Mirvetuximab Soravtansine

Mirvetuximab Soravtansine is a prescription medication used for the treatment of ovarian cancer.

• Mirvetuximab Soravtansine is available under the following different brand names: Elahere, mirvetuximab Soravtansine-gynx

Common side effects of Mirvetuximab Soravtansine include:

• tiredness,
• diarrhea,
• nausea,
• stomach pain,
• constipation, and
• abnormal blood values (liver, albumin, magnesium and red or white blood cell counts)

Serious side effects of Mirvetuximab Soravtansine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• visual impairment,
• dry eye,
• photophobia,
• eye pain,
• redness of the eye,
• increased sensitivity to light,
• blurred vision,
• dark, floating spots in the vision (floaters),
• decreased vision,
• seeing halos around lights,
• slow heart rate,
• restlessness,
• anxiety,
• confusion,
• cough,
• shortness of breath,
• abnormal chest x-rays,
• tingling or burning sensation in the hands, arms, legs, or feet,
• numbness in the feet or hands,
• sharp, stabbing or throbbing pain,
• sensitivity to touch, and
• muscle weakness

Rare side effects of Mirvetuximab Soravtansine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 100 mg/20 mL (5 mg/mL)

Ovarian Cancer

Adult dosage

• 6 mg/kg adjusted ideal body weight (AIBW) IV every 3 weeks
• Continue until disease progression or unacceptable toxicity
• Calculate AIBW
  • AIBW = Ideal body weight (IBW [kg]) + 0.4 × (actual weight [kg] – IBW)
  • Female IBW (kg) = 0.9 × height (cm) – 92

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mirvetuximab Soravtansine has severe interactions with no other drugs.
• Mirvetuximab Soravtansine has serious interactions with no other drugs.
• Mirvetuximab Soravtansine has moderate interactions with at least 25 other drugs.
• Mirvetuximab Soravtansine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mirvetuximab Soravtansine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mirvetuximab Soravtansine?”

Cautions

• Severe, life-threatening, or fatal interstitial lung disease, including pneumonitis, may occur; monitor for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams; appropriately investigate to exclude infectious, neoplastic, and other causes for such symptoms
• Peripheral neuropathy commonly occurs; the median time to onset was 1.3 months after initiation; monitor for signs and symptoms of neuropathy (eg, paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, dysesthesia)
• Based on its mechanism of action, can cause embryo-fetal harm when administered to pregnant females
• Ocular disorders
  • Can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis
  • Ophthalmic examinations are required and premedication with lubricating and corticosteroid eye drops before administration
  • The median time to onset for the first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9 months)
  • Monitor for ocular toxicity and withhold, reduce, or permanently discontinue therapy based on the severity and persistence of ocular adverse reactions
  • Advise patients to avoid the use of contact lenses during treatment unless directed by a healthcare provider
  • Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms
• Drug interaction overview
  • DM4 is a CYP3A4 substrate
  • Strong CYP3A4 inhibitors
  • Closely monitor
    • Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of adverse reactions

Pregnancy and Lactation

• Based on its mechanism of action, can cause embryo-fetal harm when administered to pregnant females because it contains a genotoxic compound (DM4) and affects actively dividing cells
• Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, mirvetuximab Soravtansine has the potential to be transmitted from the mother to the developing fetus
• There are no available human data regarding use in pregnant females to inform a drug-associated risk
• No reproductive or developmental animal toxicity studies were conducted
• Advise patients of the potential risk to the fetus
• Verify pregnancy status in females of reproductive potential before initiating
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose
• Lactation
  • Data are not available regarding the presence in human milk or its effects on breastfed children or milk production
  • Advise females not to breastfeed during treatment and for 1 month after the last dose