Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Evolocumab
Indications/Uses
Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, 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/ max tolerated statin dose; or alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Adults & adolescents ≥12 yr w/ homozygous familial hypercholesterolaemia in combination w/ other lipid-lowering therapies. 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/ max tolerated statin dose 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; established atherosclerotic CV disease Adult Recommended dose: 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 if clinically meaningful response is not achieved after 12 wk. Patients on apheresis May initiate treatment w/ 420 mg every 2 wk.
Contraindications
Special Precautions
Inj should not be given into areas w/ tender, bruised, red, or hard skin. Must not be administered IV or IM. Latex-sensitive patients. Patients w/ moderate & severe hepatic impairment. Pregnancy & lactation. Safety & efficacy has not been established in childn <18 yr for primary hypercholesterolaemia & mixed dyslipidaemia; & in childn <12 yr for homozygous familial hypercholesterolaemia.
Adverse Reactions
Nasopharyngitis, upper resp tract infection; back pain, arthralgia; flu; inj site reactions.
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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