amvuttra
Amvuttra (Vutrisiran Sodium) is a small interfering rna used to treat Polyneuropathies, Familial Amyloid Neuropathies.
Vutrisiran Sodium · by Alnylam Pharms Inc
Key facts
- Active ingredient
- Vutrisiran Sodium
- Drug class
- Small Interfering Rna
- Form
- Injectable
- Strength
- Vutrisiran Sodium EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Alnylam Pharms Inc
- FDA application
- NDA215515
What is Amvuttra?
From the FDA label:AMVUTTRA contains vutrisiran, a chemically modified double-stranded small interfering ribonucleic acid (siRNA) that targets mutant and wild-type transthyretin (TTR) messenger RNA (mRNA) and is covalently linked to a ligand containing three N -acetylgalactosamine (GalNAc) residues to enable delivery of the siRNA to hepatocytes. The structural formula of vutrisiran sodium is presented below. Dashed lines denote Watson-Crick base pairing The molecular formula of vutrisiran sodium is C 530 H 672 F 9 N 171 Na 43 O 323 P 43 S 6 with a molecular weight of 17,290 Da. The molecular formula of the free acid is C 530 H 715 F 9 N 171 O 323 P 43 S 6 with a molecular weight of 16,345 Da. AMVUTTRA is supplied as a sterile, preservative-free, clear, colorless-to-yellow solution for subcutaneous injection. Each 0.5 mL of solution contains 25 mg of vutrisiran (equivalent to 26.5 mg vutrisiran sodium), 0.2 mg sodium phosphate monobasic dihydrate, 0.7 mg sodium phosphate dibasic dihydrate, 3.2 mg sodium chloride, water for injection, and sodium hydroxide and/or phosphoric acid to adjust the pH to ~7. Chemical Structure Chemical Structure
How to use
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. Do not use if it contains particulate matter or if it is cloudy or discolored. Check the following: Syringe is not damaged, such as cracked or leaking Needle cap is attached to the syringe Expiration date on syringe label Do…
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 [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) ] . Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis In HELIOS-A, 118 patients received at least 18 months of treatment. The mean duration of treatment was 18.8 months (range: 1.7 to 19.4 months). The median patient age…
Warnings
Important safety information
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 ) 5.1 Reduced Serum Vitamin A Levels and Recommended Supplementation AMVUTTRA treatment leads to a decrease in serum vitamin A levels [see Adverse Reactions (6.1) and Clinical Pharmacology (12.2) ] . Supplementation at the recommended daily allowance of vitamin A is advised for patients taking AMVUTTRA. Higher doses than the recommended daily allowance of vitamin A should not be given to try to achieve normal serum vitamin A levels during treatment with AMVUTTRA, as serum vitamin A levels do not reflect the total vitamin A in the body. Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).
Who should not take Amvuttra
None. None. ( 4 )
Drug class
- Small Interfering RNA
- Transthyretin-directed RNA Interaction
May treat (source: NIH RxClass)
See how Amvuttra ranks — best-rated small interfering rna for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Amvuttra treat?
- Amvuttra (Vutrisiran Sodium) may be used to treat polyneuropathies, familial amyloid neuropathies, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Amvuttra?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Amvuttra. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Amvuttra?
- Amvuttra is marketed by Alnylam Pharms Inc. You can see Alnylam Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Amvuttra a brand-name or generic drug?
- Amvuttra is a brand-name product with the active ingredient Vutrisiran Sodium.
- Is Amvuttra available over the counter?
- No. Amvuttra is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Amvuttra come in?
- Amvuttra is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Amvuttra?
- Amvuttra is classified as small interfering rna, transthyretin-directed rna interaction, per the FDA's Established Pharmacologic Class.
- Is Amvuttra FDA-registered?
- Amvuttra is on record with the U.S. FDA under application number NDA215515. You can verify this on its official FDA label.
- Is Amvuttra safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Amvuttra. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Amvuttra?
- Amvuttra's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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