Veenat (100mg / 400mg) - Imatinib Tablet

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1. Chronic Myeloid Leukemia (CML) – all phases (chronic, accelerated, blast crisis)
2. Acute Lymphoblastic Leukemia (ALL) – Philadelphia chromosome-positive (Ph+)
3. Gastrointestinal Stromal Tumors (GISTs) – KIT (CD117) positive
4. Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) – associated with PDGFR mutations
5. Systemic Mastocytosis – aggressive forms with D816V negative c-KIT mutation
6. Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
7. Dermatofibrosarcoma Protuberans (DFSP) – locally advanced or metastatic
8. Adjuvant treatment of GIST after surgical resection (to prevent recurrence)

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1. Store below 30°C (86°F) in a cool, dry place
2. Protect from moisture and light
3. Keep tablets in the original packaging until use
4. Keep out of reach of children

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1. BCR-ABL (fusion protein found in CML and Ph+ ALL)
2. c-KIT (CD117) – often mutated in GIST
3. PDGFR (platelet-derived growth factor receptor)

1. These tyrosine kinases are abnormally activated in cancer cells, driving uncontrolled proliferation.
2. Imatinib competitively inhibits the ATP-binding site of these kinases, preventing phosphorylation and activation.
3. This results in inhibition of signal transduction pathways, leading to cell cycle arrest and apoptosis in malignant cells.
4. Importantly, it spares normal cells, providing targeted therapy with fewer off-target toxicities than traditional chemotherapy.

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1. Nausea, vomiting
2. Edema (especially periorbital and lower limb swelling)
3. Muscle cramps and musculoskeletal pain
4. Diarrhea or constipation
5. Skin rashes
6. Fatigue and headache

1. Bone marrow suppression – anemia, neutropenia, thrombocytopenia
2. Hepatotoxicity – elevated liver enzymes, jaundice, rare liver failure
3. Congestive heart failure – in rare cases
4. Pulmonary edema or effusions
5. Severe dermatologic reactions – Stevens-Johnson syndrome (rare)
6. Gastrointestinal bleeding or tumor rupture in GIST patients

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1. CML (chronic phase): 400 mg once daily
2. CML (accelerated/blast crisis): 600 mg once daily
3. Ph+ ALL: 600 mg once daily
4. GIST (unresectable/metastatic): 400–600 mg daily
5. Adjuvant GIST (post-surgery): 400 mg daily for up to 3 years
6. Dose may be increased to 800 mg/day (in divided doses) in resistant cases
7. Dose adjustments based on response and tolerance

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Method of Administration:

1. Oral administration with a full glass of water
2. Take with food to reduce gastric irritation
3. Do not crush or chew the tablets
4. Swallow whole and take at the same time each day for consistent plasma levels
5. Regular monitoring of blood counts and liver enzymes is essential

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1. Avoid use in pregnancy (Category D) – potential for fetal harm
2. Use effective contraception during and at least 1 month after therapy
3. Monitor for fluid retention, especially in elderly or cardiac patients
4. Regularly monitor CBC, LFTs, and renal function
5. Dose adjustment may be required in renal or hepatic impairment
6. Be cautious with patients having cardiovascular disorders or GI bleeding risk

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1. CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) – may increase imatinib levels
2. CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's Wort) – may decrease efficacy
3. Warfarin – increased risk of bleeding; monitor INR
4. Acetaminophen (paracetamol) – high doses may cause hepatotoxicity
5. Other hepatotoxic or myelosuppressive agents – increased toxicity risk

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1. Hypersensitivity to Imatinib or any tablet excipients
2. May present with rash, urticaria, angioedema, or anaphylaxis
3. Discontinue and seek immediate care if any signs of severe reaction appear

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1. Overdose may lead to severe nausea, vomiting, GI bleeding, myelosuppression, liver dysfunction
2. No specific antidote – treat symptomatically and provide supportive care
3. Gastric lavage may be considered if recent ingestion
4. Monitor vital signs, renal/liver function, electrolytes, and CBC

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1. Take the missed dose as soon as remembered if it's within a few hours
2. If it’s almost time for the next dose, skip the missed dose
3. Do not double the dose to compensate
4. Maintain a regular dosing schedule for best efficacy

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1. Long-term therapy may be needed for chronic conditions like CML – patient education is vital
2. Response to treatment is usually monitored by PCR for BCR-ABL transcript levels or CT scans for GIST
3. Generic formulations like Veenat offer a cost-effective option for long-term therapy
4. Patient support programs and frequent lab follow-ups are essential to ensure safety
5. Therapy may be lifelong in some cases unless complete molecular remission is achieved
6. Adherence to therapy is critical to avoid resistance or relapse