Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Fontus Health Ltd, 60 Lichfield Street, Walsall WS4 2BX, United Kingdom
Hanixol 50 mg tablets is indicated for the treatment of APL (acute promyelocytic leukaemia) and AML M3 (acute myeloid leukaemia M3) in adults, adolescents and children.
6-mercaptopurine treatment should be initiated and supervised by a doctor or other healthcare professional experienced in the management of patients with acute leukemia.
6-mercaptopurine may be taken with food or on an empty stomach, but patients should standardise the method of administration. 6-mercaptopurine should not be taken with milk or dairy products (see section 4.5). 6-mercaptopurine should be taken at least 1 hour before or 2 hours after ingestion of milk or dairy products.
For adults and children, the usual dose is 2.5 mg/kg bodyweight per day, or 50 to 75 mg/m² body surface area per day, but the dose and duration of administration depend on the nature and dosage of other cytotoxic agents given in conjunction with 6-mercaptopurine.
The dosage should be carefully adjusted to suit the individual patient.
6-mercaptopurine has been used in various combination therapy schedules and the literature should be consulted for details.
Studies carried out in children with acute lymphoblastic leukaemia suggested that administration of 6-mercaptopurine in the evening lowered the risk of relapse compared with morning administration.
It is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing the 6-mercaptopurine dosage.
Consideration should be given to reducing the dosage in patients with impaired renal function (see section 5.2).
Consideration should be given to reducing the dosage in patients with impaired hepatic function (see section 5.2)
When xanthine oxidase inhibitors, such as allopurinol, and 6-mercaptopurine are administered concomitantly, it is essential that only 25 % of the usual dose of 6-mercaptopurine is given since allopurinol decreases the rate of catabolism of 6-mercaptopurine. Concomitant administration of other xanthine oxidase inhibitors, such as febuxostat, should be avoided (see section 4.5).
Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe 6-mercaptopurine toxicity from conventional doses of 6-mercaptopurine and generally require substantial dose reduction.
The optimal starting dose for homozygous deficient patients has not been established (see section 4.4 and section 5.2).
Most patients with heterozygous TPMT deficiency can tolerate recommended 6-mercaptopurine doses, but some may require dose reduction. Genotypic and phenotypic tests of TPMT are available (see section 4.4 and section 5.).
Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdosage having occurred. The principal toxic effect is on the bone marrow, resulting in myelosuppression. Haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of 6-mercaptopurine. Liver dysfunction and gastroenteritis may also occur.
The risk of overdosage is also increased when allopurinol is being given concomitantly with 6-mercaptopurine (see Section 4.5).
As there is no known antidote, blood counts should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary. Active measures (such as the use of activated charcoal) may not be effective in the event of 6-mercaptopurine overdose unless the procedure can be undertaken within 60 minutes of ingestion.
Further management should be as clinically indicated or as recommended by the National Poisons Center.
3 years.
After first opening the bottle: 7 months.
Store in the original package in order to protect from light.
Type III 20 ml amber glass bottle containing 25 tablets with a polypropylene child-proof cap and silica gel desiccant.
It is recommended that 6-mercaptopurine Tablets should be handled following the prevailing local recommendations and/or regulations for the handling and disposal of cytotoxic agents.
Any unused product or waste material should be disposed of in accordance with local requirements.
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