Ponatinib

What it is used for

ICLUSIG ® is indicated 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).

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Arterial Occlusive Events
• Venous Thromboembolic Events
• Heart Failure
• Hepatotoxicity
• Hypertension
• Pancreatitis
• Neuropathy
• Ocular Toxicity
• Hemorrhage
• Fluid Retention
• Cardiac Arrhythmias
• Myelosuppression
• Tumor Lysis Syndrome
• Reversible Posterior Leukoencephalopathy Syndrome
• Impaired Wound Healing and Gastrointestinal Perforation

Who should not take it

None.

Storing it

Store ICLUSIG tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).