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Generic Name: pexidartinib
Dosage Form: Capsules
Date of Approval: August 2, 2019
Company: Daiichi Sankyo

Treatment for: Tenosynovial Giant Cell Tumor

Medically reviewed by J. Stewart, BPharm Last updated on Aug 19, 2019.

Medication Guide

Read this Medication Guide before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information

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 during treatment,
  • every 2 weeks for the next month,
  • then, every 3 months after that.

If you develop liver problems during treatment, 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. 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 during treatment:

  • 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.

What is Turalio?

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

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.
    • Use an effective method of birth control (contraception) during treatment, and for 1 month after your final dose. 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.
  • If you are a male with a female partner who is able to become pregnant:
    • Use effective birth control (contraception) during treatment and for one week after your final dose.
    • Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment.
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment, and for at least one week after your final dose.

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 vice versa. 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.

  • Avoid taking the following medicines or supplements during treatment, because they can affect how Turalio works:
    • Proton Pump Inhibitor medicines (PPIs)
    • St. John’s wort

How should I take Turalio?

  • Your healthcare provider will explain to you how you will receive your Turalio.
  • Take this medicine exactly as your healthcare provider tells you to.
  • Turalio is usually taken two times a day. Your healthcare provider will tell you how much Turalio to take and when to take it.
  • Turalio capsules must be taken on an empty stomach, at least one hour before or two hours after eating a meal or snack.
  • Swallow the 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. See What should I avoid while taking Turalio?
    • Antacid medicines: Take Turalio either two hours before or two hours after taking an antacid medicine.
    • H2 receptor blocker medicines. Take Turalio at least two 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, take your next dose at your regular time.

What should I avoid while taking Turalio?

  • Avoid drinking grapefruit juice during treatment. 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.

Turalio side effects

Turalio can cause serious side effects. See Important information.

The most common side effects of Turalio include:

  • changes in blood liver tests
  • hair color changes
  • tiredness
  • increased cholesterol level in your blood
  • decreased white blood cells and red blood cells
  • swelling in or around your eyes
  • rash
  • 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.

How should I store Turalio?

  • Store Turalio at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the storage 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.

General information about the safe and effective use of Turalio

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Turalio that is written for health professionals.

What are the ingredients in Turalio?

Active Ingredient: pexidartinib

Inactive Ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. Capsule shell: hypromellose, titanium dioxide, black iron oxide and yellow iron oxide

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.