Pronunciation:

taz-e-MET-oh-stat

Brand Names:

• Tazverik

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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 this medicine. This medicine 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other 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 this medicine, 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 this medicine 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.

• Abametapir
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Bosentan
• Carbamazepine
• Cenobamate
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Desogestrel
• Dienogest
• Diltiazem
• Dronedarone
• Drospirenone
• Efavirenz
• Enzalutamide
• Erythromycin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Gestodene
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Letermovir
• Levonorgestrel
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Medroxyprogesterone
• Mestranol
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Segesterone
• St John's Wort
• Telaprevir
• Telithromycin
• Ulipristal
• Verapamil
• Voriconazole

Other interactions—

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 this medicine 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 this medicine, 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, moderate or severe—This medicine has not been studied in patients with this condition.

Proper Use of This Medicine:

Take this medicine 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.

This medicine 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 this medicine with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing—

The dose of this medicine 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 this medicine. 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.

Missed dose—

If you miss a dose of this medicine, 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.

Storage—

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 This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine 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 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 (eg, condoms) to keep from getting pregnant during treatment and for at least 6 months after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of having other cancers (eg, acute myeloid leukemia, B-cell acute lymphoblastic leukemia, 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.

Side Effects of This Medicine:

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:

More common

Bladder pain

bleeding gums

bloody or cloudy urine

body aches or pain

chest pain or tightness

cough

coughing up blood

difficult, burning, or painful urination

difficulty in breathing or swallowing

dizziness

ear congestion

fever or chills

frequent urge to urinate

headache

increased menstrual flow or vaginal bleeding

loss of voice

lower back or side pain

muscle or bone pain

nosebleeds

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

sneezing

sore throat

stuffy or runny nose

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Confusion

fast heartbeat

lightheadedness or fainting

painful blisters on the trunk of the body

rapid, shallow breathing

Rare

General feeling of illness

hoarseness

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:

More common

Constipation

decreased appetite

diarrhea

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.