Drug Guide
Vutrisiran Sodium
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/ADrug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing 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.