Ponatinib

Indications and Usage

Ponatinib is FDA approved for the treatment of adult patients with:

• Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
  • Newly diagnosed Ph+ ALL, in combination with chemotherapy.
    This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
  • As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.
• Chronic Myeloid Leukemia (CML)
  • Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors.
  • Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated.
  • T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Side effects needing medical attention

Hypertension; rash; abdominal pain; fatigue; dizziness; headache; cough; dry skin; constipation; joint pain; nausea; diarrhea; vomiting; fever; low platelets; low red blood cells; low neutrophils; low level of lymphocytes; low white blood cell count; cardiac failure; pneumonia; respiratory tract infection, urinary tract infection; peripheral neuropathy; back pain; muscle spasms; bone pain; fatigue.

The risk of vascular occlusive events (arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures) and heart failure have been reported with ponatinib.