Turalio

Turalio (pexidartinib) is used in adults to treat giant cell tumor of the tendon sheath (also called tenosynovial giant cell tumor, or pigmented villonodular synovitis) not likely to improve with surgery.

Turalio is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Turalio belongs to a class of medications called kinase inhibitors. Pexidartinib works by blocking the action of an abnormal protein that may help the tumor to shrink.

Take Turalio exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Turalio 125 mg capsules are usually taken twice per day with a low-fat meal (about 11 to 14 grams of fat).

Avoid taking this medicine with a high-fat meal. Taking it with a high-fat meal increases the amount of medicine in your blood and can cause more severe side effects, including serious liver problems.

Turalio 200 mg capsules (discontinued) were taken twice a day on an empty stomach, at least 1 hour before or 2 hours after a meal or snack.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you vomit shortly after taking Turalio, do not take another dose. Take your next dose as scheduled.

You will need blood tests to check your liver function before and during treatment with this medicine.

Your next dose may be delayed based on the results of your liver function tests.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Turalio can cause severe or fatal effects on your liver, including liver failure and a condition called vanishing bile duct syndrome. Severe liver problems can happen even if your doctor monitors your blood tests and stops your treatment. You will need frequent blood tests to check your liver function during treatment, and your doctor may refer you to a liver specialist if you develop liver problems.

Stop using Turalio and call your doctor at once if you have dark urine or jaundice (yellowing of the skin or eyes).

Tell your doctor if you have other symptoms of liver problems, such as loss of appetite, stomach pain (upper right side), nausea, vomiting, tiredness, itching, or fever.

Turalio Risk Evaluation and Mitigation Strategy (REMS): Because of the risk of serious liver problems,Turalio is available only through a restricted program called theTuralio 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 this medicine over time. You must complete and sign an enrollment form for theT uralio REMS Program and the registry. Ask your healthcare provider for more information.

To make sure Turalio is safe for you, tell your doctor if you have ever had:

• liver or kidney disease.

Pexidartinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use effective non-hormonal birth control while using this medicine and for at least 1 month after your last dose. Hormonal birth control (such as pills) may not work as well while you are taking this medicine.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Turalio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Turalio and call your doctor at once if you have dark urine or jaundice (yellowing of the skin or eyes).

Tell your doctor if you have other symptoms of liver problems, such as:

• right-sided upper stomach pain;
• loss of appetite, nausea, vomiting;
• rash;
• fever, tiredness; or
• itching.

Dosing may be delayed or permanently discontinued if you have certain side effects.

Common Turalio side effects may include:

• abnormal lab results;
• tiredness;
• puffy eyes;
• changes in the color of your hair;
• rash, itching, hives, skin redness, acne; or
• decreased or altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Giant Cell Tumor of Bone:

Turalio 250 mg orally 2 times a day with a low-fat meal (about 11 to 14 grams of fat).

Dose modifications may be necessary due to adverse reactions, renal impairment, and hepatic impairment. Use: For symptomatic (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with pexidartinib and cause side effects. Avoid consuming grapefruit products.

Avoid spending prolonged time in sunlight. This medicine can make your skin sensitive to the sun and you may burn more easily. Wear protective clothing and use sunscreen if you must be in the sunlight.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Pexidartinib can harm your liver, especially if you also use certain medicines for infections, tuberculosis, depression, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).

Some medicines should be taken separately from your dose of this medicine:

• If you take an antacid, take your Turalio dose 2 hours before or 2 hours after you take the antacid.
• If you take medicine for heartburn or stomach acid (such as ranitidine, cimetidine, famotidine, Pepcid, Tagamet, or Zantac), take your Turalio dose 2 hours before or 10 hours after you take the antacid.

You may not be able to take a proton pump inhibitor stomach acid reducer such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

Avoid taking St. John's wort during treatment with this medicine.

This list is not complete and many other drugs may interact with pexidartinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: pexidartinib. Inactive ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. Capsule shell: hypromellose, titanium dioxide, and FD& C Blue No. 1.

Daiichi Sankyo, Inc., Basking Ridge, NJ 07920, USA.