Version July 2025
Mirvetuximab soravtansine can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam, including visual acuity and slit lamp exam, prior to initiation of mirvetuximab soravtansine, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold mirvetuximab soravtansine for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue mirvetuximab soravtansine for grade 4 ocular toxicities.
Dosage guidance:
Safety: Premedication, as well as lubricating and ophthalmic topical steroid eye drops, during mirvetuximab soravtansine treatment are recommended.
Clinical considerations: Mirvetuximab soravtansine is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting.
Ovarian cancer, platinum resistant, folate receptor-alpha positive (epithelial ovarian, fallopian tube, or primary peritoneal cancer): IV: 6 mg/kg (based on adjusted ideal body weight) once every 3 weeks; continue until disease progression or unacceptable toxicity (Ref).
Note: Adjusted ideal body weight (AIBW) calculated with the following formula:
AIBW = Ideal body weight (kg) + 0.4 × (actual weight [kg] − ideal body weight [kg])
Female ideal body weight (kg) = 0.9 × height (cm) − 92
Premedication:
|
Premedication and route |
Example (or equivalent) |
Premedication administration time |
|---|---|---|
|
a For patients who experience infusion-related reactions, consider additional premedications (including corticosteroids) on the day prior to mirvetuximab soravtansine administration. | ||
|
b Allow at least 10 minutes to elapse after instilling ophthalmic topical steroids and before administering lubricating eye drops. | ||
|
Corticosteroid (IV) |
Dexamethasone 10 mg |
At least 30 minutes prior to each mirvetuximab soravtansine dose. |
|
Antihistamine (oral or IV) |
Diphenhydramine 25 mg to 50 mg | |
|
Antipyretic (oral or IV) |
Acetaminophen 325 mg to 650 mg | |
|
Antiemetic (oral or IV) |
5HT3 serotonin receptor antagonist (or appropriate alternative) |
Prior to each mirvetuximab soravtansine dose and thereafter, as needed. |
|
Ocular premedications |
Ophthalmic topical steroidsb |
Begin ophthalmic topical steroids only after ophthalmic examination with a slit lamp. Administer 1 drop of ophthalmic topical steroids into each eye 6 times daily starting the day prior to each mirvetuximab soravtansine infusion and continue until day 4, then administer 1 drop into each eye 4 times daily for days 5 to 8 of each mirvetuximab soravtansine cycle. |
|
Lubricating eye dropsb |
Administer lubricating eye drops at least 4 times daily and as needed during mirvetuximab soravtansine treatment. | |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl 15 to <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (effects are unknown).
End-stage kidney disease: There are no dosage adjustments provided in the manufacturer's labeling (effects are unknown).
Mild impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.
Moderate to severe impairment (total bilirubin >1.5 times ULN): Avoid mirvetuximab soravtansine use.
Note: The manufacturer recommends calculating the dose based on adjusted ideal body weight to reduce exposure variability for patients that are either underweight or overweight.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of previously tolerated dose level with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).
