Glivec Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
The prescribed dose should be administered orally with a meal and a large glass of water. Doses of 400 or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and 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 tab and 200 mL for a 400-mg tab) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).
CML: Recommended Dose: 400 mg/day for patients in chronic phase CML and 600 mg/day for patients in accelerated phase or blast crisis.
Treatment should be continued as long as the patient continues to benefit.
Increase dose from 400-600 or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg daily in patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: Disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Children: Dosing in children should be on the basis of body surface area (mg/m²). The dose of 340 mg/m² daily is recommended for children with chronic phase and advanced phase CML (not to exceed the total dose of 600 mg daily). Treatment can be given as a once-daily dose or alternatively, the daily dose may be split into 2 administrations, 1 in the morning and 1 in the evening. The dose recommendation is currently based on a small number of paediatric patients (see Pharmacology and Pharmacokinetics under Actions). There is no experience with the use of Glivec in children <2 years.
Ph+ALL: Recommended Dose: 600 mg/day.
MDS/MPD: Recommended Dose: 400 mg/day.
SM: Recommended Dose: 400 mg/day for patients with SM without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with Glivec at dose of 400 mg/day may be considered for patients with SM not responding satisfactorily to other therapies.
For patients with SM associated with eosinophilia, a clonal haematological disease related to the fusion kinase FIP1L1-PDGFR-α, starting dose of 100 mg/day is recommended. A dose increase from 100-400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
HES/CEL: Recommended Dose: 400 mg/day.
For HES/CEL patients with demonstrated FIP1L1-PDGFR-α fusion kinase, a starting dose of 100 mg/day is recommended. A dose increase from 100-400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
GIST: 400 mg/day for patients with unresectable and/or metastatic, malignant GIST.
A dose increase from 400-600 or 800 mg for patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Treatment with Glivec in GIST patients should be continued until disease progression.
Adjuvant Treatment of Adult Patients Following Resection of GIST: 400 mg/day. In the adjuvant setting, the optimal treatment duration with Glivec is not known.
DFSP: Recommended Dose: 800 mg/day. Dose Adjustments for Adverse Reactions: Nonhaematological Adverse Reactions: If a severe nonhaematological adverse reaction develops with Glivec use, treatment must 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 times institutional upper limit of normal (IULN) or in liver transaminases >5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to a <1.5 x IULN and transaminase levels to <2.5 x IULN. Treatment with Glivec may then be continued at a reduced daily dose. In adults, the dose should be reduced from 400 to 300 mg, or from 600 to 400 mg, or from 800 to 600 mg, and in children from 340 to 260 mg/m²/day.
Haematological Adverse Reactions: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in Table 13. (See Table 13.)

Click on icon to see table/diagram/image

Children: There is no experience with the use of Glivec in children with CML <2 years.
There is very limited experience with the use of Glivec in children <3 years in other indications.
Hepatic Insufficiency: Imatinib is mainly metabolised through the liver. Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily. The dose can be reduced if not tolerated (see Pharmacology and Pharmacokinetics under Actions, Precautions and Adverse Reactions).
Renal Insufficiency: Imatinib and its metabolites are not significantly excreted via the kidney. Since the renal clerance of imatinib is negligible, a decrease in free drug clearance is not expected in patients with renal insufficiency. Patients with mild or moderate renal dysfunction should be given the minimum recommended dose of 400 mg daily as starting dose. Although very limited information is available (see Pharmacology and Pharmacokinetics under Actions), patients with severe renal dysfunction or on dialysis could also start at the same dose of 400 mg. However, in these patients, caution is recommended. The dose can be reduced if not tolerated or increased for lack of efficacy (see Precautions).
Elderly: No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included >20% of patients ≥65 years. No specific dose recommendation is necessary in the elderly.