Prescription medicine
Vutrisiran Brand names: Amvuttra
Vutrisiran (Amvuttra) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vutrisiran FDA label on DailyMed (effective November 6, 2025, Alnylam Pharmaceuticals, Inc.); the NDA 215515 record on Drugs@FDA; every vutrisiran label on DailyMed.
Highlights of the record
FDA label of November 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults ( 1.1 ) the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits ( 1.2 ) 1.1 Polyneuropathy of Hereditary Transthyret
Forms and strengths
- 25 mg/.5ml
Injection.
On the market
- Earliest approval on file
- June 13, 2022 Amvuttra, Alnylam Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 28, 2036 Amvuttra injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,532 through July 30, 2026
What is vutrisiran used for?
From the label: indications and usageAMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults ( 1.1 ) the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits ( 1.2 ) 1.1 Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. 1.2 Cardiomyopathy of Wild-type or Hereditary Transthyretin-mediated Amyloidosis AMVUTTRA is indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. […]
Conditions named in the indications of vutrisiran's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Small Interfering RNA and Transthyretin-directed RNA Interaction.
Source: FDA drug label (AMVUTTRA), Alnylam Pharmaceuticals, Inc., effective November 6, 2025 (SPL set 8db0facb-81b6-4006-9239-27dc6409c5d3), via openFDA; the full label on DailyMed
Is there a generic for vutrisiran (Amvuttra)?
No generic vutrisiran is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Amvuttra injection: the compound patent runs to July 28, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vutrisiran label say about other medicines?
The vutrisiran label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Vitamin a | warnings and precautions | 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: FDA drug label (AMVUTTRA), Alnylam Pharmaceuticals, Inc., effective November 6, 2025 (SPL set 8db0facb-81b6-4006-9239-27dc6409c5d3), via openFDA; the full label on DailyMed
What do FAERS reports show for vutrisiran?
The FDA Adverse Event Reporting System holds 2,532 reports that list vutrisiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 635 are coded as a death and 1,012 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as vutrisiran?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as vutrisiran or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Furosemide | Heart failure | none listed | $0.490 per mL 20 mg/2 mL vial | In shortage |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other small interfering rnas
- the pharmacologic class, with prices and generics
- Vutrisiran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other