|
a AIBW = adjusted ideal body weight. | |
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b Permanently discontinue if unable to tolerate 4 mg/kg (based on AIBW) once every 3 weeks. | |
|
Starting (usual) dose |
6 mg/kg (based on AIBWa) once every 3 weeks |
|
First dose reduction |
5 mg/kg (based on AIBW) once every 3 weeks |
|
Second dose reduction |
4 mg/kg (based on AIBW) once every 3 weeksb |
|
Adverse reaction |
Severity |
Mirvetuximab soravtansine dosage modification |
|---|---|---|
|
Hematologic toxicity |
Grade 3 or 4 |
Withhold mirvetuximab soravtansine until ≤ grade 1, then reduce the dose by 1 dose level. |
|
Infusion-related reactions/hypersensitivity |
Grade 1 |
Maintain infusion rate. |
|
Grade 2 |
Interrupt infusion and administer supportive treatment. After recovery from symptoms, resume the infusion at 50% of the previous rate. If no further symptoms occur, increase infusion rate as appropriate until infusion is completed. Administer additional premedication in future cycles. | |
|
Grade 3 or 4 |
Immediately stop infusion and administer supportive treatment. Advise patient to seek emergency treatment immediately and notify health care provider if infusion symptoms recur. Permanently discontinue mirvetuximab soravtansine. | |
|
Ocular toxicity (any) |
Any |
Promptly refer patient to an eye care professional for new or worsening ocular signs and symptoms. |
|
Ocular toxicity: Keratitis/Keratopathy |
Nonconfluent superficial keratitis |
Monitor. |
|
Confluent superficial keratitis, a cornea epithelial defect, or ≥3-line loss in best corrected visual acuity |
Withhold mirvetuximab soravtansine until improved or resolved, then maintain at same dose level or consider dose reduction. | |
|
Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse |
Withhold mirvetuximab soravtansine until improved or resolved, then reduce the dose by 1 dose level. | |
|
Corneal perforation |
Permanently discontinue mirvetuximab soravtansine. | |
|
Ocular toxicity: Uveitis |
Grade 1 (rare cell in anterior chamber) |
Monitor. |
|
Grade 2 (1 to 2+ cell or flare in anterior chamber) |
Withhold mirvetuximab soravtansine until ≤ grade 1, then maintain dose at same dose level. | |
|
Grade 3 (3+ cell or flare in anterior chamber) |
Withhold mirvetuximab soravtansine until ≤ grade 1, then reduce the dose by 1 dose level. | |
|
Grade 4 (hypopyon) |
Permanently discontinue mirvetuximab soravtansine. | |
|
Peripheral neuropathy |
Grade 2 |
Withhold mirvetuximab soravtansine until ≤ grade 1, then reduce the dose by 1 dose level. |
|
Grade 3 or 4 |
Permanently discontinue mirvetuximab soravtansine. | |
|
Pulmonary toxicity: Pneumonitis |
Grade 1 |
Monitor. Patients who are asymptomatic may continue mirvetuximab soravtansine with close monitoring. |
|
Grade 2 |
Withhold mirvetuximab soravtansine until ≤ grade 1, then resume at same dose level or consider dose reduction. | |
|
Persistent or recurrent grade 2 |
Withhold mirvetuximab soravtansine until symptoms resolve to ≤ grade 1 and consider dose reduction. | |
|
Grade 3 or 4 |
Permanently discontinue mirvetuximab soravtansine. | |
|
Other adverse reactions |
Grade 3 |
Withhold mirvetuximab soravtansine until ≤ grade 1, then resume at 1 lower dose level. |
|
Grade 4 |
Permanently discontinue mirvetuximab soravtansine. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Endocrine & metabolic: Decreased serum albumin (21% to 31%), decreased serum bicarbonate (11%), decreased serum magnesium (21% to 27%), decreased serum potassium (15%), decreased serum sodium (16%), increased serum calcium (12%)
Gastrointestinal: Abdominal distention (11%), abdominal pain (34% to 36%), constipation (27% to 30%), decreased appetite (18%), diarrhea (29% to 31%; grades 3/4: 1% to 3%), nausea (27% to 40%; grades 3/4: 2%), vomiting (18% to 19%; grades 3/4: 3%)
Hematologic & oncologic: Decreased hemoglobin (18% to 25%; grades 3/4: 1% to 3%), decreased neutrophils (22% to 26%; grades 3/4: 1% to 3%), decreased platelet count (17% to 18%; grades 3/4: 1% to 2%), leukopenia (23% to 26%; grades 3/4: 1%), lymphocytopenia (27% to 35%; grades 3/4: 3% to 7%)
Hepatic: Increased serum alanine aminotransferase (38% to 39%), increased serum alkaline phosphatase (30%), increased serum aspartate aminotransferase (50% to 57%)
Nervous system: Fatigue (47% to 49%; including asthenia), headache (14%), peripheral neuropathy (33% to 37%; grades 3/4: 2% to 4%; including hypoesthesia, neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, polyneuropathy, sensorimotor neuropathy [<1%])
