Mirvetuximab soravtansine-gynx (Intravenous)

Mirvetuximab soravtansine-gynx injection is used to treat folate receptor-alpha (FRa) positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have had 1 to 3 previous treatments. Your doctor will do a test to check for the FRa tumor before you get this medicine.

This medicine is to be given only by your doctor or under their immediate supervision.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to confirm you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy while you are receiving this medicine and for at least 7 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause eye or vision problems (for example, visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis). Check with your doctor right away if you experience blurred vision, a change in vision, difficulty seeing at night, eye pain, increased sensitivity of the eyes to sunlight, redness of the eye, or tearing. Your doctor may want you to have your eyes examined by an ophthalmologist (eye doctor).

This medicine may cause pneumonitis (swelling of the lungs). Check with your doctor right away if you have chest pain, chills, cough, fever, a general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Check with your doctor right away if you are experiencing burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness. These could be symptoms of a condition called peripheral neuropathy.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of mirvetuximab soravtansine-gynx injection in children. Its safety and effectiveness have not been established for this group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of mirvetuximab soravtansine-gynx injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the possible benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are based on their potential significance and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor might change the dose or how often you take one or both of the medicines.

• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about taking your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Eye or vision problems or
• Peripheral neuropathy (nerve problem)—Use with caution. This may worsen these conditions.

• Liver disease, moderate or severe—Use is not recommended in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Black, tarry stools
• Blindness
• Blurred vision
• Burning, numbness, tingling, or painful sensations
• Change in vision
• Chills
• Cough
• Decreased vision
• Difficulty seeing at night
• Double vision
• Dry eye
• Eye redness, irritation, or pain
• Fever
• Increased sensitivity of the eyes to sunlight
• Lower back or side pain
• Nausea
• Painful irritation of the clear front part of the eye
• Painful or difficult urination
• Pale skin
• Seeing double
• Severe constipation
• Sore throat
• Stomach pain
• Trouble breathing
• Ulcers, sores, or white spots in the mouth
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting
• Watering of the eyes
• Weakness in the arms, hands, legs, or feet

Less common

• Bleeding gums
• Blood in the urine or stools
• Chest pain
• Cough or hoarseness
• General feeling of discomfort or illness
• Pinpoint red spots on the skin
• Stomach bloating
• Thickening of bronchial secretions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also provide ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased appetite
• Diarrhea
• Muscle or joint pain

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Elahere

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mirvetuximab Soravtansine

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins once every 3 weeks (21-day cycle).

Your doctor will give you other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent infusion related reactions and nausea and vomiting.

Your doctor will also give you steroid or lubricant eye drops before and during treatment with this medicine. Do not wear contact lenses during treatment with this medicine.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.