Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, & paed ≥10 yr w/ heterozygous familial hypercholesterolaemia (HeFH), 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 & paed ≥10 yr w/ HoFH in combination w/ other lipid-lowering therapies. Adults w/ established ASCVD (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
SCPrimary hypercholesterolaemia & mixed dyslipidaemia (including HeFH)Adult & paed ≥10 yr 140 mg every 2 wk or 420 mg once mthly. HoFHAdult & paed ≥10 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. Patient on apheresis May initiate treatment w/ 420 mg every 2 wk to correspond w/ apheresis schedule. Established ASCVDAdult 140 mg every 2 wk or 420 mg once mthly.
Contraindications
Hypersensitivity.
Special Precautions
Hypersensitivity to dry natural rubber (latex derivative). Inj should not be given into areas w/ tender, bruised, red, or hard skin. Must not be administered IV or IM. Patients w/ moderate & severe hepatic impairment. Should not be used during pregnancy unless clinical condition requires. Discontinue breastfeeding or abstain from therapy when the risk outweighs the benefits. Safety & efficacy have not been established in paed <10 yr w/ HeFH or HoFH, or in paed patients w/ other types of hyperlipidaemia.
Adverse Reactions
Flu, nasopharyngitis, URTI; hypersensitivity, rash; headache; nausea; back pain, arthralgia, myalgia; inj site reactions.
Sign Out
