Mirvetuximab soravtansine-gynx Injection

(mir" ve tux' i mab)

Brand Name(s): Elahere^®

IMPORTANT WARNING:

Mirvetuximab soravtansine-gynx may cause damage to your eyes. If you experience any of the following symptoms, call your doctor immediately: vision changes, dry eye, light sensitivity, eye pain, eye redness, excess tearing or discharge from the eye, difficulty opening the eyelid because of pain, blurred vision, or feeling like something is in your eye.

Keep all appointments with your doctor. Your doctor will send you for an eye exam before and during mirvetuximab soravtansine-gynx treatment to monitor your eyes during therapy.

Your doctor may give you eye drops to take before you start and during treatment with mirvetuximab soravtansine-gynx to reduce the risk of eye toxicity from occurring. You should avoid use of contact lenses during treatment with mirvetuximab unless told otherwise by your provider. If eye symptoms develop, your doctor may need to stop or change your mirvetuximab soravtansine-gynx treatment to prevent any further damage to the eyes.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mirvetuximab soravtansine-gynx injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Mirvetuximab soravtansine-gynx injection is used to treat certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (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 antibody and microtubule inhibitor conjugates. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Mirvetuximab soravtansine-gynx injection can cause serious infusion reactions. A doctor or nurse will watch you closely while you are receiving the infusion and after the infusion to be sure you are not having a serious reaction to the medication. Your doctor will probably treat you with other medications before and during each infusion to prevent infusion reactions. Tell your doctor or nurse if you experience any of the following symptoms during or after your infusion: rash; hives; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; or flushing. If you experience any of these symptoms, your doctor will slow down or stop your infusion and treat the symptoms of the reaction. If your reaction is severe, your healthcare provider may decide not to give you any more infusions of mirvetuximab soravtansine-gynx.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with mirvetuximab soravtansine-gynx injection.

Your doctor may give you medications to prevent nausea and vomiting before you receive each dose of mirvetuximab soravtansine-gynx injection.

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, numbness or tingling in your hands or feet, 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 must take a pregnancy test before starting treatment. and you should use effective birth control to prevent pregnancy during your treatment with mirvetuximab soravtansine-gynx and for 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.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a mirvetuximab soravtansine-gynx injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Mirvetuximab soravtansine-gynx injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• feeling tired
• diarrhea
• nausea
• vomiting
• decreased appetite
• abdominal pain
• constipation
• muscle weakness or spasms
• muscle, bone, or joint pain
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• trouble breathing, cough, shortness of breath, or chest pain
• new or worsening tingling or numbness in your hands or feet or muscle weakness
• unusual bruising or bleeding

Mirvetuximab soravtansine-gynx injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to mirvetuximab soravtansine-gynx injection.

Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with mirvetuximab soravtansine-gynx injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving mirvetuximab soravtansine-gynx injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 20, 2024.