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APO-NILOTINIB is a brand name for Nilotinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-NILOTINIB (nilotinib) 150 mg and 200 mg capsules are indicated for: • The treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Clinical effectiveness of nilotinib capsules in adults with newly diagnosed Ph+ CML-CP is based on…
Verbatim from this product's HC label. Tap a section to expand.
1 Clinical Trial Adverse Drug Reactions – Pediatrics, 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, and 14 CLINICAL TRIALS). There is no experience in pediatric patients below 2 years of age or in pediatric patients with Ph+ CML-AP or blast crisis (BC).
Patients with renal impairment Clinical studies have not been performed in patients with impaired renal function. 5 times the upper limit of the normal range. 3 Pharmacokinetics). Patients with hepatic impairment Hepatic impairment has an effect on the pharmacokinetics of nilotinib in adults.
Dose adjustment is not considered necessary in hepatically impaired patients. Patients with hepatic impairment should be treated with caution and careful clinical monitoring, including close monitoring of the QTc interval (see 7 WARNINGS AND PRECAUTIONS).
APO-NILOTINIB (Nilotinib Capsules) Page 7 of 99 Unclassified / Non classifié Cardiac disorders In clinical studies, newly diagnosed Ph+ CML-CP and imatinib-resistant or -intolerant Ph+ CML- CP and CML-AP patients with any of the following uncontrolled or significant cardiac disease were excluded: recent myocardial infarction, CHF, unstable angina, or clinically significant bradycardia.
Imatinib-resistant or -intolerant Ph+ CML-CP and CML-AP patients with complete left bundle branch block and/or right bundle branch block, with left anterior hemiblock, or with bifascicular block were excluded from the study. Newly diagnosed Ph+ CML-CP patients with complete left bundle branch block were also excluded.
ECG and cardiac enzyme monitoring were conducted in patients throughout the studies. Caution should be exercised in patients with relevant cardiac disorders (see 7 WARNINGS AND PRECAUTIONS). Patients at risk of tumour lysis syndrome Due to possible occurrence of Tumour Lysis Syndrome (TLS) it is recommended to measure serum levels of creatinine, uric acid, phosphate, potassium, corrected calcium and LDH prior to the initiation of treatment with APO-NILOTINIB in order to assess the risk or presence of TLS and to monitor these parameters during the initial period of treatment with APO-NILOTINIB until a significant reduction of tumour cell burden has been achieved.
Prophylaxis of TLS such as hydration and treatment of high uric acid levels in patients at risk and treatment of abnormalities subsequent to established TLS is required. 2 Recommended Dose and Dosage Adjustment APO-NILOTINIB is available in two dosage strengths (150 mg and 200 mg).
, 10 CLINICAL PHARMACOLOGY, and 14 CLINICAL TRIALS). There is no experience in pediatric patients below 2 years of age or in pediatric patients with Ph+ CML-AP or blast crisis (BC). The long- term effects of prolonged treatment with nilotinib capsules in pediatric patients are unknown (see 7 WARNINGS AND PRECAUTIONS).
2 Geriatrics Geriatrics (≥ 65 years of age): Approximately 12% and 30% of subjects in the clinical studies (Phase III study (A2303) in newly diagnosed Ph+ CML-CP; and Phase II study (A2101) in resistant or -intolerant Ph+ CML-CP and CML-AP) were 65 years of age or older respectively.
No major differences were observed for safety and efficacy in patients ≥ 65 years of age as compared to adults 18 to 65 years of age. 2 CONTRAINDICATIONS APO-NILOTINIB (nilotinib capsules) is contraindicated in patients with: • a known long QTc prolongation or with a persistent QTc of >480 msec (see 7 WARNINGS AND PRECAUTIONS); • uncorrectable hypokalemia or hypomagnesemia; known hypersensitivity to nilotinib or to any of the excipients.
For a complete listing of excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 1 Adverse Reaction Overview) • QT interval prolongation (see 7 WARNINGS AND PRECAUTIONS,
). 2 Geriatrics Geriatrics (≥ 65 years of age): Approximately 12% and 30% of subjects in the clinical studies (Phase III study (A2303) in newly diagnosed Ph+ CML-CP; and Phase II study (A2101) in resistant or -intolerant Ph+ CML-CP and CML-AP) were 65 years of age or older respectively.
No major differences were observed for safety and efficacy in patients ≥ 65 years of age as compared to adults 18 to 65 years of age. 2 CONTRAINDICATIONS APO-NILOTINIB (nilotinib capsules) is contraindicated in patients with: • a known long QTc prolongation or with a persistent QTc of >480 msec (see 7 WARNINGS AND PRECAUTIONS); • uncorrectable hypokalemia or hypomagnesemia; known hypersensitivity to nilotinib or to any of the excipients.
For a complete listing of excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Sudden Cardiac Deaths (see 7 WARNINGS AND PRECAUTIONS and
APO-NILOTINIB (nilotinib capsules) is contraindicated in patients with: • a known long QTc prolongation or with a persistent QTc of >480 msec (see 7 WARNINGS AND PRECAUTIONS); • uncorrectable hypokalemia or hypomagnesemia; known hypersensitivity to nilotinib or to any of the excipients.
For a complete listing of excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment with APO-NILOTINIB (nilotinib capsules) should be initiated by a physician experienced in the treatment of patients with CML. In the adult clinical studies, nilotinib capsules were allowed to be given in combination with hematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G- CSF) if clinically indicated.
In the adult studies, nilotinib capsules were also allowed to be given with hydroxyurea (permitted during the first 28 days of treatment, up to 5 g/day for a maximum of 7 days) or anagrelide (permitted during the first 28 days of treatment) if clinically indicated.
Recommended Dose:
Adult patients with newly diagnosed Ph+ CML-CP The recommended dose of APO-NILOTINIB is 300 mg (2x 150 mg capsules) orally twice daily (see 14 CLINICAL TRIALS). Treatment should continue as long as the patient continues to benefit. Ph+ CML-CP and CML-AP adult patients who are resistant to or intolerant to at least one prior therapy including imatinib: APO-NILOTINIB (Nilotinib Capsules) Page 8 of 99 Unclassified / Non classifié The recommended dose of APO-NILOTINIB is 400 mg (2x 200 mg capsules) orally twice daily (see 14 CLINICAL TRIALS).
Treatment should continue as long as the patient does not show evidence of progression or unacceptable toxicity. A baseline ECG is recommended prior to initiating therapy with APO-NILOTINIB and should be repeated after 7 days and as clinically indicated.
Hypokalemia or hypomagnesemia must be corrected prior to APO-NILOTINIB administration and potassium and magnesium blood levels should be monitored periodically during therapy, particularly in patients at risk for these electrolyte abnormalities (see 7 WARNINGS AND PRECAUTIONS).
Pediatric patients with newly diagnosed Ph+ CML-CP or resistant or intolerant Ph+ CML-CP Dosing in pediatric patients is individualized and is based on body surface area (mg/m2). The recommended dose of APO-NILOTINIB is 230 mg/m2 twice daily, rounded to the nearest available dose (to a maximum single dose of 400 mg, see Table 4-1).
This dose in pediatric patients had comparable pharmacokinetic exposure as the 400 mg twice daily dose in adults. Different strengths of APO-NILOTINIB hard capsules can be combined to attain the desired dose. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
There is no experience with treatment of pediatric patients below 2 years of age. 64 m2 800 mg two 200 mg capsules twice a day Dose Adjustments or Modifications: Delay of treatment with APO-NILOTINIB in case of established TLS must be weighed in the individual patient against the […]