Glivec加以域

Glivec

imatinib

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Imatinib mesilate
Indications/Uses
Adult & ped patients: Treatment of newly diagnosed Philadelphia chromosome +ve (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the 1st-line of treatment; Ph+ CML in chronic phase after failure of interferon-α therapy, or in accelerated phase or blast crisis; newly diagnosed Philadelphia chromosome +ve acute lymphoblastic leukaemia (Ph+ ALL) integrated w/ chemotherapy; Adult patients: Treatment of relapsed or refractory Ph+ ALL as monotherapy; myelodysplastic/myeloproliferative diseases (MDS/MPD) associated w/ PDGFR gene re-arrangements; advanced hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukaemia (CEL) w/ FIP1L1-PDGFRα rearrangement. Treatment of Kit (CD117) +ve unresectable &/or metastatic malignant GI stromal tumours (GIST). Adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit +ve GIST. Treatment of unresectable dermatofibrosarcoma protuberans (DFSP) & recurrent &/or metastatic DFSP in patients not eligible for surgery.
Dosage/Direction for Use
Adult Chronic phase CML 400 mg once daily, may be increased to 600 or 800 mg. Accelerated phase or blast crisis CML 600 mg once daily, may be increased to 800 mg (given as 400 mg bd). Ph+ ALL 600 mg once daily. Relapsed/refractory Ph+ ALL 600 mg once daily. MDS/MPD 400 mg/day. HES/CEL 100-400 mg daily. Unresectable &/or metastatic, malignant GIST 400 mg/day, may be increased to 600 or 800 mg. Adjuvant treatment following resection of GIST 400 mg/day. DFSP 800 mg/day. Childn Chronic or advanced phase CML 340 mg/m2/day, may be increased to 570 mg/m2/day. Max total dose: 800 mg, Ph+ ALL 340 mg/m2/day. Max total dose: 600 mg.
Administration
Should be taken with food: Take w/ meals to minimize GI irritation. For patients w/ swallowing difficulties, open cap & dilute contents in a glass of water/apple juice.
Contraindications
Special Precautions
Concomitant use w/ protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates w/ a narrow therapeutic window, warfarin & other coumarin derivatives; strong CYP3A4 inducers. Closely monitor TSH levels in thyroidectomy patients undergoing levothyroxine replacement; & peripheral blood counts & liver enzymes in patients w/ hepatic dysfunction. Monitor for severe fluid retention & regularly weigh patients. Patients w/ cardiac disease or risk factors for cardiac failure or history of renal failure. GI & intra-tumoural hemorrhages. Correct clinically significant dehydration & treat high uric acid levels prior to initiation of therapy. Hepatitis B reactivation. Perform complete blood count & monitor liver function regularly. Evaluate renal function prior to start of therapy, & closely monitor during therapy. Severe renal impairment. May affect ability to drive or operate machinery. Women of childbearing potential must use effective contraception during treatment. Pregnancy & lactation. Childn.
Adverse Reactions
Neutropenia, thrombocytopenia, anaemia; headache; nausea, diarrhoea, vomiting, dyspepsia, abdominal pain; periorbital oedema, dermatitis/eczema/rash; muscle spasm & cramps, musculoskeletal pain (eg, myalgia, arthralgia, bone pain); fluid retention & oedema, fatigue; wt increased. Pancytopenia, febrile neutropenia; anorexia; insomnia; dizziness, paraesthesia, taste disturbance, hypoaesthesia; eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision; flushing, haemorrhage; dyspnoea, epistaxis, cough; flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis; increased hepatic enzymes; pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction; joint swelling; weakness, pyrexia, anasarca, chills, rigors; wt decreased.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors (eg, indinavir, lopinavir/ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; ketoconazole, itraconazole, posaconazole, voriconazole; erythromycin, clarithromycin, telithromycin). Decreased plasma conc w/ CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, fosphenytoin, St. John's wort). Increased Cmax & AUC of simvastatin, CYP3A4 substrates w/ narrow therapeutic window (eg, cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel & quinidine), other CYP3A4 substrates (eg, triazolo-benzodiazepines, dihydropyridine Ca channel blockers, certain HMG-CoA reductase inhibitors). Increased risk of bleeding w/ coumarin derivatives eg, warfarin. Increased plasma conc of CYP2D6 substrates w/ narrow therapeutic window (eg, metoprolol). Inhibited paracetamol O-glucuronidation. Decreased plasma exposure to levothyroxine. Increased hepatotoxicity w/ L-asparaginase.
ATC Classification
L01XE01 - imatinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Glivec cap 100 mg
Packing/Price
120's
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