
Mirvetuximab Soravtansine is an immunoconjugate consisting of the humanized monoclonal antibody M9346A against folate receptor 1 (FOLR1) conjugated, via the disulfide-containing cleavable linker sulfo-SPDB, to the cytotoxic maytansinoid DM4, with potential antineoplastic activity. The anti-FOLR1 monoclonal antibody moiety of mirvetuximab soravtansine targets and binds to the cell surface antigen FOLR1. After antibody-antigen interaction and internalization, the immunoconjugate releases DM4, which binds to tubulin and disrupts microtubule assembly/disassembly dynamics, thereby inhibiting cell division and cell growth of FOLR1-expressing tumor cells. FOLR1, a member of the folate receptor family is overexpressed on a variety of epithelial-derived cancer cells. The sulfur-SPDB linker prevents cleavage in the bloodstream and may improve this agent’s efficacy in multidrug-resistant tumor cells.
Mirvetuximab soravtansine-gynx (IMGN853) is an antibody-drug conjugate (ADC) formed by a monoclonal antibody (M9346A) that targets folate receptor alpha (FRα), covalently joined by a cleavable disulfide linker to the genotoxic compound DM4 (also known as soravtansine or ravtansine).[rx],[rx]DM4 is conjugated to the antibody with a drug-to-antibody ratio of 3.5:1.[rx]
The antibody component of mirvetuximab soravtansine-gynx binds to FRα, a receptor overexpressed on the surface of epithelial tumor cells, characteristic of ovarian, endometrial, triple-negative breast, and non-small-cell lung cancers.[rx] After an ADC/receptor complex is formed, mirvetuximab soravtansine-gynx is internalized, and DM4 is released inside the cell. DM4 leads to cell-cycle arrest and apoptosis and is also able to diffuse into neighboring cells and induce further cell death.[rx]
On November 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for the treatment of adult patients with FRα–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens. This decision was supported by findings from the phase 3 SORAYA trial (NCT04296890).[rx],[rx]
Mechanism of action
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC) formed by three components: a chimeric IgG1 antibody against folate receptor alpha (FRα), the small molecule anti-tubulin agent DM4 (a maytansine derivative) and a sulfo-SPDB linker that joins DM4 to the mirvetuximab antibody.[rx] FRα is expressed on the cell surface and has a restricted distribution in normal tissues. However, abnormally high levels of FRα have been detected in serous and endometrioid epithelial ovarian cancer, endometrial adenocarcinoma, and non–small cell lung cancer of the adenocarcinoma subtype. In ovarian cancer patients, its expression is maintained in metastatic foci and recurrent carcinomas.[rx] Mirvetuximab soravtansine-gynx binds with high affinity to FRα and is then internalized through antigen-mediated endocytosis. Inside FRα-expressing tumor cells, DM4 is released via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, leading to cell cycle arrest and apoptosis.[rx,rx] Since DM4 is electrically neutral and lipophilic, it is able to diffuse across cell membranes and lead to the death of neighboring antigen-negative cells. This “bystander effect” is an important component of mirvetuximab soravtansine-gynx, allowing it to exert a cytotoxic effect even in cells that do not express FRα on their surface.[rx],[rx]
There is an exposure-response relationship for mirvetuximab soravtansine-gynx. The increased exposure of mirvetuximab soravtansine-gynx was associated with a higher incidence of ocular adverse reactions and peripheral neuropathy grade 2 or higher. Mirvetuximab soravtansine-gynx did not cause large QTc increases (>10 msec) at the approved recommended dose.[rx] The use of mirvetuximab soravtansine-gynx has been associated with severe ocular adverse reactions, such as visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, as well as peripheral neuropathy, may also occur in patients treated with mirvetuximab soravtansine-gynx. Since mirvetuximab soravtansine-gynx contains DM4, a genotoxic compound, the use of this drug may cause embryo-fetal harm in pregnant women.[rx]
Indications
- Mirvetuximab soravtansine 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. Patients are selected for therapy based on an FDA-approved test.[rx]
- Mirvetuximab soravtansine is a folate receptor alpha-directed antibody and microtubule inhibitor conjugate used to treat folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.[rx]
- Mirvetuximab soravtansine is indicated for the treatment of adults 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.[rx][rx] Recipients are selected for therapy based on an FDA-approved test
- Platinum-Resistant Primary Peritoneal Cancer
- Platinum-resistant Epithelial Ovarian Cancer
- Platinum drug-resistant Fallopian tube cancer
Use in Cancer
Mirvetuximab soravtansine-gynx is approved to treat:
- The ovarian epithelial, fallopian tube, or primary peritoneal cancer that is folate receptor–alpha positive. It is used in adults whose cancer did not respond to or is no longer responding to platinum chemotherapy and who have received one to three types of systemic therapy.