Neuromuscular & skeletal: Musculoskeletal pain (31%; including arthralgia [17%], myalgia [10%])
Ophthalmic: Cataract (16% to 18%), corneal disease (36% to 37%; including corneal deposits, epithelial keratopathy [microcysts and defect], keratitis, punctate keratitis]), dry eye syndrome (27% to 29%), photophobia (14% to 18%), visual impairment (45% to 50%; including accommodation disturbance, blurred vision, decreased visual acuity, diplopia, error of refraction, presbyopia, vitreous opacity)
Renal: Increased serum creatinine (10% to 16%)
Respiratory: Dyspnea (12%)
1% to 10%:
Gastrointestinal: Intestinal obstruction (serious: 5% to 8%)
Hepatic: Ascites (serious: 4%)
Hypersensitivity: Hypersensitivity reaction (≤9%), infusion-related reaction (≤9%)
Immunologic: Antibody development (9%)
Infection: Serious infection (3%)
Ophthalmic: Eye pain (10%), uveitis (1%)
Respiratory: Pleural effusion (serious: 3%), pneumonitis (8% to 10%; including interstitial lung disease, respiratory failure)
Frequency not defined: Hepatic: Increased gamma-glutamyl transferase
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Ocular adverse reactions: Mirvetuximab soravtansine can cause severe ocular adverse reactions. Ocular adverse reactions occurred in over half of patients. Grade 3 ocular adverse reactions occurred, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; cases of grade 4 events were reported (keratopathy and cataract). The most common ocular adverse reactions were blurred vision, keratopathy, dry eye, cataract, photophobia, and eye pain. The median time to onset of first ocular adverse reaction was 5.1 weeks (range: up to ~69 weeks). Of patients experiencing ocular events, over half had complete resolution, while over one-third had partial improvement (decrease in severity by one or more grades from the worst grade) at last follow-up. Ocular adverse reactions led to permanent discontinuation in a small percentage of patients. Advise patients to avoid use of contact lenses during mirvetuximab soravtansine treatment unless directed by a health care provider.
• Peripheral neuropathy: Peripheral neuropathy occurred in over one-third of patients; grade 3 peripheral neuropathy has been reported. Neuropathy included peripheral neuropathy, peripheral sensory neuropathy, paresthesia, neurotoxicity, hypoesthesia, peripheral motor neuropathy, polyneuropathy, and peripheral sensorimotor neuropathy. The median time to onset of peripheral neuropathy was 5.9 weeks (range: up to ~127 weeks). Of patients experiencing peripheral neuropathy, approximately one-fourth had complete resolution, and some had partial improvement (decrease in severity by one or more grades from the worst grade) at last follow-up. Peripheral neuropathy led to mirvetuximab soravtansine discontinuation in a small percentage of patients.
• Pulmonary toxicity: Severe, life-threatening, or fatal interstitial lung disease, including pneumonitis, may occur with mirvetuximab soravtansine. Pneumonitis occurred in 10% of patients, including rare grade 3 and 4 events. Cases of fatalities due to respiratory failure were reported, either in the setting of pneumonitis and lung metastases or secondary to an unknown etiology. Pneumonitis resulted in permanent discontinuation in a small percentage of patients. Signs/symptoms of pneumonitis may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams.
Other warnings/precautions:
• Appropriate use: Select patients for treatment based on folate receptor-alpha (FR-alpha) tumor expression. Information on approved tests for measurement of FR-alpha expression may be found at http://www.fda.gov/companiondiagnostics.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Elahere: Mirvetuximab soravtansine-gynx 100 mg/20 mL (20 mL)
No
Solution (Elahere Intravenous)
100 mg/20 mL (per mL): $397.99
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mirvetuximab soravtansine is available through specialty pharmacies/distributors and various specialty institutions/accounts. Examples from the manufacturer may be found at https://www.elaherehcp.com/pdf/elahere-ordering-information-sheet.pdf.
IV: Administer as an IV infusion only, using a 0.2- or 0.22-micron polyethersulfone (PES) in-line filter. Do not substitute other membrane materials. Visually inspect infusion bag for particulate matter and discoloration prior to administration. Administer premedications prior to mirvetuximab soravtansine administration. If refrigerated, allow the infusion bag to reach room temperature prior to administration.
