Amvuttra Injection | Polyneuropathy | HK DengYueMedicine

  • Generic Name/Brand Name: Vutrisiran / Amvuttra
  • Indications: Amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients.
  • Dosage Form: Injection
  • Specification: Each single-dose prefilled syringe contains 25 mg of vutrisiran in 0.5 mL solution.

Amvuttra Injection Application Scope

Amvuttra (vutrisiran) is indicated for the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR).

Amvuttra Vutrisiran Injection
Amvuttra Vutrisiran Injection

Amvuttra Injection Characteristics

  • Ingredients: Each pre-filled syringe contains 25 mg of vutrisiran sodium in 0.5 mL solution.

  • Properties: Vutrisiran is a double-stranded small interfering RNA (siRNA) that targets hepatic production of transthyretin (TTR) protein, thereby reducing serum TTR protein levels.

  • Specification: Sterile, preservative-free, clear, colorless-to-yellow solution for subcutaneous injection.

  • Packaging Specification: Supplied as a single-dose 1-mL prefilled syringe made from Type I glass with a stainless steel 29-gauge needle and needle shield. Available in cartons containing one single-dose prefilled syringe each.

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

  • Expiry Date: 3 years from the date of manufacture.

  • Executive Standard: Complies with the standards set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

  • Approval Number: PLGB 50597/0006 (UK).

  • Date of Revision: February 18, 2025.

  • Manufacturer: Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands.

Guidelines For The Use Of Amvuttra Injection

  • Dosage and Administration: The recommended dosage is 25 mg administered via subcutaneous injection once every 3 months by a healthcare professional.
    If a dose is missed, administer Amvuttra as soon as possible and resume dosing every 3 months from the most recent dose.

  • Adverse Reactions: Common adverse reactions include pain in extremities (15%) and arthralgia (11%). Other possible side effects are dyspnea, injection site reactions (e.g., bruising, erythema, pain, pruritus, warmth), and increased blood alkaline phosphatase levels.

  • Contraindications: Severe hypersensitivity (e.g., anaphylaxis) to vutrisiran or any of its excipients.

  • Precautions: Amvuttra treatment leads to a decrease in serum vitamin A levels. Patients should take a daily vitamin A supplement (approximately 2,500 to 3,000 IU) to mitigate potential ocular symptoms due to vitamin A deficiency. Women of childbearing potential should practice effective contraception during treatment.

Amvuttra Injection Interactions

Drug Interactions:

No clinical interaction studies have been performed. Vutrisiran is not expected to cause interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes, nor to modulate the activity of transporters.

Therefore, vutrisiran is not expected to have clinically significant interactions with other medicinal products.

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
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