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sanofi-aventis u.s. llc - dronedarone (unii: jqz1l091y2) (dronedarone - unii:jqz1l091y2) - dronedarone 400 mg - multaq® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (af) [see clinical studies (14)] . multaq is contraindicated in patients with: - permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see boxed warning, warnings and precautions (5.2)] - symptomatic heart failure with recent decompensation requiring hospitalization or nyha class iv symptoms [see boxed warning, warnings and precautions (5.1)] - second or third-degree atrioventricular (av) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) - bradycardia <50 bpm - concomitant use of strong cyp3a inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see drug interactions (7.2)] - concomitant use of erythromycin [see clinical pharmacology (12.3)] - concomitant use of drugs or

United States - English - 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

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

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

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

sanofi-aventis u.s. llc - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - rifapentine 150 mg - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)] . limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)] . priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years

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

sanofi-aventis u.s. llc - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - rifapentine 150 mg - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)]. limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)]. priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years an

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

sanofi-aventis u.s. llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - - plavix is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. plavix should be administered in conjunction with aspirin. - plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. plavix should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke plavix is indicated to reduce the rate of mi and stroke. plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. plavix is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any comp

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

sanofi-aventis u.s. llc - desipramine hydrochloride (unii: 1y58do4my1) (desipramine - unii:tg537d343b) - desipramine hydrochloride 10 mg - norpramin is indicated for the treatment of depression. the use of maois intended to treat psychiatric disorders with norpramin or within 14 days of stopping treatment with norpramin is contraindicated because of an increased risk of serotonin syndrome. the use of norpramin within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration). starting norpramin in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration). norpramin is contraindicated in the acute recovery period following myocardial infarction. it should not be used in those who have shown prior hypersensitivity to the drug. cross-sensitivity between this and other dibenzazepines is a possibility.

