Adult Dosing
Ph+ CML
- Chronic phase: Start 400 mg PO qd, may increase to 600 mg/day
- Accelerated phase/blast crisis: Start 600 mg PO qd, may increase to 400 mg PO bid
Ph+ ALL
Myelodysplastic/ myeloproliferative disease (MDS/MPD)
Aggressive systemic mastocytosis (ASM)
- 400 mg PO qd; for patients with eosinophilia start 100 mg/day; increase to 400 mg if well tolerated and response insufficient
Hypereosinophilic syndrome and/or Chronic Eosinophilic Leukemia
- 400 mg PO qd, if FIP1L1-PDGFR alfa fusion kinase, start 100 mg PO qd, may increase to 400 mg if no adverse reaction and insufficient response
Dermatofibrosarcoma protuberans
Kit positive GIST
- Nonresectable/metastatic: Start 400 mg PO qd, may increase to 400 mg PO bid
- Post resection (adjuvant treatment): 400 mg PO qd
Note:
- Give with meals and large glass of water
Pediatric Dosing
Ph+ CML(>2 yrs of age)
- Chronic Phase CML, newly diagnosed: 340 mg/m2/day PO divided qd-bid. [Max: 600 mg/day]
- Chronic Phase CML, recurrent/resistant: 260 mg/m2/day PO divided qd-bid
[Outline]
Renal Dose Adjustment (Based on CrCl)
- 40-59 mL/min: Max 600 mg/day
- 20-39 mL/min: Decrease dose by 50%. Max: 400 mg/day
- < 20 mL/min: Use with caution; dose adjustments not defined
Hepatic Dose Adjustment
- Mild to moderate impairment: No dose adjustments
- Severe impairment: Decrease dose by 25%
- Edema and occasionally serious fluid retention have been reported with imatinib therapy. Monitor patient weight and signs and symptoms of fluid retention. The probability of edema increases with higher dose and age > 65 yrs
- Imatinib therapy causes anemia, neutropenia, and thrombocytopenia. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated
- Cytopenias are more frequent in patients with accelerated phase CML or blast crisis than in patients with chronic phase CML. In pediatric CML patients Grade 3 or 4, cytopenias, including neutropenia, thrombocytopenia and anemia occur generally within the first several months of therapy
- Severe congestive heart failure and left ventricular dysfunction have been observed with imatinib therapy, especially in patients with cardiac disease or risk factors. Patients should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated
- Imatinib therapy, alone or in combination with chemotherapy, may cause hepatotoxicity that is occasionally severe. Monitor LFTs before initiation of treatment and monthly, or as clinically indicated, and manage abnormalities with interruption and/or dose reduction
- Grade 3/4 hemorrhages have been reported in patients with newly diagnosed CML, unresectable or metastatic GIST
- Imatinib may cause GI irritation and therefore should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including fatalities, of GI perforation.
- Cardiogenic shock/left ventricular dysfunction has been reported with the initiation of imatinib therapy in patients with hypereosinophilic syndrome and cardiac involvement. This condition can be reversed with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib
- Perform echocardiogram and determine serum troponin in patients with HES/CEL and in patients with MDS/MPD or ASM associated with high eosinophil levels. If either is abnormal, consider prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib at the initiation of therapy
- Bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome, have been reported with use of imatinib
- Clinical cases of hypothyroidism have been reported in patients with thyroidectomy undergoing levothyroxine replacement during imatinib treatment. Closely monitor TSH levels in such patients
- Women of childbearing potential should be advised to avoid becoming pregnant and should use adequate contraception during imatinib therapy
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiac diseases
- History of cardiac diseases
- Thyroid disorder
Pregnancy Category:D
Breastfeeding: Limited information indicates that maternal doses of imatinib up to 400 mg daily produce low levels in milk. No long-term data are available and some authors warn against nursing during imatinib use. However, imatinib if used in breastfeeding women, must be accompanied by careful monitoring. Avoiding nursing for 8-9 hours after a dose would probably reduce infant exposure. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 February 2011). Manufacturer's data indicate that a breastfed infant could receive up to 10 % of the maternal therapeutic dose based on body weight. Because of the potential for serious adverse reactions in nursing infants a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Gleevec 100 MG TABS [Bottle] (NOVARTIS)
30 mg = $1640.92
90 mg = $4887.85 - Gleevec 400 MG TABS [Bottle] (NOVARTIS)
30 mg = $5963.04
60 mg = $11753.26
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
