IMATINIB 400 mg Tablets (Box of 30)

Tyrosine Kinase Inhibitor (TKI) – Antineoplastic Agent

ATC Code: L01EA01 | Prescription Only | Oral Targeted Therapy

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Product Description:

Imatinib mesylate is a selective tyrosine kinase inhibitor (TKI) that specifically targets BCR-ABL, the abnormal fusion protein created by the Philadelphia chromosome translocation (t(9;22)). It also inhibits c-KIT, PDGFR, and other tyrosine kinases involved in malignant cell proliferation. Imatinib revolutionized the treatment of chronic myeloid leukemia (CML) and is now a first-line standard of care. It is also indicated for various solid tumors and hematologic malignancies characterized by overactive kinase signaling.

Available Presentation:

• Strength: 400 mg per film-coated tablet
• Packaging: Bottle or blister pack of 30 tablets (monthly cycle)
• Formulation: Oral solid dose; tablets are orange or light brown depending on manufacturer
• Route of Administration: Oral, once daily with a meal and a full glass of water
• Storage Conditions: Store below 30°C; protect from moisture

Uses:

• Chronic Myeloid Leukemia (CML):
  • First-line treatment of adult and pediatric patients with Ph+ CML in chronic, accelerated, or blast phase
• Acute Lymphoblastic Leukemia (Ph+ ALL):
  • In combination with chemotherapy in newly diagnosed patients
• Gastrointestinal Stromal Tumors (GIST):
  • Unresectable, metastatic, or recurrent tumors expressing c-KIT (CD117)
• Other Uses:
  • Dermatofibrosarcoma protuberans (DFSP)
  • Systemic mastocytosis (with D816V-negative KIT mutation)
  • Hypereosinophilic syndrome

Indications:

• Philadelphia chromosome–positive CML in adults and children
• Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL)
• KIT-positive gastrointestinal stromal tumors (GIST)
• Systemic mastocytosis, hypereosinophilic syndrome, and chronic eosinophilic leukemia
• DFSP in unresectable, recurrent, or metastatic cases

Regulatory and Safety Profile:

• ATC Code: L01EA01
• Pharmacologic Class: BCR-ABL Tyrosine Kinase Inhibitor
• Pregnancy Category: D – Use only in life-threatening cases
• Common Side Effects: Edema, nausea, muscle cramps, rash, fatigue, abdominal pain
• Severe Adverse Effects: Cytopenias, hepatotoxicity, fluid retention, cardiotoxicity
• Contraindications: Hypersensitivity to imatinib or its excipients
• Monitoring Parameters: CBC, liver function tests, renal function, electrolytes, response via BCR-ABL transcript levels

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