, or if it looks like medicine is still coming out of the pen, you may not have received a full dose. dispose of (throw away) the pen and contact your healthcare provider right away. - do not give a second dose without speaking to your healthcare provider. do not give a second dose without speaking to your healthcare provider. do not dispose of (throw away) dupixent pre-filled pens and green caps in your household trash. - made of a heavy-duty plastic, - can be closed with a tightfitting, 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. 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. dupixent® (du-pix-ent) (dupilumab) injection, for subcutaneous use single-dose pre-filled pen (200 mg/1.14 ml) this instructions for use contains information on how to inject dupixent. read this instructions for use before using the dupixent pre-filled pen. do not inject yourself or someone else until you have been shown how to inject dupixent. your healthcare provider can show you or your caregiver how to prepare and inject a dose of dupixent before you try to do it yourself for the first time. keep this instructions for use. call your healthcare provider if you have any questions. this dupixent pre-filled pen is only for use in adults and children aged 2 years and older. this dupixent pre-filled pen is a single-dose device. it contains 200 mg of dupixent for injection under the skin (subcutaneous injection). the parts of the dupixent pre-filled pen are shown below: - read all of the instructions carefully before using the dupixent pre-filled pen. - ask your healthcare provider how often you will need to inject the medicine. - in children 12 years of age and older, it is recommended that dupixent be administered by or under supervision of an adult. - in children 2 years to less than 12 years of age, dupixent should be given by a caregiver. - choose a different injection site for each injection. - do not press or touch the orange needle cover with your fingers. - do not inject through clothes. - do not remove the yellow cap until just before you give the injection. - do not try to put the yellow cap back on the dupixent pre-filled pen. - throw away (dispose of) the used dupixent pre-filled pen right away after use. - do not re-use a dupixent pre-filled pen. - store unused dupixent pre-filled pens in the refrigerator between 36°f to 46°f (2°c to 8°c). - store dupixent pre-filled pens in the original carton to protect from light. - if necessary, you may keep dupixent pre-filled pens at room temperature up to 77°f (25°c) for up to 14 days . - do not store dupixent pre-filled pens at room temperature more than 77°f (25°c). - after removing a dupixent pre-filled pen from the refrigerator, it must be used within 14 days or thrown away (disposed of). - do not shake the dupixent pre-filled pen at any time. - do not heat the dupixent pre-filled pen. - do not freeze the dupixent pre-filled pen. - do not put the dupixent pre-filled pen into direct sunlight. - keep dupixent pre-filled pens and all medicines out of the reach of children. - do not use the dupixent pre-filled pen if it has been damaged. - do not use the dupixent pre-filled pen if the yellow cap is missing or not securely attached. - do not use the dupixent pre-filled pen if the window is yellow before use. - check to be sure that you have the correct medicine and dose. - check the expiration date. - do not use the dupixent pre-filled pen if the expiration date has passed. do not use the dupixent pre-filled pen if the expiration date has passed. - look at the medicine through the window: it should be clear and colorless to pale yellow. - note: you may see an air bubble, this is normal. - do not use the dupixent pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles. do not use the dupixent pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles. - lay the dupixent pre-filled pen on a flat surface and let it warm up at room temperature less than 77°f (25°c) for at least 30 minutes. - do not heat the dupixent pre-filled pen in a microwave, hot water or direct sunlight. do not heat the dupixent pre-filled pen in a microwave, hot water or direct sunlight. - thigh - stomach except for the 2 inches (5 cm) around your belly button (navel). - a caregiver can also inject in the outer area of the upper arm . - choose a different site for each injection. - do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins. do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins. - do not inject through clothes. do not inject through clothes. - clean the injection site with an alcohol wipe. - let the skin dry before injecting. - do not touch the injection site again or blow on it before the injection. do not touch the injection site again or blow on it before the injection. - remove the yellow cap by pulling it straight off, as shown. do not twist the yellow cap off. - do not remove the yellow cap until you are ready to inject. - do not press or touch the orange needle cover with your fingers. the needle is inside. - do not put the yellow cap back on the dupixent pre-filled pen after you have removed it. do not put the yellow cap back on the dupixent pre-filled pen after you have removed it. - hold the dupixent pre-filled pen as shown so that you can see the window. place the orange needle cover on the skin. - place the orange needle cover on the skin at approximately a 90-degree angle. - pinching is not needed for adults and children aged 12 years and older. - there will be a "click " when the injection starts, and - the window will start to turn yellow. - keep pressing the dupixent pre-filled pen against the skin. - the window will turn completely yellow, and - you will hear a 2nd "click" . - keep pressing the dupixent pre-filled pen against the skin. - after you have completed the injection pull straight up to remove dupixent pre-filled pen from the skin. the orange needle cover will cover the needle. - if you see any blood at the site, lightly dab a cotton ball or gauze pad. - do not rub the skin after the injection. do not rub the skin after the injection. - if the window does not turn completely yellow, or if it looks like medicine is still coming out of the pen, you may not have received a full dose. dispose of (throw away) the pen and contact your healthcare provider right away. - do not give a second dose without speaking to your healthcare provider. do not give a second dose without speaking to your healthcare provider. do not dispose of (throw away) dupixent pre-filled pens and yellow caps in your household trash. - made of a heavy-duty plastic, - can be closed with a tightfitting, 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. 