givosiran (Givlaari)
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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
More general terms
- 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