Preparing for Treatment
TURALIO is a prescription medicine used to treat certain adults who have tenosynovial giant cell tumor (TGCT) that is not likely to improve with surgery. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS).
It is not known if TURALIO is safe and effective in children.
Before taking TURALIO, tell your healthcare provider about all of your medical conditions, including if you:
- have or had liver problems.
are pregnant or plan to become pregnant. TURALIO may harm your unborn baby.
If you are a female who is able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with TURALIO.
- Use an effective method of birth control (contraception) during treatment with TURALIO and for 1 month after your final dose of TURALIO. Talk with your healthcare provider about birth control methods you can use during this time.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with TURALIO.
If you are a male with a female partner who is able to become pregnant:
- Use effective birth control (contraception) during treatment and for 1 week after your final dose of TURALIO.
- Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment with TURALIO.
- are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with TURALIO and for at least 1 week after your final dose of TURALIO.
Avoid taking the following medicines or supplements during treatment with TURALIO because they can affect how TURALIO works:
- Proton Pump Inhibitor medicines (PPIs)
- St. John’s wort
Serious liver problems: TURALIO can cause serious injury to the liver, which can be severe and lead to death.
Before starting treatment, your doctor will do blood tests to check for liver problems. These tests will be repeated while you are taking TURALIO. If you develop liver problems during treatment with TURALIO, your healthcare provider may do blood tests more often to monitor you. It is important to stay under the care of your healthcare provider during treatment with TURALIO.
Stop taking TURALIO and call your healthcare provider right away if you develop:
- yellowing of your skin and whites of your eyes
- dark urine
Tell your healthcare provider right away if you have any of these symptoms of liver problems while taking TURALIO:
- lack or loss of appetite
- right upper stomach-area (abdomen) pain or tenderness
- feeling overly tired
TURALIO Risk Evaluation and Mitigation Strategy (REMS): Because of the risk of serious liver problems, TURALIO is available only through a restricted program called the TURALIO REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed TURALIO. There is a registry that collects information about the effects of taking TURALIO over time. You must complete and sign an enrollment form for the TURALIO REMS Program and the registry. Ask your healthcare provider for more information.
- changes in blood liver tests
- hair color changes
- increased cholesterol level in your blood
- decreased white blood cells and red blood cells
- swelling in or around your eyes
- loss of taste or changes in the way things taste
TURALIO may affect fertility in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of TURALIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or fda.gov/medwatch. You may also report side effects to Daiichi Sankyo, Inc. at 1-877-4DS-PROD (1-877-437-7763).
- Your healthcare provider will explain to you how you will receive your TURALIO.
- Take TURALIO exactly as your healthcare provider tells you to.
- TURALIO is usually taken 2 times a day. Your healthcare provider will tell you how much TURALIO to take and when to take it.
- TURALIO must be taken on an empty stomach with no food or snack at least 2 hours before or at least 1 hour after medication.
It’s important that you adhere to the following dosing instructions:
- Swallow TURALIO capsules whole.
- Do not open, break, or chew TURALIO capsules.
If you need to take an acid-reducing medicine, follow your healthcare provider’s instructions for which medicine to take and when to take it.
- Antacid medicines: Take TURALIO either 2 hours before or 2 hours after taking an antacid medicine.
- H2 receptor blocker medicines. Take TURALIO at least 2 hours before or 10 hours after taking an H2 receptor blocker medicine.
- If you vomit after taking a dose, or if you miss a dose of TURALIO, take your next dose at your regular time.
Ready to learn more about TURALIO?