Description
1. Active Substance:
- Nilotinib: Tasigna contains nilotinib as its active pharmaceutical ingredient. Nilotinib is a tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia (CML). It works by inhibiting the activity of BCR-ABL tyrosine kinase, which is responsible for the abnormal proliferation of leukemia cells.
2. Indications:
- Chronic Myeloid Leukemia (CML): Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP), as well as patients with resistant or intolerant CML-CP or accelerated phase (CML-AP) CML.
3. Dosage and Administration:
- The recommended dosage of Tasigna for newly diagnosed CML-CP is usually 300 mg orally twice daily.
- For patients with resistant or intolerant CML-CP or CML-AP, the recommended dosage may vary depending on individual patient factors and treatment response.
- Tasigna capsules should be taken on an empty stomach, at least 1 hour before or 2 hours after eating.
- The capsules should be swallowed whole with a glass of water and should not be crushed, chewed, or opened.
4. Administration:
- Tasigna capsules are taken orally with a full glass of water.
- The capsules should be swallowed whole and not crushed, chewed, or opened.
- It is important to take Tasigna exactly as prescribed by a healthcare professional to maximize treatment effectiveness and minimize the risk of adverse effects.
5. Effectiveness:
- Tasigna has been shown to be effective in inducing and maintaining hematologic and cytogenetic responses in patients with newly diagnosed and resistant or intolerant CML.
- Clinical studies have demonstrated significant improvements in progression-free survival and overall survival rates with the use of nilotinib compared to standard treatments.
6. Safety Profile:
- Tasigna is generally well-tolerated when used as prescribed. Common side effects may include nausea, vomiting, diarrhea, fatigue, headache, and rash.
- Serious side effects such as QT prolongation, myelosuppression (neutropenia, thrombocytopenia), pancreatitis, and liver toxicity may occur but are rare.
- Patients should be monitored regularly for signs of adverse reactions, including blood cell counts, electrocardiograms, and liver function tests.
7. Contraindications:
- Tasigna is contraindicated in patients with a known hypersensitivity to nilotinib or any of the excipients in the formulation.
- It should not be used in patients with a history of QT prolongation, severe liver impairment, or concurrent use of strong CYP3A4 inhibitors or inducers.
8. Precautions:
- Tasigna should be used with caution in patients with pre-existing cardiovascular disease, electrolyte imbalances, or a history of pancreatitis.
- It should be avoided in pregnant or breastfeeding women, as well as in patients with impaired renal function.
9. Storage:
- Tasigna capsules should be stored at room temperature (25°C) in their original packaging, away from moisture and heat.
- Keep the medication out of reach of children and pets.
Tasigna capsules, containing nilotinib as the active ingredient, offer an effective treatment option for patients with chronic myeloid leukemia. Treatment should be initiated and supervised by a qualified oncologist, and patients should be closely monitored for both efficacy and safety throughout the treatment course.
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