Nilotinib

Nilotinib is a prescription medicine used for the treatment of chronic myeloid leukemia.

• Nilotinib is available under the following different brand names: Tasigna

Adult and pediatric dosage

Capsule

• 50mg
• 150mg
• 200mg

Chronic Myeloid Leukemia

Adult dosage

• Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML)
  • 300 mg orally every 12 hours
• Resistant or intolerant
  • 400 mg orally every 12 hours

Pediatric dosage

• 230 mg/m2 orally twice daily, round to the nearest 50-mg dose; not to exceed 400 mg/dose
• Dosing based on body surface area (BSA)
  • Less than 0.32 m2: 50 mg per dose; total daily dose (TDD): 100 mg
  • 0.33–0.54 m2: 100 mg per dose; TDD: 200 mg
  • 0.55–0.76 m2: 150 mg per dose; TDD: 300 mg
  • 0.77–0.97 m2: 200 mg per dose; TDD: 400 mg
  • 0.98–1.19 m2: 250 mg per dose; TDD: 500 mg
  • 1.2–1.41 m2: 300 mg per dose; TDD: 600 mg
  • 1.42–1.63 m2: 350 mg per dose; TDD: 700 mg
  • Above 1.64 m2: 400 mg per dose; TDD: 800 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Nilotinib include:

• nausea,
• vomiting,
• diarrhea,
• constipation,
• rash,
• temporary hair loss,
• night sweats,
• pain in the bones, spine, joints, or muscles,
• headache,
• tiredness,
• runny or stuffy nose,
• sneezing,
• cough, and
• sore throat.

Serious side effects of the Nilotinib include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fast or pounding heartbeats,
• sudden dizziness,
• lightheadedness,
• bruising,
• blood in the urine or stools,
• swelling,
• rapid weight gain,
• shortness of breath,
• sudden headache,
• confusion,
• vision problems,
• upper stomach pain (that may spread to the back),
• nausea,
• vomiting,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• fever,
• chills,
• night sweats,
• mouth sores,
• pale skin,
• unusual weakness,
• leg pain,
• cold feeling,
• chest pain,
• numbness,
• trouble walking,
• speech problems,
• muscle cramps,
• fast or slow heart rate,
• decreased urination, and
• tingling in the hands and feet or around the mouth

Rare side effects of the Nilotinib include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.