Tazemetostat (taz-e-MET-oh-stat)

Treats cancer, including epithelioid sarcoma and follicular lymphoma.

Brand Name(s):

Tazverik

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose or vomit after taking your dose, skip that dose and take the next dose at your regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tazemetostat works. Tell your doctor if you are using fluconazole, midazolam, repaglinide, or St John's wort.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well while you are using this medicine. Use an effective form of birth control (including condoms) to keep from getting pregnant during treatment and for at least 6 months after your last dose. Males with female partners must use effective birth control during and for at least 3 months after the last dose of this medicine.
• Do not breastfeed during treatment and for at least 1 week after your last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may increase your risk of having other cancers (including acute myeloid leukemia, B-cell acute lymphoblastic leukemia, myelodysplastic syndrome).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, change in how much or how often you urinate, difficult, burning, or painful urination
• Chest pain, trouble breathing
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Muscle or bone pain, paleness, tiredness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea, vomiting, stomach pain, decrease appetite, weight loss
• Hair loss
• Headache
• Skin rash

If you notice other side effects that you think are caused by this medicine, tell your doctor

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