HPE HPE 85 – Spring 2017 - Page 64

XALUPRINE ® ORAL SUSPENSION A fluid approach to acute lymphoblastic leukaemia AC Xaluprine oral suspension offers your patients: CU RATE Natural raspberry taste with no artificial colours, flavours or added sugar 1 T PA L ATA www.xaluprine.com Abbreviated Prescribing Information for Xaluprine (mercaptopurine) 20 mg/ml oral suspension: Please refer to the full Summary of Product Characteristics and the treatment protocol when prescribing Xaluprine. Presentation: Oral suspension, each 1 ml contains 20 mg mercaptopurine (as monohydrate), 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 mg ethyl hydroxybenzoate (as the sodium salt), 1 mg potassium sorbate and sucrose (trace). Indications: For the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. Dose and Administration: The dose is governed by cautiously monitored haematotoxicity and should be carefully adjusted to suit the individual patient. Starting or target doses vary between 25 - 75mg/m 2 body surface area per day, but should be lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) activity. Elderly: Monitor renal and hepatic function and if there is any impairment, consider reducing the dose. Renal impairment: Consider reduced starting doses. Monitor patients for dose related adverse reactions. Hepatic impairment: Consider reduced starting doses. Monitor patients for dose related adverse reactions. Switching between tablet and oral suspension and vice versa: The oral suspension and tablet are not bioequivalent. Intensified haematological monitoring is advised on switching formulations. Administration: Redisperse by shaking vigorously at least for 30 seconds. Xaluprine should be taken in the evening and may be taken with food or on an empty stomach. Standardise the method of administration. Xaluprine should not be taken with milk or dairy products but it should be taken at least 1 hour before or 2 hours after milk or dairy products. Water should be taken after each dose. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concomitant use with yellow fever vaccine. Special Warnings and Precautions for Use: Cytotoxicity and haematological monitoring: Monitor haematological parameters. Interrupt treatment immediately at the first sign of abnormally large fall in leucocyte and platelet counts. Bone marrow suppression is reversible if 6–mercaptopurine is withdrawn early. Patients with little or no inherited TPMT activity are at increased risk for severe toxicity and require substantial dose reduction. 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