Is Pexidartinib approved by the FDA?

Yes, Pexidartinib, marketed under the brand name Turalio, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Pexidartinib on August 2, 2019.

What is Pexidartinib?

Pexidartinib is a multikinase inhibitor used in the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT), also known as giant cell tumor of the tendon sheath or pigmented villonodular synovitis (PVNS). This condition involves the overgrowth of the lining of the joints and tendons and is not likely to improve with surgery alone.

Uses of Pexidartinib

Pexidartinib is specifically indicated for treating TGCT associated with severe morbidity or functional limitations when the disease is not amenable to improvement with surgery. This medication provides a new treatment option for patients with this rare and debilitating condition.

Dosage

The typical dosage of Pexidartinib for adults is 400 mg taken orally twice a day. The capsules come in two forms: 125 mg and 200 mg. It is important to follow the specific dosing instructions provided by your healthcare provider:

• 125 mg capsules: Usually taken twice per day with a low-fat meal.
• 200 mg capsules: Usually taken twice per day on an empty stomach, at least one hour before or two hours after a meal or snack.

Side Effects

Common Side Effects:

• Abnormal lab results
• Fatigue
• Puffy eyes
• Changes in hair color
• Rash, itching, hives, skin redness, acne
• Decreased or altered sense of taste

Serious Side Effects:

• Liver problems (dark urine, jaundice, right-sided upper stomach pain, loss of appetite, nausea, vomiting, tiredness, itching, fever)

Pexidartinib can cause severe liver damage, necessitating frequent liver function tests before and during treatment. Your doctor may delay or permanently discontinue the medication if liver problems occur.

Warnings and Precautions

• Liver Harm: Pexidartinib can cause liver damage. Regular blood tests are necessary to monitor liver function.
• Pregnancy and Birth Control: Pexidartinib can harm an unborn baby. Both men and women should use effective birth control during treatment and for a period after the last dose (women: 1 month; men: 1 week). Women may need a pregnancy test before starting the medication.
• Breastfeeding: Do not breastfeed while taking Pexidartinib and for at least 1 week after the last dose.

How to Take Pexidartinib

• Follow the prescription label and medication guide carefully.
• Take the capsules as directed, either with a low-fat meal (for 125 mg capsules) or on an empty stomach (for 200 mg capsules).
• Swallow the capsules whole without crushing, chewing, or breaking them.
• If you vomit shortly after taking a dose, do not take an extra dose. Instead, take the next dose as scheduled.
• Store the medication at room temperature, away from moisture and heat.

Drug Interactions

Pexidartinib can interact with various medications, potentially affecting blood levels and increasing side effects or reducing effectiveness. Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements. Notable interactions include:

• Antacids: Take Pexidartinib two hours before or after taking an antacid.
• Heartburn or Stomach Acid Medications: Take Pexidartinib two hours before or ten hours after taking medications like ranitidine or famotidine.
• Proton Pump Inhibitors: These should generally be avoided while taking Pexidartinib.

Conclusion

Pexidartinib (Turalio) is an FDA-approved medication for the treatment of tenosynovial giant cell tumor (TGCT) in adults. Approved on August 2, 2019, it offers a critical treatment option for patients whose condition is not likely to improve with surgery. Always consult with a healthcare provider for personalized advice and follow all prescribed guidelines and monitoring requirements to ensure safe and effective use of Pexidartinib.

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