Mirvetuximab soravtansine-gynx is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that it provides a clinical benefit in these patients. Mirvetuximab soravtansine-gynx is also being studied in the treatment of other types of cancer.
Contraindications
- a painful condition that affects the nerves in the legs and arms called peripheral neuropathy
- pregnancy
- a patient who is producing milk and breastfeeding
Dosage
Strengths: gynx 100 mg/20 mL
Ovarian Cancer
- Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
- This indication is granted accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Confirm the presence of folate receptor alpha tumor expression prior to initiation of treatment.
- Information regarding FDA-approved tests for folate receptor alpha tumors is available at http://www.fda.gov/CompanionDiagnostics.
- Refer to manufacturer product information for AIBW calculation.
- Administer premedications (corticosteroid, antihistamine, antipyretic, antiemetic) before each infusion of this drug to reduce the incidence of severity of infusion-related reactions (IRRs), nausea, and vomiting.
- Refer to the manufacturer’s product labeling for more information on the dosing of premedications.
- Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with folate receptor alpha-positive tumor expression who have previously received one to three lines of systemic treatments.
Fallopian Tube Cancer
- Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
- This indication is granted accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Confirm the presence of folate receptor alpha tumor expression prior to initiation of treatment.
- Information regarding FDA-approved tests for folate receptor alpha tumors is available at http://www.fda.gov/CompanionDiagnostics.
- Refer to manufacturer product information for AIBW calculation.
- Administer premedications (corticosteroid, antihistamine, antipyretic, antiemetic) before each infusion of this drug to reduce the incidence of severity of infusion-related reactions (IRRs), nausea, and vomiting.
- Refer to the manufacturer’s product labeling for more information on the dosing of premedications.
- Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with folate receptor alpha-positive tumor expression who have previously received one to three lines of systemic treatments
Peritoneal Cancer
- Usual dose: 6 mg/kg adjusted ideal body weight (AIBW) as an IV infusion once every 3 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
- This indication is granted accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Confirm the presence of folate receptor alpha tumor expression prior to initiation of treatment.
- Information regarding FDA-approved tests for folate receptor alpha tumors is available at http://www.fda.gov/CompanionDiagnostics.
- Refer to manufacturer product information for AIBW calculation.
- Administer premedications (corticosteroid, antihistamine, antipyretic, antiemetic) before each infusion of this drug to reduce the incidence of severity of infusion-related reactions (IRRs), nausea, and vomiting.
- Refer to the manufacturer’s product labeling for more information on the dosing of premedications.
- Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with folate receptor alpha-positive tumor expression who have previously received one to three lines of systemic treatments.
Dose Adjustments
DOSE REDUCTION FOR ADVERSE REACTIONS:
- Starting dose: 6 mg/kg AIBW
- First dose reduction: 5 mg/kg AIBW
- Second dose reduction: 4 mg/kg AIBW
- This drug should be discontinued permanently in patients who cannot tolerate 4 mg/kg AIBW dose.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
Keratitis/Keratopathy:
- Nonconfluent superficial keratitis: Monitor
- Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity: Withhold dose 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 the dose until improved or resolved, then resume at one lower dose level.
- Corneal perforation: Discontinue the drug permanently.
Uveitis:
- Grade 1/Rare cell in anterior chamber: Monitor
- Grade 2/1-2+ Cell or Flare in anterior chamber: Withhold the dose until severity reduces to grade 1 or less, then maintain dose at same dose level.
- Grade 3/3+ Cell or Flare in anterior chamber: Withhold the dose until severity reduces to grade 1 or less, then resume at one lower dose level.
- Grade 4/Hypopyon: Discontinue the drug permanently.
Pneumonitis:
- Grade 1: Monitor
- Grade 2: Withhold the dose until severity reduces to grade 1 or less, then maintain the same dose or consider dose reduction by one dose level
- Grade 3 or 4: Discontinue the drug permanently.
Infusion-Related Reactions/Hypersensitivity:
- Grade 1: Maintain infusion rate
- Grade 2:
- Interrupt infusion and administer supportive treatment.
