Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Evolocumab
Indications/Uses
Adjunct to diet & standard care therapy including moderate- to high-intensity statin therapy alone or in combination w/ other lipid-lowering therapy to reduce risk of MI, stroke & coronary revascularization in adults w/ atherosclerotic CV disease. Reduction of elevated LDL-C in adults w/ primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH): Adjunct to diet & statin therapy w/ or w/o other lipid-lowering therapies in patients requiring additional lowering of LDL-C, or alone or in combination w/ non-statin lipid-lowering therapies for patients whom statin is contraindicated. Adjunct to diet & other LDL-lowering therapies in adults & ped patients ≥10 yr w/ HoFH requiring additional lowering of LDL-C. Adjunct to diet & other LDL-C-lowering therapies eg, statins, ezetimibe in ped patients ≥10 yr w/ HeFH requiring additional lowering of LDL-C.
Dosage/Direction for Use
SC Adult w/ established CV disease or primary hyperlipidemia including HeFH & ped patient ≥10 yr w/ HeFH 140 mg every 2 wk or 420 mg once mthly. HoFH 420 mg once mthly.
Contraindications
Special Precautions
Discontinue use if hypersensitivity reactions occur. Avoid inj into areas w/ scars or stretch marks; tender, bruised, red or indurated skin. Latex-sensitive individuals. Severe hepatic impairment. Pregnancy & lactation. Ped patients <10 yr. Elderly.
Adverse Reactions
Nasopharyngitis, URTI, flu, back pain, inj site reactions (eg, erythema, pain, bruising), cough, UTI, sinusitis, headache, myalgia, dizziness, musculoskeletal pain, HTN, diarrhea, gastroenteritis; arthralgia, nausea, fatigue, muscle spasms, contusion; hypersensitivity reactions eg, rash, eczema, erythema, urticaria; DM; oropharyngeal pain; angioedema, flu-like illness.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX13 - evolocumab ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Repatha soln for inj 140 mg/mL
Packing/Price
((auto-injector)) 1's
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