Nilonix

150 mg

200 mg

💊 Generic Name

• Nilotinib (INN)

---

📦 Formulation & Strengths

• Available as oral capsules.

• Common strengths: 150 mg and 200 mg (as nilotinib hydrochloride mono­hydrate) 

---

🧬 Mechanism of Action

• Targets and inhibits the BCR‑ABL tyrosine kinase—an abnormal, cancer-driving protein in Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML).

• By blocking this enzyme, it halts cancer cell growth and proliferation 

---

🎯 Indications

Used to treat:

• Newly diagnosed Ph+ CML in chronic phase in adults and children (≥ 1 year).

• Ph+ CML in chronic or accelerated phase for patients intolerant or resistant to imatinib 

---

📐 Dosage Guidelines

• Newly diagnosed chronic-phase CML: 300 mg orally twice daily.

• Imatinib‑resistant/intolerant CML: 400 mg orally twice daily (split into two doses) 

• Administration instructions:

  • Take on an empty stomach (no food 2 h before and 1 h after dose) 

  • Capsules should be swallowed whole; contents may be mixed with applesauce if swallowing is difficult

---

⚠️ Key Warnings & Side Effects

• QT‑interval prolongation: may lead to arrhythmia, fainting, seizures, or sudden death. Monitor ECG and electrolytes (potassium/magnesium) regularly 

• Other adverse reactions include:

  • Hematologic: low blood counts (platelets, WBCs, RBCs)

  • Gastrointestinal: nausea, vomiting, diarrhea, constipation

  • Musculoskeletal: headache, fatigue, rash, muscle/joint pain 

• Also associated with liver toxicity, pancreatitis, and electrolyte imbalances .

• Contraindicated in pregnancy and breastfeeding; may cause fetal harm .

---

🏭 Manufacturer

• Marketed by Beacon Pharmaceuticals Ltd, often in collaboration with distributors like Onco Solution and Orio Pharma 

---

📊 Summary Table