- Post recovery from symptoms, resume the infusion at 50% of the previous rate, and if no further symptoms develop, consider increasing the infusion rate as appropriate until the completion.
- Administer additional premedication for future cycles.
- Grade 3 or 4:
- Immediately stop infusion and administer supportive treatment.
- Advise patients to seek emergency treatment and notify their healthcare provider, promptly, if the infusion-related symptoms reappear.
- Discontinue the drug permanently.
Other adverse reactions:
- Grade 3: Withhold the dose until severity reduces to grade 1 or less, then resume at one lower dose level.
- Grade 4: Discontinue the drug permanently.
Administration advice:
- The infusion bag should be visually inspected for particulate matter and discoloration prior to administration.
- Pre-medications should be administered before administering this drug.
- For IV administration only; 0.2 or 0.22-micron polyethersulfone (PES) in-line filter should be used and must not be substituted with any other filter.
- The initial dose should be administered as an IV infusion at the rate of 1 mg/min; If well tolerated after 30 minutes, the infusion rate can be increased to 3 mg/min; If well tolerated after 30 minutes, the infusion rate can be increased to 5 mg/min.
- If the patient does not experience any infusion-related reactions with the previous dose, the subsequent infusions can be administered at a maximum infusion rate of 5 mg/min, as tolerated.
- After infusion, the infusion line should be flushed with 5% dextrose injection, USP to ensure full delivery of dose; Other IV fluids are not compatible with this drug and must not be used for flushing.
Reconstitution/preparation techniques:
- This drug is hazardous. Follow appropriate handling and disposal procedures.
- Refer to manufacturer product information for reconstitution/preparation techniques.
IV compatibility:
- This drug is incompatible with 0.9% sodium chloride injection.
- This should not be mixed with any other drug or intravenous fluid.
Patient advice:
- Patients should read the FDA-approved drug product labeling.
- Patients should be informed about possible ocular toxicities and the need for an eye examination before initiating and during the treatment.
- If a patient experiences any ocular discomfort, immediately contact the health care provider.
- Patients should take prophylactic care of their eyes by using steroid eye drops and artificial tear substitutes.
- Patients should immediately report any new or worsening respiratory symptoms to their healthcare provider.
- Females of childbearing potential or pregnant women should be apprised of the potential risk to a fetus.
- Inform health care provider in case of known or suspected pregnancy.
- Females of childbearing potential should use an effective method of contraception during the treatment and for 7 months after the last dose.
- Women should not breastfeed during treatment and for 1 month after the last dose.
Side Effects
The Most Common
- feeling tired
- diarrhea
- nausea
- abdominal pain
- constipation
- muscle weakness or spasms
- trouble breathing, cough, shortness of breath, or chest pain
- new or worsening tingling or numbness in your hands or feet or muscle weakness
More Common
- dry eyes, sensitivity to light, blurred vision, eye pain, or new or worsening vision changes;
- cough, chest pain, trouble breathing, shortness of breath; or
- numbness, tingling, or burning pain in your hands or feet.
- abnormal lab results;
- nausea, stomach pain, diarrhea, constipation;
- fever, mouth sores, skin sores, sore throat, cough; or
- pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.
