INDICATIONS AND USAGE

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

DOSAGE

Recommended Dosage

In adults with established cardiovascular disease or with primary hyperlipidemia:

The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously.

If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

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.

If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

In adults and pediatric patients aged 10 years and older with HoFH:

The initial recommended dosage of REPATHA is 420 mg once monthly administered subcutaneously.

The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.

Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Administer REPATHA after the apheresis session is complete.

Assess LDL-C when clinically appropriate. The LDL-lowering effect of REPATHA may be measured as early as 4 weeks after initiation.

When monitoring LDL-C for patients receiving REPATHA 420 mg once monthly, note that LDL-C can vary during the dosing interval in some patients; recommend measuring LDL-C just prior to the next scheduled dose.

ADVERSE REACTIONS

Serious Allergic Reactions. Some people taking REPATHA have had serious allergic reactions. Stop taking REPATHA and call your healthcare provider or seek emergency medical help right away if you or your child have any of these symptoms:

trouble breathing or swallowing

raised bumps (hives)

rash, or itching

swelling of the face, lips, tongue, throat or arms

The most common side effects of REPATHA include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes) and redness, pain, or bruising at the injection site.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/709338ae-ab8f-44a9-b7d5-abaabec3493a/spl-doc?hl=Repatha

Repathainformation