Mirvetuximab soravtansine (Elahere)
Antibody Drug Conjugate | Antineoplastic Agent
Black Boxed Warning: Elahere carries a black boxed warning for ocular toxicity, including vision loss. Patients should be monitored for ocular symptoms, and prompt evaluation and management are critical to prevent serious outcomes.
Clinical Pearls for Elahere (mirvetuximab soravtansine):
- Mechanism of Action: Elahere is an antibody-drug conjugate that specifically targets FRα-expressing cells. The conjugate binds to FRα on cancer cells and delivers the cytotoxic agent DM4 directly to the tumor, sparing normal tissues. Understanding this mechanism can help in explaining the potential side effects and interactions.
- Indication Specificity: Elahere is indicated for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. It is vital to confirm FRα positivity via an FDA-approved test prior to initiation.
- Dosing and Administration: Administered by intravenous infusion, typically once every three weeks. Dose adjustments may be necessary based on the patient’s tolerance and the occurrence of adverse reactions such as neutropenia or neuropathy.
- Management of Ocular Toxicities: Given the black box warning for ocular toxicities, it's crucial to conduct baseline and ongoing ophthalmologic assessments. Advise patients to report any visual disturbances immediately. Temporary or permanent discontinuation of Elahere may be warranted for severe ocular side effects.
- Drug Interactions: Careful consideration should be given to concomitant use of drugs known to cause ocular toxicity or those that can enhance the cytotoxic effects, potentially increasing the risk of adverse reactions.
- Patient Counseling: Educate patients on the importance of attending all treatment sessions and follow-up appointments for eye exams. Discuss potential side effects, particularly the risk of vision loss and other ocular effects, to ensure patients are fully informed.
- Symptom Management: Proactively manage symptoms of toxicity, including GI disturbances, fatigue, and peripheral neuropathy, to improve tolerance to therapy and overall quality of life for patients.
- Monitoring for Efficacy and Safety: Regular monitoring through clinical assessments and imaging studies is necessary to evaluate the therapeutic response and modify treatment as needed based on disease progression and toxicities.
https://www.elahere.com/pdf/prescribing-information.pdf -
prescribing information
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