Imatero-400

Imatero-400 Dosage/Direction for Use

imatinib

Manufacturer:

Camber

Distributor:

Camber
Full Prescribing Info
Dosage/Direction for Use
General dosing considerations: If a severe nonhematologic adverse reaction develops (eg, severe hepatotoxicity, severe fluid retention); imatinib should be withheld until the reaction has resolved. Thereafter, treatment can be resumed as appropriate, depending on the initial severity of the event.
Dose reduction or treatment interruptions for revere neutropenia and thrombocytopenia are recommended.
Adults: Acute lymphoblastic leukemia: 600 mg/day.
Aggressive systemic mastocytosis: 400 mg/day without D816V c-Kit mutation.
If c-Kit mutational status is not known or unavailable, treatment with imatinib 400 mg/day may be considered for patients with aggressive systemic mastocytosis not responding satisfactorily to other therapies.
Aggressive systemic mastocytosis associated with eosinophilia: Initial dosage: 100 mg/day.
Dosage adjustment: A dose increase from 100 to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Chronic eosinophilic leukemia: 400 mg/day.
Chronic eosinophilic leukemia with demonstrated FIP1L1-PDGF receptor alpha fusion kinase: Initial dosage: 100 mg/day.
Dosage adjustment: A dose increase from 100 to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Chronic myeloid leukemia: Accelerated phase or blast crisis: Usual dosage: 600 mg/day.
Dosage adjustment: A dose increase from 600 to 800 mg (given as 400 mg twice daily) may be considered in the absence of severe adverse drug reactions 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, and loss of a previously achieved hematologic or cytogenetic response.
Chronic phase: Usual dosage: 400 mg/day.
Dosage adjustment: A dose increase from 400 to 600 mg may be considered in the absence of severe adverse drug reactions 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, and loss of a previously achieved hematologic or cytogenetic response.
Dermatofibrosarcoma protuberans: 800 mg/day.
GI stromal tumors: Adjuvant treatment of GI stromal tumors: Usual dosage: 400 mg/day.
Duration of therapy: In the clinical study, imatinib was administered for 1 year and 3 years. In the patient population defined in study 2, 3 years of imatinib is recommended. The optimal treatment duration with imatinib is not known.
Unresectable and/or metastatic, malignant GI stromal tumors: Usual dosage: 400 mg/day.
Dosage adjustment: A dosage increase of up to 800 mg daily (given as 400 mg twice daily) may be considered, as clinically indicated, in patients showing clear signs or symptoms of disease progression at a lower dose and in the absence of severe adverse drug reactions.
Hypereosinophilic syndrome: 400 mg/day.
Hypereosinophilic syndrome with demonstrated FIP1L1-PDGF receptor alpha fusion kinase: Initial dosage: 100 mg/day.
Dosage adjustment: A dose increase from 100 to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Myelodysplastic/Myeloproliferative diseases: 400 mg/day.
Children: Children 2 years and older: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia chronic phase: Usual dosage: 340 mg/m2/day.
Maximum dose: 600 mg/day.
Renal Function Impairment: Mild renal impairment (creatinine clearance 40 to 59 mL/min): Dose more than 600 mg are not recommended.
Moderate renal impairment (creatinine clearance 20 to 39 mL/min): Maximum dose: Doses of more than 400 mg are not recommended.
Initial dosage: Decrease recommended starting dose by 50% and increase as tolerated.
Severe renal impairment (creatinine clearance less than 20 mL/min): Use with caution. A dosage of 100 mg/day was tolerated in 2 patients with severe renal impairment.
Hepatic Function Impairment: Severe hepatic impairment: Decrease recommended dose by 25%.
Concomitant Therapy: The use of concomitant strong CYP3A4 inducers (eg, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifampicin) should be avoided. If patients must be coadministered strong CYP3A4 inducers, based on pharmacokinetic studies, the dosage of imatinib should be increased by at least 50%, and clinical response should be carefully monitored.
Dosage Adjustment: Hematologic: Adults: (see Table 1.)

Click on icon to see table/diagram/image

Children: See Table 2.

Click on icon to see table/diagram/image

Hepatotoxicity: Adults: See Table 3.

Click on icon to see table/diagram/image

Children: See Table 4.

Click on icon to see table/diagram/image

Duration of Therapy: Continue treatment as long as there is no evidence of progressive disease or unacceptable toxicity.
Preparation for Administration: Imatinib is considered a cytotoxic agent. Follow Safe Handling procedures when preparing, administering, or dispensing imatinib.
Do not crush imatinib tablets. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly. Personnel should avoid exposure to crushed tablets.
Administration: Administer orally with a meal and a large glass of water. Doses of 400 or 600 mg should be administered once daily; a dose of 800 mg should be administered as 400 mg twice per day. For daily dosing of 800 mg and higher, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron. In children, imatinib treatment can be given as a once-daily dose or, alternatively, the daily dose may be split into 2 (once in the morning and once in the evening).
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 tablets.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in