Tazemetostat

Tazemetostat is used to treat advanced epithelioid sarcoma, which is a rare and slow-growing type of soft tissue cancer. tazemetostat is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Tazemetostat is for adults and children who are at least 16 years old.

Tazemetostat was approved by the US Food and Drug Administration (FDA) through an "accelerated" process. In clinical studies, some people responded to this medicine, but more studies are needed.

Tazemetostat may also be used for purposes not listed in this medication guide.

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

You may take tazemetostat with or without food.

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

If you vomit shortly after taking tazemetostat, 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.

Using tazemetostat may increase your risk of developing bone marrow disorders or other cancers. Tell your doctor if you feel unusually tired or have a fever, pale skin, easy bruising, or bone pain.

Using tazemetostat 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 tazemetostat.

• If you are a woman, do not use tazemetostat 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 tazemetostat, 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.

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

Tazemetostat may cause serious side effects. Call your doctor right away 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 stopped permanently if you experience certain side effects.

Common side effects of tazemetostat 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.

Usual Adult Dose for Soft Tissue Sarcoma:

800 mg orally twice dailyDuration: Until disease progression or unacceptable toxicity.Uses: 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 twice dailyDuration: Until disease progression or unacceptable toxicity.Comment:Select patients with relapsed or refractory (R/R) follicular lymphoma (FL) based on the presence of EZH2 mutation.Uses: For the treatment of adult patients with, relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation and who have received at least 2 prior systemic therapies or who have no satisfactory alternative treatment options

Usual Pediatric Dose for Soft Tissue Sarcoma:

16 years and older:800 mg orally twice dailyDuration: 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

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

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.

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

Other drugs may affect 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.