Rare
- vision impairment,
- fatigue,
- increased aspartate aminotransferase,
- nausea,
- increased alanine aminotransferase,
- keratopathy,
- abdominal pain,
- decreased lymphocytes,
- peripheral neuropathy,
- diarrhea,
- decreased albumin,
- constipation,
- increased alkaline phosphatase,
- dry eye,
- decreased magnesium,
- decreased leukocytes,
- decreased neutrophils,
- decreased hemoglobin.[rx]
Drug Interactions
DRUG | INTERACTION |
---|---|
Abciximab | The risk or severity of adverse effects can be increased when Abciximab is combined with Mirvetuximab Soravtansine. |
Adalimumab | The risk or severity of adverse effects can be increased when Adalimumab is combined with Mirvetuximab Soravtansine. |
Aducanumab | The risk or severity of adverse effects can be increased when Aducanumab is combined with Mirvetuximab Soravtansine. |
Alemtuzumab | The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Mirvetuximab Soravtansine. |
Alirocumab | The risk or severity of adverse effects can be increased when Alirocumab is combined with Mirvetuximab Soravtansine. |
Amiodarone | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Amiodarone. |
Amivantamab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Amivantamab. |
Amprenavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Amprenavir. |
Anifrolumab | The risk or severity of adverse effects can be increased when Anifrolumab is combined with Mirvetuximab Soravtansine. |
Ansuvimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Ansuvimab. |
Anthrax immune globulin human | The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Mirvetuximab Soravtansine. |
Antilymphocyte immunoglobulin (horse) | The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Mirvetuximab Soravtansine. |
Antithymocyte immunoglobulin (rabbit) | The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Mirvetuximab Soravtansine. |
Articaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Articaine. |
Asfotase alfa | The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Mirvetuximab Soravtansine. |
Atazanavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Atazanavir. |
Atezolizumab | The risk or severity of adverse effects can be increased when Atezolizumab is combined with Mirvetuximab Soravtansine. |
Atoltivimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Atoltivimab. |
Avelumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Mirvetuximab Soravtansine. |
Bamlanivimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Bamlanivimab. |
Basiliximab | The risk or severity of adverse effects can be increased when Basiliximab is combined with Mirvetuximab Soravtansine. |
Belantamab mafodotin | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Belantamab mafodotin. |
Belimumab | The risk or severity of adverse effects can be increased when Belimumab is combined with Mirvetuximab Soravtansine. |
Benralizumab | The risk or severity of adverse effects can be increased when Benralizumab is combined with Mirvetuximab Soravtansine. |
Benzocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Benzocaine. |
Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Benzyl alcohol. |
Besilesomab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Besilesomab. |
Bevacizumab | The risk or severity of adverse effects can be increased when Bevacizumab is combined with Mirvetuximab Soravtansine. |
Bezlotoxumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Bezlotoxumab. |
Bimekizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Bimekizumab. |
Blinatumomab | The risk or severity of adverse effects can be increased when Blinatumomab is combined with Mirvetuximab Soravtansine. |
Boceprevir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Boceprevir. |
Brentuximab vedotin | The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Mirvetuximab Soravtansine. |
Brodalumab | The risk or severity of adverse effects can be increased when Brodalumab is combined with Mirvetuximab Soravtansine. |
Brolucizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Brolucizumab. |
Bupivacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Bupivacaine. |
Burosumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Burosumab. |
Butacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Butacaine. |
Butamben | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Butamben. |
Canakinumab | The risk or severity of adverse effects can be increased when Canakinumab is combined with Mirvetuximab Soravtansine. |
Caplacizumab | The risk or severity of adverse effects can be increased when Caplacizumab is combined with Mirvetuximab Soravtansine. |
Capromab pendetide | The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Mirvetuximab Soravtansine. |
Capsaicin | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Capsaicin. |
Casirivimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Casirivimab. |
Catumaxomab | The risk or severity of adverse effects can be increased when Catumaxomab is combined with Mirvetuximab Soravtansine. |
Cemiplimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Cemiplimab. |
Certolizumab pegol | The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Mirvetuximab Soravtansine. |
Cetuximab | The risk or severity of adverse effects can be increased when Cetuximab is combined with Mirvetuximab Soravtansine. |
Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Chloroprocaine. |
Cilgavimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Cilgavimab. |
Cinchocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Cinchocaine. |
Clarithromycin | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Clarithromycin. |
Cobicistat | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Cobicistat. |
Cocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Cocaine. |
Conivaptan | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Conivaptan. |
Conjugated estrogens | Conjugated estrogens may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Curcumin | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Curcumin. |
Danazol | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Danazol. |
Daratumumab | The risk or severity of adverse effects can be increased when Daratumumab is combined with Mirvetuximab Soravtansine. |
Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mirvetuximab Soravtansine. |
Darunavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Darunavir. |
