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Crohn’s disease guideline from NICE advises on off-label drug use

By News team

Several medicines have been recommended for off-label use for the treatment of patients with Crohn’s disease, in a published by the National Institute for Health and Clinical Excellence today (10 October 2012).

Prescribers are reminded that they must follow professional guidance when dealing with drugs outside their licensed UK indications and must take full responsibility for the prescribing decision. Informed consent should also be sought and recorded, NICE advises.

Off-label use of the recommended drugs is already common in UK clinical practice and the advice was arrived at after careful consideration of the available evidence, it says.

Azathioprine and mercaptopurine are recommended for use as an add-on to conventional glucocorticosteroid or budesonide treatment to induce remission in certain patients, and as a monotherapy to maintain remission (including after surgery).

NICE recommends budesonide off-label as a treatment for patients with a first presentation of Crohn’s disease or with a single exacerbation in 12 months, and to induce remission.

Methotrexate can be used as an add-on treatment to induce remission in certain patients who cannot tolerate azathioprine or mercaptopurine, or who have deficient thiopurine methyltransferase (TPMT) activity. It can also be used to maintain remission in patients who needed methotrexate to induce remission or who cannot receive azathioprine or mercaptopurine maintenance therapy.

Specific guidance is set out for monitoring the effects of these treatments, including assessing TPMT activity and monitoring for neutropenia in patients taking azathioprine or mercaptopurine and following British National formulary cautions on prescribing methotrexate.

The 5-aminosalicylates mesalazine, olsalazine and balsalazide should be considered for the treatment of a first presentation or a single exacerbation in 12 months in patients for whom glucocorticosteroid treatment has failed or is not tolerated. They can also be used to maintain remission after surgery, NICE says.

Citation: Electronicjuice URI: 11108559

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