Drug updated on 9/4/2024
| Dosage Form | Injection (subcutaneous; 189 mg/mL) |
| Drug Class | Aminolevulinate synthase 1-directed small interfering RNAs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with acute hepatic porphyria (AHP).
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Summary
- Givlaari (givosiran) is indicated for the treatment of adults with acute hepatic porphyria (AHP).
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Reduction in Acute Attack Rates: Givosiran is reported to effectively reduce the rates of acute attacks in patients with Acute Intermittent Porphyria (AIP).
- Effectiveness in Terminating Recurrent Attacks: Givosiran has demonstrated effectiveness in terminating recurrent attacks of AIP.
- Non-serious side effects associated with givosiran include fatigue and nausea, with severe side effects like pain also reported.
- There is limited safety data on the impact of givosiran on renal and liver function, particularly in patients with existing kidney and liver diseases, indicating a need for further research.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Givlaari (givosiran) Prescribing Information. | 2023 | Alnylam Pharmaceuticals, Inc., Cambridge, MA |