INDICATIONS AND USAGE（适应症）

Iclusig is indicated for the treatment of adult patients with:

Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.

T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

DOSAGE（服用剂量）

CP-CML

The recommended starting dosage is 45 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of ≤1% BCR-ABL1IS. Patients with loss of response can re-escalate the dose of Iclusig to a previously tolerated dosage of 30 mg or 45 mg orally once daily. Continue Iclusig until loss of response at the re-escalated dose or unacceptable toxicity.

Consider discontinuing Iclusig if hematologic response has not occurred by 3 months.

AP-CML, BP-CML, and Ph+ ALL

The optimal dose of Iclusig has not been identified.

The recommended starting dosage of Iclusig is 45 mg orally once daily. Consider reducing the dose of Iclusig for patients with accelerated phase (AP) CML who have achieved a major cytogenetic response. Continue Iclusig until loss of response or unacceptable toxicity.

Consider discontinuing Iclusig if response has not occurred by 3 months.

Administration

Advise patients of the following:

Iclusig may be taken with or without food.

Swallow tablets whole. Do not crush, break, cut or chew tablets.

If a dose is missed, take the next dose at the regularly scheduled time the next day.

ADVERSE REACTIONS（不良反应）

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

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/16d804b6-4957-43ee-b18c-3b36ec37c5ac/spl-doc?hl=ponatinib

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