Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Uses for tazemetostat
Tazemetostat is used to treat epithelioid sarcoma that has spread or grown and cannot be removed by surgery.
Tazemetostat is also used to treat follicular lymphoma that has come back or did not respond to treatment. It is used in patients whose tumors have an abnormal EZH2 gene and who have received at least 2 cancer treatments. Your doctor will perform a test to check for the EZH2 tumor before you receive tazemetostat. Tazemetostat is also used to treat follicular lymphoma that has come back or did not respond to treatment in patients who have no other treatment options.
Tazemetostat is available only with your doctor's prescription.
Before using tazemetostat
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 tazemetostat, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to tazemetostat 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tazemetostat in children 16 years of age and older with epithelioid sarcoma. However, safety and efficacy have not been established in children younger than 16 years of age with epithelioid sarcoma and in children with follicular lymphoma.
Appropriate studies on the relationship of age to the effects of tazemetostat have not been performed in the geriatric population. Safety and efficacy have not been established.
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.
Interactions with 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 taking tazemetostat, 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 tazemetostat 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.
- Ethinyl Estradiol
- St John's Wort
Interactions with food/tobacco/alcohol
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using tazemetostat with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tazemetostat, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems
The presence of other medical problems may affect the use of tazemetostat. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease, moderate or severe—Tazemetostat has not been studied in patients with this condition.
Proper use of tazemetostat
Take tazemetostat exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Tazemetostat should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it. You may take tazemetostat with or without food.
Do not eat grapefruit or drink grapefruit juice while you are using tazemetostat. Grapefruit and grapefruit juice may change the amount of tazemetostat that is absorbed in the body.
The dose of tazemetostat will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tazemetostat. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For epithelioid sarcoma:
- Adults and children 16 years of age and older—800 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For follicular lymphoma:
- Adults—800 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For epithelioid sarcoma:
If you miss a dose of tazemetostat, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you 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. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions while using tazemetostat
It is very important that your doctor check your progress at regular visits to make sure that tazemetostat is working properly. Blood tests may be needed to check for unwanted effects.
Using tazemetostat while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using tazemetostat to make sure you are not pregnant. Birth control pills may not work as well while you are using tazemetostat. Use an effective form of birth control (eg, condoms) to keep from getting pregnant during treatment and for at least 6 months after your last dose. Males who are taking tazemetostat, with female partners who can become pregnant must use effective birth control during and for at least 3 months after the last dose of tazemetostat. If you think you have become pregnant while using the medicine, tell your doctor right away.
Tazemetostat may increase your chances of having other cancers (eg, leukemia, lymphoma, myelodysplastic syndrome). Discuss these possible effects with your doctor.
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 (eg, St. John's wort) or vitamin supplements.
Tazemetostat side effects
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 immediately if any of the following side effects occur:
- Bladder pain
- bleeding gums
- bloody or cloudy urine
- body aches or pain
- chest pain or tightness
- coughing up blood
- difficult, burning, or painful urination
- difficulty in breathing or swallowing
- ear congestion
- fever or chills
- frequent urge to urinate
- increased menstrual flow or vaginal bleeding
- loss of voice
- lower back or side pain
- muscle or bone pain
- pale skin
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- redness, itching, pain, swelling, tenderness, or warmth on the skin
- sore throat
- stuffy or runny nose
- unusual bleeding or bruising
- unusual tiredness or weakness
- fast heartbeat
- lightheadedness or fainting
- painful blisters on the trunk of the body
- rapid, shallow breathing
- General feeling of illness
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- weight loss
- yellow skin and eyes
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:
- decreased appetite
- hair loss or thinning
- nausea or vomiting
- skin rash
- stomach 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.