beling
Revised: 11/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Relapsed or Refractory Acute Myeloid Leukemia
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosage
2.3 Dose Modification
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Posterior Reversible Encephalopathy Syndrome
5.2 Prolonged QT Interval
5.3 Pancreatitis
5.4 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on XOSPATA
7.2 Effect of XOSPATA on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Relapsed or Refractory Acute Myeloid Leukemia
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Relapsed or Refractory Acute Myeloid Leukemia
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML)with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of AML with XOSPATA based on the presence of FLT3 mutations in the blood or bonemarrow [see Clinical Studies (14)]. Information on FDA-approved tests for the detection of a FLT3 mutation in AML isavailable at http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dosage
The recommended starting dose of XOSPATA is 120 mg orally once daily with or without food. Response may bedelayed. In the absence of disease progression or unacceptable toxicity, treatment for a minimum of 6 months isrecommended to allow time for a clinical response.
Do not break or crush XOSPATA tablets. Administer XOSPATA tablets orally about the same time each day. If a dose ofXOSPATA is missed or not taken at the usual time,administer the dose as soon as possible on the same day, and at least12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doseswithin 12 hours.
2.3 Dose Modification
Assess blood counts and blood chemistries, including creatine phosphokinase, prior to the initiation of XOSPATA, at leastonce weekly for the first month, once every other week for the second month, and once monthly for the duration oftherapy. Perform electrocardiogram (ECG) prior to initiation of treatment with gilteritinib, on days 8 and 15 of cycle 1,and prior to the start of the next two subsequent cycles.
Interrupt dosing or reduce dose for toxicities as per Table 1.
Table 1: Dosage Modifications for XOSPATA-Related Toxicities*
Adverse Reaction Recommended Action
• Posterior ReversibleEnce |
