What is the most important information I should know about tazemetostat?
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.
What is tazemetostat?
Tazemetostat is used to treat 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.
Tazemetostat is for use in adults and children at least 16 years old.
Tazemetostat 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.
Tazemetostat may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking tazemetostat?
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 this medicine.
- 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.
How should I take tazemetostat?
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.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking tazemetostat?
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.
What are the possible side effects of tazemetostat?
Get emergency medical help if you have signs of an allergic reaction: 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 side effects may include:
- nausea, vomiting, loss of appetite;
- pain; or
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.
What other drugs will affect tazemetostat?
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 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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