Givlaari Generic Name & Formulations
Givosiran 189mg/mL; soln for SC inj; preservative-free.
Aminolevulinate synthase 1-directed small interfering RNA.
Acute hepatic porphyria (AHP).
Givlaari Dosage and Administration
Give by SC inj into the abdomen, the back or side of the upper arms, or the thighs; rotate inj sites. 2.5mg/kg once monthly. For severe or clinically significant transaminase elevations, reduce dose to 1.25mg/kg once monthly; if no recurrence, may increase to 2.5mg/kg.
Givlaari Boxed Warnings
Have medical support readily available. Monitor for anaphylaxis; discontinue immediately and treat if occurs. Obtain LFTs prior to initiation, repeat monthly during the 1st 6 months, then as clinically indicated. Interrupt or discontinue therapy if clinically significant transaminase elevations occur (see Adults). Monitor renal function. Pregnancy. Nursing mothers.
Avoid concomitant use with CYP1A2 or CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities; if unavoidable, decrease the dose of substrates.
Givlaari Adverse Reactions
Nausea, inj-site reactions, rash, serum creatinine increased, transaminase elevations, fatigue.
Givlaari Clinical Trials
Givlaari Patient Counseling