Mirvetuximab soravtansine: clinical use

Prescribing considerations

• Confirm qualifying FRα expression using an appropriate validated immunohistochemistry test.
• Treatment must be initiated and supervised by a clinician experienced with anticancer therapy.
• Arrange an ophthalmic examination before treatment and assess new or worsening ocular symptoms before further administration.
• Review ocular disease, peripheral neuropathy, pulmonary symptoms, pregnancy potential, hepatic function and CYP3A4-modifying medicines.
• Record the product name and batch number for traceability.

Contraindications and cautions

• Hypersensitivity to mirvetuximab soravtansine or any excipient.
• Avoid in moderate or severe hepatic impairment because exposure and safety have not been established.
• Severe renal impairment and end-stage renal disease have not been evaluated.
• Use is not recommended during pregnancy or breastfeeding.

Monitoring

• Ophthalmic symptoms and findings, including corneal toxicity and visual acuity.
• Respiratory symptoms and radiological findings where pneumonitis is suspected; exclude infectious, malignant and other causes.
• Peripheral neuropathy and infusion-related or hypersensitivity reactions.
• Pregnancy status before initiation where relevant.
• Adverse reactions requiring interruption, modification or permanent discontinuation according to severity.

Clinical pharmacology

An IgG1 antibody–drug conjugate binds FRα and is internalised, releasing the microtubule inhibitor DM4. The antibody is catabolised to peptides; DM4 and S-methyl-DM4 are mainly metabolised by CYP3A4 and eliminated through biliary and faecal pathways.

Formulation and product differences

• Preservative-free, single-use concentrate in a vial.
• Requires dilution with 5% glucose and is incompatible with sodium chloride infusion solution.
• Requires a specified polyethersulfone in-line filter and cytotoxic handling procedures.

Solution for infusion

Route: Intravenous

Strengths: 5 mg/mL