AMVUTTRA 25 mg/.5mL
VUTRISIRAN · INJECTION · Alnylam Pharmaceuticals, Inc.
AMVUTTRA is a injection containing vutrisiran at 25 mg/.5mL, taken subcutaneous. Manufactured by Alnylam Pharmaceuticals, Inc..
Key Facts
- Brand Name
- AMVUTTRA
- Generic Name
- VUTRISIRAN
- NDC Code (Product)
71336-1003- Manufacturer
- Alnylam Pharmaceuticals, Inc.
- Strength
- 25 mg/.5mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA215515
- Marketing Start
- 06/13/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AMVUTTRA 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months. ( 2.1 ) AMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months [see Dosage and Administration (2.2) ] . Missed Dose If a dose is missed, administer AMVUTTRA as soon as possible. Resume dosing every 3 months from the most recently administered dose. 2.2 Administration Instructions AMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional. Syringe Appearance Before and After Use Before Use After Use Image Image Preparation and Administration 1. Prepare the syringe If stored cold, allow the syringe to warm to room temperature for 30 minutes prior to use. Remove the syringe from the packaging by gripping the syringe body. Do not touch the plunger rod until ready to inject. Visually inspect the drug solution for discoloration and particulate matter prior to administration. AMVUTTRA is a sterile, preservative-free, clear, colorless-to-yellow solution. …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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 [see Warnings and Precautions (5.1) ] The most common adverse reactions (≥5%) were pain in extremity, arthralgia, dyspnea, and vitamin A decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AMVUTTRA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two Phase 3 randomized, multi-center studies evaluated the safety of AMVUTTRA in 448 transthyretin-mediated amyloidosis (ATTR) patients, including 122 patients with hATTR-PN (HELIOS-A) and 326 patients with ATTR-CM (HELIOS-B) [see Clinical Studies (14) ] . In both studies, patients were instructed to take the recommended daily allowance of vitamin A [see Warnings and Precautions (5.1) ] . Polyneuropa…
Frequently Asked Questions
What is AMVUTTRA used for?
AMVUTTRA contains VUTRISIRAN. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is AMVUTTRA a controlled substance?
AMVUTTRA is not classified as a controlled substance by the DEA.
What is the generic name for AMVUTTRA?
The generic name for AMVUTTRA is VUTRISIRAN. There are no other listed brand versions of VUTRISIRAN.
What is the NDC code for AMVUTTRA 25 mg/.5mL?
The NDC (National Drug Code) for AMVUTTRA 25 mg/.5mL is 71336-1003, listed by Alnylam Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)