Product Introduction:
Imatero is a prescription-only oral chemotherapy agent used for the treatment of various cancers characterized by abnormal tyrosine kinase activity. Manufactured by Hetero Healthcare, it is available in tablet form in 100 mg and 400 mg strengths, making it adaptable for different cancer treatment protocols based on the stage and patient-specific needs.
Uses (Indications):
Imatinib (Imatero) is indicated in the treatment of the following conditions:
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Chronic Myeloid Leukemia (CML) – All phases (chronic, accelerated, and blast crisis)
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Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
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Gastrointestinal Stromal Tumors (GIST) – Especially c-KIT positive tumors
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Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) – Associated with PDGFR gene rearrangement
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Hypereosinophilic Syndrome (HES) and Chronic Eosinophilic Leukemia (CEL)
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Aggressive Systemic Mastocytosis (ASM)
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Dermatofibrosarcoma Protuberans (DFSP) – Recurrent or unresectable cases
Storage Instructions:
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Store at a temperature range of 15°C to 30°C.
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Keep away from moisture and direct sunlight.
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Store in the original packaging until use.
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Keep out of reach of children and pets.
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Do not use after the expiry date mentioned on the label.
How It Works (Mechanism of Action):
Imatinib is a selective tyrosine kinase inhibitor (TKI). It blocks the activity of:
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BCR-ABL fusion protein, the abnormal tyrosine kinase resulting from the Philadelphia chromosome translocation seen in CML and Ph+ ALL.
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c-KIT (CD117) – active in GIST
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PDGFR (Platelet-derived growth factor receptor) – involved in MDS/MPD
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It works by binding to the ATP-binding site of these kinases, inhibiting their phosphorylation and blocking downstream signaling pathways responsible for cell proliferation, survival, and resistance.
This targeted approach leads to reduced cancer cell growth and induces apoptosis (programmed cell death) in malignant cells.
Side Effects:
Common Side Effects:
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Nausea, vomiting
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Edema (especially periorbital and lower limbs)
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Muscle cramps
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Rash or itching
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Diarrhea
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Headache
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Fatigue and dizziness
Severe Side Effects:
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Hepatotoxicity – Elevated liver enzymes, jaundice
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Myelosuppression – Neutropenia, anemia, thrombocytopenia
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Cardiotoxicity – Congestive heart failure, particularly in the elderly
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Fluid retention – Pulmonary edema, pleural effusion
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Tumor lysis syndrome (TLS) – Metabolic abnormalities due to rapid tumor cell death
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Severe skin reactions – Including Stevens-Johnson Syndrome (rare)
Dosage (Typical Recommended Dose):
Dosage is based on indication, patient’s weight, and treatment phase:
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Chronic phase CML: 400 mg once daily
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Accelerated/blast phase CML: 600 mg once daily
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GIST: 400 mg daily; may be increased to 800 mg in resistant cases
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Pediatric CML (≥1 year): 260–340 mg/m² daily (max: 600 mg)
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Dosage may need to be adjusted based on tolerance, response, or adverse effects
Always follow oncologist’s prescription for precise dosing.
Method of Administration:
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Administer orally with a full glass of water.
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Take with food to minimize gastrointestinal upset.
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Swallow whole; do not crush or chew.
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For patients with swallowing difficulties, tablets may be dissolved in water or apple juice and consumed immediately.
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Take the dose at the same time each day for optimal blood levels.
Precautions:
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Regular monitoring of complete blood count (CBC), liver function, and kidney function.
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Use with caution in patients with cardiac disorders, liver disease, or renal impairment.
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May cause growth retardation in children; monitor growth patterns.
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Avoid pregnancy and breastfeeding – known teratogenic effects.
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Use contraception during and for at least one month after stopping the drug.
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Be cautious if driving or operating machinery – may cause dizziness or visual disturbances.
Drug Interactions:
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CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may increase Imatinib levels – risk of toxicity.
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CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy by lowering plasma concentration.
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Warfarin: increased risk of bleeding – INR monitoring required.
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Paracetamol: use with caution due to possible liver interaction.
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Live vaccines: contraindicated due to immunosuppression.
Allergies (Warnings for Allergic Reactions):
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Hypersensitivity to Imatinib or any excipients in the formulation.
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Symptoms include skin rash, urticaria, itching, swelling, and in rare cases anaphylaxis.
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Discontinue use and seek emergency care in the event of a severe reaction.
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Mild symptoms may be managed with antihistamines or corticosteroids under physician guidance.
Overdose Information:
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Overdose can lead to severe gastrointestinal symptoms, myelosuppression, or liver toxicity.
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Immediate supportive care, gastric lavage, and monitoring of vital signs and electrolytes recommended.
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No specific antidote is available; treatment is symptomatic and supportive.
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Hospitalization may be necessary for close observation.
Missed Dose Instructions:
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Take the missed dose as soon as remembered, unless it's near the time of the next dose.
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Do not double the dose to compensate for a missed one.
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Maintain regular dosing schedule for continuous therapeutic effectiveness.
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If multiple doses are missed, contact your doctor for advice.
Additional Notes:
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Imatero is a cost-effective generic alternative to the original brand Glivec®.
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Continuous therapy may be required for years or even lifelong in CML patients.
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Patients should be educated about signs of infection, bleeding, or fluid overload.
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Regular monitoring ensures early detection of side effects and improves long-term safety.
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Encourage adherence to therapy, as non-compliance is a major cause of treatment failure.