Delavirdine | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Delavirdine. |
Denosumab | The risk or severity of adverse effects can be increased when Denosumab is combined with Mirvetuximab Soravtansine. |
Dienestrol | Dienestrol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Diethylstilbestrol | Diethylstilbestrol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Digoxin Immune Fab (Ovine) | The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Mirvetuximab Soravtansine. |
Dinutuximab | The risk or severity of adverse effects can be increased when Dinutuximab is combined with Mirvetuximab Soravtansine. |
Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Diphenhydramine. |
Dostarlimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Dostarlimab. |
Dulaglutide | The risk or severity of adverse effects can be increased when Dulaglutide is combined with Mirvetuximab Soravtansine. |
Dupilumab | The risk or severity of adverse effects can be increased when Dupilumab is combined with Mirvetuximab Soravtansine. |
Durvalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Mirvetuximab Soravtansine. |
Dyclonine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Dyclonine. |
Ebola Zaire vaccine (live, attenuated) | The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Mirvetuximab Soravtansine. |
Econazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Econazole. |
Eculizumab | The risk or severity of adverse effects can be increased when Eculizumab is combined with Mirvetuximab Soravtansine. |
Efalizumab | The risk or severity of adverse effects can be increased when Efalizumab is combined with Mirvetuximab Soravtansine. |
Efavirenz | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Efavirenz. |
Eflapegrastim | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Eflapegrastim. |
Eftrenonacog alfa | The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Mirvetuximab Soravtansine. |
Elotuzumab | The risk or severity of adverse effects can be increased when Elotuzumab is combined with Mirvetuximab Soravtansine. |
Elvitegravir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Elvitegravir. |
Emapalumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Emapalumab. |
Emicizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Emicizumab. |
Eptinezumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Eptinezumab. |
Erenumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Erenumab. |
Ergotamine | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Ergotamine. |
Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Mirvetuximab Soravtansine. |
Esterified estrogens | Esterified estrogens may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estetrol | Estetrol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estradiol | Estradiol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estradiol acetate | Estradiol acetate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estradiol benzoate | Estradiol benzoate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estradiol cypionate | Estradiol cypionate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estradiol valerate | Estradiol valerate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estriol | Estriol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estrone | Estrone may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Estrone sulfate | Estrone sulfate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Ethinylestradiol | Ethinylestradiol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Ethyl chloride. |
Etidocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Etidocaine. |
Evolocumab | The risk or severity of adverse effects can be increased when Evolocumab is combined with Mirvetuximab Soravtansine. |
Fanolesomab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Fanolesomab. |
Fremanezumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Fremanezumab. |
Galcanezumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Galcanezumab. |
Gemtuzumab ozogamicin | The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Mirvetuximab Soravtansine. |
Glofitamab | The risk or severity of adverse effects can be increased when Mirvetuximab soravtansine is combined with Glofitamab. |
Golimumab | The risk or severity of adverse effects can be increased when Golimumab is combined with Mirvetuximab Soravtansine. |
Guselkumab | The risk or severity of adverse effects can be increased when Guselkumab is combined with Mirvetuximab Soravtansine. |
Hepatitis B immune globulin | The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Mirvetuximab Soravtansine. |
Human cytomegalovirus immune globulin | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Human cytomegalovirus immune globulin. |
Human immunoglobulin G | The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Mirvetuximab Soravtansine. |
Human Rho(D) immune globulin | The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Mirvetuximab Soravtansine. |
Human varicella-zoster immune globulin | The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Mirvetuximab Soravtansine. |
Ibalizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Ibalizumab. |
Ibritumomab tiuxetan | The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Mirvetuximab Soravtansine. |
Idarucizumab | The risk or severity of adverse effects can be increased when Idarucizumab is combined with Mirvetuximab Soravtansine. |
Imdevimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Imdevimab. |
Imlifidase | The therapeutic efficacy of Mirvetuximab Soravtansine can be decreased when used in combination with Imlifidase. |
Indinavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Indinavir. |
Inebilizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Inebilizumab. |
Infliximab | The risk or severity of adverse effects can be increased when Infliximab is combined with Mirvetuximab Soravtansine. |
Inotuzumab ozogamicin | The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Mirvetuximab Soravtansine. |
Ipilimumab | The risk or severity of adverse effects can be increased when Ipilimumab is combined with Mirvetuximab Soravtansine. |
Isatuximab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Isatuximab. |
Itraconazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Itraconazole. |
