Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - alirocumab (unii: pp0shh6v16) (alirocumab - unii:pp0shh6v16) - alirocumab 75 mg in 1 ml - praluent® is indicated: - to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. - as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c. - as an adjunct to other ldl-c-lowering therapies in adult patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 8 years and older with hefh to reduce ldl-c. praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in praluent. hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on praluent use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered alirocumab during organogenesis at dose exposures up to 12-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. in monkeys, suppression of the humoral immune response was observed in infant monkeys when alirocumab was dosed during organogenesis to parturition at dose exposures 13-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. no additional effects on pregnancy or neonatal/infant development were observed at dose exposures up to 81-fold the maximum recommended human dose of 150 mg every two weeks. measurable alirocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that alirocumab, like other igg antibodies, crosses the placental barrier. monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, alirocumab has the potential to be transmitted from the mother to the developing fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. there is a pregnancy safety study for praluent. if praluent is administered during pregnancy, healthcare providers should report praluent exposure by contacting regeneron at 1-844-734-6643. data animal data in sprague dawley rats, no effects on embryo-fetal development were observed when alirocumab was dosed at up to 75 mg/kg/dose by the subcutaneous route on gestation days 6 and 12 at exposures 12-fold the maximum recommended human dose of 150 mg every two weeks, based on serum auc. in cynomolgus monkeys, suppression of the humoral immune response to keyhole limpet hemocyanin (klh) antigen was observed in infant monkeys at 4 to 6 months of age when alirocumab was dosed during organogenesis to parturition at 15 mg/kg/week and 75 mg/kg/week by the subcutaneous route, corresponding to 13-fold and 81-fold the human exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. the lowest dose tested in the monkey resulted in humoral immune suppression; therefore, it is unknown if this effect would be observed at clinical exposure. no study designed to challenge the immune system of infant monkeys was conducted. no additional embryo-fetal, prenatal or postnatal effects were observed in infant monkeys, and no maternal effects were observed, when alirocumab was dosed at up to 75 mg/kg/week by the subcutaneous route, corresponding to maternal exposure of 81-fold the exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. risk summary there is no information regarding the presence of alirocumab in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for praluent and any potential adverse effects on the breastfed infant from praluent or from the underlying maternal condition. human igg is present in human milk, but published data suggest that breast milk igg antibodies do not enter the neonatal and infant circulation in substantial amounts. the safety and effectiveness of praluent as an adjunct to diet and other ldl-c-lowering therapies for the treatment of hefh have been established in pediatric patients aged 8 years and older. use of praluent for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with hefh. in the trial, 101 patients received praluent and 52 patients received placebo; 26 patients (17%) were 8 to 9 years of age. this indication is supported by evidence from controlled trials in adults [see adverse reactions (6.1) and clinical studies (14.3)]. the safety and effectiveness of praluent have not been established in pediatric patients with hefh who are younger than 8 years of age or in pediatric patients with other types of hyperlipidemia. in controlled trials, 3663 patients treated with praluent were ≥65 years of age and 734 patients treated with praluent were ≥75 years of age. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed for patients with mild or moderately impaired renal function. no data are available in patients with severe renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is needed for patients with mild or moderate hepatic impairment. no data are available in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (75 mg/ml) - the device is a single-dose disposable pen. it contains 75 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be given by or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the green button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. 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 # 1752 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) praluent is a registered trademark of sanofi ©2024 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc revised: march 2024 praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (150 mg/ml) - the device is a single-dose disposable pen. it contains 150 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be given by or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the gray button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. 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 # 1752 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) praluent is a registered trademark of sanofi ©2024 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc revised: march 2024