Administer the initial dose at a rate of 1 mg/minute. If 30 minutes at a rate of 1 mg/minute is well tolerated, increase infusion rate to 3 mg/minute. If 30 minutes at 3 mg/minute is well tolerated, increase infusion rate to 5 mg/minute. If no infusion-related reactions occur with the previous dose, subsequent infusions should be started at the maximally tolerated rate and may be increased up to a maximum infusion rate of 5 mg/minute, as tolerated. Flush infusion line with D5W after infusion to ensure delivery of the dose; do not use any other IV fluids for flushing.
Mirvetuximab soravtansine is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf#page=24, must be dispensed with this medication.
Ovarian cancer, platinum-resistant, folate receptor-alpha positive (epithelial ovarian, fallopian tube, or primary peritoneal cancer): Treatment of folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have received one to three prior systemic treatment regimens (select patients for therapy based on an approved test).
Elahere may be confused with Enhertu.
Mirvetuximab soravtansine may be confused with brentuximab vedotin, cetuximab, margetuximab, mirikizumab, mogamulizumab, mosunetuzumab, moxetumomab pasudotox, rituximab, siltuximab, ublituximab.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP3A4 (Minor), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase serum concentration of Mirvetuximab Soravtansine. Risk C: Monitor
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Verify pregnancy status prior to treatment initiation in patients who could become pregnant.
Patients who could become pregnant should use effective contraception during therapy and for 7 months after the last mirvetuximab soravtansine dose.
Animal reproduction studies have not been conducted.
Based on the mechanism of action, in utero exposure to mirvetuximab soravtansine may cause fetal harm. Mirvetuximab soravtansine is an antibody-drug conjugate that includes a monoclonal antibody component (IgG) and a small molecule anti-tubulin agent DM4. DM4 is genotoxic and acts on actively dividing cells. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
It is not known if mirvetuximab soravtansine is present in breast milk.
Mirvetuximab soravtansine is an antibody-drug conjugate that includes a monoclonal antibody component (IgG). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued during therapy and for 1 month after the last mirvetuximab soravtansine dose.
Folate receptor-alpha tumor expression. CBC with differential and serum chemistries (as clinically indicated). Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Monitor for ocular toxicity (promptly refer to an eye care professional for new or worsening ocular signs and symptoms). Monitor for signs/symptoms of pneumonitis (eg, hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams); assess appropriately to rule out other causes of pulmonary symptoms (eg, infectious, neoplastic, and/or other causes). Monitor for signs/symptoms of neuropathy (eg, paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia). Monitor for signs/symptoms of infusion reactions.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Mirvetuximab soravtansine is an antibody-drug conjugate which consists of 3 components, a folate receptor alpha (FRα)-directed monoclonal antibody (IgG1 subtype), a small molecule anti-tubulin agent DM4 (a maytansine derivative), and a linker that covalently attaches DM4 to the mirvetuximab antibody. The antibody portion is a chimeric IgG1 directed against folate receptor alpha (FRα); DM4 is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine is internalized and then intracellularly releases DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptosis.
Pharmacokinetic note: Dosing based on adjusted ideal body weight reduced exposure variability for patients who are either underweight or overweight.
Distribution: Vdss: 2.6 L.
Protein binding: DM4 and S-methyl DM4: >99%; to plasma proteins.
Metabolism: The monoclonal antibody portion of mirvetuximab soravtansine is expected to be catabolized into small peptides. Unconjugated DM4 and S-methyl DM4 undergo hepatic metabolism via CYP3A4; DM4 and S-methyl DM4 are the main circulating metabolites, accounting for ~0.4% and ~1.4%, of mirvetuximab soravtansine AUC’s, respectively.
Half-life elimination: Mirvetuximab soravtansine: 4.8 days; unconjugated DM4 (metabolite): 2.8 days; S-methyl DM4 (metabolite): 5 days.
Time to peak: Mirvetuximab soravtansine: Near the end of infusion; unconjugated DM4 (metabolite): second day after administration; S-methyl DM4 (metabolite): ~3 days after administration.
Excretion: S-methyl DM4 and DM4-sulfo-SPDB-lysine are the main metabolites detected in urine within 24 hours of infusion.
Clearance: Mirvetuximab soravtansine: 19 mL/hour; unconjugated DM4 (metabolite): 14 L/hour; S-methyl DM4 (metabolite): 4.3 L/hour.
