Abbreviated Prescribing Information:

Xaluprine® (mercaptopurine monohydrate) 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 monohydrate, 3 mg aspartame, 1 mg methyl parahydroxybenzoate (as the sodium salt), 0.5 mg ethyl parahydroxybenzoate (as the sodium salt) and sucrose (trace).
Indication: For the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Dosage and Administration: The dose is governed by cautiously monitored haematotoxicity and should be carefully adjusted to suit the individual patient. Starting or target doses generally vary between 25 – 75 mg/m² body surface area per day but should be lower in patients with reduced or absent TPMT and/or NUDT 15 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 prior to dosing. 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. Xaluprine 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 Bone marrow suppression is reversible if mercaptopurine is withdrawn early enough. Patients with little or no inherited TPMT and/or NUDT15 activity are at increased risk for severe toxicity and require substantial dose reduction. TPMT/NUDT15 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 immediately 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. Pancreatitis is a common (frequency of ≥ 1/100 to < 1/10) adverse reaction in patients treated for the unlicensed indication inflammatory bowel disease. Mutagenicity and carcinogenicity Increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi’s and non-Kaposi’s) and uterine cervical cancer in situ. A combination of multiple immunosuppressants (including thiopurines) given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. Hepatosplenic T-cell lymphoma has been reported in patients with inflammatory bowel disease (unlicensed indication) with or without concomitant treatment with anti- TNF alpha antibody. Macrophage activation syndrome A life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (unlicensed indication). Infections Increased susceptibility to viral, fungal and bacterial infections, including severe or atypical infection, and viral reactivation. Metabolic and nutritional disorders Purine analogues (azathioprine and mercaptopurine) may interfere with the niacin pathway, potentially leading to nicotinic acid deficiency (pellagra). Diagnosis of pellagra should be considered in patients with a localised pigmented rash (dermatitis), gastroenteritis, or neurological deficits including cognitive deterioration. Appropriate medical care with niacin/nicotinamide supplementation must be initiated. UV exposure: Patients treated with mercaptopurine are more sensitive to the sun. Exposure to sunlight and UV light should be limited, and patients should be recommended to wear protective clothing and to use a sunscreen with a high protection factor. Paediatric population: Cases of symptomatic hypoglycaemia have been reported in children with ALL, particularly in those under six years or with low body mass index. Excipients Aspartame (E951) may be harmful for people with phenylketonuria. Sodium methyl parahydroxybenzoate and sodium ethyl parahydroxybenzoate may cause allergic reaction (possibly delayed). 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 mercaptopurine are administered concomitantly only a quarter of the usual dose of mercaptopurine must be given. Other xanthine oxidase inhibitors should be avoided. Reinforced monitoring of INR is recommended in patients coadministered anticoagulants. Aminosalicylate derivatives inhibit TPMT enzyme and should be administered with caution. Azathioprine (a pro-drug of mercaptopurine) and infliximab may cause transient increases in 6-TGN levels and decreases in leucocyte count initially, resolving after 3 months. When administered concomitantly with high dose methotrexate, the mercaptopurine dose may need adjustment. Concomitant administration of ribavirin is not advised due to risk of severe myelosuppression.
Contraception: Both sexually active men and women should use effective methods of contraception during treatment and for at least three or six months respectively after receiving the last dose.
Pregnancy and Lactation: Do not use during pregnancy unless expected benefits outweigh any possible risk. Do not use while breastfeeding. Cholestasis of pregnancy has occasionally been reported in association with azathioprine (a prodrug of mercaptopurine) therapy. A careful assessment of benefit to the mother and impact on the foetus should be performed, if cholestasis of pregnancy is confirmed.
Undesirable Effects: Refer to the SmPC for full list. Very common Bone marrow suppression, leucopenia and thrombocytopenia. Common Anaemia, anorexia, diarrhoea, vomiting, nausea, biliary stasis and hepatotoxicity. Uncommon Bacterial and viral infections, infections associated with neutropenia, arthralgia, skin rash, drug fever, oral ulceration and hepatic necrosis. Not known Hepatosplenic T-cell lymphoma, hypoglycaemia, pellagra, stomatitis, cheilitis, portal hypertension, nodular regenerative hyperplasia, sinusoidal obstruction syndrome, photosensitivity reaction, erythema nodosum, mucosal inflammation and coagulation factors decreased. Rare Neoplasms, skin cancers, sarcomas and uterine cervical cancer in situ, facial oedema, alopecia and transient oligospermia, pancreatitis. Very rare Secondary leukaemia, myelodysplasia and intestinal ulceration. Overdose: There is no known 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 monohydrate) 20 mg/ml oral suspension, 1 adaptor and 2 syringes (1 ml and 5 ml).
Shelf life: 18 months; 56 days after first opening.
Storage: Do not store above 25°C.
Legal category: POM
Marketing Authorisation Number: PLGB 13581/0002
Marketing Authorisation Holder: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, United Kingdom
Date of latest revision: June 2025
Job number: XalABVPI005
NHS Price: £170.00

Further information is available from: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Tel: +44 (0)116 223 0100