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alirocumab, quantity: 150 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals. praluent-ccdsv12-piv9-d3-30sep22 page 2 of 35 prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alirocumab, quantity: 75 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alirocumab, quantity: 150 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alirocumab, quantity: 75 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Ísrael - enska - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 150 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Ísrael - enska - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 75 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alirocumab, quantity: 300 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi us corporation - alirocumab (unii: pp0shh6v16) (alirocumab - unii:pp0shh6v16) - praluent® is indicated: - to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. - as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c. - as an adjunct to other ldl-c-lowering therapies in adult patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 8 years and older with hefh to reduce ldl-c. praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in praluent. hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on praluent use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered alirocumab during organogenesis at dose exposures up to 12-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. in monkeys, suppression of the humoral immune response was observed in infant monkeys when alirocumab was dosed during organogenesis to parturition at dose exposures 13-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. no additional effects on pregnancy or neonatal/infant development were observed at dose exposures up to 81-fold the maximum recommended human dose of 150 mg every two weeks. measurable alirocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that alirocumab, like other igg antibodies, crosses the placental barrier. monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, alirocumab has the potential to be transmitted from the mother to the developing fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. there is a pregnancy safety study for praluent. if praluent is administered during pregnancy, healthcare providers should report praluent exposure by contacting regeneron at 1-844-734-6643. data animal data in sprague dawley rats, no effects on embryo-fetal development were observed when alirocumab was dosed at up to 75 mg/kg/dose by the subcutaneous route on gestation days 6 and 12 at exposures 12-fold the maximum recommended human dose of 150 mg every two weeks, based on serum auc. in cynomolgus monkeys, suppression of the humoral immune response to keyhole limpet hemocyanin (klh) antigen was observed in infant monkeys at 4 to 6 months of age when alirocumab was dosed during organogenesis to parturition at 15 mg/kg/week and 75 mg/kg/week by the subcutaneous route, corresponding to 13-fold and 81-fold the human exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. the lowest dose tested in the monkey resulted in humoral immune suppression; therefore, it is unknown if this effect would be observed at clinical exposure. no study designed to challenge the immune system of infant monkeys was conducted. no additional embryo-fetal, prenatal or postnatal effects were observed in infant monkeys, and no maternal effects were observed, when alirocumab was dosed at up to 75 mg/kg/week by the subcutaneous route, corresponding to maternal exposure of 81-fold the exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. risk summary there is no information regarding the presence of alirocumab in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for praluent and any potential adverse effects on the breastfed infant from praluent or from the underlying maternal condition. human igg is present in human milk, but published data suggest that breast milk igg antibodies do not enter the neonatal and infant circulation in substantial amounts. the safety and effectiveness of praluent as an adjunct to diet and other ldl-c-lowering therapies for the treatment of hefh have been established in pediatric patients aged 8 years and older. use of praluent for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with hefh. in the trial, 101 patients received praluent and 52 patients received placebo; 26 patients (17%) were 8 to 9 years of age. this indication is supported by evidence from controlled trials in adults [see adverse reactions (6.1) and clinical studies (14.3)]. the safety and effectiveness of praluent have not been established in pediatric patients with hefh who are younger than 8 years of age or in pediatric patients with other types of hyperlipidemia. in controlled trials, 3663 patients treated with praluent were ≥65 years of age and 734 patients treated with praluent were ≥75 years of age. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed for patients with mild or moderately impaired renal function. no data are available in patients with severe renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is needed for patients with mild or moderate hepatic impairment. no data are available in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (75 mg/ml) - the device is a single-dose disposable pen. it contains 75 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be given by or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the green button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. 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 # 1752 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) praluent is a registered trademark of sanofi ©2024 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc revised: march 2024 praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (150 mg/ml) - the device is a single-dose disposable pen. it contains 150 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be given by or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the gray button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. 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 # 1752 marketed by: sanofi-aventis u.s. llc (bridgewater, nj 08807) and regeneron pharmaceuticals, inc. (tarrytown, ny 10591) praluent is a registered trademark of sanofi ©2024 regeneron pharmaceuticals, inc. / sanofi-aventis u.s. llc revised: march 2024

