mirvetuximab soravtansine
Elahere · ATC code L01FX26
Also known as: Mirvetuximab-Soravtansin, Mirvetuksimab soravtansin
- Key facts
- Active substance
- mirvetuximab soravtansine
- ATC code
- L01FX26
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ELAHERE 5 mg/mL concentrate for solution for infusion
- Marketing authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Information as of
- 2026-10-28
Key facts
Mirvetuximab soravtansine is an antibody-drug conjugate targeting folate receptor-alpha (FRα) used to treat platinum-resistant ovarian, fallopian tube or primary peritoneal cancer in adults (Elahere).
What it is used for
- Monotherapy in adults with FRα-positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
Dosing
- FRα status must be determined with a validated test (at least 75% of viable tumour cells with moderate and/or strong membrane staining).
- Elahere: 6 mg/kg adjusted ideal body weight (AIBW) once every 3 weeks (21-day cycle) as an intravenous infusion until progression or unacceptable toxicity.
- Dose reductions to 5 mg/kg, then 4 mg/kg AIBW; permanently discontinue if 4 mg/kg is not tolerated.
- Pre-medication before each infusion with a corticosteroid (e.g. dexamethasone 10 mg), antihistamine, antipyretic and antiemetic.
- Ophthalmic exam (visual acuity, slit lamp) before starting; lubricating eye drops during treatment.
- No dose adjustment in mild hepatic impairment; avoid in moderate to severe hepatic impairment.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Severe ocular adverse reactions: visual impairment (mainly blurred vision), keratopathy, dry eye, photophobia, eye pain; report new or worsening symptoms; modify dose by severity.
- Pneumonitis/interstitial lung disease, including life-threatening or fatal cases.
- Peripheral neuropathy, including Grade ≥3.
- Can cause embryo-foetal harm.
Side effects
- Most common: blurred vision (43%), nausea (41%), diarrhoea (39%), fatigue (35%), abdominal pain (30%), keratopathy (29%), dry eye (27%), constipation (26%), vomiting (23%), decreased appetite (22%), peripheral neuropathy (20%) and headache (19%).
- Most common serious: pneumonitis (4%), small intestinal obstruction (3%), intestinal obstruction (3%), pleural effusion (2%).
- Permanent discontinuation due to adverse reactions in 12% of patients.
Interactions
- No clinical interaction studies. Strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, ritonavir, voriconazole) may increase DM4 exposure; if unavoidable, monitor closely.
- Strong CYP3A4 inducers (e.g. phenytoin, rifampicin, carbamazepine) may decrease DM4 exposure.
Pregnancy and breastfeeding
- Not recommended during pregnancy; verify pregnancy status before starting; effective contraception during treatment and for 7 months after the last dose.
- Do not breast-feed during treatment and for 1 month after the last dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ElahereAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/005036
Source: European Medicines Agency (EMA), product information
Turkey
- ElahereABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Elahere
- Liechtenstein
- Elahere
- Norway
- Elahere
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Elahere – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.