n-alpha (IFN) Therapy
1.3 Pediatric Patients with Ph+ CML in Chronic Phase
1.4 Ph+ Acute Lymphoblastic Leukemia (ALL)
1.5 Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)
1.6 Aggressive Systemic Mastocytosis (ASM)
1.7 Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
1.8 Dermatofibrosarcoma Protuberans (DFSP)
1.9 Kit+ Gastrointestinal Stromal Tumors (GIST)
1.10 Adjuvant Treatment of GIST
2DOSAGE AND ADMINISTRATION
2.1 Adult Patients with Ph+ CML CP, AP and BC
2.2 Pediatric Patients with Ph+ CML
2.3 Ph+ ALL
2.4 MDS/MPD
2.5 ASM
2.6 HES/CEL
2.7 DFSP
2.8 GIST
2.9 Dose Modification Guidelines
2.10 Dose Adjustment for Hepatotoxicity and Non-Hematologic Adverse Reactions
2.11 Dose Adjustment for Hematologic Adverse Reactions
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1 Fluid Retention and Edema
5.2Hematologic Toxicity
5.3 Severe Congestive Heart Failure and Left Ventricular Dysfunction
5.4Hepatotoxicity
5.5Hemorrhage
5.6Gastrointestinal Disorders
5.7 Hypereosinophilic Cardiac Toxicity
5.8Dermatologic Toxicities
5.9 Hypothyroidism
5.10Toxicities from Long-Term Use
5.11 Use in Pregnancy
6 ADVERSE REACTIONS
6.1 Chronic Myeloid Leukemia
6.2 Hematologic Toxicity6.3 Hepatotoxicity
6.4 Adverse Reactions in Pediatric Population
6.5 Adverse Reactions in Other Subpopulations
6.6 Acute Lymphoblastic Leukemia
6.7 Myelodysplastic/Myeloproliferative Diseases
6.8 Aggressive Systemic Mastocytosis
6.9 Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia
6.10 Dermatofibrosarcoma Protuberans
6.11 Gastrointestinal Stromal Tumors
6.12 Additional Data from Multiple Clinical Trials
6.13 Postmarketing Experience
7DRUG INTERACTIONS
7.1 Agents Inducing CYP3A Metabolism
7.2 Agents Inhibiting CYP3A Metabolism7.3 Interactions with Drugs Metabolized by CYP3A4
7.4 Interactions with Drugs Metabolized by CYP2D6
7.5 Interaction with Acetaminophen
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14CLINICAL STUDIES
14.1 Chronic Myeloid Leukemia
14.2 Pediatric CML
14.3 Acute Lymphoblastic Leukemia
14.4 Myelodysplastic/Myeloproliferative Diseases
14.5 Aggressive Systemic Mastocytosis
14.6 Hypereosinophilic Syndrome/Chronic Eosinophilic Leukemia
14.7 Dermatofibrosarcoma Protuberans14.8 Gastrointestinal Stromal Tumors
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
17.1 Dosing and Administration
17.2 Pregnancy and Breast-Feeding
17.3 Adverse Reactions
17.4 Drug Interactions
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
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FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGE
1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)
Newly diagnosed adult patients with Philadelphia chromosome positive chronic m
