Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Evolocumab
Indications/Uses
Primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia in adults, as an adjunct to diet: in combination w/ a statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ the max tolerated dose of a statin or, alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia in adults & adolescents ≥12 yr in combination w/ other lipid-lowering therapies. Established atherosclerotic CV disease (MI, stroke or peripheral arterial disease) in adults 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.
Dosage/Direction for Use
SC Primary hypercholesterolaemia & mixed dyslipidaemia Adult 140 mg every 2 wk or 420 mg once mthly. Homozygous familial hypercholesterolaemia Adult & adolescent ≥12 yr Initially 420 mg once mthly. After 12 wk, can be up-titrated to 420 mg once every 2 wk if clinically meaningful response is not achieved. Patients on apheresis May initiate treatment w/ 420 mg every 2 wk. Established atherosclerotic CV disease Adult 140 mg every 2 wk or 420 mg once mthly.
Contraindications
Special Precautions
Discontinue treatment in case of signs & symptoms of serious allergic reactions eg, rash, urticaria. Latex-sensitive patients. Severe renal impairment. Moderate & severe hepatic impairment. Pregnancy & lactation. Ped patients.
Adverse Reactions
Nasopharyngitis, upper resp tract infection, back pain, arthralgia, influenza, inj site reactions (bruising, erythema, haemorrhage, inj site pain & swelling).
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;1's
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