Imafer 400 mg
Indonesia • Ferron Par Pharmaceuticals
Indication
- Treatment of patients with newly diagnosed Philadelphia chromosome (BCR-ABL) positive (Ph+) chronic myeloid leukemia (CML), as well as for the treatment of patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis.
- Treatment of adult and pediatric above 1 year of age patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
- Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.
- Treatment of adult patients with myelodysplastic syndromes/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.
- Treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
- Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL).
- Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Composition
Imatinib mesilate equivalent to imatinib 400 mg
Package
Dosage Forms
TabletATC Classification
Warning
Dosage
0-1 Years Old
There is no experience with the use of imatinib in children with Ph+ ALL below 1 year of age.
1-18 Years Old
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 Ph+ ALL (not to exceed the total dose of 600 mg daily). Treatment can be given as a once daily dose in Ph+ ALL.
18-65 Years Old
Doses of 400 mg 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 in the evening.
The prescribed dose should be administered orally with a meal and a large glass of water to minimize the risk of gastrointestinal disturbances.
65 Years Old and Above
No specific dose recommendation is necessary in the elderly.
Patients with Hepatic Impairment
Imatinib is mainly metabolized through the liver. Patients with mild, moderate, or severe liver impairment should be given the minimum recommended dose of 400 mg daily. The dose can be reduced if not tolerated.
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, 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.