Pronunciation:

mir-ve-TUX-i-mab soe-rav-TAN-seen - gynx

Brand Names:

• Elahere

Dosage Forms:

• Solution

Warnings:

Warning: Ocular ToxicityMirvetuximab soravtansine-gynx can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of mirvetuximab soravtansine-gynx, every other cycle for the first 8 cycles, and as clinically indicated.Administer prophylactic artificial tears and ophthalmic topical steroids.Withhold mirvetuximab soravtansine-gynx for ocular toxicities until improvement and resume at the same or reduced dose.Discontinue mirvetuximab soravtansine-gynx for Grade 4 ocular toxicities .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mirvetuximab Soravtansine

Uses of This Medicine:

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 received 1 to 3 previous treatments. Your doctor will perform a test to check for the FRa tumor before you receive this medicine.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mirvetuximab soravtansine-gynx injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mirvetuximab soravtansine-gynx injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Eye or vision problems or
• Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

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 an IV catheter that is 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 make sure 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 (eg, visual impairment, keratitis, dry eye, photophobia, eye pain, and uveitis). Check with your doctor right away if you have blurred vision, changes 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 checked 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, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Check with your doctor right away if you are having 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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur 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.