Mirvetuximab Medication Guide for Special Populations

Somituximab (Mirvetuximab) is an antibody drug conjugate (ADC) targeting ovarian cancer overexpressing folate receptor α (FRα). Its cytotoxic part is DM4, which can selectively destroy the microtubule structure of tumor cells, thereby achieving anti-tumor effects. Because its mechanism involves rapidly dividing cells, Elahere needs to be used with extreme caution in special populations, including pregnant women, lactating women, the elderly, and patients with impaired liver and kidney function.

1. Pregnant women and women of childbearing age:Elahere contains the genotoxic compound DM4, which is potentially embryotoxic and teratogenic to actively dividing cells, so there is a significant risk when used by pregnant women. Human data are lacking to assess fetal safety, and comprehensive reproductive or developmental toxicity studies have not been conducted in animal models. Immunoglobulin G is known to cross the placental barrier, and Elahere has the potential to be passed from the mother to the developing fetus. Clinical background data show that the risk of major birth defects and miscarriage in pregnancies in the general U.S. population are 2-4% and 15-20%, respectively, but the risks of using Elahere are unclear. Therefore, it is recommended that females of reproductive potential undergo a pregnancy test before initiating treatment and use effective contraception during treatment and for at least 7 months after the last dose to prevent potential fetal damage.

2. Breastfeeding women: There is currently a lack of data on the transmission of Elahere through breast milk and its impact on the baby. Serious adverse reactions may occur in breastfed children due to the cytotoxic properties of the drug. Therefore, it is clinically recommended that women avoid breastfeeding while using Elahere and within 1 month after the last dose to ensure the safety of the baby.

3. Pediatric patients:The safety and effectiveness of Elahere in children and adolescent patients have not been confirmed, so routine use in pediatrics is not recommended, and use must be strictly limited to clinical trials or specific indications.

4. Elderly patients: In a study of 682 ovarian cancer patients, about 44% of the patients were ≥65 years old. The proportion of elderly patients experiencing grade ≥3 adverse reactions was slightly higher than that of younger patients (51% vs 45%), but there was no significant difference between them in terms of efficacy and overall safety. Age has no significant effect on pharmacokinetics, and no dose adjustment is required for clinical use, but attention should be paid to combined chronic diseases and drug interactions.

5. Patients with renal impairment: For mild to moderate renal impairment (CLcr 30 to 89 mL/min), Elahere does not require dose adjustment. However, the impact on drug exposure and safety in patients with severe renal impairment (CLcr 15 to <30 mL/min) and end-stage renal disease is unclear, so use must be done with caution and under the guidance of a specialist.

6. Patients with liver function impairment: moderate to severe liver damage (total bilirubin>1.5 ULN) patients should avoid using Elahere to prevent hepatic metabolism disorders leading to drug accumulation and increased toxicity. Patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > ULN and AST within the range of 1-1.5 times ULN) do not need to adjust the dose, but liver function indicators need to be monitored regularly to assess tolerance and drug safety.

To sum up,Elahere needs to be strictly evaluated for risks when used by special groups. For pregnant women, lactating women, the elderly and patients with impaired liver and kidney function, individualized management strategies should be adopted to ensure the efficacy of the drug while minimizing potential safety risks through pregnancy testing, contraceptive measures, liver and kidney function monitoring and regular follow-up.

Reference materials:https://www.elahere.com/