Tasigna Application Scope

Tasigna (nilotinib) is indicated for:
- Adult and pediatric patients (≥ 1 year) with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
- Adult patients with Ph+ CML in chronic phase (CP) or accelerated phase (AP) who are resistant or intolerant to prior therapy, including imatinib.
- Pediatric patients ≥ 1 year with Ph+ CML-CP resistant or intolerant to prior TKI therapy.
  tasigna nilotinib

Tasigna Characteristics

Ingredients: Nilotinib
Properties: Oral formulation
Packaging Specification: Varies by country and strength (e.g., 50 mg, 150 mg, 200 mg hard capsules)
Storage: Store in a dry place, below 30 °C (86 °F); protect from heat, moisture and light
Expiry Date: Use the expiration date printed on the packaging
Executive Standard: Depends on local regulatory standards
Approval Number: Specific to each country; see local product labeling
Date of Revision: For the latest version, check the official package insert
Manufacturer: Novartis Pharmaceuticals Corporation

Guidelines for the Use of Tasigna

Dosage and Administration:
- Recommended Dose:
  - Newly diagnosed Ph+ CML-CP (adult, first-line): 300 mg twice daily (i.e., 300 mg × 2).
  - Resistant/intolerant Ph+ CML (CP or AP): 400 mg twice daily (i.e., 800 mg/day).
  - Pediatric dosing: Weight/BSA-based; see local pediatric dosing in package insert.
- Administration:
  - Take on an empty stomach: No food for at least 2 hours before the dose and no food for at least 1 hour after the dose.
  - Swallow capsules whole with water; do not chew, crush, or open.
  - Space doses approximately 12 hours apart.
  - Perform ECG monitoring (baseline, ~7 days after start, after dose changes, and periodically thereafter) and monitor electrolytes (potassium, magnesium) prior to and during therapy.
- Missed Dose:
  - If less than ~6 hours late, take dose as soon as possible (observing empty stomach rule).
  - If more than ~6 hours late, skip the missed dose; take the next dose at scheduled time. Do not double up.
  - Refer to local label for more precise guidance.
Adverse Reactions:
- Common Adverse Reactions:
  - Rash, pruritus (itching).
  - Headache, fatigue, nausea, constipation, diarrhea, and vomiting.
  - Myalgia, arthralgia, and back pain.
  - Hematologic: Thrombocytopenia, neutropenia, and anemia.
  - Elevated bilirubin or liver enzymes (AST, ALT).
  - Elevated pancreatic enzymes (lipase, amylase).
  - Hyperglycemia (blood glucose increase).
- Serious Adverse Reactions:
  - QT interval prolongation, torsades de pointes, and sudden death—a boxed warning in many labels.
  - Vascular events: Peripheral arterial occlusive disease, ischemic heart disease, and cerebrovascular events.
  - Hepatotoxicity, severe liver injury.
  - Pancreatitis (abdominal pain with elevated lipase).
  - Hemorrhage (bleeding).
  - Tumor lysis syndrome (rare).
Contraindications:
- Hypokalemia, hypomagnesemia (unless corrected).
- Congenital long QT syndrome.
- Hypersensitivity to nilotinib or any component of the formulation.
Precautions:
- Monitor ECG/QTc and correct electrolyte abnormalities before and during treatment.
- Evaluate and manage cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, and smoking) because of risk of arterial events.
- Hepatic impairment: caution; may require dose reduction and closer QT monitoring.
- Pancreatic enzyme monitoring; interrupt dose if pancreatitis suspected.
- Monitor for signs of bleeding.
- In pediatric patients, monitor growth and development.
- Pregnancy/fetal risk: may cause fetal harm; use effective contraception.
- Caution in patients with prior gastric surgery (e.g., gastrectomy) may affect absorption.

Tasigna Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib levels → increased QT risk.
Strong CYP3A4 inducers (e.g., rifampin, phenytoin): may reduce nilotinib levels → reduced efficacy.
Drugs that prolong QT interval: additive risk → avoid concomitant use.
Grapefruit/grapefruit juice: avoid (affects CYP3A4 and nilotinib absorption)

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.