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Turalio

Last reviewed on RxList: 5/4/2020
Turalio Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Turalio?

Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

What Are Side Effects of Turalio?

Common side effects of Turalio include:

Dosage for Turalio

The recommended dosage of Turalio is 400 mg orally twice daily, administered on an empty stomach, at least 1 hour before or 2 hours after a meal or snack.

What Drugs, Substances, or Supplements Interact with Turalio?

Turalio may interact with grapefruit or grapefruit juice, St John's wort, UGT inhibitors, and proton pump inhibitors (PPIs).

Tell your doctor all medications and supplements you use.

Turalio During Pregnancy and Breastfeeding

Turalio is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Turalio and for 1 month after the final dose. Males with female partners of reproductive potential are advised to use effective contraception during treatment with Turalio and for 1 week after the final dose. It is unknown if Turalio passes into breast milk. Because of the potential for serious adverse reactions in the breastfed child breastfeeding is not recommended while using Turalio and for at least one week after the final dose.

Additional Information

Our Turalio (pexidartinib) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Turalio Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pexidartinib and call your doctor at once if you have dark urine or jaundice (yellowing of the skin or eyes).

Tell your doctor if you have other symptoms of liver problems, such as:

  • right-sided upper stomach pain;
  • loss of appetite, nausea, vomiting;
  • fever, tiredness; or
  • itching.

Your pexidartinib doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • abnormal liver function tests;
  • high cholesterol;
  • low blood cell counts;
  • puffy eyes;
  • changes in the color of your hair;
  • rash; or
  • decreased or altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Turalio (Pexidartinib Capsules)

Turalio Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of TURALIO was evaluated in ENLIVEN [see Clinical Studies]. ENLIVEN excluded patients with ALT, AST, or total bilirubin >1.5 × ULN; and known active or chronic infection with hepatitis B or C virus, or human immunodeficiency virus. Patients received TURALIO without food at a dose of 400 mg in the morning and 600 mg in the evening orally for 2 weeks followed by 400 mg orally twice daily until disease progression or unacceptable toxicity. Seventy-nine percent of patients received TURALIO for 6 months or longer and 66% for greater than one year.

The median age of TURALIO-treated patients was 44 years (range: 22-75), 57% were females, and 85% were White.

Serious adverse reactions were reported in 13% of patients who received TURALIO. Most frequent (occurring in >1 patient) serious adverse reactions included abnormal liver tests (3.3%) and hepatotoxicity (3.3%).

Permanent discontinuation due to an adverse reaction occurred in 13% of patients who received TURALIO. Most frequent adverse reactions (occurring in >1 patient) requiring permanent discontinuation included increased ALT (4.9%), increased AST (4.9%) and hepatotoxicity (3.3%).

Dose reductions or interruptions occurred in 38% of patients who received TURALIO. Most frequent adverse reactions (occurring in >1 patient) requiring a dosage reduction or interruption were increased ALT (13%), increased AST (13%), nausea (8%), increased ALP (7%), vomiting (4.9%), increased bilirubin (3.3%), increased GGT (3.3%), dizziness (3.3%), and abdominal pain (3.3%).

The most common (>20%) adverse reactions, including laboratory abnormalities, in patients who received TURALIO 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.

Tables 4, 5 and 6 summarize the adverse reactions and laboratory abnormalities in ENLIVEN during the randomized phase (Week 25).

Table 4: Adverse Reactions (≥10% All Grades or >2% Grade ≥ 3) in Patients Receiving TURALIO with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in ENLIVEN

Adverse ReactionTURALIO
N=61
Placebo
N=59
All Grades (%)Grade ≥ 3 (%)All Grades (%)Grade ≥ 3 (%)
Skin and subcutaneous tissue
Hair color changes6703.40
Rasha281.670
Pruritusb1803.40
General
Fatiguec640410
Peripheral edemad20070
Eye
Eye edemae301.650
Nervous system
Dysgeusiaf2601.70
Neuropathyg10050
Gastrointestinal
Vomiting201.650
Constipation12050
Metabolism and nutrition
Decreased appetite160100
Vascular
Hypertension154.9100
a Rash includes rash, maculo-papular rash, rash pruritic, urticaria, erythema, dermatitis acneiform, dermatitis allergic.
b Pruritis includes pruritus, pruritus generalized.
c Fatigue includes fatigue, asthenia, malaise.
d Peripheral edema includes face edema, localized edema, edema peripheral, peripheral swelling.
e Eye edema includes periorbital edema, eye edema, eyelid edema, papilledema.
f Dysgeusia includes dysgeusia, ageusia.
g Neuropathy includes neuropathy peripheral, paresthesia, hypoesthesia, burning sensation.

Table 5: Hepatic Laboratory Abnormalities (≥10% All Grades or >2% Grade ≥ 3) Worsening from Baseline in Patients Receiving TURALIO with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in ENLIVEN

Laboratory AbnormalitybTURALIOaPlaceboa
Grade 1 (%)Grade 2 (%)Grade ≥ 3 (%)Grade 1 (%)Grade 2 (%)Grade ≥ 3 (%)
Liver Tests
Increased AST6115121500
Increased ALT3113202200
Increased ALP313.34.91.700
Increased bilirubin3.33.33.3000
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ALP = alkaline phosphatase
a Each test incidence is based on the number of patients who had both a baseline and at least one onstudy measurement TURALIO (n=61) and placebo (n=59).
b Graded per NCI CTCAE v 4.03

Table 6: Other Laboratory Abnormalities Worsening from Baseline (≥10% All Grades or >2% of Grade ≥ 3) in Patients Receiving TURALIO with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in ENLIVEN

Laboratory AbnormalitybTURALIOaPlaceboa
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
Chemistry
Increased LDHc92050
Increased cholesterol444.9250
Decreased phosphate253.350
Hematology
Decreased neutrophils443.390
Decreased lymphocytes381.63.40
Decreased hemoglobin300141.7
Decreased platelets15050
LDH=Lactate Dehydrogenase
a Each test incidence is based on the number of patients who had both a baseline and at least one onstudy measurement TURALIO (n = 61) and placebo (n = 58-59).
b Graded per NCI CTCAE v 4.03 except for LDH
c LDH: Grade 1 >ULN to ≤2.5 x ULN; Grade 2 >2.5 to ≤5 x ULN; Grade 3 >5 to ≤20 x ULN; Grade 4 >20 x ULN

Clinically relevant adverse reactions occurring in <10% of patients were:

Eye: blurred vision, photophobia, diplopia, reduced visual acuity

Gastrointestinal: dry mouth, stomatitis, mouth ulceration

General: pyrexia

Hepatobiliary: cholangitis, hepatotoxicity, liver disorder

Neurological: cognitive disorders (memory impairment, amnesia, confusional state, disturbance in attention, attention deficit/hyperactivity disorder)

Skin and subcutaneous tissue: alopecia, skin pigment changes (hypopigmentation, depigmentation, discoloration, hyperpigmentation)

Read the entire FDA prescribing information for Turalio (Pexidartinib Capsules)

Related Resources for Turalio

© Turalio Patient Information is supplied by Cerner Multum, Inc. and Turalio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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