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Familial heterozygous hypercholesterolaemia Clinical criteria: Treatment Phase: Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication, AND The treatment must be in conjunction with dietary therapy and exercise, AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician.
Non-familial hypercholesterolaemia Clinical criteria: Treatment Phase: Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication, AND The treatment must be in conjunction with dietary therapy and exercise, AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician.
“Inclisiran is a cholesterol-lowering double-stranded small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilises the RNA interference mechanism and directs catalytic breakdown of mRNA for proprotein convertase subtilisin/kexin type 9.”
“The terminal elimination half-life of inclisiran is approximately 9 hours, and no accumulation occurs with multiple dosing.”
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Inclisiran is not a substrate, inhibitor or inducer of cytochrome P450 (CYP450) enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and/or 3A4/5) or common drug transporters (MDR1/P-gp, BCRP, BSEP, MATE1, MATE2K, OAT1, OAT3, OCT1, OCT2, OCT3, OATP1B1, OATP1B3), and therefore Leqvio is not expected to have clinically significant interactions with other medications.”