Imatib-100

Available in stock
International Name
- Imatib-100
Manufacturer
- Natco
Contains
- Imatinib mesylate-100
Packing
- 10
Strength
- 100mg
Form
- Capsule

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Imatib is indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha
therapy.

Imatib is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant GIST.

Dosage and Administration
Therapy should be initiated by a physician experienced in the treatment of patients with chronic myeloid leukemia or gastrointestinal stromal tumors.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.

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

Recommended dosage of imatinib mesylate for patients in:
• Chronic phase CML is – 400 mg/day
• Accelerated phase or blast crisis is – 600 mg/day
• Unresectable and/or metastatic, malignant GIST – 400 mg/day or 600 mg/day
In CML, dose increase from 400 mg to 600 mg in patients with chronic phase disease, or from 600 to 800 mg (given as 400 mg twice daily) inpatients 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; loss of a previously achieved hematologic response.

Dose adjustment for Hepatotoxicity and Other Non-Hematologic Adverse Reactions
If a severe non-hematologic adverse reaction develops (such as severe hepatotoxicity or severe fluid retention), Imatinib mesylate should be withheld until the event has resolved. Thereafter, treatment can be resumed as
appropriate depending on the initial severity of the event.If elevations in bilirubin > 3´ institutional upper limit of normal (IULN) or in liver transaminases > 5´ IULN occur, Imatinib mesylate should be withheld until bilirubin levels have returned to < 1.5´ IULN and transaminase levels to < 2.5´ IULN. Treatment with Imatinib mesylate may then be continued at a reduced daily dose (i.e., 400 mg to 300 mg or 600 mg to 400 mg).

Hematologic Adverse Reactions

Dose reduction or treatment interruptions for severe neutropenia and thrombocytopenia are recommended.

Paediatric
The safety and efficacy of Imatinib mesylate in patients under the age of 18 years have not been established.

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