Molecule
Givosiran is an aminolevulinate synthase 1-directed RNA interaction indicated for the treatment of adults with acute hepatic porphyria (AHP). It is available as injection for subcutaneous use. MedsAcross supplies Givosiran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP).
Source: US FDA prescribing information
Givosiran is a double-stranded small interfering RNA that causes degradation of aminolevulinate synthase 1 ( ALAS1 ) mRNA in hepatocytes through RNA interference, reducing the elevated levels of liver ALAS1 mRNA. This leads to reduced circulating levels of neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), factors associated with attacks and other disease manifestations of AHP.
Source: US FDA prescribing information
The recommended dose of GIVLAARI is 2.5 mg/kg once monthly by subcutaneous injection. Recommended Dosage The recommended dose of GIVLAARI is 2.5 mg/kg administered via subcutaneous injection once monthly. Dosing is based on actual body weight. Missed Dose Administer GIVLAARI as soon as possible after a missed dose. Resume dosing at monthly intervals following administration of the missed dose. Dose Modification for Adverse Reactions In patients with severe or clinically significant transaminase elevations, who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly. In patients who resume dosing at 1.25 mg/kg once monthly without recurrence of severe or clinically significant transaminase elevations, the dose may be increased to the recommended dose of 2.5 mg/kg once monthly.
Source: US FDA prescribing information
GIVLAARI is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis. Severe hypersensitivity to givosiran.
Source: US FDA prescribing information
Anaphylactic Reaction: Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms. If anaphylaxis occurs, discontinue GIVLAARI and administer appropriate medical treatment. Hepatic Toxicity: Measure liver function at baseline and periodically during treatment with GIVLAARI. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. Renal Toxicity: Monitor renal function during treatment with GIVLAARI as clinically indicated. Injection Site Reactions: May occur, including recall reactions. Monitor for reactions and manage clinically as needed. Blood Homocysteine Increased: Measure blood homocysteine at baseline and monitor for changes during treatment with GIVLAARI.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Anaphylactic Reaction Transaminase Elevations Serum Creatinine Increase Injection Site Reactions Blood Homocysteine Increased Pancreatitis The most common adverse reactions (≥20% of patients) included nausea and injection site reactions.
Source: US FDA prescribing information
Sensitive CYP1A2 and CYP2D6 Substrates: Avoid concomitant use with CYP1A2 and CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities.
Source: US FDA prescribing information
Store at 2°C to 25°C (36°F to 77°F). Store GIVLAARI in its original container until ready for use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Givosiran, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Givlaari 189 mg/1 mL injectionSubcutaneous | Alnylam Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Givosiran in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Givosiran and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Givosiran, including Givlaari.
Yes. The US FDA first approved Givosiran on 20 November 2019, according to Drugs@FDA.
Yes. Givosiran has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Givosiran is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Givosiran is classified under ATC code A16AX16 (Givosiran).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.