Bandaríkin - enska - NLM (National Library of Medicine)

regeneron pharmaceuticals, inc. - alirocumab (unii: pp0shh6v16) (alirocumab - unii:pp0shh6v16) - praluent® is indicated: - to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. - as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c. - as an adjunct to other ldl-c-lowering therapies in adult patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 8 years and older with hefh to reduce ldl-c. praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in praluent. hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on praluent use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered alirocumab during organogenesis at dose exposures up to 12-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. in monkeys, suppression of the humoral immune response was observed in infant monkeys when alirocumab was dosed during organogenesis to parturition at dose exposures 13-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. no additional effects on pregnancy or neonatal/infant development were observed at dose exposures up to 81-fold the maximum recommended human dose of 150 mg every two weeks. measurable alirocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that alirocumab, like other igg antibodies, crosses the placental barrier. monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, alirocumab has the potential to be transmitted from the mother to the developing fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. there is a pregnancy safety study for praluent. if praluent is administered during pregnancy, healthcare providers should report praluent exposure by contacting regeneron at 1-844-734-6643. data animal data in sprague dawley rats, no effects on embryo-fetal development were observed when alirocumab was dosed at up to 75 mg/kg/dose by the subcutaneous route on gestation days 6 and 12 at exposures 12-fold the maximum recommended human dose of 150 mg every two weeks, based on serum auc. in cynomolgus monkeys, suppression of the humoral immune response to keyhole limpet hemocyanin (klh) antigen was observed in infant monkeys at 4 to 6 months of age when alirocumab was dosed during organogenesis to parturition at 15 mg/kg/week and 75 mg/kg/week by the subcutaneous route, corresponding to 13-fold and 81-fold the human exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. the lowest dose tested in the monkey resulted in humoral immune suppression; therefore, it is unknown if this effect would be observed at clinical exposure. no study designed to challenge the immune system of infant monkeys was conducted. no additional embryo-fetal, prenatal or postnatal effects were observed in infant monkeys, and no maternal effects were observed, when alirocumab was dosed at up to 75 mg/kg/week by the subcutaneous route, corresponding to maternal exposure of 81-fold the exposure at the maximum recommended human dose of 150 mg every two weeks, based on serum auc. risk summary there is no information regarding the presence of alirocumab in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for praluent and any potential adverse effects on the breastfed infant from praluent or from the underlying maternal condition. human igg is present in human milk, but published data suggest that breast milk igg antibodies do not enter the neonatal and infant circulation in substantial amounts. the safety and effectiveness of praluent as an adjunct to diet and other ldl-c-lowering therapies for the treatment of hefh have been established in pediatric patients aged 8 years and older. use of praluent for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with hefh. in the trial, 101 patients received praluent and 52 patients received placebo; 26 patients (17%) were 8 to 9 years of age. this indication is supported by evidence from controlled trials in adults [see adverse reactions (6.1) and clinical studies (14.3)]. the safety and effectiveness of praluent have not been established in pediatric patients with hefh who are younger than 8 years of age or in pediatric patients with other types of hyperlipidemia. in controlled trials, 3663 patients treated with praluent were ≥65 years of age and 734 patients treated with praluent were ≥75 years of age. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed for patients with mild or moderately impaired renal function. no data are available in patients with severe renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is needed for patients with mild or moderate hepatic impairment. no data are available in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . instructions for use praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (75 mg/ml) - the device is a single-dose disposable pen. it contains 75 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be givenby or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the green button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: regeneron pharmaceuticals, inc. tarrytown, ny 10591 u.s. license # 1760 praluent is a registered trademark of regeneron pharmaceuticals, inc. ©2024 regeneron pharmaceuticals, inc. all rights reserved. revised: march 