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Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Evolocumab
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. Ped patients ≥10 yr w/ heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet, alone or in combination w/ other lipid-lowering therapy, to reduce LDL-C. Adult & ped patients ≥10 yr w/ HoFH in combination w/ other lipid-lowering therapies.
Dosage/Direction for Use
SC Adult & ped patient ≥10 yr Hyperlipidaemia (including HeFH) 140 mg every 2 wk or 420 mg once mthly. HoFH 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. Established atherosclerotic CV disease Adult 140 mg every 2 wk or 420 mg once mthly.
Contraindications
Special Precautions
Must not be administered IV or IM. Inj sites should be rotated & inj should not be given into areas where the skin is tender, bruised, red, or hard. Closely monitor patients w/ moderate hepatic impairment. Moderate & severe hepatic impairment. Pregnancy & lactation. Childn <10 yr w/ HeFH or HoFH or in ped patient w/ other types of hyperlipidaemia. Pregnancy & lactation.
Adverse Reactions
Flu, nasopharyngitis, URTI; hypersensitivity, rash; headache, nausea; back pain, arthralgia, myalgia; inj site reactions.
Drug Interactions
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 mL x 1's;1 mL x 1's
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