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. read this instructions for use before using the dupixent pre-filled syringe. do not inject the child until you have been shown how to inject dupixent. your healthcare provider can show you how to prepare and inject a dose of dupixent before you try to do it yourself the first time. keep these instructions for future use. call your healthcare provider if you have any questions. this device is a single-dose pre-filled syringe (called "dupixent syringe" in these instructions). it contains 100 mg of dupixent for injection under the skin (subcutaneous injection). the parts of the dupixent syringe are shown below: - read all of the instructions carefully before using the dupixent syringe. - ask your healthcare provider how often you will need to inject the medicine. - in children 6 months to less than 12 years of age, dupixent should be given by a caregiver. - rotate the injection site each time you inject. - do not use the dupixent syringe if it has been dropped on a hard surface or damaged. - do not use the dupixent syringe if the needle cap is missing or not securely attached. - do not touch the plunger rod until you are ready to inject. - do not inject through clothes. - do not get rid of any air bubble in the dupixent syringe. - to reduce the risk of accidental needle sticks, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given the injection. - do not pull back on the plunger rod at any time. - do not remove the needle cap until just before you give the injection. - throw away (dispose of) the used dupixent single-dose pre-filled syringe right away after use. see "step 13: dispose" below. - do not re-use a dupixent single-dose pre-filled syringe . - keep dupixent syringes and all medicines out of the reach of children. - store dupixent syringes in the refrigerator between 36°f to 46°f (2°c to 8°c). - store dupixent syringes in the original carton to protect them from light. - dupixent syringes can be stored at room temperature up to 77°f (25°c) up to 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. - do not shake the dupixent syringe. - do not heat the dupixent syringe. - do not freeze the dupixent syringe. - do not put the dupixent syringe into direct sunlight. step 1: remove remove the dupixent syringe from the carton by holding the middle of the syringe body. do not pull off the needle cap until you are ready to inject. do not use the dupixent syringe if it has been dropped on a hard surface or damaged. step 2: prepare ensure you have the following: - the dupixent pre-filled syringe - 1 alcohol wipe* - 1 cotton ball or gauze* - a sharps disposal container* (see step 13) *items not included in the carton step 3: check when you receive the dupixent syringes, always check to see that: - you have the correct medicine and dose. - the expiration date on the single-dose pre-filled syringe has not passed. do not use the dupixent syringe if the expiration date has passed. step 4: inspect look at the medicine through the viewing window on the dupixent syringe: check to see if the liquid is clear and colorless to pale yellow. note: you may see an air bubble, this is normal. do not use the dupixent syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles. step 5: wait 30 minutes lay the dupixent syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes. do not heat the dupixent syringe. do not put the dupixent syringe into direct sunlight. do not keep dupixent syringes at room temperature for more than 14 days. throw away (dispose of) any dupixent syringes that have been left at room temperature for longer than 14 days. step 6: choose the injection site - you can inject into the thigh, outer area of the upper arm or stomach, except for the 2 inches (5 cm) around the belly button (navel). - choose a different site each time you inject dupixent. do not inject into skin that is tender, damaged, bruised or scarred. step 7: clean wash your hands. clean the injection site with an alcohol wipe. let the skin dry before injecting. do not touch the injection site again or blow on it before the injection. step 8: remove needle cap hold the dupixent syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap. do not put the needle cap back on. do not touch the needle. inject the medicine right away after removing the needle cap. step 9: pinch pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around the belly button, or outer area of the upper arm). the figure below shows an example of pinching a fold of skin on the stomach. step 10: insert insert the needle completely into the fold of the skin at about a 45° angle. step 11: push relax the pinch. push the plunger rod down slowly and steadily as far as it will go until the dupixent syringe is empty. note: you will feel some resistance. this is normal. step 12: release and remove lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site. lightly press a cotton ball or gauze on the injection site if you see any blood. do not put the needle cap back on. do not rub the skin after the injection. step 13: dispose put used needles, dupixent syringes, and needle caps in a fda-cleared sharps disposal container right away after use. do not dispose of (throw away) needles, dupixent syringes, and needle caps in your household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container 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. do not put the needle cap back on. manufactured by: regeneron pharmaceuticals, inc. tarrytown, ny 10591 u.s. license no. 1760 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) dupixent® is a registered trademark of sanofi biotechnology © 2023 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 500 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; polysorbate 80; histidine - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 120 mg - injection, concentrated - excipient ingredients: histidine; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; polysorbate 80 - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - dupilumab, quantity: 175 mg/ml - injection, solution - excipient ingredients: arginine hydrochloride; histidine; polysorbate 80; sodium acetate; glacial acetic acid; sucrose; water for injections - dupixent is indicated for the following type 2 inflammatory diseases:,atopic dermatitis,adults and adolescents,dupixent is indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. dupixent is not intended for episodic use.,children 6 months to 11 years of age,dupixent is indicated for the treatment of severe atopic dermatitis in patients aged 6 months to 11 years old who are candidates for chronic systemic therapy. dupixent is not intended for episodic use.,asthma,dupixent is indicated as add on maintenance treatment in patients aged 6 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated feno) that is inadequately controlled despite therapy with other medicinal products for maintenance treatment (see section 5.1 pharmacodynamic properties ? clinical trials).,chronic rhinosinusitis with nasal polyposis (crswnp),dupixent is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (crswnp).