AMVUTTRA- vutrisiran injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VUTRISIRAN (UNII: GB4I2JI8UI) (VUTRISIRAN - UNII:GB4I2JI8UI)

Available from:

Alnylam Pharmaceuticals, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. None. Risk Summary There are no available data on AMVUTTRA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. AMVUTTRA treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking AMVUTTRA. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects. The effects on the fetus of a reduction in maternal serum TTR caused by AMVUTTRA and of vitamin A supplementation are unknown [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)] . In animal studies, subcutaneous administration of vutrisiran to pregnant rats resulted in developmental toxicity (reduced fetal body weight and embryofetal mortality) at doses associated with maternal toxicity (see Data) . In the U.S. general population, the estimated

Product summary:

AMVUTTRA is a sterile, preservative-free, clear, colorless-to-yellow solution for subcutaneous injection. AMVUTTRA is supplied as 25 mg/0.5 mL solution in a single-dose 1-mL prefilled syringe made from Type I glass with stainless steel 29-gauge needle with a needle shield. The prefilled syringe components are not made with natural rubber latex. AMVUTTRA is available in cartons containing one single-dose prefilled syringe each. The NDC is: 71336-1003-1. Store at 2°C to 30°C (36°F to 86°F) in the original carton, until ready for use. Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

AMVUTTRA- VUTRISIRAN INJECTION
ALNYLAM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMVUTTRA™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMVUTTRA.
AMVUTTRA (VUTRISIRAN) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2022
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)
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)
DOSAGE FORMS AND STRENGTHS
Injection: 25 mg/0.5 mL in a single-dose prefilled syringe. (3)
CONTRAINDICATIONS
None. (4)
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. (5.1)
ADVERSE REACTIONS
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.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Reduced Serum Vitamin A Levels and Recommended Supplementation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmac