Amvuttra (vutrisiran) (Vutrisiran INJECTION) 25 mg/.5mL

Amvuttra (vutrisiran) is an FDA-approved orphan drug developed by Alnylam Pharmaceuticals for treating hereditary ATTR amyloidosis. It represents a breakthrough in neurology and cardiology, offering subcutaneous administration for patients with this rare, progressive genetic disorder affecting the nervous system and heart.

Strength

25 mg/.5mL

Pack Size

1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS

Manufacturer / TM Owner

Alnylam Pharmaceuticals, Inc.

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Pack/s

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Indications & Clinical Uses

Amvuttra is indicated for hereditary ATTR amyloidosis (hATTR) in adult patients with polyneuropathy (PN) and cardiomyopathy (CM). This rare genetic disorder results from mutations in the transthyretin (TTR) gene, causing misfolded protein accumulation in peripheral nerves and cardiac tissue. Vutrisiran is an RNA interference (RNAi) therapeutic that silences TTR messenger RNA, reducing the production of both wild-type and mutant TTR protein. This mechanism halts disease progression by decreasing amyloid fibril formation. The drug targets patients experiencing progressive neurological symptoms such as peripheral neuropathy, autonomic dysfunction, and cardiac manifestations including cardiomyopathy and conduction abnormalities. Amvuttra offers a disease-modifying approach for this previously difficult-to-treat population, improving quality of life and slowing disease progression.

Side Effects

Common adverse events include injection site reactions (pain, erythema, induration), upper respiratory tract infections, and arthralgia. Serious adverse events may include glomerulonephritis and thrombocytopenia. Patients require baseline and periodic monitoring of platelet counts, renal function, and liver function tests. Ophthalmologic monitoring is recommended due to potential retinal changes observed in preclinical studies. Regular assessment of neurological and cardiac status is essential to evaluate therapeutic response and detect emerging complications. Healthcare providers should monitor for signs of infection and bleeding disorders.

Precautions & Warnings

Amvuttra is contraindicated in patients with known hypersensitivity to vutrisiran or excipients. Caution is warranted in patients with thrombocytopenia, renal impairment, or hepatic dysfunction. Pregnancy category data should be reviewed with healthcare providers; animal studies showed potential fetal risk. Pediatric use has not been established; safety and efficacy in children remain unknown. Patients with severe renal or hepatic disease may require dose adjustments or careful monitoring. Concurrent use of other RNAi therapeutics should be avoided. Patients should be counseled regarding injection technique and site care.

Avoid Interactions

No major drug-drug interactions have been identified with Amvuttra. However, concurrent administration with other RNAi therapeutics is not recommended due to potential additive effects. Patients on anticoagulants or antiplatelet agents should be monitored closely for bleeding risk. No significant food interactions are documented. Patients should inform healthcare providers of all medications, supplements, and herbal products before initiating therapy.

Frequently Asked Questions

Amvuttra is used to treat hereditary ATTR amyloidosis (hATTR) in adults with polyneuropathy and cardiomyopathy. It works by reducing the production of transthyretin protein, slowing disease progression and improving symptoms associated with this rare genetic disorder.

Amvuttra is administered as a subcutaneous injection. Patients receive a loading dose followed by maintenance doses on a specific schedule. Healthcare providers or trained patients can administer injections, typically at home after proper training.

Common side effects include injection site reactions, upper respiratory infections, and joint pain. Most adverse events are mild to moderate. Serious but rare side effects may include kidney inflammation and low platelet counts, requiring monitoring.

Amvuttra is manufactured by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company specializing in RNA interference therapeutics.

Yes, Amvuttra received FDA orphan drug designation for hereditary ATTR amyloidosis. This status recognizes its development for a rare disease affecting fewer than 200,000 people in the United States, providing regulatory incentives and market exclusivity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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