Mirvetuximab soravtansine (Specialist drug)

SOURCE: no UK SPC was fetched (providers.emc is null). The dose above is taken verbatim from the US prescribing information for ELAHERE (ImmunoGen, Inc., label date 2025-07-14, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=47f1c78d-c469-4cd7-926e-51ce5b2d26f5) §2.2 — verify against the UK SPC before use. INDICATION/PATIENT SELECTION (§2.1): platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, selected on the presence of FRalpha tumour expression using an FDA-approved test. AIBW CALCULATION (§2.2, quoted): 'AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] - IBW)'; 'Female IBW [kg] = 0.9*height[cm] - 92'. Dosing based on AIBW reduces exposure variability for patients who are either under or overweight. PREMEDICATION before EACH infusion (§2.3, Table 1): a corticosteroid (example: intravenous dexamethasone 10 mg), an antihistamine (example: oral or intravenous diphenhydramine 25 mg to 50 mg) and an antipyretic (example: oral or intravenous acetaminophen/paracetamol 325 mg to 650 mg), each at least 30 minutes prior; plus an antiemetic (oral or intravenous 5-HT3 serotonin receptor antagonist or appropriate alternatives) before each dose and thereafter as needed. Consider additional premedication including corticosteroids the day prior for patients who have experienced infusion-related reactions. REQUIRED EYE CARE (§2.3): ophthalmic exam including visual acuity and slit lamp exam prior to initiation, every other cycle for the first 8 cycles, and as clinically indicated; ophthalmic topical steroids recommended — one drop in each eye 6 times daily starting the day prior to each infusion until day 4, then one drop in each eye 4 times daily on days 5-8 of each cycle (initial prescription and renewals only after slit-lamp examination); lubricating eye drops at least four times daily and as needed, waiting at least 10 minutes after topical steroid before instilling. DOSE REDUCTION LEVELS (§2.4, Table 2): first dose reduction 5 mg/kg AIBW once every 3 weeks; second dose reduction 4 mg/kg AIBW once every 3 weeks; permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW. DOSE MODIFICATIONS (§2.4, Table 3) include: keratitis/keratopathy — monitor for nonconfluent superficial keratitis; withhold for confluent superficial keratitis, corneal epithelial defect or 3-line or more loss in best corrected visual acuity, then same dose level or consider reduction; withhold and reduce by one dose level for corneal ulcer, stromal opacity or best corrected distance visual acuity 20/200 or worse; permanently discontinue for corneal perforation. Uveitis — Grade 2 withhold until Grade 1 or less then same dose; Grade 3 withhold then reduce one level; Grade 4 (hypopyon) permanently discontinue. Pneumonitis — Grade 2 withhold until Grade 1 or less then same dose or consider reduction; Grade 3 or 4 permanently discontinue. Peripheral neuropathy — Grade 2 withhold until Grade 1 or less then reduce one level; Grade 3 or 4 permanently discontinue. Infusion-related reactions/hypersensitivity — Grade 1 maintain infusion rate; Grade 2 interrupt and give supportive treatment, then after recovery resume at 50% of the previous rate and increase as appropriate if no further symptoms, and add premedication for future cycles. WARNING — the fetched §2 posology text was TRUNCATED at the source-fetch limit part-way through the Grade 3/4 infusion-reaction row; the remainder of the dose-modification table and the §2.5 preparation/administration instructions (including infusion rate and duration) were NOT retrieved and must be sourced separately. PAEDIATRIC (§8.4): 'Safety and effectiveness of ELAHERE have not been established in pediatric patients.' No per-kg paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. ELDERLY (§8.5): no clinically meaningful differences in efficacy or safety between patients aged 65 years and over and younger patients; age does not have a clinically meaningful effect on the pharmacokinetics.