TURALIO Capsule (2020)

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Daiichi Sankyo Inc.

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BOXED WARNING SECTION

WARNING: HEPATOTOXICITY TURALIO can cause serious and potentially fatal liver injury [see Warnings and Precautions (5.1)]. Monitor liver tests prior to initiation of TURALIO and ...

1. Indications and Usage

TURALIO is 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 ...

2. Dosage and Administration

2.1 Important Administration Instructions Administer TURALIO on an empty stomach, at least one hour before or two hours after a meal or snack [see Warnings and Precautions (5.1), Clinical Pharmacology ...

3. Dosage Forms and Strengths

Capsules: 200 mg, size 0 with white opaque body and dark green opaque cap with white print "T10"

4. Contraindications

None.

5. Warnings and Precautions

5.1 Hepatotoxicity 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) [see Warnings ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions (5.1)].

6.1. 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 ...

7. Drug Interactions

7.1 Use with Hepatotoxic Products TURALIO can cause hepatotoxicity. In patients with increased serum transaminases, total bilirubin, or direct bilirubin (>ULN) or active liver or biliary tract disease, ...

8.1. Pregnancy

Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], TURALIO may cause embryo-fetal harm when administered to a pregnant woman. The ...

8.2. Lactation

Risk Summary There are no data on the presence of pexidartinib or its metabolites in either human or animal milk or its effects on a breastfed child or on milk production. Because of the potential for ...

8.3. Females and Males of Reproductive Potential

TURALIO may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior ...

8.4. Pediatric Use

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

8.5. Geriatric Use

Clinical studies of TURALIO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

8.6. Renal Impairment

Reduce the dose when administering TURALIO to patients with mild to severe renal impairment (CLcr 15 to 89 mL/min, estimated by Cockcroft-Gault [C-G]) [see Dosage and Administration (2.6), Clinical ...

8.7. Hepatic Impairment

No dosage adjustment is recommended for patients with mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than ...

10. Overdosage

Due to the high plasma protein binding, TURALIO is not expected to be dialyzable [see Clinical Pharmacology (12.3)].

11. Description

Pexidartinib is a kinase inhibitor. The chemical name of pexidartinib hydrochloride is 5-[(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)methyl]N{[6-(trifluoromethyl)pyridin-3-yl]methyl}pyridin-2-amine monohydrochloride. ...

12.1. Mechanism of Action

Pexidartinib is a small molecule tyrosine kinase inhibitor that targets colony stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) ...

12.2. Pharmacodynamics

Exposure-Response Relationships There is an exposure response relationship between pexidartinib steady state exposure and serum transaminase levels (ALT and AST) with a higher risk of increased serum transaminases ...

12.3. Pharmacokinetics

The pharmacokinetics of TURALIO was evaluated following single doses in healthy subjects and following multiple doses in patients as summarized in Table 9. Table 9. TURALIO Exposure and Pharmacokinetic ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were performed in mice and rats. Both studies were negative for carcinogenic findings at exposures up to 9 times the human exposure at the recommended daily dose of 800 mg based ...

13.2. Animal Toxicology and/or Pharmacology

In repeat dose toxicity studies of up to 26 weeks in rats, there were findings of myxomatous change in the skin, tongue, and gastrointestinal tract, lymphoid depletion of the bone marrow and thymus, and ...

14. Clinical Studies

14.1 Tenosynovial Giant Cell Tumor The efficacy of TURALIO was evaluated in ENLIVEN (NCT02371369), a double-blind, randomized (1:1), placebo-controlled, multicenter trial in patients with symptomatic TGCT ...

16.1. How Supplied

TURALIO 200 mg capsules are supplied as size 0 with white opaque body and dark green opaque cap with white print T10, available in: 28 count bottle NDC#: 65597-402-28 120 count bottle NDC#: 65597-402-20 ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep containers closed and do not remove desiccant from bottles.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hepatotoxicity Advise patients of the risk of hepatotoxicity that could be fatal and that they will need to undergo monitoring ...