Glivec

Glivec

imatinib

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Imatinib (as mesilate β crystals)
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
Should be taken with food: Take w/ a large glass of water. For patients unable to swallow, disperse tab 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.
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.
Adverse 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.
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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Glivec FC tab 100 mg
Packing/Price
60's
Form
Glivec FC tab 400 mg
Packing/Price
30's
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