Tasigna 200mg Capsule

Salt Composition: Nilotinib  
Manufacturer: NOVARTIS INDIA LTD  
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About

Nilotinib is a potent and selective tyrosine kinase inhibitor (TKI) primarily used in the treatment of chronic myeloid leukemia (CML). It works by specifically targeting the Bcr-Abl fusion protein, which is the hallmark of CML and drives the uncontrolled proliferation of myeloid cells. By inhibiting the kinase activity of Bcr-Abl, nilotinib blocks the signaling pathways essential for cancer cell survival and proliferation, leading to apoptosis of CML cells. It is particularly effective in patients who are resistant or intolerant to prior imatinib therapy, or in newly diagnosed patients with Philadelphia chromosome-positive CML. Its targeted action helps to achieve deep molecular responses and improve long-term outcomes for patients, representing a significant advancement in CML management.

Uses

  • Treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML.
  • Treatment of Ph+ CML in chronic or accelerated phase resistant to prior therapy.
  • Management of CML in patients intolerant to prior therapy.
  • Used in specific types of chronic myeloid leukemia.

Directions For Use

Take the capsules orally twice daily, approximately 12 hours apart, on an empty stomach (at least 2 hours after food and 1 hour before food). Swallow whole with water.

Benefits

  • Highly effective in treating Philadelphia chromosome-positive CML.
  • Can achieve deep molecular responses.
  • Improves progression-free and overall survival.
  • Offers an alternative for imatinib-resistant/intolerant patients.
  • Targeted therapy with a specific mechanism of action.
  • Helps to control the proliferation of leukemia cells.

Side Effects

  • Nausea and vomiting
  • Diarrhea or constipation
  • Fatigue
  • Headache
  • Rash
  • Myelosuppression (low blood counts)
  • Elevated liver enzymes
  • Pancreatitis
  • Fluid retention
  • QT prolongation (cardiac effect)
  • Muscle pain
  • Electrolyte imbalances

Safety Measures

  • Alcohol - Avoid or limit alcohol consumption as it may increase the risk of liver toxicity and exacerbate gastrointestinal side effects.
  • Pregnancy - Nilotinib can cause fetal harm and is contraindicated in pregnancy. Women of childbearing potential must use effective contraception during treatment and for at least 2 weeks after the last dose.
  • Breastfeeding - Breastfeeding is contraindicated during Nilotinib treatment and for at least 2 weeks after the last dose, due to potential harm to the infant.
  • Liver - Use with caution in patients with hepatic impairment. Liver function tests should be monitored regularly, and dose adjustments may be necessary.
  • Kidney - Use with caution in patients with renal impairment. No specific dose adjustment is typically required, but close monitoring is advised.
  • Lung - Rarely, pulmonary arterial hypertension (PAH) or interstitial lung disease can occur. Patients should report any new or worsening shortness of breath or chest pain.

Disclaimer

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