Prescription medicine
Mirvetuximab soravtansine Brand names: Elahere
Mirvetuximab soravtansine (Elahere) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the mirvetuximab soravtansine FDA label on DailyMed (effective July 14, 2025); every mirvetuximab soravtansine label on DailyMed.
Highlights of the record
FDA label of July 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
OCULAR TOXICITY.
ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated [see Dosage and Administration ( 2.3 )]. Administer prophylactic artificial tears and ophthalmic topical steroids [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.1 )]. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. Discontinue ELAHERE for Grade 4 ocular toxicities [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. ( 5.1 , 6.1 ) Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. ( 2.3 ) Administer prophylactic artificial tears and ophthalmic topical steroids. […]
Used for
From the label: indications and usageELAHERE ® 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.
Forms and strengths
- 5 mg/ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,651 through July 30, 2026
What is mirvetuximab soravtansine used for?
From the label: indications and usageELAHERE ® 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. Select patients for therapy based on an FDA-approved test [see Dosage and Administration ( 2.1 )]. ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. […]
Source: FDA drug label (ELAHERE), ImmunoGen, Inc., effective July 14, 2025 (SPL set 00c424b5-6ccd-48ab-9e88-1986451120e2), via openFDA; the full label on DailyMed
What does the patient leaflet for mirvetuximab soravtansine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ELAHERE?ELAHERE can cause serious side effects, including: Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes. Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems. Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider. Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider. See “What are the possible side effects of ELAHERE?” for more information about side effects.
Source: FDA drug label (ELAHERE), ImmunoGen, Inc., effective July 14, 2025 (SPL set 00c424b5-6ccd-48ab-9e88-1986451120e2), via openFDA; the full label on DailyMed
Is there a generic for mirvetuximab soravtansine (Elahere)?
No generic mirvetuximab soravtansine is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for mirvetuximab soravtansine?
The FDA Adverse Event Reporting System holds 1,651 reports that list mirvetuximab soravtansine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 196 are coded as a death and 265 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Mirvetuximab soravtansine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other