Turalio Side Effects
Generic name: pexidartinib
Medically reviewed by Drugs.com. Last updated on Oct 6, 2024.
Note: This document provides detailed information about Turalio Side Effects associated with pexidartinib. Some dosage forms listed on this page may not apply specifically to the brand name Turalio.
Applies to pexidartinib: oral capsule.
Important warnings
This medicine can cause some serious health issues
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 and dose reduce or permanently discontinue pexidartinib based on severity of hepatotoxicity.
Pexidartinib is available only through a restricted program called the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed before starting this medicine, every week for the first 8 weeks during treatment, every 2 weeks for the next month, and then every 3 months after to check for liver problems.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills during treatment with this medicine and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
For healthcare professionals
Applies to pexidartinib: oral capsule.
General adverse events
The most common adverse reactions with a frequency of more than 20%, including laboratory abnormalities were increased lactate dehydrogenase (LDH), increased AST, hair color changes, fatigue, increased ALT, decreased neutrophils, increased cholesterol, increased ALP, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate. Dose reductions or interruptions due to adverse events occurred in 38% of the patients who received this drug.[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]
Hematologic
- Very common (10% or more): Decreased neutrophils (44%), decreased lymphocytes (38%), decreased hemoglobin (30%), decreased platelets (15%)[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
Postmarketing: Vanishing bile duct syndrome[Ref]
Metabolic
- Very common (10% or more): Increased lactate dehydrogenase (92%), increased cholesterol (44%), decreased phosphate (25%), anorexia (16%)[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]
Ocular
- Very common (10% or more): Eye edema (30%)
- Common (1% to 10%): Blurred vision, photophobia, diplopia, reduced visual acuity[Ref]
Other
- Very common (10% or more): Fatigue (64%), peripheral edema (20%)
- Common (1% to 10%): Pyrexia[Ref]
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References
1. (2024) "Product Information. Turalio (pexidartinib)." Daiichi Sankyo, Inc.
2. (2019) "Product Information. Turalio (pexidartinib)." Daiichi Sankyo, Inc.
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Further information
Turalio side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.