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Tyrosine Kinase Inhibitor — CML Pregnancy: Contraindicated — teratogenic; effective contraception required during treatment

Nilotinib

Brand names: Tasigna

Adult dose

Dose: Newly diagnosed CML: 300 mg twice daily; Resistant/intolerant CML: 400 mg twice daily
Route: Oral
Frequency: Twice daily — 12 hours apart; taken on EMPTY STOMACH (no food 2 hours before or 1 hour after)
Max: 400 mg twice daily
Second-generation BCR-ABL1 TKI. Used in CML (chronic and accelerated phase), imatinib-resistant/intolerant CML. Active against most imatinib-resistant mutations (except T315I). QT prolongation risk — ECG monitoring mandatory.

Paediatric dose

Dose: 230 mg/m² twice daily mg/m²/kg
Route: Oral
Frequency: Twice daily
Max: 400 mg twice daily
BNFc: licensed in children ≥2 years with newly diagnosed or resistant/intolerant Ph+ CML

Dose adjustments

Renal

No dose adjustment required

Hepatic

Reduce dose in moderate-severe hepatic impairment — hepatic metabolism

Paediatric weight-based calculator

BNFc: licensed in children ≥2 years with newly diagnosed or resistant/intolerant Ph+ CML

Clinical pearls

  • MUST be taken on an empty stomach — food increases bioavailability causing unpredictable drug exposure and QT risk
  • Peripheral arterial occlusive disease (PAOD): increased incidence vs imatinib — monitor for limb claudication; avoid in patients with pre-existing vascular disease
  • ENESTnd trial: nilotinib superior to imatinib in MMR and CMR rates at 12 months in newly diagnosed CP-CML
  • QTc monitoring: ECG at baseline, 7 days, 3 months, then every 6 months; withhold if QTc >480 ms
  • Correct hypokalaemia and hypomagnesaemia before initiating — electrolyte abnormalities increase QT risk
  • T315I gated-keeper mutation: resistant to both imatinib and nilotinib/dasatinib — requires ponatinib or asciminib

Contraindications

  • Hypokalaemia or hypomagnesaemia (correct before starting)
  • Long QT syndrome
  • Concomitant QT-prolonging drugs (relative)
  • Pregnancy

Side effects

  • QT prolongation
  • Peripheral arterial occlusive disease (PAOD)
  • Sudden death (cardiovascular)
  • Rash
  • Pruritus
  • Myelosuppression
  • Hyperglycaemia
  • Hypercholesterolaemia
  • Elevated lipase/pancreatitis

Interactions

  • Strong CYP3A4 inhibitors (azoles, macrolides) — increase nilotinib levels significantly; avoid or reduce dose
  • QT-prolonging drugs — additive QTc prolongation; avoid
  • Antacids, PPIs — avoid (reduce absorption)
  • Warfarin — monitor INR

Monitoring

  • ECG (QTc — before initiation, at 7 days, 3 months, 6 months)
  • Electrolytes (K+ and Mg²⁺)
  • FBC
  • BCR-ABL1 PCR (every 3 months)
  • Lipids and glucose
  • Peripheral vascular assessment

Reference: BNFc; BNF 90; BNFc; ENESTnd Trial (Saglio et al. NEJM 2010); NICE TA251; SPC Tasigna. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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