REPATHA- evolocumab injection, solution REPATHA- evolocumab kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EVOLOCUMAB (UNII: LKC0U3A8NJ) (EVOLOCUMAB - UNII:LKC0U3A8NJ)

Available from:

Amgen Inc

INN (International Name):

EVOLOCUMAB

Composition:

EVOLOCUMAB 140 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REPATHA is indicated: - In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - 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 diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C - As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C REPATHA is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. Serious hypersensitivity reactions including angioedema have occurred in patients treated with REPATHA [see Warnings and Precautions (5.1)]. Risk Summary Available data fr

Product summary:

REPATHA is a clear to opalescent, colorless to pale yellow solution supplied as follows: The needle cover of the glass single-dose prefilled syringe and the single-dose prefilled autoinjector contain dry natural rubber (a derivative of latex). The single-dose on-body infusor with prefilled cartridge is not made with natural rubber latex. Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. For convenience, REPATHA may be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton for 30 days. If not used within the 30 days, discard REPATHA.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

REPATHA- EVOLOCUMAB INJECTION, SOLUTION
REPATHA- EVOLOCUMAB
AMGEN INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REPATHA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REPATHA.
REPATHA (EVOLOCUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2021
Dosage and Administration (2.1)
09/2021
Dosage and Administration (2.3)
02/2021
Contraindications (4)
02/2021
Warnings and Precautions (5.1)
02/2021
INDICATIONS AND USAGE
REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9)
inhibitor indicated:
in adults with established cardiovascular disease (CVD) to reduce the
risk of myocardial infarction,
stroke, and coronary revascularization (1)
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 (1)
as an adjunct to diet and other LDL-C-lowering therapies in pediatric
patients aged 10 years and older
with HeFH, to reduce LDL-C (1)
as an adjunct to other LDL-C-lowering therapies in adults and
pediatric patients aged 10 years and
older with homozygous familial hypercholesterolemia (HoFH), to reduce
LDL-C (1)
DOSAGE AND ADMINISTRATION
In adults with established CVD or with primary hyperlipidemia:
The recommended dosage of REPATHA is either 140 mg every 2 weeks OR
420 mg once monthly
administered subcutaneously. (2.1)
If switching dosage regimens, administer the first dose of the new
regimen on the next scheduled date
of the prior regimen. (2.1)
In pediatric patients aged 10 years and older with HeFH:
The recommended dosage of REPATHA is either 140 mg every 2 weeks OR
420 mg once monthly
administered subcutaneously. (2.1)
If switching dosage regimens, administer the first dose of the new
regimen on the next scheduled date
of the prior regimen. (2.1)
In adults and pediatric patients aged