2024 instructions for use praluent ® (prahl-u-ent) (alirocumab) injection, for subcutaneous injection single-dose pre-filled pen (150 mg/ml) - the device is a single-dose disposable pen. it contains 150 mg of praluent (alirocumab) in 1 ml. - the praluent pen contains medicine prescribed by your healthcare provider. - the medicine is injected under your skin and can be given by yourself or someone else (caregiver). - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - in children aged 8 to 11 years, praluent must be given by a caregiver. - in children aged 12 to 17 years, it is recommended that praluent be given by or under supervision of an adult. - this pen can only be used for 1 single injection, and must be thrown away (discarded) after use. - read all of the instructions carefully before using the praluent pen. - follow these instructions every time you use a praluent pen. - do not touch the yellow safety cover. - do not use the pen if it has been dropped or damaged. - do not use the pen if the blue cap is missing or not securely attached. - do not re-use a pen. - store unused pens in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not freeze. - do not expose the pen to extreme heat or direct sunlight. - do not shake. - praluent should be allowed to warm to room temperature for 30 to 40 minutes before use. - if needed, praluent may be kept at room temperature up to 77°f (25°c) for 30 days in the original carton to protect from light. do not store above 77°f (25°c). - after praluent is removed from the refrigerator it must be used within 30 days or thrown away. - keep the praluent pens and all medicines out of the reach of children. keep this leaflet. if you have questions, ask your healthcare provider or call 1-844-praluent (1-844-772-5836). the parts of the praluent pen are shown in this picture. step a: getting ready for your injection. before you start you will need: - the praluent pen - 1 alcohol wipe - 1 cotton ball or gauze - a sharps container or a puncture-resistant container (see step b8) a1: look at the label on the pen. - check that you have the correct product and the correct dose. - check the expiration date (exp): do not use if this date has passed. a2: look at the window. - check the liquid is clear, colorless to pale yellow and free from particles (see figure a). - you may see air bubbles. this is normal. - do not use if the window appears solid yellow (see figure b). - do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles. a3: let the pen warm up at room temperature for 30 to 40 minutes. - this is important for administering the entire dose and helps minimize discomfort. - take praluent out of the refrigerator to warm up before using. - do not heat the pen, let it warm up on its own. - do not put the pen back in the refrigerator. a4: prepare the injection site. - wash your hands with soap and water and dry with a towel. - clean skin in the injection area with an alcohol wipe. - you can inject into your (see picture): thighs stomach (except for the 2 inch area around your belly button) upper arms - thighs - stomach (except for the 2 inch area around your belly button) - upper arms - you can stand or sit to give yourself an injection. important: - change (rotate) your injection site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the site you used last time. - do not inject into areas where the skin is tender, bruised, hard, or red. do not inject praluent into areas with visible veins, scars or stretch marks. step b: how to give your injection. b1: after completing all steps in "step a: getting ready for your injection", pull off the blue cap. - do not pull off the cap until you are ready to inject. - do not put the blue cap back on. b2: hold the praluent pen like this. - do not touch the yellow safety cover. - make sure you can see the window. b3: press the yellow safety cover on your skin at roughly a 90° angle. - for children younger than 12 years of age, pinching the skin before and during the injection is required. - in adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm. - press and firmly hold the pen against your body until the yellow safety cover is no longer visible. the pen will not work if the yellow safety cover is not depressed fully. b4: push and immediately release the gray button with your thumb. - you will hear a click. your injection has now started. - the window will start to turn yellow. b5: keep holding the pen against your skin after releasing the button. - the injection may take up to 20 seconds. b6: check the window has turned yellow, before removing the pen. - do not remove the pen until the entire window has turned yellow. - your injection is complete when the window has turned completely yellow, you may hear a second click. - if the window does not turn completely yellow, call 1-844-772-5836 for help. do not give yourself a second dose without speaking to your healthcare provider. b7: pull pen away from your skin. - do not rub the skin after the injection. - if you see any blood, press a cotton ball or gauze on the site until the bleeding stops. b8: throw away (discard) pen and cap. - do not put the blue cap back on. - throw away pen and cap in a puncture-resistant container immediately after they have been used. disposing of used pens: - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens and 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. - 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. keep praluent and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: regeneron pharmaceuticals, inc. tarrytown, ny 10591 u.s. license # 1760 praluent is a registered trademark of regeneron pharmaceuticals, inc. ©2024 regeneron pharmaceuticals, inc. all rights reserved. revised: march 2024