Ninlib Capsules 150 mg

Composition:

Nilotinib capsules, for oral use

About Ninlib Capsules 150 mg

Nilotinib is a kinase inhibitor indicated for the treatment of Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Ninlib Capsules 150 mg

*To be consumed as directed by physician.


Usage Instructions

Nilotinib is a kinase inhibitor indicated for the treatment of
  • Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
  • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
  • Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

Safety Information

  • Recommended Adult Dose: Newly diagnosed Ph+ CML-CP: 300 mg orally twice daily. Resistant or intolerant Ph+ CML-CP and CML-AP: 400 mg orally twice daily.
  • Recommended Pediatric Dose: Newly Diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI therapy: 230 mg/m2 orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).
  • Reduce starting dose in patients with baseline hepatic impairment.
  • Eligible newly diagnosed adult patients with Ph+ CML-CP who have received Nilotinib for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received Nilotinib for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.
The capsules should be swallowed whole with water. No food should be consumed for at least 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.