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Indications & Uses
Nilotin is indicated for:
Pharmacology
Chronic myelogenous leukaemia (CML) is caused by the BCR-ABL oncogene, and Nilotinib works by blocking the tyrosine kinase activity of the BCR-ABL protein. It fits into the ATP-binding site of that protein with higher affinity than imatinib does, so it can over-ride the resistance that mutations cause.
AMN107 can also inhibit TEL-platelet-derived growth factor receptor-beta (TEL-PDGFRbeta), which causes chronic myelomonocytic leukaemia, and FIP1-like-1-PDGFRalpha, which causes hypereosinophilic syndrome. This suggests it may have a use in myeloproliferative diseases that are marked by these kinase fusions.
AMN107 also inhibits the c-Kit receptor kinase, including the D816V-mutated variant of KIT, at concentrations that can be reached in the body with the medicine. This supports its potential use in treating mastocytosis and gastrointestinal stromal tumours.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Nilotinib for newly diagnosed Ph+ CML-CP is 300 mg orally twice daily. For resistant or intolerant Ph+ CML-CP and for CML-AP, the dose is 400 mg orally twice daily. Administer the doses approximately 12 hours apart. Nilotinib must not be taken with food. Swallow the capsules whole with water, and don't eat for at least 2 hours before the dose or for at least one hour after it. The dose may need to be adjusted for hematologic and non-hematologic toxicities, and for drug interactions. In patients with hepatic impairment (at baseline), a lower starting dose is recommended.
Side Effects
Side effects of nilotinib include rash, pruritus, hepatotoxicity, headache, fever and fatigue. GI disturbances are also seen (nausea, constipation, diarrhoea), along with alopecia, asthenia, muscle spasms, arthralgia and myalgia. Some people have pain (e.g. musculoskeletal or chest pain), oedema, folliculitis or papilloma. Others report insomnia, dizziness, vertigo, anxiety, paraesthesia and hyperhidrosis. Skin and eye problems include dry skin, urticaria, acne, conjunctivitis, dry eye and flushing. Dyspnoea and cough can occur too. Nilotinib can cause myelosuppression (e.g. thrombocytopenia, neutropenia, and anaemia). Thrombotic disorders or haemorrhage may happen. Heart and circulation effects include arrhythmias, heart failure, pericarditis, palpitations, HTN, angina and MI. Blood tests may show elevated AST/ALT and serum lipase, and electrolyte imbalances can also occur.
Cautions & Contraindications
Warnings & Precautions
Take care with Nilotinib in patients who have a history of pancreatitis or who have had a total gastrectomy. Care is also needed in patients with hepatic impairment. Before starting treatment, make sure the patient is well hydrated, and correct uric acid levels, hypomagnesaemia, hypokalaemia and any other electrolyte imbalances.
Contraindications
Nilotinib should not be given to patients with hypokalaemia, hypomagnesaemia or long QT syndrome. It is also contraindicated when taken together with potent CYP3A4 inhibitors, or with antiarrhythmics and other medicines that prolong the QT interval. Potent CYP3A4 inducers must not be used with it either.
Pregnancy & Breastfeeding
Nilotinib is Pregnancy Category D. This means there is positive evidence of human foetal risk, but the benefits in pregnant women may still be acceptable despite that risk, for example when the medicine is needed in a life-threatening situation or for a serious disease where safer drugs can't be used or don't work.
Women who are sexually active should use effective contraception while on treatment. Nilotinib should not be used while breast-feeding.
There is no data to support its use in children. In patients with hepatic impairment, a lower starting dose is recommended.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Symptoms of a Nilotinib overdose include neutropenia, vomiting and drowsiness.
Management: monitor the patient and give supportive treatment.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Nilotinib in a cool, dry place where the temperature stays at or below 30°C, and away from light. Make sure children can't reach it.
Drug Interactions
Common questions about Nilotin 150 mg
What is Nilotin 150 mg Capsule?
Nilotin 150 mg Capsule is a medicine that contains Nilotinib. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Targeted Cancer Therapy group of medicines.
What is Nilotin used for?
Nilotin is used for: Cancer.
What are the side effects of Nilotin?
Side effects of nilotinib include rash, pruritus, hepatotoxicity, headache, fever and fatigue. GI disturbances are also seen (nausea, constipation, diarrhoea), along with alopecia, asthenia, muscle spasms, arthralgia and myalgia.
Can I take Nilotin during pregnancy or while breastfeeding?
Nilotinib is Pregnancy Category D. This means there is positive evidence of human foetal risk, but the benefits in pregnant women may still be acceptable despite that risk, for example when the medicine is needed in a life-threatening situation or for a serious disease where safer drugs can't be used or don't work. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Nilotin?
Symptoms of a Nilotinib overdose include neutropenia, vomiting and drowsiness. Management: monitor the patient and give supportive treatment. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Nilotin?
Keep Nilotinib in a cool, dry place where the temperature stays at or below 30°C, and away from light. Make sure children can't reach it.
Can I take other medicines with Nilotin?
Some medicines can interact with Nilotinib, for example: Vonoprazan + Amoxicillin + Clarithromycin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Nilotin is already among the lowest-priced brands of Nilotinib at this strength.
Do I need a prescription for Nilotin?
Nilotin is a prescription (Rx) medicine. Take it as your doctor advises.