Nilotinib

Indications & Dose:

Treatment of newly diagnosed chronic myeloid leukaemia in the chronic phase l

• BY MOUTH

Adult: 300 mg twice daily

Treatment of chronic and accelerated phase chronic myeloid leukaemia in patients who have resistance to or intolerance of previous therapy, including imatinib 

• BY MOUTH

Adult: 400 mg twice daily

Contraindications:

 Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome

Side Effects:

Cautions:

Precautions:

Interaction:

Drug 

• Food Effects: Food increases blood levels of nilotinib. • Avoid food 2 hours before and 1 hour after a dose.

• Total gastrectomy: More frequent follow-up of these patients should be considered. If necessary, dose increase may be considered

• Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking This drug 

Warnings:

Myelosuppression: Associated with neutropenia, thrombocytopenia and anemia. CBC should be done every 2 weeks for the first 2 months, then monthly. Reversible by withholding dose. Dose reduction may be required.

• QT Prolongation: Nilotinib prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. (5.7) Use with caution in patients with hepatic impairment (5.9). Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

• Sudden deaths: Sudden deaths have been reported in patients with resistant or intolerant Ph+ CML receiving nilotinib. Ventricular repolarization abnormalities may have contributed to their occurrence

. • Elevated serum lipase: Check serum lipase periodically. In case lipase elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis. Caution is recommended in patients with history of pancreatitis.

• Liver function abnormality: Nilotinib may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase. Check hepatic function tests periodically.

• Electrolyte abnormalities: Nilotinib can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating nilotinib and monitor periodically during therapy.

• Hepatic impairment: Nilotinib exposure is increased in patients with impaired hepatic function (at baseline). A dose reduction is recommended in these patients and QT interval should be monitored closely.

• Tumor Lysis Syndrome: Cases of tumor lysis syndrome have been reported in Nilotinib treated patients with resistant or intolerant CML. Due to potential for tumor lysis syndrome, maintain adequate hydration and correct uric acid levels prior to initiating therapy with Nilotinib.

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Rash, pruritus, headache, nausea, fatigue, myalgia, nasopharyngitis, constipation, diarrhea,

abdominal pain, vomiting, arthralgia, pyrexia, upper respiratory tract infection, back pain, cough, and asthenia. Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia and anemia. 

Patient And Carer Advice: