Givosiran

(Givlaari®)

Givlaari®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 189 mg/mL)
Drug ClassAminolevulinate synthase 1-directed small interfering RNA
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with acute hepatic porphyria (AHP).

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Givosiran is effective in treating acute and recurrent attacks of Acute Intermittent Porphyria (AIP), with reported outcomes including decreased rates of acute attacks and termination of recurrent attacks.
  • The studies indicate a need for further research to understand the impact of givosiran on renal and liver function, particularly in patients with pre-existing kidney and liver diseases, as this population may have different risk profiles or treatment outcomes.
  • Non-serious side effects of givosiran include fatigue and nausea, while a serious side effect reported is pain. There is limited information on the impact of givosiran on renal and liver function, particularly in patients with pre-existing kidney and liver diseases.
  • Further studies are needed to understand the safety profile of givosiran in specific populations, especially those with kidney and liver diseases, as they may have different risk profiles or treatment outcomes.
  • The studies primarily focus on patients with AIP, with specific mention of subgroups including patients with kidney and liver diseases. Further research is needed to understand the impact of givosiran in these subgroups, as they may exhibit different risk profiles or treatment outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Givlaari (givosiran) Prescribing Information.2024Alnylam Pharmaceuticals, Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses