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Turalio Side Effects

Generic Name: pexidartinib

Note: This document contains side effect information about pexidartinib. Some of the dosage forms listed on this page may not apply to the brand name Turalio.

For the Consumer

Applies to pexidartinib: oral capsule

Warning

Oral route (Capsule)

Pexidartinib can cause serious and potentially fatal liver injury. Monitor liver tests prior to initiation of pexidartinib and at specified intervals during treatment. Withhold dose and reduce or permanently discontinue pexidartinib based on severity of hepatotoxicity. Pexidartinib is available only through a restricted program call the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program

Side effects requiring immediate medical attention

Along with its needed effects, pexidartinib (the active ingredient contained in Turalio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pexidartinib:

Less common

  • Abdominal or stomach pain or tenderness
  • clay colored stools
  • dark urine
  • decreased appetite
  • fever
  • headache
  • itching or skin rash
  • loss of appetite
  • nausea and vomiting
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of pexidartinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • change or loss of taste
  • difficulty having a bowel movement (stool)
  • dizziness
  • hair color changes
  • nervousness
  • pounding in the ears
  • sensation of pins and needles
  • slow or fast heartbeat
  • stabbing pain
  • swelling of the eyes

For Healthcare Professionals

Applies to pexidartinib: oral capsule

Hematologic

Very common (10% or more): decreased neutrophils (44%), decreased lymphocytes (38%), de creased hemoglobin (30%), decreased platelets (15%)[Ref]

Ocular

Very common (10% or more): Eye edema (30%)

Common (1% to 10%): Blurred vision, photophobia, diplopia, reduced visual acuity[Ref]

Metabolic

Very common (10% or more): Increased lactate dehydrogenase (92%), increased cholesterol (44%), decreased phosphate (25%), anorexia (16%)[Ref]

Hepatic

Very common (10% or more): Increased AST (61%), increased ALT (31%), increased ALP (31%)

Common (1% to 10%): Increased bilirubin, cholangitis, hepatotoxicity, liver disorder[Ref]

Other

Very common (10% or more): Fatigue (64%), peripheral edema (20%)

Common (1% to 10%): Pyrexia[Ref]

Nervous system

Very common (10% or more): Dysgeusia/ageusia (26%), neuropathy (e.g., neuropathy peripheral, paresthesia, hypoesthesia, burning sensation) (10%)

Common (1% to 10%): Cognitive disorders (memory impairment, amnesia, confusional state, disturbance in attention, attention deficit/hyperactivity disorder)[Ref]

Cardiovascular

Very common (10% or more): Hypertension (15%)[Ref]

Dermatologic

Very common (10% or more): Hair color changes (67%), rash (e.g., maculopapular rash, rash pruritic, urticaria, erythema, dermatitis acneiform, dermatitis allergic) (28%), pruritus (18%)

Common (1% to 10%): Alopecia, skin pigment changes (hypopigmentation,

depigmentation, discoloration, hyperpigmentation)[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (20%), constipation (12%)

Common (1% to 10%): Dry mouth, stomatitis, mouth ulceration[Ref]

References

1. "Product Information. Turalio (pexidartinib)." Daiichi Sankyo, Inc., Parsippany, NJ.

Further information

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

Some side effects may not be reported. You may report them to the FDA.