Drug Guide

Generic Name

Vutrisiran Sodium

Brand Names Amvuttra

Classification

Therapeutic: Genetic Amyloidosis treatment

Pharmacological: RNA interference (RNAi) therapeutic

FDA Approved Indications

  • Hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with polyneuropathy

Mechanism of Action

Vutrisiran is a small interfering RNA (siRNA) that targets and degrades transthyretin (TTR) mRNA in the liver, thereby reducing the production of TTR protein and its amyloid deposits.

Dosage and Administration

Adult: Dose: 25 mg subcutaneously every 3 months after initial doses of 2 and 3 months.

Pediatric: Not established.

Geriatric: No specific dosage adjustments required; use with caution in elderly.

Renal Impairment: No specific adjustment needed; however, monitor as per clinical judgment.

Hepatic Impairment: No specific adjustment needed.

Pharmacokinetics

Absorption: Subcutaneous absorption with peak concentrations around 4-6 days.

Distribution: Widely distributed; data limited.

Metabolism: Metabolized via normal pathways for nucleic acids; hepatic metabolism of siRNA strands.

Excretion: Primarily degraded into small nucleotides and nucleosides, eliminated via renal and hepatic pathways.

Half Life: Approximately 4-12 days.

Contraindications

  • Hypersensitivity to vutrisiran or excipients.

Precautions

  • Monitor for hypersensitivity reactions, including anaphylaxis; assess hepatic function; monitor for emerging symptoms of amyloidosis.

Adverse Reactions - Common

  • Injection site reactions (pain, swelling) (Occasional)
  • Fatigue (Common)
  • Nausea (Common)
  • Musculoskeletal pain (Common)

Adverse Reactions - Serious

  • Hypersensitivity reactions including anaphylaxis (Rare)
  • Hepatic events (elevated liver enzymes, hepatic failure) (Rare)

Drug-Drug Interactions

N/A

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of hypersensitivity, hepatic function, and neurological status.

Diagnoses:

  • Risk for allergic reaction
  • Impaired liver function

Implementation: Administer subcutaneously as prescribed, observe for immediate reactions, educate patient on injection site care.

Evaluation: Assess for efficacy in symptom reduction, monitor adverse effects.

Patient/Family Teaching

  • Report any signs of allergic reactions immediately.
  • Attend regular follow-up appointments for monitoring.
  • Maintain hydration and report any unusual symptoms.

Special Considerations

Black Box Warnings:

  • None specifically related to black box warnings.

Genetic Factors: Genetic testing may be recommended to confirm diagnosis and guide therapy.

Lab Test Interference: Potential impacts on liver function tests; interpret with caution.

Overdose Management

Signs/Symptoms: Allergic reactions, injection site pain, elevated liver enzymes.

Treatment: Supportive care, manage allergic reactions with antihistamines or epinephrine as needed. No specific antidote.

Storage and Handling

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until the expiration date printed on the label when refrigerated.

This guide is for educational purposes only and is not intended for clinical use.