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MedsAcross

Molecule

Vutrisiran

Also known as vutrisiran sodium
Available on requestOrphanNeurology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Vutrisiran is a small interfering RNA indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, among other approved uses. MedsAcross supplies Vutrisiran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Rna, Small Interfering RNA, Transthyretin-directed RNA Interaction, Decreased RNA Integrity, Increased Protein Breakdown
ATC classification
N07XX18 Vutrisiran · Other nervous system medicines, subgroup N07X, subgroup N07XX
US FDA first approval
13 June 2022
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Identifiers
UNII GB4I2JI8UICAS 1867157-35-4DrugBank DB16699Q112620160

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months. AMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional.

Source: US FDA prescribing information

Warnings and precautions

Reduced serum vitamin A levels and recommended supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Reduced Serum Vitamin A Levels and Recommended Supplementation The most common adverse reactions (≥5%) were pain in extremity, arthralgia, dyspnea, and vitamin A decreased.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Vutrisiran, sorted by availability.

MedicineManufacturerRegisterAvailability
Amvuttra 25 mg/0.5 mL injectionSubcutaneousAlnylam PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 13 June 2022Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Vutrisiran available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Vutrisiran and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Vutrisiran have?

The catalogue lists 1 brand names for Vutrisiran, including Amvuttra.

Is Vutrisiran approved by the US FDA?

Yes. The US FDA first approved Vutrisiran on 13 June 2022, according to Drugs@FDA.

Is Vutrisiran authorised in the European Union?

Yes. Vutrisiran has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Vutrisiran need cold chain shipping?

No listed presentation of Vutrisiran is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Vutrisiran in?

Vutrisiran is classified under ATC code N07XX18 (Vutrisiran).

References

  1. AMVUTTRA prescribing information (Alnylam Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 6 November 2025
  2. Amvuttra: European public assessment report (EPAR). European Medicines Agency. Retrieved 9 September 2026

Request Vutrisiran for export supply

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