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givosiran (Givlaari)
Indications:
- acute hepatic porphyria
Dosage:
- monthly subcutaneous injections of givosiran 2.5 mg/kg
Injection: 1 mL givosiran 189 mg/mL (single dose vial)
Adverse effects:
- injection site reactions
- nausea
- hepatoxicity (elevation in serum transaminases)
- nephrotoxicity (renal failure)
Drug interactions:
- avoid concomitant use with CYP1A2 & CYP2D6 substrates
Mechanism of action:
- aminolevulinate synthase 1-directed siRNA
General
short interfering double-stranded RNA; antisense oligonucleotide (siRNA, microRNA, miRNA)
metabolic agent (metabolic modifier)
References
- RxNorm
- FDA Drig Approvals. Nov 20, 2019
FDA approves givosiran for acute hepatic porphyria.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-givosiran-acute-hepatic-porphyria
- Highlights of Prescribing Information.
GIVLAARI (givosiran) injection, for subcutaneous use
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0212194s000lbl.pdf