• Inborn errors of metabolism

Amvuttra Generic Name & Formulations

General Description

Vutrisiran 25mg/0.5mL; soln for SC inj; preservative-free.

Pharmacological Class

Transthyretin-directed small interfering RNA.

How Supplied

Single-dose prefilled syringe—1

Generic Availability


Mechanism of Action

Vutrisiran is a double-stranded siRNA-GalNAc conjugate that causes degradation of mutant and wild-type TTR mRNA through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Amvuttra Indications


Polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Amvuttra Dosage and Administration


Give by SC inj in abdomen, thighs, or upper arms. 25mg once every 3 months.


Not established.

Amvuttra Contraindications

Not Applicable

Amvuttra Boxed Warnings

Not Applicable

Amvuttra Warnings/Precautions


Supplement with recommended daily Vit. A allowance. Refer for eye exam if ocular symptoms of Vit. A deficiency occur (eg, night blindness). Moderate or severe hepatic impairment, severe renal impairment, or ESRD: not studied. Elderly. Pregnancy. Nursing mothers.

Amvuttra Pharmacokinetics


Tmax (Median [range]): 4 (0.17, 12.0) hours.


Estimated volume of distribution (% RSE): 10.1 (5.8) L. Plasma protein binding: 80%. Organ distribution: primarily to the liver.


Primary pathway: by endo- and exonucleases to short nucleotide fragments of varying sizes within the liver.


Primary pathway: mean fraction of unchanged vutrisiran eliminated in urine was ~19.4% at the recommended dose of 25 mg. The mean renal clearance of vutrisiran ranged from 4.5 to 5.7 L/hour.

Half-life (Median [range]): 5.2 (2.2, 6.4) hours. Apparent clearance (Median [range]): 21.4 (19.8, 30) L/hour.

Amvuttra Interactions

Not Applicable

Amvuttra Adverse Reactions

Adverse Reactions

Arthralgia, dyspnea, Vit. A decreased; inj site reactions, AV heart block.

Amvuttra Clinical Trials

See Literature

Amvuttra Note

Not Applicable

Amvuttra Patient Counseling

See Literature