INDICATIONS AND USAGE（适应症）

SPRYCEL (dasatinib) is indicated for the treatment of adult patients with

newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.

Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with 

Ph+ CML in chronic phase.

newly diagnosed Ph+ ALL in combination with chemotherapy.

DOSAGE（服用剂量）

Dosage of SPRYCEL in Adult Patients

The recommended starting dosage of SPRYCEL for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of SPRYCEL for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Tablets should not be crushed, cut, or chewed; they should be swallowed whole. SPRYCEL can be taken with or without a meal, either in the morning or in the evening.

Dosage of SPRYCEL in Pediatric Patients with CML or Ph+ ALL

The recommended starting dosage for pediatrics is based on body weight as shown in Table 1. The recommended dose should be administered orally once daily with or without food. Recalculate the dose every 3 months based on changes in body weight, or more often if necessary.

ADVERSE REACTIONS（不良反应）

Myelosuppression

Bleeding-related events

Fluid retention

Cardiovascular toxicity

Pulmonary arterial hypertension

QT prolongation

Severe dermatologic reactions

Tumor lysis syndrome

Effects on growth and development in pediatric patients

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/4764f37b-c9e6-4ede-bcc2-8a03b7c521df/spl-doc?hl=Dasatinib

Dyronibinformation