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Care During Chemotherapy and Beyond

Pexidartinib

(pex-i-DAR-ti-nib)

Trade Name: Turalio®

Pexidartinib is the generic name for the trade name drug Turalio. In some cases, health care professionals may use the trade name Turalio when referring to the generic drug name pexidartinib.

Drug Type: Pexidartinib is a targeted therapy drug. This medication is classified as a tyrosine kinase inhibitor (for more detail, see “How Pexidartinib Works” below).

What Pexidartinib Is Used For

  • For treatment of patients ≥ 18 years old with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe symptoms that are not able to be improved with surgery

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Pexidartinib Is Given

  • Pexidartinib is a capsule that should be taken on an empty stomach. It should be taken at least 1 hour before or 2 hours after any meals or snacks.
  • Capsules should be swallowed whole. They should not be opened, broken, or chewed.
  • If you throw up after taking a dose or miss a dose of pexidartinib, do not take another dose; take the next dose at the next scheduled time.
  • Pexidartinib is usually taken twice a day

Side Effects

Important things to remember about the side effects of pexidartinib:

  • Most people will not experience all of the pexidartnib side effects listed.
  • Side effects are often predictable in terms of their onset, duration, and severity.
  • Most side effects will improve after therapy is complete.
  • There may be actions your treatment team can take to minimize or prevent side effects

The following side effects are common (occurring in greater than 30%) for patients taking pexidartinib:

Pexidartinib 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 less common side effects (occurring in 10-29%) for patients receiving pexidartinib:

These are rare, but serious, side effects for patients receiving pexidartinib:

  • Liver problems
    • This is a condition that affects the way your liver works and can be life threatening. Your doctor will conduct regular blood tests before you start and while you take pexidartinib. Symptoms of severe liver problems include: yellowing of your skin or whites of your eyes, or dark colored urine, and right upper stomach pain.

Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Signs of an allergic reaction such as a rash, trouble breathing, or tightness of your throat
  • If you notice any yellowing of your skin or whites of your eyes
  • If you have urine that is very dark in color

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Fever of 100.4º F (38º C) or higher
  • Vomiting (vomiting more than 4-5 times in a 24 hour period
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Pain or burning with urination
  • Extreme fatigue (unable to carry on self-care activities)
  • Lack of appetite and right upper stomach pain or tenderness

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting pexidartinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
  • Take pexidartinib 2 hours before or 2 hours after locally-acting antacids (ex. TUMS®, calcium carbonate; Maalox®, alum-mag hydroxide-simethicone)
  • Take pexidartinib at least 2 hours before or 10 hours after famotidine or ranitidine
  • Avoid taking pexidartinib with pantoprazole, omeprazole, lansoprazole, etc.
  • Avoid drinking grapefruit juice.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category has not been evaluated at this time. May cause fetal harm when given to a pregnant woman, based on how pexidartinib works in the body. Pexidartinib must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking pexidartinib, the medication must be stopped immediately and the woman given appropriate counseling.
  • For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking pexidartinib. Barrier methods of contraception, such as condoms, are recommended for up to 1 month after last dose of pexidartinib.
  • Do not breast feed while taking pexidartinib.

Self-Care Tips

  • Wash your hands often.
  • Get plenty of rest.
  • Maintain good nutrition.
  • Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Pexidartinib

You will be checked regularly by your doctor while you are taking pexidartinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor organ function such as liver function.

Pexidartinib is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), because of the risk of hepatotoxicity. Notable requirements of the Turalio® REMS Program include the following:

  • Prescriber must be certified with the program by enrolling and completing training
  • Patients must complete and sign an enrollment form for inclusion in a patient registry
  • Pharmacist must be certified with the program and must only dispense to patients who are authorized to receive pexidartinib

How Pexidartinib Works

Cancer is a disease caused by changes, also known as mutations, in DNA that change the way cells grow and divide. Cancer cells can be destroyed using many different types of medications that work in very different ways. Examples of medications that destroy cancer cells include cytotoxic chemotherapy, targeted therapy, immunotherapy, and antibody-drug conjugates.

Targeted therapy is about identifying the other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Many targeted therapies are small molecule drugs. These drugs are small enough to enter the cell and affect other molecules such as proteins or DNA. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

Pexidartinib is a small molecule tyrosine kinase inhibitor that selectively inhibits a receptor called colony stimulating factor 1 receptor (CSF1R). Pexidartinib also targets other receptors such as KIT proto-oncogene receptor tyrosine kinase (KIT) and FMS-like tyrosine kinase 3 (FLT3). By binding to these receptors, pexidartinib blocks an important pathway that promotes cell division and causes the cancer cells to die.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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