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Repatha
Generic Name: Evolocumab
Drug Category: PCSK9 Inhibitor Antibody
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 13 years old for a maximum duration of 3 years.
| Approved Uses |
|
Indicated: Prevention of Cardiovascular Events: • In adults with established cardiovascular disease, REPATHA is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization. Primary Hyperlipidemia (Including Heterozygous Familial Hypercholesterolemia): • As an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C). Homozygous Familial Hypercholesterolemia: • As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. The long-term effects of very low levels of LDL-C induced by REPATHA are unknown. REPATHA is not indicated for use in patients without familial hypercholesterolemia or atherosclerotic CVD. The safety and effectiveness of REPATHA have not been established in pediatric patients with HoFH who are younger than 13 years old. The safety and effectiveness of REPATHA have not been established in pediatric patients with primary hyperlipidemia or HeFH. Hypersensitivity reactions (e.g., angioedema, rash, urticaria) have been reported in patients treated with As with all therapeutic proteins, there is potential for immunogenicity. There are no data available on use of REPATHA in pregnant women to inform a drug-associated risk. FDA’s experience with monoclonal antibodies in humans indicates that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimester. There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. |
| Off-label Uses |
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• Use in patients under the age of 13. GoToSource • Use in pediatric patients with primary hyperlipidemia or HeFH. GoToSource • Use in patients without familial hypercholesterolemia or atherosclerotic CVD. GoToSource |
| Adverse Events |
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Arthralgia, limb pain and fatigue. GoToSource Urinary tract infection, hypertension, diarrhea and gastroenteritis (inflammation of the stomach and intestines). GoToSource Nasopharyngitis (inflammation of the nose and pharynx), upper respiratory tract infection, influenza and back pain. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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