Preparing for Treatment
The only oral therapy: A different way to treat TGCT
When surgery is not likely to improve your TGCT, TURALIO offers a way without surgery to help reduce the size of your tumor and improve some of your symptoms.
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. You might find it helpful to take TURALIO at the same time each day. Your healthcare provider will tell you how much TURALIO to take and when to take it.
Remember: Take TURALIO with a low-fat meal (approximately 11 to 14 grams of total fat). Taking TURALIO with a high-fat meal increases the amount of TURALIO in your blood. This may make it more likely for you to develop side effects and may cause more severe side effects, including serious liver problems. See "What are the possible side effects of TURALIO?"
Talk with your healthcare provider about examples of foods that you can eat for a low-fat meal that contains about 11 to 14 grams of total fat. Your healthcare provider may refer you to a dietician, if needed.
It’s important that you adhere to the following dosing instructions:
- Swallow the capsules whole with water. Do not open, break, or chew them.
- 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. See “What should I avoid while taking TURALIO?”
- 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.
Before you take TURALIO, tell your doctor about all of your medical conditions, including the following:
- Do you have liver problems, or have you had liver problems in the past?
- Do you have kidney problems, or have you had kidney problem in the past?
Are you breastfeeding or do you plan to breastfeed?
- Do not breastfeed during treatment with TURALIO and for at least 1 week after the final dose.
Are you pregnant or do you plan to become pregnant?
- TURALIO can harm an 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.
- Females who are able to become pregnant should use an effective nonhormonal method of birth control (contraception) during treatment with TURALIO and for 1 month after your final dose of TURALIO
- Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with 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 you taking any medicines (including prescription and over-the-counter medicines, vitamins, and herbal supplements)?
- Certain medicines may affect the way TURALIO works and TURALIO may affect how other medicines work. Taking TURALIO with certain medicines may increase the amount of TURALIO in your blood. This may make it more likely for you to have side effects and may cause more severe side effects.
- Avoid taking the following medicines during treatment with TURALIO because they can affect how TURALIO works: proton pump inhibitor medicines (PPIs); St. John’s wort.
TURALIO can cause serious side effects, including serious liver problems, which may be severe and can lead to death. Your healthcare provider will do blood tests to check for liver problems:
- before starting treatment with TURALIO
- every week for the first 8 weeks of treatment
- every 2 weeks for the next month
- every 3 months after that
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 or dark urine.
Please see the Important Safety Information below regarding serious liver problems.
The most common side effects of TURALIO include:
- changes in liver test results
hair color changes
- About 67% (41 of 61) of patients treated with TURALIO in the clinical trial had hair color changes. Once the patients stopped taking TURALIO, their hair returned to its natural color.
- Ask your doctor if hair dye may be used during treatment with TURALIO to achieve your preferred shade.
- increased cholesterol level in the blood
- decreased white blood cells and red blood cells
- swelling in and around your eyes
- rash, itching, hives, skin redness, and acne
- loss of taste or changes in the way things taste
- decreased phosphate in your blood
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.
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. You can also learn more online at turalioREMS.com or by calling