| Obligatory | Must not donate if:
a) Has caused symptomatic disease.
b) Associated with cardiovascular disease.
c) Is currently being treated with systemic monoclonal antibody therapy e.g. Evolocumab (Repatha®), Alirocumab (Praluent®).
d) Has been treated with Evolocumab (Repatha®) or Alirocumab (Praluent®) in the last 4 months.
e) Has been treated with any other monoclonal antibody therapy or biologic treatments in the last 6 months. |
| Discretionary | a) If has not led to symptomatic disease, even if currently on treatment (other than monoclonal antibody therapy), accept.
b) If it is more than 4 months since cessation of treatment with Evolocumab (Repatha®) or Alirocumab (Praluent®), accept.
c) If it is more than 6 months since cessation of treatment with any other monoclonal antibody therapy or biologic treatment, accept. |
| See if Relevant | Cardiovascular Disease
Cerebrovascular Disease and Intracranial Haemorrhage |
| Additional Information | Hypercholesterolaemia occurs when the level of cholesterol in the blood is outside of the reference range for the donor's age and sex. Usually this is managed by modifying the diet and often by the use of oral drugs.
Treatment may be with monoclonal antibodies which are administered by subcutaneous injection; these can affect the immune system making individuals more susceptible to infections and/or masking the usual symptoms of an infection, thus increasing the chance that a donor may unknowingly have an infection present at the time of donation. This effect may last until the drug is cleared from the body. Observing a deferral period after cessation of treatment with monoclonal antibody therapy will minimise this risk. The deferral periods advised take into account the characteristics of these drugs, including the time it takes for them to be cleared once treatment stops.
High levels of cholesterol are of themselves not a reason to defer a donor. If the hypercholesterolaemia has led to symptomatic disease, such as cardiovascular problems or transient visual or other neurological problems the donor should not be accepted, even if their cholesterol has returned to normal levels.
It is important to ensure that donors on treatment for hypercholesterolaemia do not have any associated cardiovascular disease. |
| Reason for change | The deferral period following treatment with other monoclonal antibody therapy has been modified to be consistent with the Monoclonal antibody therapy and other Biological Modalities entry. Reference to other biologic treatments has also been included for the same reason. |
| Donor Information | If you wish to obtain more information regarding a personal medical issue, please contact your National Help Line.
Please do not contact this web site for personal medical queries, as we are not in a position to provide individual answers. |