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Use in Pediatric Ph+ CML

TASIGNA

Your child's first step with TASIGNA

If your child has been diagnosed with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), your child’s doctor may prescribe TASIGNA® (nilotinib) capsules.

 

Dosing for your child

Your child’s doctor will determine the appropriate dose of TASIGNA based on the body surface area of your son or daughter. This is measured in m2 and calculated from body weight and height.

 

Results among children who were newly diagnosed

In a clinical study of 25 children whose first treatment for Ph+ CML-CP was TASIGNA:

 

60% of children achieved a major molecular response (MMR) at 12 cycles (28 days per cycle or 336 days, so under 1 year).

 

60 percent of patients achieved an MMR at 12 cycles

 

Results among children who were switched to TASIGNA

In a clinical study of 44 children who couldn’t tolerate or no longer benefited from GLEEVEC® (imatinib mesylate) tablets or dasatinib who were switched to TASIGNA:

 

41% of children achieved a MMR at 12 cycles (28 days per cycle or 336 days, so under 1 year).

 

40 percent of patients achieved an MMR at 12 cycles

 

Whether your child has been recently diagnosed with Ph+ CML-CP or is currently taking another medication to treat the disease, it may be time to talk to your child’s doctor about TASIGNA.

 

In clinical trials with TASIGNA, the most common side effects in children included:

  • Nausea
  • Headache
  • Itching
  • Diarrhea
  • Constipation
  • Vomiting
  • Rash
  • Tiredness
  • Fever
  • Cough
  • Muscle and joint pain
  • Night Sweats
  • Runny or stuffy nose, sneezing, sore throat