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INDICATIONS AND USAGE

SPRYCEL® (dasatinib) is a prescription medicine used to treat:

  • adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including imatinib
  • adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment
  • children 1 year of age and older with Ph+ CML in chronic phase
  • children 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

It is not known if SPRYCEL is safe and effective in children under 1 year of age.

Children Safety Information

What were the side effects seen in the trials with children with Ph+ CML in CP?

Adverse Reactions reported in ≥10% of SPRYCEL-treated pediatric patients with Ph+ CML in CP (n=97)

Clinical trial results showing side effects reported in child patients on SPRYCEL® (dasatinib) vs imatinib

Ninety-seven children were included in total in the studies that looked at the safety profile of SPRYCEL. One of the children (1%) stopped taking treatment because of side effects.

According to Common Terminology Criteria for Adverse Events (CTCAE), Grade 3 side effects are considered severe, and Grade 4 side effects are considered potentially life-threatening.

How Was SPRYCEL Studied in Children?

Learn more about SPRYCEL clinical study results in children.

GET THE STUDY RESULTS
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