泊那替尼片ponatinib hydrochloride 15mg

Ponatinib hydrochloride is a kinase inhibitor indicated for the treatment of adult patients with the following conditions: Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) In combination with chemotherapy for newly diagnosed Ph+ ALL. As monotherapy for Ph+ ALL or T315I-positive Ph+ ALL in patients for whom no other kinase inhibitor is indicated. Chronic myeloid leukemia (CML) Chronic-phase (CP) CML in patients who are resistant or intolerant to at least two prior kinase inhibitors. Accelerated-phase (AP) or blast-phase (BP) CML in patients for whom no other kinase inhibitor is indicated. T315I-positive CML (chronic, accelerated, or blast phase). Use Restriction: Ponatinib is not indicated and not recommended for the treatment of newly diagnosed CP-CML patients.

Newly Diagnosed Ph+ ALL: The recommended initial dose is 30 mg once daily. After achieving a minimal residual disease (MRD)-negative (≤ 0.01% BCR::ABL1/ABL1) complete remission (CR) at the end of induction, reduce the dose to 15 mg once daily. Monotherapy for Ph+ ALL or T315I-positive Ph+ ALL (no other kinase inhibitor indicated): The recommended initial dose is 45 mg once daily. CP-CML: The recommended initial dose is 45 mg once daily. When the BCR::ABL1 international scale (IS) reaches ≤ 1%, reduce the dose to 15 mg once daily. AP-CML and BP-CML: The recommended initial dose is 45 mg once daily. This product may be administered with or without food.

Hypertension: Monitor blood pressure and manage hypertension according to clinical indications. Pancreatitis: Monitor serum lipase levels. Neuropathy: Monitor for signs and symptoms of peripheral and cranial neuropathy. Ocular Toxicity: Perform comprehensive ophthalmic examinations at baseline and periodically during treatment. Hemorrhage: Monitor for bleeding and manage patients according to clinical indications. Fluid Retention: Monitor for fluid retention and manage patients according to clinical indications. Arrhythmias: Monitor for signs or symptoms of arrhythmias and manage patients according to clinical indications. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue ponatinib until resolution. The safety of reinitiating ponatinib treatment in recovered patients is unknown. Impaired Wound Healing and Gastrointestinal Perforation: Withhold ponatinib for at least 1 week before elective surgery. Do not administer the drug for at least 2 weeks after major surgery until the wound is fully healed. Embryo-Fetal Toxicity: May cause fetal harm. Inform females of reproductive potential about the potential risk to the fetus and advise them to use effective contraception.

Rash and related cutaneous disorders, arthralgia, abdominal pain, headache, constipation, xeroderma, hypertension, fatigue, fluid retention and edema, pyrexia, nausea, pancreatitis/elevated lipase, hemorrhage, anemia, hepatic dysfunction, and arterial occlusive events (AOEs).

30 tablets per bottle.

Store at room temperature, below 30℃. Keep out of the reach of children.