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

Applies to pexidartinib: oral capsule.

Serious side effects of Turalio

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:

More common

• Blurred vision
• decreased appetite
• dizziness
• fever
• headache
• itching or skin rash
• loss of appetite
• nausea and vomiting
• nervousness
• pounding in the ears
• slow or fast heartbeat
• swelling of the feet or lower legs

Less common

• Clay colored stools
• confusion
• dark urine
• defects in intelligence, short-term memory, learning ability, and attention
• stomach pain or tenderness
• unusual tiredness or weakness
• yellow eyes or skin

Other side effects of Turalio

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

• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change or loss of taste
• difficulty having a bowel movement (stool)
• hair color changes
• sensation of pins and needles
• stabbing pain
• swelling of the eyes

Less common

• Change in color vision
• changes in skin coloring
• darkening or lightening of skin color
• decrease in vision
• difficulty seeing at night
• double vision, seeing double
• dry mouth
• hair loss, thinning of hair
• increased sensitivity of the eyes to sunlight
• irritation, soreness, or swelling of the mouth

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]