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RXDRUG-BR-1266

REPATHA Evolocumab 140mg / mL Solution for Injection in Pre-filled Autoinjector 1's

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Description

Indications/Uses

Adults w/ established atherosclerotic CV disease (MI, stroke, or peripheral arterial disease) to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors in combination w/ the max tolerated dose of a statin w/ or w/o other lipid-lowering therapies or, alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Adults w/ hyperlipidaemia, alone or in combination w/ other lipid-lowering therapies, as an adjunct to diet to reduce LDL-C. Adults & adolescents ≥12 yr w/ homozygous familial hypercholesterolaemia in combination w/ other lipid-lowering therapies.

Dosage/Direction for Use

SC Hyperlipidaemia & prevention of CV events 140 mg every 2 wk or 420 mg once mthly. Homozygous familial hypercholesterolaemia Adult & adolescent ≥12 yr Initially 420 mg once mthly. Can be up-titrated to 420 mg once every 2 wk after 12 wk of treatment if a clinically meaningful response is not achieved. Patient on apheresis May initiate treatment w/ 420 mg every 2 wk to correspond w/ the apheresis schedule.

Contraindications

Hypersensitivity.

Special Precautions

Must not be administered IV or IM. Closely monitor patients w/ moderate hepatic impairment. Severe renal (eGFR <30 mL/min/1.73 m2) & severe hepatic (Child-Pugh C) impairment. Pregnancy & lactation. Childn <18 yr (for primary hypercholesterolaemia & mixed dyslipidaemia); <12 yr (for homozygous familial hypercholesterolaemia).

Adverse Reactions

Flu, nasopharyngitis, upper resp tract infection; rash; nausea; back pain, arthralgia; inj site reactions.

MedsGo Class

Dyslipidaemic Agents

Features

Brand
Repatha
Full Details
Dosage Strength
140 mg / ml
Drug Ingredients
  • Evolocumab
Drug Packaging
Solution for Injection in Pre-filled Autoinjector 1's
Generic Name
Evolocumab
Dosage Form
Solution for Injection in Pre-filled Autoinjector
Registration Number
BR-1266
Drug Classification
Prescription Drug (RX)
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