Practice Update | Onology

Glivec ® [imatinib (as mesylate)] available from Mylan Australia. Order Glivec ® by contacting your Mylan Australia Business Advisor or Customer Service on 1800 274 276.

PBS Information: Authority Required. Refer to PBS Schedule for full authority information.

Indications: Treatment of chronic myeloid leukaemia (CML); adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy; adults with relapsed or refractory Ph+ ALL as monotherapy; adults with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangement where conventional therapies have failed; adults with aggressive systemic mastocytosis (ASM) where conventional therapies have failed; adults with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL); kit (CD117) positive unresectable and/or metastatic malignant gastrointestinalstromal tumours (GIST);adjuvant treatmentofadultpatientsathigh riskof recurrence followingcompletegross resectionofKIT (CD117)-positiveprimaryGIST;adultswithunresectable, recurrentand/ormetastaticdermatofibrosarcoma protuberans (DFSP). Dosage: CML chronic phase (CML-CP): 400 mg once daily; CML accelerated phase or blast crisis (CML-AP/BC): 600 mg once daily; increase dose from 400 mg to 600 mg or 800 mg (400 mg twice daily) in CML-CP, or from 600 mg to 800 mg (400 mg twice daily) in CML-AP/BC in certain circumstances. Ph+ALL: 600 mg once daily. GIST, GIST adjuvant treatment, MDS/MPD, ASM, HES/CEL: 400 mg once daily; HES/CEL with FIP1L1-PDGFR-alpha fusion kinase: 100 mg daily increasing to 400 mg daily. DFSP: 800 mg daily. Children: For CML and Ph+ALL: 340 mg/m 2 daily (not to exceed the total dose of 600 mg a day). No experience in children for CML below 2 years of age, and for ALL below 1 year of age. Patients with hepatic or renal impairment should be given 400 mg daily as a starting dose. Dose adjustment may be required due to side-effects or insufficient response to therapy. Monitoring of response to Glivec therapy in CML patients should be performed routinely and when therapy is modified, to identify suboptimal response, loss of response to therapy, poor patient compliance, or possible drug-drug interaction. Results of monitoring should guide appropriate CML management. Contraindications: Hypersensitivity to imatinib or excipients. Precautions: Other medicines. Take with food and a large glass of water to minimise the risk of gastrointestinal disturbances; severe fluid retention, especially in elderly or patients with a history of cardiac disease, patients should be weighed and monitored regularly for signs of fluid retention; regular monitoring of complete blood counts and liver function. Monitoring of hepatic function is recommended when used concomitantly with hepatotoxic chemotherapy regimens in Ph+ALL patients. Test for hepatitis B infection before initiating treatment with Glivec. In patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for hepatitis B infection during treatment, consult experts before initiating treatment. Closely monitor for signs and symptoms of active hepatitis B infection in carriers of hepatitis B virus throughout therapy and for several months following termination of therapy. Caution in patients with history of cardiac disease or history of renal failure. Careful monitoring of patients with cardiac disease, risk factors for cardiac failure or history of renal failure. Cardiac screening should be considered in patients with HES/CEL, and patients with MDS/MPD or ASM with high level of eosinophils (echocardiogram, serum troponin level) – if either is abnormal, prophylactic use of systemic steroids to be considered for 1 to 2 weeks concomitantly with imatinib at the initiation of therapy; hepatic or severe renal impairment; monitor TSH levels in thyroidectomy patients undergoing levothyroxine therapy. Reports of gastrointestinal haemorrhage and haemorrhages. Reports of gastric antral vascular ectasia (GAVE) in patientswithCML,ALLandotherdiseases.Monitoring forgastrointestinalsymptomsat thestartofandduring treatment.Glivecdiscontinuationmaybeconsidered.Reportsof tumor lysissyndrome (TLS).Correctionofclinicallysignificantdehydration and treatment of high uric acid levels prior to initiation. Driving and using machinery; pregnancy (reports of spontaneous abortion/infant congenital anomalies); women of child-bearing potential must be advised to use highly effective contraception; breast-feeding. Children/adolescents: close monitoring of growth due to growth retardation reports. Interactions: Numerous (see full Product Information) including concomitant use of drugs inhibiting or inducing CYP3A4 (e.g. ketoconazole, dexamethasone, rifampicin, clarithromycin, phenytoin, carbamazepine, St John’s Wort), being substrates of CYP3A4 (e.g. cyclosporin, dihydropridine calcium channel blockers, simvastatin, triazolo-benzodiazepines), CYP2C9 (e.g. warfarin) or CYP2D6 (e.g. metoprolol), or paracetamol (including OTC preparations). Adverse reactions: Very common: myelosuppression, neutropenia, thrombocytopenia, anaemia, fluid retention and oedema, fatigue, weight increased, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, increased hepatic enzymes, upper respiratory tract infection, muscle spasm and cramps, musculoskeletal pain including myalgia, arthralgia, bone pain, musculoskeletal pain upon treatment discontinuation (including myalgia, pain in extremity, arthralgia, bone pain, spinal pain), headache, blood creatinine increased, periorbital oedema, dermatitis/eczema/rash. Common: pancytopenia, febrile neutropenia, pyrexia, weakness, rigors, anasarca, chills, weight decreased, eyelid oedema, conjunctivitis, lacrimation increased, conjunctival haemorrhage, dry eye, vision blurred, abdominal distension, flatulence, constipation, gastro-oesophageal reflux, dry mouth, gastritis, hyperbilirubinaemia, anorexia, joint swelling, dizziness, taste disturbance, paraesthesia, hypoaesthesia, insomnia, epistaxis, dyspnoea, cough, face oedema, pruritis, erythema, dry skin, alopecia, night sweats, photosensitivity reaction, flushing, haemorrhage. Please note changes to Product Information in italics. Glivec is a registered trademark of Novartis AG. Copyright © 2017 Mylan N.V. All rights reserved. Alphapharm Pty Ltd (trading as Mylan Australia), ABN 93 002 359 739, Level 1, 30 The Bond, 30–34 Hickson Road, Millers Point NSW 2000. Tel: 1800 274 276. www.mylan.com.au. DH MYO0167. IMA-2017-0006. Date of preparation June 2017. Before prescribing/dispensing, please review the Product Information for Glivec ® (imatinib (as mesylate)) available on request fromNovartis or access the Product Information from http://www.guildlink.com.au/gc/ws/nv/pi.cfm?product=nvpglior20914