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Givlaari Generic Name & Formulations
Legal Class
Rx
General Description
Givosiran 189mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Aminolevulinate synthase 1-directed small interfering RNA.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Givlaari Indications
Indications
Acute hepatic porphyria (AHP).
Givlaari Dosage and Administration
Adult
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.
Children
Not established.
Givlaari Contraindications
Not Applicable
Givlaari Boxed Warnings
Not Applicable
Givlaari Warnings/Precautions
Warnings/Precautions
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.
Givlaari Pharmacokinetics
See Literature
Givlaari Interactions
Interactions
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
Adverse Reactions
Nausea, inj-site reactions, rash, serum creatinine increased, transaminase elevations, fatigue.
Givlaari Clinical Trials
See Literature
Givlaari Note
Not Applicable
Givlaari Patient Counseling
See Literature
