You have been given this information because your doctor may want to prescribe you a medicine that does not have a licence. Your medical team will have thought carefully about which medicines are best for you in your situation.
You can find why some medicines are unlicensed and what this might mean for you on the NHS choices website at:
https://www.nhs.uk/conditions/medicines-information/#hownew-medicines-become-available
This leaflet contains information about a medicine called alemtuzumab that is used to prevent kidney transplant rejection.
It tells you:
- How the medicine works.
- How/when it will be given to you.
- If there are any side-effects you may expect to experience.
Before you are listed for transplant you will be asked if you are happy to receive alemtuzumab if it is felt that it is the right medicine for you. You will also be asked to sign a document to say if you are happy or not to be administered alemtuzumab.
Why have I been given this leaflet?
The leaflet will help you remember what your transplant team has told you about this medicine and is yours to take home to keep. It will also help you to decide whether you are happy to be treated with the medicines we may wish to give you at the point of transplant.
For most medicines, information is provided by the manufacturer in the medicine package. In the UK, this medicine does not have a licence for use in preventing kidney transplant rejection so the information provided in the packaging will not tell you everything we feel you need to know. We have written this leaflet to give you some extra information and to help best inform you about your treatment.
What are my options at the point of transplant?
The transplant team at Leeds would usually give alemtuzumab as it generally means you will have to take less medication after your kidney transplant, and it has been shown that there is less rejection in the first year after a transplant with alemtuzumab when compared with basiliximab. However, not all patients can have alemtuzumab, so the Leeds transplant team do need to use basiliximab for some patients.
Why does alemtuzumab not have a licence?
Alemtuzumab does not have a licence for the use of preventing kidney transplant rejection because of the relatively small amount of use in the United Kingdom means that the manufacturer considers that applying for a licence is not worth their while.
Alemtuzumab was previously licenced to treat a type of leukaemia and is now used more commonly in multiple sclerosis.
The licence was given up by the manufacturer and is now only made available as it is needed for individual patients, such as those who require it for preventing rejection of transplants. We will not routinely give your name or details to the manufacturer but they (and others involved in ensuring the systems are safe) can request some personal data in connection with the supply process.
Remember that your transplant team will have thought carefully about which medicine is best for your transplant.
What is alemtuzumab and how does it work?
Alemtuzumab is an antibody injection that works as an immunosuppressant or anti-rejection medicine.
Alemtuzumab is a powerful medicine that gets rid of some special white blood cells (called T-lymphocytes) that can attack your new transplant. It is used with other medicines to provide extra protection against rejection in the first few months after the transplant. The beneficial effects wear off over the course of the first year.
How will I be given alemtuzumab?
It is given only once; as an injection under the skin whilst you are in the operating theatre and under the anaesthetic.
When should alemtuzumab not be used?
- You will not be given this medicine if you have on-going infections (including HIV or viral hepatitis), if you are pregnant or wishing to continue breast-feeding after a previous pregnancy, if you know that you have cancer/ previously had cancer or if you know that you have an allergy to mouse proteins.
- We will also choose to use an alternative anti-rejection medicine if we know that you have a condition called Alport’s Syndrome.
- If you will continue to use mycophenolate and steroids afteryour transplant for another condition we may also look atusing another immunosuppressant.
Please tell your transplant team if you are affected by any of these or if you have any concerns about being given alemtuzumab.
Are there any side-effects?
Most medicines cause side-effects. A full list of these can be found in the product information sheet. You can ask for a copy of this at any point.
When given as an injection under the skin alemtuzumab can cause mild irritation at the injection site.
It is also known to bind to the sperm of men who are given the drug. It is recommended that both men and women who are given alemtuzumab use effective contraception for at least six months following treatment.
As already discussed in this leaflet other side-effects mentioned of alemtuzumab that we want you to be aware of are:
- Increased risk of certain types of cancers – mainly if you previously had or currently have active cancer (this applies to all immunosuppression).
- Increased risk of infection (this applies to all immunosuppression).
Will alemtuzumab affect any other medicines?
Alemtuzumab is not known to interact with any other medicines but it is not recommended to receive live vaccines for 12 months after its use, however as a transplant patient on long term immunosuppression, you will be advised to avoid live vaccines all together.
Why do I need to agree to take this medicine?
Your agreement should be obtained before prescribing any medicine. This leaflet has explained that alemtuzumab does not have a licence and has provided information about possible side effects. Please ask any questions if you need more information.
If after agreeing to have this medicine you change your mind, that is ok, but please contact your transplant team so that this can be documented.
If you have any further questions about alemtuzumab, or any other immunosuppression that may be used, please do feel free to ask any member of your transplant team who will be happy to give further advice.