Turalio

Turalio is a prescription medication used to treat adults with tenosynovial giant cell tumor (TGCT) that is not likely to improve with surgery.

Turalio belongs to a group of drugs called kinase inhibitors. In tenosynovial giant cell tumor (TGCT), a small number of cells that line the joints can have a defect that causes them to make too much of a protein called colony-stimulating factor 1 (CSF-1). CSF-1 acts like a magnet and attracts inflammatory cells into the joint space to form a tumor. Turalio blocks the signals of CSF-1.

This medication comes in capsule form. It is taken twice daily on an empty stomach, at least 1 hour before or 2 hours after a meal or snack. Swallow Turalio capsules whole. Do not open, break, or chew the capsules.

Common side effects include changes in blood liver tests, hair color changes and tiredness.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Turalio. See "Turalio Precautions" section.

The most common side effects of Turalio include:

• changes in blood liver tests
• decreased white blood cells and red blood cells
• hair color changes
• swelling in or around eyes
• tiredness
• rash
• increased blood cholesterol level
• 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 FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, 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 can 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.

Especially tell your healthcare provider if you take:

• Proton Pump Inhibitor medicines (PPIs) 
• St. John’s wort

This is not a complete list of Turalio drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported 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 during treatment,
• every 2 weeks for the next month,
• then, 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
• 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
• nausea
• vomiting 
• fever
• rash
• itching

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.

Avoid drinking grapefruit juice during treatment with Turalio. Grapefruit juice can cause you to have too much Turalio in your blood and may lead to increased side effects and more severe side effects.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Turalio may harm your unborn baby.

• 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.

Tell your doctor if you 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.

• 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, at least 1 hour before or 2 hours after eating a meal or snack.
• 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.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

The recommended dosage is 400 mg taken twice daily on an empty stomach until disease progression or unacceptable toxicity.

If you take too much Turalio, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Turalio at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Turalio container closed tightly.
• Turalio comes with a drying agent (desiccant) in the container. Keep the desiccant in the container. 
• Keep Turalio and all medicines out of the reach of children.

WARNING: HEPATOTOXICITY

• TURALIO can cause serious and potentially fatal liver injury.

• Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity.

• TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.