Givosiran Sodium (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: SUBCUTANEOUS.
Brand Names
- GIVLAARI
Related Health Topics
Indications and Usage
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).
Contraindications
GIVLAARI is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)].
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Anaphylactic Reaction [see Warnings and Precautions (5.1)] Transaminase Elevations [see Warnings and Precautions (5.2)] Serum Creatinine Increase [see Warnings and Precautions (5.3)] Injection Site Reactions [see Warnings and Precautions (5.4)] Blood Homocysteine Increased [see Warnings and Precautions (5.5)] Pancreatitis [see Warnings and Precautions (5.6)]
Mechanism of Action
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.