Mirvetuximab soravtansine

What is Mirvetuximab soravtansine?

Mirvetuximab soravtansine (Elahere) is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC) consisting of three components:

• 1) an anti-FRα monoclonal antibody of IgG1 subtype
• 2) the small molecule anti-tubulin agent DM4 (a maytansine derivative) and
• 3) a linker, sulfo-SPDB (1-(2,5-dioxopyrrolidin-1-yl)oxy-1-oxo-4-(pyridin-2-yldisulfanyl)butane-2-sulfonic acid) that covalently attaches DM4 to the mirvetuximab antibody.

Mirvetuximab soravtansine

Mirvetuximab soravtansine structure

What are the uses of this medicine?

Mirvetuximab soravtansine (Elahere) is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:

• have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
• have received 1 to 3 prior types of chemotherapy.

How does this medicine work?

• 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 sulfo-SPDB linker prevents cleavage in the bloodstream and may improve this agent’s efficacy in multidrug resistant tumor cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Mirvetuximab soravtansine was approved for medical use in the United States in November 2022.
• The US Food and Drug Administration considers it to be a first-in-class medication.

How should this medicine be used?

• 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 using an FDA-approved test.
• Premedicate with a corticosteroid, antihistamine, and antipyretic.
• Premedicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops.

Recommended dosage:

• 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.

Administration:

• Elahere will be given to you by infusion into your vein (intravenous).
• Before each dose of Elahere you will receive medicines to help prevent infusion related reactions, nausea, and vomiting.
• Elahere is usually given every 3 weeks (21-day cycle).
• Your healthcare provider will decide how many cycles you need.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/20 mL (5 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Elahere

What side effects can this medication cause?

The most common side effects of this medicine may include:

• feeling tired
• increased liver enzymes in the blood
• nausea
• stomach-area (abdominal) pain
• decreased red or white blood cell counts
• diarrhea
• decreased albumin level in the blood
• constipation
• decreased magnesium level in the blood

Less common, but serious side effects may include:

• Eye problems
• Lung problems (pneumonitis)
• Peripheral neuropathy

What special precautions should I follow?

• LAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis. Advise patients to contact their healthcare provider promptly if they experience any visual changes. Advise patients to use steroid eye drops and artificial tear substitutes.
• Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with Elahere. Advise patients to immediately report new or worsening respiratory symptoms.
• Peripheral neuropathy occurred in patients with ovarian cancer treated with Elahere. Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening peripheral neuropathy, withhold dosage, dose reduce, or permanently discontinue Elahere based on the severity of peripheral neuropathy.
• 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. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Elahere and for 7 months after the last dose.
• Advise women not to breastfeed during treatment with Elahere and for 1 month after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in 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.
• Elahere can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Elahere.
• Your healthcare provider should do a pregnancy test before you start treatment with Elahere.
• You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of Elahere.

Can this medicine be used in children?

• Safety and effectiveness of Elahere have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mirvetuximab soravtansine-gynx
• Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection.

Who manufactures and distributes this medicine?

Manufactured by: ImmunoGen, Inc., Waltham, MA

What should I know about storage and disposal of this medication?

• Store Elahere vials upright in a refrigerator at 2°C to 8°C (36°F to 46°F) until the time of preparation in the original carton to protect from light.
• Do not freeze or shake.
• Elahere is a hazardous drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Mirvetuximab soravtansine
• FDA Mirvetuximab soravtansine

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