XALUPRINE ORAL SUSPENSION ®
A fluid approach to acute lymphoblastic leukaemia
A
Xaluprine oral suspension offers your patients:
aluprine ptopurine oral suspension and haematological monitoring is
• Accuracy of dosing to 2 mg1 • Flexibility of dosing • Consistent absorption2 • A palatable alternative to tablets
• Natural raspberry flavour with no artificial colours, flavours or added sugar1
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
administration: Treatment
should be supervised by a physician or other healthcare professional experienced in the management of patients with ALL. 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 - 75 mg/m2
Xaluprine XaluprineXaluprine
lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) activity. Elderly: Monitor
body surface area per day, but should be renal and
ercaptopurine oral suspension Mercaptopurine oral suspension formulations. Administration: Redisperse by
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 switching
advised on
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
INR is anti-coagulants.
consideration should be given to the theoretical risk of carcinogenesis. Hepatosplenic T-cell lymphoma has been reported in patients with inflammatory bowel disease (unlicensed
indication) with treatment with anti-TNF or without alpha concomitant antibody. Excipients:
Aspartame may be harmful for people with phenylketonuria. Sodium methyl parahydroxybenzoate and sodium ethyl parahydroxybenzoate may cause delayed allergic reaction. Safe handling of the suspension: Avoid Xaluprine contact with skin or mucous membrane. For contact with skin or mucosa, wash immediately and thoroughly with soap and water. Interactions: When allopurinol and 6–mercaptopurine are administered concomitantly only a quarter of the usual dose of 6– mercaptopurine must be given. Other xanthine oxidase inhibitors should be avoided. Reinforced monitoring of
recommended in patients co-administered Aminosalicylate
derivatives inhibit
TPMT enzyme and should be administered with caution. Pregnancy and Lactation: Do not use during pregnancy unless expected benefits outweigh any possible risk. Do not use whilst breast-feeding. Contraception: Sexually active men and women should use effective methods of contraception during treatment and for at least three months
authorisation Mercaptopurine oral suspension Adverse events should be reported.
Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard Adverse events
should also be reported to: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Tel: +44 (0)116 223 0100
References 1. Xaluprine Summary of product Characteristics. 2. Mulla H et al. J Clin Pharmacol 2012;52:1610-3.
Mercaptopurine oral suspension Xaluprine PUL-XAL15-006 Date of preparation: June 2015 347501 Xaluprine Journal
Advert_APPROVED.indd 1 ®
Xaluprine Mercaptopurine oral suspension is potentially
Xaluprine B R
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. TPMT testing cannot substitute for haematological monitoring. Immunosuppression: Immunisations with live organism vaccines are not recommended. Hepatotoxicity: Monitor liver function weekly. More frequent monitoring may be advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy. Discontinue Xaluprine if jaundice becomes apparent. Renal toxicity: Monitor uric acid levels in blood and urine during remission induction. Hydration and urine alkalinisation may minimize potential renal complications. Mutagenicity 6–mercaptopurine
and carcinogenicity: carcinogenic
and transient oligospermia,
www.xaluprine.com www.novalabs.co.uk Mercaptopurine oral suspension
Xalup Mercaptopurine or
after receiving the last dose. Undesirable effects: Refer to the SPC for full list. Bone marrow suppression leading to leucopenia and thrombocytopenia is the most common adverse reaction. Anaemia, anorexia, stomatitis, diarrhoea, vomiting, nausea,
biliary stasis and hepatotoxicity are
common adverse reactions. The following adverse reactions have also been reported from uncommonly to very rarely: arthralgia, skin rash, drug fever, pancreatitis, oral ulceration, hepatic necrosis, facial oedema, hypoglycaemia, alopecia, photosensitivity,
secondary
leukaemia, myelodysplasia, hepatosplenic T-cell lymphoma and intestinalulceration. Overdose: There is no antidote to Xaluprine. Monitor the blood picture and if necessary provide general supportive measures together with appropriate blood transfusion. Activated charcoal or gastric lavage can be undertaken within 60 minutes of ingestion. Pack size: 1 glass bottle containing 100 ml Xaluprine (mercaptopurine) 20mg/ml oral suspension. Shelf-life/Storage: 1 year; 56 days after first opening. Do not store above 25ºC. Legal category: POM. Marketing
number:
EU/1/11/727/001. Marketing authorisation holder: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Date of latest revision of brief prescribing information: Nov 2014. Further information including full prescribing information is available from: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Tel: +44 (0)116 223 0100.
Mercaptopurine or Xalup 19/06/2015 09:01
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