Ixekizumab | The risk or severity of adverse effects can be increased when Ixekizumab is combined with Mirvetuximab Soravtansine. |
Ketoconazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Ketoconazole. |
Lanadelumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Lanadelumab. |
Lecanemab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Lecanemab. |
Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Levobupivacaine. |
Levoketoconazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Levoketoconazole. |
Lidocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Lidocaine. |
Lonafarnib | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Lonafarnib. |
Loncastuximab tesirine | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Loncastuximab tesirine. |
Lopinavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Lopinavir. |
Maftivimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Maftivimab. |
Margetuximab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Margetuximab. |
Meloxicam | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Meloxicam. |
Mepivacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Mepivacaine. |
Mepolizumab | The risk or severity of adverse effects can be increased when Mepolizumab is combined with Mirvetuximab Soravtansine. |
Mestranol | Mestranol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Methimazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Methimazole. |
Methoxy polyethylene glycol-epoetin beta | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Mirvetuximab Soravtansine. |
Midostaurin | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Midostaurin. |
Mogamulizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Mogamulizumab. |
Mosunetuzumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Mosunetuzumab. |
Muromonab | The risk or severity of adverse effects can be increased when Muromonab is combined with Mirvetuximab Soravtansine. |
Natalizumab | The risk or severity of adverse effects can be increased when Natalizumab is combined with Mirvetuximab Soravtansine. |
Necitumumab | The risk or severity of adverse effects can be increased when Necitumumab is combined with Mirvetuximab Soravtansine. |
Nefazodone | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Nefazodone. |
Nelfinavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Nelfinavir. |
Nilotinib | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Nilotinib. |
Nivolumab | The risk or severity of adverse effects can be increased when Nivolumab is combined with Mirvetuximab Soravtansine. |
Obiltoxaximab | The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Mirvetuximab Soravtansine. |
Obinutuzumab | The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Mirvetuximab Soravtansine. |
Ocrelizumab | The risk or severity of adverse effects can be increased when Ocrelizumab is combined with Mirvetuximab Soravtansine. |
Odesivimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Odesivimab. |
Ofatumumab | The risk or severity of adverse effects can be increased when Ofatumumab is combined with Mirvetuximab Soravtansine. |
Olaratumab | The risk or severity of adverse effects can be increased when Olaratumab is combined with Mirvetuximab Soravtansine. |
Omalizumab | The risk or severity of adverse effects can be increased when Omalizumab is combined with Mirvetuximab Soravtansine. |
Oxetacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Oxetacaine. |
Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Oxybuprocaine. |
Palivizumab | The risk or severity of adverse effects can be increased when Palivizumab is combined with Mirvetuximab Soravtansine. |
Panitumumab | The risk or severity of adverse effects can be increased when Panitumumab is combined with Mirvetuximab Soravtansine. |
Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Mirvetuximab Soravtansine. |
Pembrolizumab | The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Mirvetuximab Soravtansine. |
Pertuzumab | The risk or severity of adverse effects can be increased when Pertuzumab is combined with Mirvetuximab Soravtansine. |
Phenol | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Phenol. |
Polatuzumab vedotin | The risk or severity of adverse effects can be increased when Polatuzumab vedotin is combined with Mirvetuximab Soravtansine. |
Polyestradiol phosphate | Polyestradiol phosphate may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Posaconazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Posaconazole. |
Pramocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Pramocaine. |
Prilocaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Prilocaine. |
Procaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Procaine. |
Proparacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Proparacaine. |
Propoxycaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Propoxycaine. |
Quinestrol | Quinestrol may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Ramucirumab | The risk or severity of adverse effects can be increased when Ramucirumab is combined with Mirvetuximab Soravtansine. |
Ranibizumab | The risk or severity of adverse effects can be increased when Ranibizumab is combined with Mirvetuximab Soravtansine. |
Ravulizumab | The risk or severity of adverse effects can be increased when Ravulizumab is combined with Mirvetuximab Soravtansine. |
Raxibacumab | The risk or severity of adverse effects can be increased when Raxibacumab is combined with Mirvetuximab Soravtansine. |
Reslizumab | The risk or severity of adverse effects can be increased when Reslizumab is combined with Mirvetuximab Soravtansine. |
Ribociclib | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Ribociclib. |
Risankizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Risankizumab. |
Ritonavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Ritonavir. |
Rituximab | The risk or severity of adverse effects can be increased when Rituximab is combined with Mirvetuximab Soravtansine. |
Romosozumab | The risk or severity of adverse effects can be increased when Romosozumab is combined with Mirvetuximab Soravtansine. |
Ropivacaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Ropivacaine. |
Sacituzumab govitecan | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Sacituzumab govitecan. |
Saquinavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Saquinavir. |
