IMATINIB 100 mg Tablets

Oral Tyrosine Kinase Inhibitor – Antineoplastic Agent

ATC Code: L01EA01 | Prescription Only | Targeted Therapy

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Product Description:

Imatinib mesylate is a selective tyrosine kinase inhibitor (TKI) that specifically blocks the activity of BCR-ABL (the fusion protein associated with the Philadelphia chromosome), c-KIT, and PDGFR. It is indicated in various malignancies driven by abnormal tyrosine kinase signaling, most notably in Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) and gastrointestinal stromal tumors (GIST). The 100 mg formulation is commonly used in dose-adjusted pediatric regimens and for patients requiring lower or divided daily doses.

Available Presentation:

• Strength: 100 mg per tablet
• Formulation: Film-coated tablet (color and shape may vary by manufacturer)
• Packaging: Bottle or blister pack of 30, 60, or 90 tablets
• Route of Administration: Oral
• Storage Conditions: Store at ≤30°C; keep in a dry place

Uses:

• First-line and maintenance therapy in Ph+ CML (all phases: chronic, accelerated, blast crisis)
• Pediatric use in children with Ph+ CML
• Ph+ acute lymphoblastic leukemia (ALL) in combination with chemotherapy
• Unresectable or metastatic GIST expressing c-KIT (CD117)
• Other off-label or approved indications based on mutation analysis, including:
  • Hypereosinophilic syndrome (HES)
  • Chronic eosinophilic leukemia (CEL)
  • Systemic mastocytosis
  • Dermatofibrosarcoma protuberans (DFSP)

Indications:

• Chronic Myeloid Leukemia (CML): Adults and children with Ph+ CML in all disease phases
• Acute Lymphoblastic Leukemia (Ph+ ALL): Newly diagnosed adults and children, in combination with chemotherapy
• Gastrointestinal Stromal Tumor (GIST): Patients with unresectable or metastatic KIT-positive tumors
• Systemic Mastocytosis and HES/CEL: In patients with mutations responsive to imatinib
• Dermatofibrosarcoma Protuberans (DFSP): Unresectable, recurrent, or metastatic tumors

Regulatory and Safety Profile:

• ATC Code: L01EA01
• Pharmacologic Class: BCR-ABL Tyrosine Kinase Inhibitor
• Pregnancy Category: D – Contraindicated unless essential
• Common Adverse Effects: Edema, nausea, rash, muscle cramps, fatigue
• Serious Adverse Effects: Hepatotoxicity, cytopenias, cardiotoxicity, severe fluid retention
• Contraindications: Hypersensitivity to imatinib or its excipients
• Monitoring Parameters: CBC, liver function, renal profile, serum electrolytes, and molecular response (BCR-ABL levels in CML)

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For institutional pricing, pediatric oncology tender quotes, or regulatory documentation, please contact our commercial team at info@panamfarma.com.