NICE Issues Guidance On Immunosuppressive Therapy For Young Kidney Transplant Patients, UK

Main Category: Transplants / Organ Donations
Also Included In: Urology / Nephrology;  Pediatrics / Children's Health
Article Date: 27 Apr 2006 - 0:00 PDT

email to a friend   printer friendly   opinions  

NICE has today issued guidance on the use of immunosuppressive therapy for renal (kidney) transplantation in children and adolescents.

The aim of immunosuppressant treatments after kidney transplantation is to suppress the immune system to reduce the likelihood of acute rejection and to prolong the survival of the transplanted organ. People who undergo kidney transplantation need to receive lifelong (or at least, long-term) treatment with immunosuppressive drugs.

Previously, there was no standard immunosuppressant regimen for children or adolescents receiving a kidney transplant, but most children in the UK received triple therapy with a calcineurin inhibitor (ciclosporin or tacrolimus), a DNA proliferation inhibitor (usually azathioprine), and a corticosteroid.

The NICE guidance says:

--_Basiliximab or daclizumab are recommended as options for induction treatment (treatment given for two weeks immediately after the kidney transplant) to help prevent acute organ rejection in children and adolescents undergoing kidney transplants. These drugs should be used as part of a ciclosporin-based immunosuppressive treatment. The less expensive of the two drugs (basiliximab or daclizumab) should be used unless it is contraindicated.

--__Tacrolimus (a calcineurin inhibitor) can be used instead of ciclosporin when a child or adolescent needs a calcineurin inhibitor as part of their initial or maintenance immunosuppressive treatment after a kidney transplant. The drug (tacrolimus or ciclosporin) that is least likely to have serious side effects in that particular person should be used.

--__Mycophenolate mofetil (MMF) is recommended as part of immunosuppressive treatment for child and adolescent kidney transplant recipients only when:
-_there is proven intolerance to calcineurin inhibitors particularly nephrotoxicity which could lead to a risk of long term damage to the transplanted kidney, or
-_there is a very high risk of nephrotoxicity requiring minimising or avoiding calcineurin inhibitors until the high risk period has passed.

--__MMF in corticosteroid reduction or withdrawal strategies for child and adolescent kidney transplant recipients is recommended for use only within clinical trials.

--__Mycophenolate sodium is currently not recommended for use as part of an immunosuppressive treatment in child or adolescent kidney transplant recipients.

--__Sirolimus is not recommended for children or adolescents having a kidney transplant except when proven intolerance to calcineurin inhibitors (including nephrotoxicity) requires these treatments to be completely withdrawn.

--__As a consequence of following this guidance, some medicines may be prescribed outside the terms of their UK marketing authorisation. Healthcare professionals prescribing these medicines should ensure that children and adolescents receiving renal transplants and/or their legal guardians are aware of this, and that they consent to the use of these medicines in these circumstances.

Andrew Dillon, NICE Chief Executive and Executive Lead said: "This guidance will help young kidney transplant patients to get the most effective drug treatments to help their bodies accept a new kidney transplant.

"Sticking to the medication regimen is a major problem in children and adolescents with kidney transplants, the problem being greatest among adolescents. The potential for side effects is a major contributor to lack of concordance with the prescribed treatment. The side effect profiles of the drugs are not the same, and the risks and relative importance of different side effects vary between individuals.

"These recommendations contain advice that may result in some medicines being prescribed outside the terms of their marketing authorisation, which is unusual for NICE guidance. Clinicians prescribing these drugs should ensure that young patients, and their parents or guardians are aware of this, and they obtain consent for the medicines to be used in this way."

1. National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.

2. NICE produces guidance in three areas of health:

-- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

-- health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS

-- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. The guidance 'Immunosuppressive therapy for renal transplantation in children and adolescents' is available at nice.org.uk/page.aspx?o=308587

4. NICE published 'Guidance on the use of immunosuppressive therapy for renal transplantation in adults. NICE Technology Appraisal Guidance No. 85' in 2004, available on the NICE website, nice.org.uk.

• Additional
• References
• Citations