Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, & paed patients ≥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 patients ≥10 yr w/ homozygous familial hypercholesterolaemia (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 patient ≥10 yr 140 mg every 2 wk or 420 mg once mthly. HoFH Adult & paed patient ≥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 ASCVD Adult 140 mg every 2 wk or 420 mg once mthly. Deliver 420-mg dose using 3 pre-filled autoinjectors administered consecutively w/in 30 min.
Contraindications
Hypersensitivity.
Special Precautions
Exclude secondary causes of hyperlipidaemia or mixed dyslipidaemia (eg, nephrotic syndrome, hypothyroidism) prior to treatment initiation. Rotate inj sites. Do not inj into areas w/ tender, bruised, red, or hard skin. Must not be administered IV or IM. Needle cover is made from dry natural rubber (latex derivative), which may cause severe allergic reactions. Reduction in total evolocumab exposure was observed in patients w/ moderate hepatic impairment. Patients w/ severe hepatic impairment have not been studied. Should not be used during pregnancy unless clinical condition requires. Discontinue breast-feeding or discontinue/abstain from Repatha therapy. Safety & effectiveness have not been established in paed patients <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.
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