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Amvuttra Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
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
Indications
Polyneuropathy of hereditary transthyretin-mediated amyloidosis.
Amvuttra Dosage and Administration
Adult
Give by SC inj in abdomen, thighs, or upper arms. 25mg once every 3 months.
Children
Not established.
Amvuttra Contraindications
Not Applicable
Amvuttra Boxed Warnings
Not Applicable
Amvuttra Warnings/Precautions
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
Absorption
Tmax (Median [range]): 4 (0.17, 12.0) hours.
Distribution
Estimated volume of distribution (% RSE): 10.1 (5.8) L. Plasma protein binding: 80%. Organ distribution: primarily to the liver.
Elimination
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
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