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See related Glivec film-coated tab information |
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Manufacturer |
Novartis |
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Distributor |
Zuellig |
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Contents |
Imatinib mesilate |
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Indications |
Newly diagnosed chronic myeloid leukaemia (CML). CML in blast crisis, accelerated phase or in chronic phase after failure of interferon-α therapy. Newly diagnosed/relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Myelodysplastic/myeloproliferative diseases (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene rearrangements . Systemic mastocytosis (SM) w/o the D816V c-Kit mutation or w/ c-Kit mutational status unknown. Hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukemia (CEL). Unresectable, recurrent &/or metastatic dermatofibrosarcoma protuberans (DFSP). Unresectable &/or metastatic, malignant GI stromal tumors (GIST). Adjuvant treatment following resection of GIST w/ a tumor size ≥3 cm.
Click to view Glivec detailed prescribing infomation |
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Dosage |
CML Adult Chronic phase: 400 mg/day. Accelerated phase or blast crisis: 600 mg/day. Max: 800 mg/day. Childn Chronic & advanced phase: 340 mg/m2/day. Max: 600 mg/day. Adult Ph+ALL 600 mg/day. GIST, MDS/MPD, SM, HES/CEL 400 mg/day. DFSP 800 mg/day.
Click to view Glivec detailed prescribing infomation |
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Overdosage |
View Glivec overdosage for action to be taken in the event of an overdose. |
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Administration |
Should be taken with food (Take w/ a large glass of water. For patients unable to swallow, the tab may be dispersed in a glass of water or apple juice. Place the required number of tab in the appropriate vol of beverage (approx 50 mL for a 100-mg tab & 200 mL for a 400-mg tab) & stir w/ a spoon. Drink immediately after tab completely disintegrates.). |
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Contraindications |
[Click for Glivec detailed prescribing infomation] |
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Special Precautions |
Hepatic or severe renal impairment, cardiac diseases, severe fluid retention. Monitor patient's wt, CBC & liver function regularly. Monitor TSH levels in patient undergoing levothyroxine replacement. Cardiac screening in HES/CEL/MDS/MPD or SM patients w/ high level of eosinophils (ECG, serum troponin level); if either is abnormal, consider prophylactic use of systemic steroids for 1-2 wk concomitantly w/ imatinib at the start of therapy. Childn <3 yr, pregnancy & lactation.
Click to view Glivec detailed prescribing infomation |
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Adverse Drug Reactions |
Very common: Neutropenia, thrombocytopenia, anemia, headache, nausea, diarrhea, vomiting, dyspepsia, abdominal pain, periorbital edema, dermatitis/eczema/rash, muscle spasm & cramps, myalgia, arthralgia, bone pain, fluid retention & edema, fatigue, increased wt. Common: Pancytopenia, febrile neutropenia, anorexia, insomnia, dizziness, paresthesia, taste disturbance, hypoaesthesia, eyelid edema, increased lacrimation, conjunctival hemmorhage, conjunctivitis, dry eye, blurred vision, flushing, hemorrhage, dyspnea, epistaxis, cough, flatulence, abdominal distension, GERD, constipation, dry mouth, gastritis, increased hepatic enzymes, pruritus, face edema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction, joint swelling, weakness, pyrexia, anasarca, chills, rigors, decreased wt.
View ADR Monitoring Form |
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Drug Interactions |
CYP3A4 inducers (eg dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, St. John's wort), CYP3A4 inhibitors (eg ketoconazole, itraconazole, erythromycin, clarithromycin), substrates of CYP3A4 (eg cyclosporin or pimozide), paracetamol, warfarin.
View more drug interactions with Glivec |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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Description |
View Glivec description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Glivec mechanism of action for pharmacodynamics and pharmacokinetics details. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Glivec film-coated tablet |
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Glivec 100 mg x 60's |
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Glivec 400 mg x 30's |
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Manufacturer: |
Novartis |
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Distributor: |
Zuellig
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