Title

Description description description. Description description description. Description description description.

Use in Pediatric Ph+ CML

YOUR CHILD’S BLOOD DEMANDS TO BE HEARD.

As a parent, you have to speak up for your child. That means talking to the doctor about why TASIGNA® (nilotinib) capsules may be the right option to treat your child’s Philadelphia chromosome–positive chronic myeloid leukemia.

 

TASIGNA is a prescription medicine used to treat:

  • Children (ages 1 year and older) with newly diagnosed Ph+ CML in chronic phase
  • Children (ages 1 year and older) with chronic phase Ph+ CML or accelerated phase Ph+ CML who:
    • are no longer benefiting from treatment with a tyrosine kinase inhibitor medicine, or
    • have taken another tyrosine kinase inhibitor medicine and cannot tolerate it

It is not known if TASIGNA is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase.

 

The long-term effects of treating children with TASIGNA for a long period of time are not known.

 

Dosing for children

Your child’s doctor will determine the proper dose of TASIGNA based on your child’s body weight and height.

Results among children who were newly diagnosed

In a clinical study of 25 children whose first treatment of Ph+ CML-CP was TASIGNA, nearly 7 out of 10 children (17 of 25 patients or 68%) achieved a major molecular response (MMR) by 24 cycles (28 days per cycle or 672 days, so under 2 years).

17 of 25 patients (68%) achieved an MMR by 24 cycles (28 days per cycle)

Results among children who were switched to TASIGNA

In a clinical study of 33 children who couldn’t tolerate or no longer benefited from GLEEVEC® (imatinib mesylate) or dasatinib who were switched to TASIGNA, nearly 6 out of 10 children (19 of 33 patients or 57%) achieved a MMR by 24 cycles (28 days per cycle or 672 days, so under 2 years).

19 of 33 patients (57%) achieved an MMR by 24 cycles (28 days per cycle)

Whether your child is newly diagnosed or is currently taking another medication to treat the disease, make yourself heard—and speak with your child’s doctor about TASIGNA.

 

 

Common side effects

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

 

  • Higher-than-normal level of bilirubin in the blood
  • Headache
  • Increased levels of liver enzymes in the blood
  • Rash
  • Fever
  • Nausea
  • Pain in hands or feet
  • Upper respiratory infections
  • Vomiting
  • Diarrhea
  • Runny or stuffy nose, sneezing, sore throat

 

Be sure to review information about the serious and most common side effects of TASIGNA. Learn more