Elahere 5 mg/mL intravenous solution

Generic name:
Mirvetuximab soravtansine - injection

Pronunciation
(MIR-ve-TUX-i-mab SOE-rav-TAN-seen)

Brand name(s)
Elahere

This medication may cause eye problems that can be serious (such as changes in vision, decreased/blurred vision, dry eyes, eye redness/pain, sensitivity to light). Your doctor will have you do eye exams before starting and during treatment with this medication. Your doctor may also prescribe eye medications or products (such as lubricant eye drops, steroids such as prednisolone) to lessen the risk or severity of eye problems. Tell your doctor right away if you have new or worsening eye symptoms.

This medication is used to treat certain cancers (such as epithelial ovarian, fallopian tube, primary peritoneal). Mirvetuximab soravtansine works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start using mirvetuximab soravtansine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually every 3 weeks. The injection is given by a health care professional. Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such shaking, chest tightness, chills, flushing, fast heartbeat, or dizziness.

The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.

See also Warning and How to Use sections.

Tiredness, nausea, vomiting, diarrhea or constipation, loss of appetite, abdominal pain, or muscle/joint pain may occur. Nausea and vomiting can be severe. Your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of lung problems (such as cough, shortness of breath)
• numbness/tingling/burning sensation (including in the arms or legs)
• muscle weakness
• change in sense of touch

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using mirvetuximab soravtansine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Mirvetuximab soravtansine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mirvetuximab soravtansine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may cause vision changes such as decreased or blurred vision. Do not drive, use machinery, or do anything that needs clear vision until you can do it safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mirvetuximab soravtansine. Mirvetuximab soravtansine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 7 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 month after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts, eye exams, kidney/liver function) should be done before starting and while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.