Vutrisiran

What is Vutrisiran?

• Vutrisiran (Amvuttra) is ,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.
• It is used for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Vutrisiran v01

What are the uses of this medicine?

• Vutrisiran (Amvuttra) is used for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (an inherited condition in which abnormal proteins build up and deposit in tissues, resulting in nerve damage) in adults.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Vutrisiran was approved for medical use in the United States in June 2022.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Amvuttra is 25 mg administered by subcutaneous injection once every 3 months.
• If a dose is missed, administer Amvuttra as soon as possible.
• Resume dosing every 3 months from the most recently administered dose.
• No dose adjustment is recommended in patients with mild or moderate renal impairment.
• No dose adjustment is recommended in patients with mild hepatic impairment.

Administration:

• Vutrisiran injection comes as a solution to be given subcutaneously.
• It is usually given by a doctor or a nurse in a clinic every 3 months.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 25 mg/0.5 mL of vutrisiran

This medicine is available in fallowing brand namesː

• Amvuttra

What side effects can this medication cause?

The most common side effects of this medicine include:

• Pain in extremity
• Arthralgia
• Dyspnea
• Vitamin A decreased

Less common, but serious side effects may include:

• Atrioventricular (AV) heart block
• Injection site reactions
• difficulty seeing at night or in low light
• irregular heartbeat

What special precautions should I follow?

• Amvuttra treatment leads to a decrease in serum vitamin A levels. Instruct patients to take the recommended daily allowance of vitamin A. Advise patients to contact their healthcare provider if they experience ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness) and refer them to an ophthalmologist if they develop these symptoms.
• Instruct patients that if they are pregnant or plan to become pregnant while taking Amvuttra they should inform their healthcare provider. Inform patients of the potential risk to the fetus, including that Amvuttra treatment leads to a decrease in serum vitamin A levels.
• There is no information regarding the presence of vutrisiran in human milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• vutrisiran sodium

Inactive ingredients:

• 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.

Who manufactures and distributes this medicine?

Manufactured for:

• Alnylam Pharmaceuticals, Inc., Cambridge, MA
• Amvuttra is a pending trademark of Alnylam Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store at 2°C to 30°C (36°F to 86°F) in the original carton, until ready for use.
• Do not freeze.

• Dailymed label info on Vutrisiran
• FDA Vutrisiran

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