Nilotinib INN (Nilonib) (TASIGNA)

Nilotinib INN

Composition: Each capsule contains Nilotinib 200 mg as Nilotinib Monohydrochloride Monohydrade INN.

Indications: Adult And Pediatric Patients with Newly Diagnosed Ph+ CML-CP: Nilonib (nilotinib) is 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 Resistant or Intolerant Ph+ CML-CP and CML-AP: Nilonib is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Pediatric Patients with Resistant or Intolerant Ph+ CML-CP: Nilonib is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

Dosage and Administration: Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP: The recommended dose of Nilonib is 300 mg orally twice daily. Or, as directed by the registered physician.

Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP: The recommended dose of Nilonib is 400 mg orally twice daily.

Dosage in Pediatric Patients with Newly Diagnosed Ph+ CML-CP Or Resistant or Intolerant Ph+ CML-CP: The recommended dose of Nilonib for pediatric patients is 230 mg/m² orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg). Or, as directed by the registered physician.

Use in Pregnancy and Lactation: Nilonib can cause fetal harm when administered to a pregnant woman. So, Females should be advised to inform their healthcare provider if they are pregnant or become pregnant.

Packing: Each box contains 30’s capsules in a Container.