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Nilotinib 150mg - Tasigna Capsules

Tasigna 150mg is a prescription anti-cancer medicine containing Nilotinib, a tyrosine kinase inhibitor (TKI) used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic and accelerated phases. It is effective in inhibiting the abnormal BCR-ABL protein that drives leukemia progression.

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General Information:
Generic Name: Nilotinib
Brand Name: Tasigna
Packing: Bottle of 28 or 120 capsules (varies)
Strength: 150 mg
Manufacturer: Novartis
Form: Oral capsules
Category: Tyrosine Kinase Inhibitor (TKI), Antineoplastic
Product Intro:
Tasigna 150mg is an advanced, second-generation BCR-ABL tyrosine kinase inhibitor designed to manage chronic myeloid leukemia (CML) that is resistant or intolerant to prior therapies like imatinib. Manufactured by Novartis, it provides targeted therapy with improved potency and fewer off-target effects compared to first-generation TKIs.

Uses:
  1. Chronic phase Ph+ CML in newly diagnosed adult patients
  2. Chronic or accelerated phase Ph+ CML in adult patients resistant or intolerant to prior therapy (e.g., Imatinib)
  3. Used in maintenance therapy to prevent relapse
  4. Investigational use in other BCR-ABL–driven malignancies
  5. A part of targeted precision cancer therapy protocols

Storage Instructions:
  1. Store at 20°C to 25°C (68°F to 77°F)
  2. Protect from moisture and direct heat
  3. Keep in original container
  4. Keep out of reach of children

How it Works (Mechanism of Action):
Nilotinib inhibits the BCR-ABL tyrosine kinase, which is produced by the Philadelphia chromosome abnormality in CML patients. By blocking this enzyme, it prevents cancer cell growth and induces apoptosis (programmed cell death). It is more selective and potent than Imatinib in inhibiting mutated BCR-ABL.

Side Effects:
Common Side Effects:
  1. Nausea and vomiting
  2. Rash and itching
  3. Headache
  4. Fatigue
  5. Muscle aches
  6. Constipation or diarrhea
Serious Side Effects:
  1. QT prolongation (irregular heartbeat)
  2. Pancreatitis
  3. Hepatotoxicity (liver damage)
  4. Elevated lipase or amylase levels
  5. Electrolyte imbalance
  6. Myelosuppression (low blood counts)

Dosage (Typical Recommended Dose):
  1. Standard dose: 300 mg orally twice daily (for newly diagnosed chronic phase CML)
  2. Dosage may be adjusted based on response, liver function, or adverse effects
  3. Must be taken on an empty stomach (avoid food 2 hours before and 1 hour after)

Method of Administration:
  1. Administer orally with water
  2. Must be taken at least 2 hours after eating and 1 hour before the next meal
  3. Swallow capsule whole—do not crush or open

Precautions:
  1. Baseline ECG and electrolyte tests required before starting
  2. Avoid in patients with prolonged QT syndrome
  3. Use with caution in liver or pancreatic impairment
  4. Avoid use in pregnant or breastfeeding women
  5. Monitor blood glucose, liver enzymes, and blood counts regularly
  6. May require dose reduction in patients with hepatic dysfunction

Drug Interactions:
  1. Avoid use with strong CYP3A4 inhibitors/inducers (e.g., ketoconazole, rifampin)
  2. May interact with QT-prolonging drugs (e.g., antiarrhythmics, certain antibiotics)
  3. Antacids or proton pump inhibitors may affect absorption
  4. Avoid grapefruit juice

Allergies:
  1. Contraindicated in individuals with known hypersensitivity to nilotinib or excipients
  2. Watch for signs like rash, swelling, breathing difficulty, or hives

Overdose Information:
  1. Symptoms may include severe heart rhythm issues, fainting, or nausea
  2. Immediate medical attention is required
  3. Supportive treatment and ECG monitoring should be performed

Missed Dose Instructions:
  1. If a dose is missed, skip it and take the next scheduled dose
  2. Do not take two doses at once to make up for the missed dose

Additional Notes:
  1. Regular monitoring of ECG, electrolytes (potassium, magnesium), liver function, and CBC is essential
  2. Strict adherence to dosing schedule and fasting rules is critical for effectiveness
  3. Patients should be educated on recognizing symptoms of serious side effects such as palpitations or jaundice
  4. Not approved for use in children under 18 years
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