Basic Information
REDISTRA CAPSULE 100MG
CAPSULE
Regulatory Information
SIN16378P
November 15, 2021
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
Company Information
Active Ingredients
Strength: 100 mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** Use in patients with a hypersensitivity to the active substance or to any of the excipients is contraindicated.
Indication Information
**Indications** Imatinib is indicated for the - treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML). - treatment of adult and paediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. - treatment of paediatric 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 Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). - adjuvant treatment of adult patients following complete gross resection of Kit+ GIST The effectiveness of Imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in relapsed or refractory adult Ph+ ALL, on objective response rates in unresectable and/or metastatic GIST and on recurrence free survival in adjuvant GIST. Except in newly diagnosed chronic phase CML there are no controlled trials demonstrating increased survival.