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INDICATIONS AND USAGE（适应症）

 

Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.

 

Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy

Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

 

Adult patients with Ph+ Acute Lymphoblastic Leukemia (ALL)

Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL).

 

Pediatric patients with Ph+ Acute Lymphoblastic Leukemia (ALL)

Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

 

Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)

Adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements.

 

Aggressive Systemic Mastocytosis (ASM)

Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.

 

Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.

 

Dermatofibrosarcoma Protuberans (DFSP)

Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.

 

DOSAGE（服用剂量）

 

Drug Administration

The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day.

For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water or apple juice. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 mL for a 100 mg tablet, and 200 mL for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron.

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

 

Adult Patients with Ph+ CML CP, AP, or BC

The recommended dose of imatinib mesylate tablets is 400 mg/day for adult patients in chronic phase CML and 600 mg/day for adult patients in accelerated phase or blast crisis.

In CML, a dose increase from 400 mg to 600 mg in adult patients with chronic phase disease, or from 600 mg to 800 mg (given as 400 mg twice daily) in adult patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6 to 12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response.

 

Pediatric Patients with Ph+ CML CP

The recommended dose of imatinib mesylate tablets for children with newly diagnosed Ph+ CML is 340 mg/m2/day (not to exceed 600 mg). Imatinib mesylate treatment can be given as a once daily dose or the daily dose may be split into two–one portion dosed in the morning and one portion in the evening. There is no experience with imatinib mesylate treatment in children under 1 year of age.

 

Adult Patients with Ph+ ALL

The recommended dose of imatinib mesylate tablets is 600 mg/day for adult patients with relapsed/refractory Ph+ ALL.

 

Pediatric Patients with Ph+ ALL

The recommended dose of imatinib mesylate tablets to be given in combination with chemotherapy to children with newly diagnosed Ph+ ALL is 340 mg/m2/day (not to exceed 600 mg). Imatinib mesylate tablets treatment can be given as a once daily dose.

 

Adult Patients with MDS/MPD

Determine PDGFRb gene rearrangements status prior to initiating treatment.

 

The recommended dose of imatinib mesylate tablets is 400 mg/day for adult patients with MDS/MPD.

 

Adult Patients with ASM

Determine D816V c-Kit mutation status prior to initiating treatment.

The recommended dose of imatinib mesylate tablets is 400 mg/day for adult patients with ASM without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with imatinib mesylate tablets 400 mg/day may be considered for patients with ASM not responding satisfactorily to other therapies. For patients with ASM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRα, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

 

Adult Patients with HES/CEL

The recommended dose of imatinib mesylate tablets is 400 mg/day for adult patients with HES/CEL. For HES/CEL patients with demonstrated FIP1L1-PDGFRα fusion kinase, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.  

 

Adult Patients with DFSP

The recommended dose of imatinib mesylate tablets is 800 mg/day for adult patients with DFSP.

 

ADVERSE REACTIONS（不良反应）

 

Fluid Retention and Edema

Hematologic Toxicity

Congestive Heart Failure and Left Ventricular Dysfunction

Hepatotoxicity

Hemorrhage

Gastrointestinal Disorders

Hypereosinophilic Cardiac Toxicity

Dermatologic Toxicities

Hypothyroidism

Growth Retardation in Children and Adolescents

Tumor Lysis Syndrome

Impairments Related to Driving and Using Machinery

Renal Toxicity

 

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/559dd8e5-11f9-70cd-3fb0-9f9eb8484a37/spl-doc?hl=imatinib

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