Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Evolocumab
Indications/Uses
Primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia in adults & paed ≥10 yr w/ heterozygous familial hypercholesterolaemia as adjunct to diet in combination w/ a statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ max tolerated dose of statin, or as monotherapy or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. In combination w/ other lipid-lowering therapies for adults & paed ≥10 yr w/ homozygous familial hypercholesterolaemia. 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 as monotherapy or in combination w/ other lipid-lowering therapies in those who are statin-intolerant, or for whom a statin is contraindicated.
Dosage/Direction for Use
SC Administer into the abdomen, thigh or upper arm region. Adult & paed ≥10 yr Primary hypercholesterolaemia & mixed dyslipidaemia 140 mg every 2 wk or 420 mg once mthly. Homozygous familial hypercholesterolaemia Initially 420 mg once mthly. Can be up-titrated to 420 mg once every 2 wk after 12 wk of treatment if response is not achieved. Patients on apheresis Initially 420 mg every 2 wk to correspond w/ apheresis schedule. Adult Established atherosclerotic CV disease 140 mg every 2 wk or 420 mg once mthly.
Contraindications
Special Precautions
Not to be administered IV or IM. Closely monitor patients w/ moderate hepatic impairment. Severe hepatic impairment (Child-Pugh C). Not to be used during pregnancy & lactation.
Adverse Reactions
Flu, nasopharyngitis, URTI; hypersensitivity, rash, urticaria; headache; nausea; angioedema; back pain, arthralgia, myalgia; inj site reactions; 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
(autoinjector) 1's
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