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Turalio

Last reviewed on RxList: 5/4/2020

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.

What are the possible side effects of Turalio?

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 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

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 your eyes
  • tiredness
  • rash
  • increased cholesterol level in your blood
  • 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.

WARNING

HEPATOTOXICITY

  • TURALIO can cause serious and potentially fatal liver injury [see WARNINGS AND PRECAUTIONS].
  • 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 [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
  • TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program [see WARNINGS AND PRECAUTIONS].

DESCRIPTION

Pexidartinib is a kinase inhibitor. The chemical name of pexidartinib hydrochloride is 5- [(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)methyl]-N-{[6-(trifluoromethyl)pyridin-3- yl]methyl}pyridin-2-amine monohydrochloride. Pexidartinib hydrochloride is an off-white to white solid. The molecular formula for pexidartinib hydrochloride is C20H15ClF3N5•HCl. The molecular weight is 454.28 for the hydrochloride salt and 417.81 for the free base. The chemical structure is:

TURALIO™ (pexidartinib) Structural Formula  - Illustration

The solubility of pexidartinib hydrochloride in aqueous solutions decreases with increasing pH. The pKa1 and pKa2 were determined to be 2.6 and 5.4 respectively for the conjugate acids. Pexidartinib hydrochloride is soluble in methanol, slightly soluble in water and ethanol, and practically insoluble in heptane.

TURALIO (pexidartinib) capsules are for oral use. Each capsule contains 200 mg pexidartinib which is equivalent to 217.5 mg pexidartinib hydrochloride. The capsule contains the following inactive ingredients: poloxamer 407, mannitol, crospovidone, and magnesium stearate. The hypromellose capsule shell contains hypromellose, titanium dioxide, black iron oxide and yellow iron oxide.

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