Vutrisiran

Vutrisiran is a prescription medication used for the treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (hATTR).

• Vutrisiran is available under the following different brand names: Amvuttra

Common side effects of Vutrisiran include:

• shortness of breath, 
• decreased Vitamin A, 
• tiredness, 
• dizziness, 
• fainting, 
• abnormal heartbeats, 
• chest pain, 
• nausea, and
• redness, tenderness, warmth and itching at the injection site

Serious side effects of Vutrisiran include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• dizziness, and 
• joint stiffness

Rare side effects of Vutrisiran include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 25 mg/0.5 mL single-dose prefilled syringe

Polyneuropathy

Adult dosage

• 25 mg SC every 3 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vutrisiran has no noted severe interactions with any other drugs.
• Vutrisiran has no noted serious interactions with any other drugs.
• Vutrisiran has no noted moderate interactions with any other drugs.
• Vutrisiran has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vutrisiran?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vutrisiran?”

Cautions

• Vitamin A deficiency
• Decreases serum vitamin A levels
• Supplement vitamin A at recommended daily allowance (RDA)
• Do not give higher doses than RDA to try to achieve normal serum vitamin A levels during treatment, as serum vitamin A levels do not reflect the total vitamin A in the body
• Refer patients to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness) develop

Pregnancy and Lactation

• Data regarding use in pregnant females are not available to inform of drug-associated risk of adverse developmental outcomes
• Vutrisiran leads to decreased serum vitamin A levels, and vitamin A supplementation is advised
• Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects
• Lactation
  • Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for vutrisiran and any potential adverse effects on the breastfed infant from vutrisiran or from the underlying maternal condition