United States - English - 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

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

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or any of the excipients in lantus [see warnings and precautions (5.5)] risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data) . 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. the estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional hba1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal and/or embryo-fetal risk hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data human data published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. animal data subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and himalayan rabbits. insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. in rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis. the effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. however, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. fertility and early embryonic development appeared normal. risk summary there are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. endogenous insulin is present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lantus, and any potential adverse effects on the breastfed child from lantus or from the underlying maternal condition. the safety and effectiveness of lantus to improve glycemic control in pediatric patients with diabetes mellitus have been established. use of lantus for this indication is supported by evidence from an adequate and well-controlled study (study d) in 174 lantus-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of lantus in adults with diabetes mellitus [see clinical pharmacology (12.3), clinical studies (14.2)]. in the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with lantus, 15% (n=316) were ≥65 years of age and 2% (n=42) were ≥75 years of age. no overall differences in safety or effectiveness of lantus have been observed between patients 65 years of age and older and younger adult patients. nevertheless, caution should be exercised when lantus is administered to geriatric patients. in geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in geriatric patients. the effect of kidney impairment on the pharmacokinetics of lantus has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with kidney failure. frequent glucose monitoring and dosage adjustment may be necessary for lantus in patients with kidney impairment [see warnings and precautions (5.3)]. the effect of hepatic impairment on the pharmacokinetics of lantus has not been studied. frequent glucose monitoring and dosage adjustment may be necessary for lantus in patients with hepatic impairment [see warnings and precautions (5.3)] . these instructions for use contain information on how to inject lantus using the vial. read these instructions for use before you start taking lantus and each time you get a new lantus vial. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your lantus syringes with other people, even if the needle has been changed. you may give other people a serious infection, or get a serious infection from them. supplies needed to give your injection: - a lantus 10 ml vial - a u-100 insulin syringe and needle - 2 alcohol swabs - 1 sharps container for throwing away used needles and syringes. see "disposing of used needles and syringes" at the end of these instructions. preparing to inject lantus: - wash your hands with soap and water or clean your hands with alcohol. - check the lantus label to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - check the lantus in the vial to make sure it is clear and colorless. do not use lantus if it is colored or cloudy, or if you see particles in the solution. - do not use lantus after the expiration date stamped on the label or 28 days after you first use it. - always use a syringe that is marked for u-100 insulin. if you use a syringe other than a u-100 insulin syringe, you may get the wrong dose of lantus. - always use a new syringe and a new needle for each injection to help prevent infections and prevent blocked needles. step 1: if you are using a new lantus vial, remove the protective cap. do not remove the stopper. step 2: wipe the top of the vial with an alcohol swab. you do not have to shake the vial of lantus before use. step 3: draw air into the syringe equal to your lantus dose. put the needle through the rubber top of the vial and push the plunger to inject the air into the vial. step 4: leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly in one hand. make sure the tip of the needle is in the lantus solution. with your free hand, pull the plunger to withdraw the correct dose into the syringe. step 5: before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw insulin back in until you have the correct dose. step 6: remove the needle from the vial. do not let the needle touch anything. you are now ready to inject. injecting lantus - inject your lantus (with a syringe) exactly as your healthcare provider has shown you. - lantus is injected once daily at any time of the day but at the same time every day. step 7: choose your injection site: - lantus is injected under the skin (subcutaneously) of your upper arms, thighs, or stomach area (abdomen). - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in the skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - wipe the skin with an alcohol swab to clean the injection site. let the injection site dry before you inject your dose. step 8: - pinch the skin. - insert the needle under the skin in the way your healthcare provider showed you. - release the skin. - slowly push in the plunger of the syringe all the way, making sure you have injected all the lantus. - leave the needle in the skin for about 10 seconds. step 9: - pull the needle straight out of your skin. - gently press the injection site for several seconds. do not rub the area. - do not recap the used needle. recapping the needle can lead to a needle-stick injury. disposing of used needles and syringes - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not 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. storing and disposing lantus? unopened (not in-use) lantus vials - store unused lantus vials in the refrigerator from 36°f to 46°f (2°c to 8°c). - do not freeze lantus. - keep lantus away from direct heat and light. - if a vial has been frozen or overheated, throw it away. - unopened vials can be used until the expiration date on the carton and vial label if they have been stored in the refrigerator (they can be stored past 28 days in the refrigerator). - unopened vials should be thrown away after 28 days if they are stored at room temperature. after lantus vials have been opened (in-use) - store in-use (opened) lantus vials in a refrigerator from 36°f to 46°f (2°c to 8°c) or at room temperature below 86°f (30°c) for up to 28 days . - do not freeze lantus. if a vial has been frozen, throw it away. - keep lantus out of direct heat and light. - the lantus vial you are using should be thrown away after 28 days or if the expiration date has passed, even if it still has insulin left in it. