• Inborn errors of metabolism

Givlaari Generic Name & Formulations

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

Generic Availability


Givlaari Indications


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.


Not established.

Givlaari Contraindications

Not Applicable

Givlaari Boxed Warnings

Not Applicable

Givlaari 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


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