Tazverik is used to treat adults and pediatric patients aged 16 years and older with advanced epithelioid sarcoma, a rare slow-growing type of soft tissue cancer. This medicine is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Tazverik is also used to treat follicular lymphoma when the disease has come back or did not respond to treatment in adults:

• whose tumors have an abnormal EZH2 gene, and who have been treated with at least two prior medicines. Your healthcare provider will perform a test to make sure Tazverik is right for you.
• who have no other satisfactory treatment options.

Tazverik was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Using Tazverik may increase your risk of developing bone marrow disorders or other cancers.

Tazverik can cause serious side effects, including:

• Risk of new cancers. An increase in new (second) cancers has happened in people who were treated with Tazverik. Talk with your healthcare provider about your risk of developing new cancers. Tell your healthcare provider if you are more tired than usual, or have easy bruising, fever, bone pain, or paleness.

Take Tazverik exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Tazverik with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking this medicine, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Soft Tissue Sarcoma:

800 mg orally 2 times a day until disease progression or unacceptable toxicity

Use: For the treatment of adult patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

Usual Adult Dose for Follicular Lymphoma:

800 mg orally 2 times a day

Use: For the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for the treatment of adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

Usual Pediatric Dose for Soft Tissue Sarcoma:

16 years and older:
800 mg orally 2 times a day until disease progression or unacceptable toxicity

Use: For the treatment of pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

Using Tazverik may increase your risk of developing bone marrow disorders or other cancers, such as leukemia or lymphoma. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

Tazemetostat can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Tazverik if you are pregnant. Use effective nonhormonal birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

Tazemetostat can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with tazemetostat and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Get emergency medical help if you have signs of an allergic reaction to Tazverik: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• unusual tiredness;

• bone pain; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Tazverik side effects may include:

• nausea, vomiting, loss of appetite;

• constipation;

• pain; or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with tazemetostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.