pharmacopeia
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Boxed warning

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.

Mechanism of action

Sourced from openFDA

Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα).

Indications

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  • ELAHERE ® 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 )].

Contraindications

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  • None. None.contraindicated

Dosage & administration

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Administer ELAHERE as an intravenous infusion only after dilution in 5% Dextrose Injection, USP. ELAHERE is incompatible with normal saline. ( 2.5 ) The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight administered as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. ( 2.2 ) Premedicate with a corticosteroid, antihistamine, and antipyretic. ( 2.3 ) Premedicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops. ( 2.3 , 5.1 ) See full Prescribing Information for preparation and administration instructions and dose modifications for adverse reactions. ( 2 ) 2.1 Patient Selection Select patients for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with ELAHERE based on the presence of FRα tumor expression [see Indications & Usage ( 1 ) and Clinical Studies ( 14 )] using an FDA-approved test. Information on FDA-approved tests for the measurement of FRα tumor expression is available at http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage The recommended dosage of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity [see Dosage and Administration ( 2.5 )]. Dosing based on AIBW reduces exposure variability for patients who are either under or overweight.

Warnings & precautions

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Pneumonitis: Withhold ELAHERE for persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue ELAHERE for Grade 3 or 4 pneumonitis. ( 2.4 , 5.2 ) Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of peripheral neuropathy. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity: ELAHERE can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Ocular Disorders ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis. Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%). [see Adverse Reactions ( 6.1 )]. The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed elsewhere in the labeling: Ocular Disorders [see Warnings and Precautions ( 5.1 )] . Pneumonitis [see Warnings and Precautions ( 5.2 )] . Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] . The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in Warnings and Precautions reflect exposure to ELAHERE in 682 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer at 6 mg/kg AIBW administered intravenously once every 3 weeks until disease progression or unacceptable toxicity in Study 0416, Study 0417, Study 0403 (NCT02631876), and Study 0401 (NCT01609556).

Use in specific populations

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Lactation: Advise not to breastfeed. ( 8.2 ) Moderate or severe hepatic impairment: Avoid use. ( 8.7 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, ELAHERE has the potential to be transmitted from the mother to the developing fetus. There are no available human data on ELAHERE use in pregnant women to inform a drug-associated risk. No reproductive or developmental animal toxicity studies were conducted with mirvetuximab soravtansine-gynx. Advise patients of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data: No reproductive or developmental animal toxicity studies have been conducted with mirvetuximab soravtansine-gynx.

Pharmacokinetics

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Metabolism
The pharmacokinetics were characterized in patients who received mirvetuximab soravtansine-gynx 0.16 mg/kg to 8.7 mg/kg adjusted ideal body weight (AIBW) (0.03 times to 1.4 times the approved recommended dose of 6 mg/kg AIBW), unless otherwise noted. Table 8 summarizes the exposure parameters of mirvetuximab soravtansine-gynx, unconjugated DM4, and its metabolite S-methyl-DM4 following administration after the first cycle (3-weeks).

Approval history

Sourced from openFDA
  • Nov 14, 2022BLABLA761310Immunogen Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,457 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Neuropathy Peripheral1107.5%
  2. 2Vision Blurred1067.3%
  3. 3Death906.2%
  4. 4Diarrhoea906.2%
  5. 5Abdominal Pain886.0%
  6. 6Cataract795.4%
  7. 7Pneumonitis775.3%
  8. 8Nausea735.0%
  9. 9Disease Progression694.7%
  10. 10Dry Eye533.6%
  11. 11Fatigue523.6%
  12. 12Keratitis513.5%
  13. 13Visual Impairment483.3%
  14. 14Vomiting483.3%
  15. 15Keratopathy453.1%

Literature

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Recent PubMed references pinned to Mirvetuximab Soravtansine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 27 ClinicalTrials.gov registrations naming Mirvetuximab Soravtansine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Mirvetuximab Soravtansine work?
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα).
What is Mirvetuximab Soravtansine used for?
According to FDA labeling, Mirvetuximab Soravtansine carries indications including: ELAHERE ® 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 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Mirvetuximab Soravtansine?
Mirvetuximab Soravtansine is classified as Other monoclonal antibodies and antibody drug conjugates, Antibody-Receptor Interactions, Microtubule Inhibition.
What are the brand names for Mirvetuximab Soravtansine?
Mirvetuximab Soravtansine is marketed under brand names including Elahere.
What are the contraindications for Mirvetuximab Soravtansine?
Mirvetuximab Soravtansine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for mirvetuximab-soravtansine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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