Pexidartinib

What is Pexidartinib?

• Pexidartinib (Turalio) is a kinase inhibitor used to treat certain adults who have tenosynovial giant cell tumor (TGCT).

What are the uses of this medicine?

• 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).

How does this medicine work?

• A small-molecule receptor tyrosine kinase (RTK) inhibitor of proto-oncogene receptor tyrosine kinase (KIT), colony-stimulating factor-1 receptor (CSF1R) and FMS-like tyrosine kinase 3 (FLT3), with antineoplastic activity.
• Upon oral administration, pexidartinib targets, binds to and inhibits phosphorylation of KIT, CSF1R and FLT3 harboring an internal tandem duplication (ITD) mutation.
• This results in the inhibition of tumor cell proliferation.
• FLT3, CSF1R and FLT3 are overexpressed or mutated in many cancer cell types and play major roles in tumor cell proliferation and metastasis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

Turalio can cause hepatotoxicity. Avoid coadministration of Turalio with other products known to cause hepatotoxicity. Avoid coadministration of Turalio with:

• Moderate or Strong CYP3A Inhibitors
• Strong CYP3A Inducers
• UGT Inhibitors
• Acid-Reducing Agents
• CYP3A Substrates

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Administer Turalio on an empty stomach, at least one hour before or two hours after a meal or snack.

Recommended Dosage

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

Dosage Modification for Renal Impairment

• The recommended dosage of Turalio for patients with mild to severe renal impairment is 200 mg in the morning and 400 mg in the evening.

Administration

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 200 mg

This medicine is available in fallowing brand namesː

• Turalio

What side effects can this medication cause?

The most common side effects of this medicine 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 can cause serious side effects, including:

• Serious Liver Problems which may be severe and can lead to death

What special precautions should I follow?

• Turalio can cause serious and potentially fatal liver injury and is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
• This medicine may cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use an effective non-hormonal method of contraception.

What to do in case of emergency/overdose?

• Due to the high plasma protein binding, Turalio is not expected to be dialyzable.

Can this medicine be used in pregnancy?

• Turalio may cause embryo-fetal harm when administered to a pregnant woman.
• The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of Turalio.

Can this medicine be used in children?

• The safety and effectiveness of Turalio in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

• Manufactured for: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Pexidartinib
• FDA Pexidartinib

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