Generic Name Ponatinib
Other Brand Name Ponaxen
Packing 30
Form Tablet
Strength 15mg, 45mg
Manufacturer Everest Pharmaceuticals Ltd.
COMPOSITION
PONAXEN 15 Tablet: Each film-coated tablet contains Ponatinib Hydrochloride INN equivalent to Ponatinib 15 mg.
PONAXEN 45 Tablet: Each film-coated tablet contains Ponatinib Hydrochloride INN equivalent to Ponatinib 45 mg.
INDICATIONS AND USAGE
Chronic Myeloid Leukemia (CML)
Ponatinib is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T3151 mutation.
Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph ALL)
Ponatinib has indicated in adult patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315! mutation.
DOSAGE AND ADMINISTRATION
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukemia. Haematol- logic support such as platelet transfusion and hematopoietic growth factors can be used during treatment if clinically indicated.
Before starting treatment with ponatinib, the cardiovascular status of the patient should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed. Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimized during treatment with ponatinib.
