IMPORTANT SAFETY INFORMATION AND INDICATIONS
What is the most important information I should know about TAZVERIK?
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. Your healthcare provider will monitor you for new cancers after your treatment with TAZVERIK. Tell your healthcare provider if you are more tired than usual, or have easy bruising, fever, bone pain, or paleness.
Before taking TAZVERIK, tell your healthcare provider about all of your medical conditions, including if you:
- Are pregnant or plan to become pregnant. TAZVERIK can harm your unborn baby. Your healthcare provider will give you a pregnancy test before you start treatment with TAZVERIK. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
- Females who are able to become pregnant should use effective non-hormonal birth control (such as condoms) during treatment and for 6 months after the final dose of TAZVERIK. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with TAZVERIK. Talk to your healthcare provider about birth control options that are right for you.
- Males with female partners who are able to become pregnant should use effective birth control during treatment and for 3 months after the final dose of TAZVERIK.
- Are breastfeeding or plan to breastfeed. It is not known if TAZVERIK passes into your breast milk. Do not breastfeed during treatment and for 1 week after the final dose of TAZVERIK.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAZVERIK may affect the way other medicines work and other medicines may affect how TAZVERIK works.
What should I avoid while taking TAZVERIK?
- Avoid eating grapefruit or drinking grapefruit juice during treatment with TAZVERIK.
- Avoid taking St. John’s wort during treatment with TAZVERIK.
Talk to your healthcare provider before starting any new medications or supplements.
What are the possible side effects of TAZVERIK?
The most common side effects of TAZVERIK in people with follicular lymphoma include:
- Tiredness
- Cold-like symptoms (upper respiratory infection)
- Bone and muscle pain
- Nausea
- Stomach (abdominal) pain
These are not all the possible side effects of TAZVERIK.
Call your doctor for medical advice about side effects. You may report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or
INDICATIONS
What is TAZVERIK?
TAZVERIK is a prescription medicine used to treat:
- Adults with follicular lymphoma when the disease has come back or did not respond to treatment, 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.
- Adults with follicular lymphoma when the disease has come back or did not respond to treatment, who have no other satisfactory treatment options.
The approval of TAZVERIK in these patients is based on a study that measured the percentage of patients whose tumor shrank or disappeared after treatment and how long that response lasted. TAZVERIK is still being studied to confirm these benefits.
It is not known if TAZVERIK is safe and effective in children less than 16 years of age.
