Gen. Code and Des.
76353 evolocumab SUBCUT WEAR INJCT 420 MG/3.5
420 mg/3.5 mL
Fine Line Class
850085008510 All Rx Products
24062400 PCSK9 INHIBITORS
9865 polysorbate 80 9005656
REPATHA- evolocumab injection, solution
1 INDICATIONS AND USAGE
1.1 Primary Hyperlipidemia
REPATHA® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).
1.2 Homozygous Familial Hypercholesterolemia
REPATHA is indicated 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.
1.3 Limitations of Use
The effect of REPATHA on cardiovascular morbidity and mortality has not been determined.
2 DOSAGE AND ADMINIST R ATION
2.1 Recommended Dosage
The recommended subcutaneous dosage of REPATHA in patients with HeFH or patients with primary hyperlipidemia with established clinical atherosclerotic CVD is either 140 mg every 2 weeks OR 420 mg once monthly. When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.
The recommended subcutaneous dosage of REPATHA in patients with HoFH is 420 mg once monthly. In patients with HoFH, measure LDL-C levels 4 to 8 weeks after starting REPATHA, since response to therapy will depend on the degree of LDL-receptor function.
If an every 2 week or once monthly dose is missed, instruct the patient to:
Administer REPATHA as soon as possible if there are more than 7 days until the next scheduled dose, or,
Omit the missed dose and administer the next dose according to the original schedule.