Generic Name

Mirvetuximab Soravtansine-gynx

---

Classification

FDA Approved Indications

• Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer expressing folate receptor alpha (FRα) who have received one to three prior systemic treatments

Mechanism of Action

Mirvetuximab soravtansine is an antibody-drug conjugate that binds to folate receptor alpha (FRα) on cancer cells. The antibody is linked to a microtubule inhibitor, DM4, which, upon binding and internalization, disrupts microtubule assembly, leading to cell death.

Dosage and Administration

Adult: Dose and schedule should be determined by a healthcare professional, typically involves intravenous infusion once every 3 weeks; specific dose is usually 6 mg/kg, but adjustments are made based on tolerability and side effects.

Pediatric: Not established; use in pediatric populations not recommended due to lack of sufficient data.

Geriatric: No specific dosage adjustments recommended; monitor for increased toxicity.

Renal Impairment: No specific adjustments required; monitor patient closely.

Hepatic Impairment: No specific adjustments recommended; use with caution and monitor for toxicity.

Pharmacokinetics

Absorption: Administered intravenously; absorption not applicable.

Distribution: Distribution details are limited but expected to have a moderate volume of distribution.

Metabolism: Metabolized within cells after binding to FRα; metabolism involves proteolytic degradation of the antibody and lysosomal processing of the drug component.

Excretion: Primarily excreted via the feces; renal excretion is minimal.

Half Life: Approximately 6-9 days.

Contraindications

• Hypersensitivity to mirvetuximab soravtansine or its components.

Precautions

• Monitor for infusion reactions, hepatotoxicity, bone marrow suppression, and other adverse effects. Use cautiously in patients with hepatic impairment, or with a history of significant drug hypersensitivity.

Adverse Reactions - Common

• Nausea (High)
• Fatigue (High)
• Blurred vision (High)
• Infusion reactions (Moderate)

Adverse Reactions - Serious

• Hepatotoxicity (elevated liver enzymes, bilirubin) (Low)
• Myelosuppression (neutropenia, thrombocytopenia) (Low)
• Pulmonary toxicity (Rare)
• Severe infusion reactions including hypersensitivity (Rare)

Drug-Drug Interactions

• Potential increased toxicity with other myelosuppressive or hepatotoxic drugs.

Drug-Food Interactions

• No specific interactions reported.

Drug-Herb Interactions

• No specific interactions reported.

Nursing Implications

Patient/Family Teaching

• Report any signs of allergic reactions, hepatotoxicity, or unusual bleeding.
• Inform about potential side effects including fatigue, nausea, and vision changes.
• Advise on the importance of routine blood tests and liver function monitoring.
• Emphasize adherence to scheduled visits and tests.

Special Considerations

Black Box Warnings:

• Severe hypersensitivity reactions observed during infusions.

Genetic Factors: Studies limited; consider folate receptor alpha expression for efficacy.

Lab Test Interference: Potential interference with certain lab tests; communicate use to laboratory personnel.

Overdose Management

Signs/Symptoms: Severe infusion reactions, toxicity signs related to marrow suppression or liver injury.

Treatment: Supportive care, discontinue drug, provide symptomatic treatment, and manage complications accordingly.

Storage and Handling

Storage: Store refrigerated at 2-8°C; protect from light.

Stability: Stable for specified period as per manufacturer instructions; discard unused portions per protocol.