Rx Item-Repatha evolocumab SUBCUT WEAR INJCPUSHTRONEX 420 Mg Sys 3.5 Ml By Amgen

Clinical Information
Gen. Code and Des.
76353 evolocumab SUBCUT WEAR INJCT 420 MG/3.5
Strength
420 mg/3.5 mL
Dose Form
WEARABLE INJECTOR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24062400 PCSK9 INHIBITORS
Active Ingredients
16368 evolocumab
Inactive Ingredients
3245 adhesive
9865 polysorbate 80 9005656


REPATHA- evolocumab injection, solution
REPATHA- evolocumab
Amgen Inc

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.

Repatha evolocumab SUBCUT
Repatha evolocumab SUBCUT WEAR INJCPUSHTRONEX 420 Mg Sys 3.5 Ml By Amgen item No.:RX823492 NDC No.72511-0770-01 72511-770-01 7251177001 UPC No.:372511770018 NDC No.72511-0770-01 72511-770-01 UPC/GTI

Repatha 420 Mg Sys 3.5 Ml By Amgen
BRAND: REPATHA NDC: 55513-0760-02,55513076002 UPC: 3-72511-77001-8,372511770018 Amgen Inc

EVOLOCUMAB SUB-Q PEN INJC
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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REPATHA 420 MG SYS 3.5 ML
Repatha evolocumab SUBCUT WEAR INJCPUSHTRONEX 420 Mg Sys 3.5 Ml By Amgen item No.:RX823492 NDC No.72511-0770-01 72511-770-01 7251177001 UPC No.:372511770018 NDC No.72511-0770-01 72511-770-01 UPC/GTI

REPATHA 420 MG SYS 3.5 ML
Repatha evolocumab SUBCUT WEAR INJCPUSHTRONEX 420 Mg Sys 3.5 Ml By Amgen item No.:RX823492 NDC No.72511-0770-01 72511-770-01 7251177001 UPC No.:372511770018 NDC No.72511-0770-01 72511-770-01 UPC/GTI

DRUG INFRO FROM DAILYMED
DRUG INFRO FROM DAILYMED