Repatha

Repatha

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Evolocumab
Indications/Uses
Prevention of CV events in adults w/ established CV disease, in combination w/ an optimally dosed statin &/or other lipid-lowering therapies to reduce the risk of MI, stroke & coronary revascularisation. Adults & adolescents ≥12 yr w/ homozygous familial hypercholesterolaemia, in combination w/ other lipid-lowering therapies. Adjunct to diet for adults w/ primary hyperlipidaemia (including heterozygous familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C), in combination w/ a statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ 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.
Dosage/Direction for Use
SC Primary hyperlipidaemia (including heterozygous familial hypercholesterolaemia) & prevention of CV events Adult 140 mg every 2 wk or 420 mg once mthly. Homozygous familial hypercholesterolaemia Adult & adolescent ≥12 yr Initially 420 mg once mthly. Patient on apheresis May initiate treatment w/ 420 mg every 2 wk to correspond w/ their apheresis schedule.
Contraindications
Special Precautions
Hypersensitivity to dry natural rubber (derivative of latex). Contains Na (23 mg per dose). Severe renal (eGFR <30 mL/min/1.73 m2) & hepatic impairment. Pregnancy & lactation. Childn <18 yr (for primary hypercholesterolaemia & mixed dyslipidaemia), <12 yr (for homozygous familial hypercholesterolaemia).
Adverse Reactions
Influenza, nasopharyngitis, upper resp tract infection; hypersensitivity, rash; nausea; back pain, arthralgia; 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;1's
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