Nilonib
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.
Prescribing Description