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Tasigna 50mg Capsule
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Indications & Clinical Uses
- Tasigna 50 mg capsules contain nilotinib, a BCR-ABL tyrosine kinase inhibitor, and are the lower-strength capsule used mainly for weight- or body-surface-area-based dosing in children and for adults needing a reduced dose; the same medicine is also supplied as 150 mg and 200 mg capsules for standard adult dosing, and the strengths must not be interchanged without a prescriber recalculating the total dose.
- Tasigna is approved for adults and children 1 year and older with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, both as initial treatment and for chronic- or accelerated-phase disease resistant to or intolerant of prior imatinib.
- Novartis, headquartered in Switzerland, holds the marketing authorisation in both the United States and the European Union.
- Capsules are taken twice daily by mouth, and treatment is directed by a haematologist or oncologist, though the medicine is taken at home.
Side Effects
- Tasigna carries a boxed warning: it prolongs the heart's QT interval and sudden deaths have been reported, so blood tests and heart tracings (ECGs) are required before and during treatment.
- Common side effects, affecting more than 1 in 10 people, include nausea, rash, headache, fatigue, itching, muscle or joint pain, diarrhoea, constipation and night sweats; blood tests may show low platelet, red or white blood cell counts.
- Less common but serious reactions include pancreatitis, raised liver enzymes, fluid retention around the heart or lungs, and tumour lysis syndrome shortly after starting in patients with a high leukaemia cell burden.
- Seek urgent medical attention for a fast, slow or irregular heartbeat, fainting, chest pain, or severe abdominal pain.
Precautions & Warnings
- Correct low potassium or magnesium before starting Tasigna, and expect a baseline ECG, a repeat around 7 days after starting, and further checks after any dose change or added interacting medicine.
- Tasigna must not be used in people with long QT syndrome or uncorrected electrolyte problems, and the dose is adjusted in liver impairment.
- Never substitute between the 50 mg, 150 mg and 200 mg capsule strengths without your prescriber recalculating the dose.
- Take capsules on an empty stomach, at least 2 hours after and 1 hour before food.
- Effective contraception is required during treatment and for 2 weeks after the last dose in women, since Tasigna may harm an unborn baby; blood glucose and lipids are also monitored.
Avoid Interactions
- Avoid grapefruit and grapefruit juice, and avoid strong CYP3A4 inhibitors such as ketoconazole, clarithromycin and ritonavir, which raise nilotinib levels and QT-prolongation risk.
- Strong CYP3A4 inducers such as rifampin, phenytoin and St John's Wort reduce Tasigna's effect.
- Antacids, H2-blockers and proton pump inhibitors lower nilotinib absorption and need to be timed apart from your dose as advised.
- Avoid other medicines that affect heart rhythm, and tell your healthcare provider about every medicine and supplement you take before starting Tasigna, including any other cancer therapy, since combined effects on the heart or liver may need closer monitoring.
References
Frequently Asked Questions
Tasigna (nilotinib) treats Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in adults and children aged 1 and over. It is used both as first-line treatment and for CML that has not responded to, or was not tolerated with, an earlier medicine called imatinib.
Swallow Tasigna capsules whole, twice daily about 12 hours apart, on an empty stomach - at least 2 hours after and 1 hour before any food. Doses come in 50 mg, 150 mg and 200 mg capsules; always check your prescribed strength before taking a dose.
Common Tasigna side effects include nausea, rash, headache, tiredness, itching, and joint or muscle pain. Tasigna carries a boxed warning: it can prolong the heart's QT interval, and sudden deaths have occurred, so you'll need regular ECGs and blood tests for potassium and magnesium.
Avoid grapefruit and grapefruit juice, food around dosing times, and other medicines that affect heart rhythm. Strong CYP3A4 inhibitors such as ketoconazole and inducers such as rifampin change nilotinib levels and must be avoided or managed by your prescriber.
Before starting Tasigna you'll need blood tests for potassium, magnesium and liver function, plus a baseline ECG. Follow-up ECGs are done about 7 days after starting and after any dose change, because nilotinib can prolong the QT interval and trigger a dangerous irregular heartbeat.
Yes - Tasigna is approved for children aged 1 and older with Philadelphia chromosome-positive CML, using the 50 mg capsules for weight-based dosing. It should be avoided in pregnancy, since it may harm the fetus; women need effective contraception during treatment and for 2 weeks after the last dose.
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