Sarilumab | The risk or severity of adverse effects can be increased when Sarilumab is combined with Mirvetuximab Soravtansine. |
Secukinumab | The risk or severity of adverse effects can be increased when Secukinumab is combined with Mirvetuximab Soravtansine. |
Siltuximab | The risk or severity of adverse effects can be increased when Siltuximab is combined with Mirvetuximab Soravtansine. |
Sotrovimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Sotrovimab. |
Spesolimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Spesolimab. |
Stiripentol | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Stiripentol. |
Sulesomab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Sulesomab. |
Sutimlimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Sutimlimab. |
Synthetic Conjugated Estrogens, A | Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Synthetic Conjugated Estrogens, B | Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Tafasitamab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tafasitamab. |
Telaprevir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Telaprevir. |
Telithromycin | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Telithromycin. |
Teplizumab | The risk or severity of adverse effects can be increased when Teplizumab is combined with Mirvetuximab Soravtansine. |
Terfenadine | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Terfenadine. |
Tetanus immune globulin, human | The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Mirvetuximab Soravtansine. |
Tetracaine | The risk or severity of methemoglobinemia can be increased when Mirvetuximab Soravtansine is combined with Tetracaine. |
Tezepelumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tezepelumab. |
Tibolone | Tibolone may increase the thrombogenic activities of Mirvetuximab Soravtansine. |
Tildrakizumab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tildrakizumab. |
Tipranavir | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Tipranavir. |
Tisotumab vedotin | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tisotumab vedotin. |
Tixagevimab | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tixagevimab. |
Tocilizumab | The risk or severity of adverse effects can be increased when Tocilizumab is combined with Mirvetuximab Soravtansine. |
Tositumomab | The risk or severity of adverse effects can be increased when Tositumomab is combined with Mirvetuximab Soravtansine. |
Tralokinumab | The risk or severity of adverse effects can be increased when Tralokinumab is combined with Mirvetuximab Soravtansine. |
Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab is combined with Mirvetuximab Soravtansine. |
Trastuzumab deruxtecan | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Trastuzumab deruxtecan. |
Trastuzumab emtansine | The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Mirvetuximab Soravtansine. |
Tremelimumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mirvetuximab Soravtansine. |
Troleandomycin | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Troleandomycin. |
Ublituximab | The risk or severity of adverse effects can be increased when Ublituximab is combined with Mirvetuximab Soravtansine. |
Ustekinumab | The risk or severity of adverse effects can be increased when Ustekinumab is combined with Mirvetuximab Soravtansine. |
Vedolizumab | The risk or severity of adverse effects can be increased when Vedolizumab is combined with Mirvetuximab Soravtansine. |
Voriconazole | The serum concentration of Mirvetuximab Soravtansine can be increased when it is combined with Voriconazole. |
Pregnancy and Lactation
US FDA pregnancy category: Not assigned
Pregnancy
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, Nonclinical Toxicology. 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.
Lactation
No information is available on the clinical use of mirvetuximab soravtansine during breastfeeding. Because mirvetuximab is a large protein molecule with a molecular weight of 150,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant’s gastrointestinal tract and absorption by the infant is probably minimal. However, mirvetuximab is conjugated with the small-molecule toxin, mafodotin, which might be excreted into milk. The manufacturer recommends that breastfeeding be discontinued during therapy and for 1 month after the last dose.
Why is this medication prescribed?
Mirvetuximab soravtansine-gynx injection is used to treat certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (the tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Mirvetuximab soravtansine-gynx is in a class of medications called folate receptor alpha-directed antibodies and microtubule inhibitor conjugates. It works by killing cancer cells.
How should this medicine be used?
Mirvetuximab soravtansine-gynx injection comes as a solution (liquid) to be given by a doctor or nurse at a clinic or hospital as an intravenous (into the vein) infusion. It is usually given once every 3 weeks. Your doctor will decide how many cycles you should receive. Before each infusion of mirvetuximab soravtansine-gynx, you will receive medications to prevent infusion-related reactions, nausea and vomiting. Your doctor or nurse will monitor you during the infusion and may adjust the infusion rate or dose of the current infusion or any future infusion based on any side effects you may experience.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving mirvetuximab soravtansine-gynx injection,
- tell your doctor and pharmacist if you are allergic to mirvetuximab soravtansine-gynx, any other medications, or any of the ingredients in mirvetuximab soravtansine-gynx injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking mirvetuximab soravtansine-gynx injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had vision or eye problems or kidney or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving mirvetuximab soravtansine-gynx injection. You should use effective birth control to prevent pregnancy during your treatment with mirvetuximab soravtansine-gynx and for at least 7 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving mirvetuximab soravtansine-gynx, call your doctor immediately. Mirvetuximab soravtansine-gynx may harm the fetus.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving mirvetuximab soravtansine-gynx and for at least 1 month after your final dose.