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company u.s. license no. 1752 ©2022 sanofi-aventis u.s. llc. revised: june 2023 read these instructions for use before you start taking the lantus solostar pen and each time you get a new lantus solostar pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your lantus solostar pen with other people, even if the needle has been changed. you may give other people a serious infection, or get a serious infection from them. people who are blind or have vision problems should not use the lantus solostar prefilled pen without help from a person trained to use the lantus solostar prefilled pen. lantus solostar is a disposable prefilled pen used to inject lantus. each lantus solostar pen has 300 units of insulin which can be used for multiple injections. you can select doses from 1 to 80 units in steps of 1 unit. the pen plunger moves with each dose. the plunger will only move to the end of the cartridge when 300 units of lantus have been given. important information you need to know before injecting lantus - do not use your pen if it is damaged or if you are not sure that it is working properly. - do not use a syringe to remove lantus from your pen. - do not reuse needles. if you do, you might get the wrong dose of lantus and/or increase the chance of getting an infection. - always perform a safety test (see step 3 ). - always carry a spare pen and spare needles in case they got lost or stop working. - change (rotate) your injection sites within the area you choose for each dose (see "places to inject" ). learn to inject - talk with your healthcare provider about how to inject before using your pen. - ask for help if you have problems handling the pen, for example if you have problems with your sight. - read all these instructions before using your pen. if you do not follow all these instructions, you may get too much or too little insulin. need help? if you have any questions about your pen or about diabetes, ask your healthcare provider, or go to www.lantus.com or call sanofi-aventis at 1-800-633-1610. extra items you will need - a new sterile needle (see step 2 ). - an alcohol swab. - a puncture-resistant container for used needles and pens. (see "throwing your pen away" ) places to inject - inject your insulin exactly as your healthcare provider has shown you. - inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. get to know your pen step 1: check your pen take a new pen out of the refrigerator at least 1 hour before you inject. cold insulin is more painful to inject. 1a check the name and expiration date on the label of your pen. - make sure you have the correct insulin. - do not use your pen after the expiration date. 1b pull off the pen cap. 1c check that the insulin is clear. - do not use the pen if the insulin looks cloudy, colored or contains particles. 1d wipe the rubber seal with an alcohol swab. if you have other injector pens: - making sure you have the correct medicine is especially important if you have other injector pens. step 2: attach a new needle - do not reuse needles. always use a new sterile needle for each injection. this helps stop blocked needles, contamination, and infection. only use needles2 that are compatible for use with lantus solostar, such as bd ultra-fine® . 2a take a new needle and peel off the protective seal. 2b keep the needle straight and screw it onto the pen until fixed. do not over-tighten. 2c pull off the outer needle cap. keep this for later. 2d pull off the inner needle cap and throw away. handling needles - take care when handling needles to prevent needle-stick injury and cross-infection. step 3: do a safety test always do a safety test before each injection to: - check your pen and the needle to make sure they are working properly. - make sure that you get the correct lantus dose. 3a select 2 units by turning the dose selector until the dose pointer is at the 2 mark. 3b press the injection button all the way in. when insulin comes out of the needle tip, your pen is working correctly: if no insulin appears: - you may need to repeat this step up to 3 times before seeing insulin. - if no insulin comes out after the third time, the needle may be blocked. if this happens: – change the needle (see step 6 and step 2 ), – then repeat the safety test (step 3 ). - do not use your pen if there is still no insulin coming out of the needle tip. use a new pen. - do not use a syringe to remove insulin from your pen. if you see air bubbles: - you may see air bubbles in the insulin. this is normal, they will not harm you. step 4: select the dose do not select a dose or press the injection button without a needle attached. this may damage your pen. 4a make sure a needle is attached and the dose is set to "0." 4b turn the dose selector until the dose pointer lines up with your dose. - if you turn past your dose, you can turn back down. - if there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left. - if you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose. how to read the dose window even numbers are shown in line with dose pointer. odd numbers are shown as a line between even numbers. units of lantus in your pen: - your pen contains a total of 300 units of lantus. you can select doses from 1 to 80 units in steps of 1 unit. each pen contains more than 1 dose. - you can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale. step 5: injecting your lantus dose if you find it hard to press the injection button in, do not force it as this may break your pen. see the section below for help. 5a choose a place to inject as shown in the picture above. 5b push the needle into your skin as shown by your healthcare provider. do not touch the injection button yet. 5c place your thumb on the injection button. then press all the way in and hold. - do not press at an angle. your thumb could block the dose selector from turning. 5d keep the injection button held in and when you see "0" in the dose window, slowly count to 10. - this will make sure you get your full dose. 5e after holding and slowly counting to 10, release the injection button. then remove the needle from your skin. if you find it hard to press the button in: - change the needle (see step 6 and step 2 ) then do a safety test (see step 3 ). - if you still find it hard to press in, get a new pen. - do not use a syringe to remove insulin from your pen. step 6: remove the needle - take care when handling needles to prevent needle-stick injury and cross-infection. - do not put the inner needle cap back on. 6a grip the widest part of the outer needle cap. keep the needle straight and guide it into the outer needle cap. then push firmly on. - the needle can puncture the cap if it is recapped at an angle. 6b grip and squeeze the widest part of the outer needle cap. turn your pen several times with your other hand to remove the needle. - try again if the needle does not come off the first time. 6c throw away the used needle in a puncture-resistant container (see "throwing your pen away" at the end of this instructions for use). 6d put your pen cap back on. - do not put the pen back in the refrigerator. storing the lantus solostar pen before first use - keep new pens in the refrigerator between 36°f to 46°f (2°c to 8°c) . - do not freeze. do not use lantus if it has been frozen. after first use - keep your pen at room temperature below 86°f (30°c) . - keep your pen away from heat or light. - store your pen with the pen cap on. - do not put your pen back in the refrigerator. - do not store your pen with the needle attached. - keep out of the reach of children. - only use your pen for up to 28 days after its first use. throw away the lantus solostar pen you are using after 28 days, even if it still has insulin left in it. caring for your lantus solostar pen handle your pen with care - do not drop your pen or knock it against hard surfaces. - if you think that your pen may be damaged, do not try to fix it. use a new one. protect your pen from dust and dirt - you can clean the outside of your pen by wiping it with a damp cloth (water only). do not soak, wash or lubricate your pen. this may damage it. throwing your pen away - the used lantus solostar pen may be thrown away in your household trash after you have removed the needle. - put the used needle in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the used needles 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. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company u.s. license no. 1752 ©2023 sanofi-aventis u.s. llc. revised: june 2023

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

sanofi-aventis u.s. llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 6.25 mg - ambien cr (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). the clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see clinical studies (14)] . ambien cr is contraindicated in patients - who have experienced complex sleep behaviors after taking ambien cr [see warnings and precautions (5.1)]. - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.4)]. risk summary neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see clinical considerations and data] . published data on the use