Draft

Hull and East Riding Prescribing Committee
Prescribing Framework for Sirolimus
(RAPAMUNE) Post Renal Transplant
Patients Name:………………………… Unit Number: ………………
Patients Address:………………………(Use addressograph sticker)
G.P’s Name:……………………………………………………….…….

Communication

We agree to treat this patient within this Prescribing Framework. Signature:…………………………………………. Signature:………………………………………………….

If the General Practitioner is unwilling to accept prescribing
responsibility for the above patient the consultant should be
informed within one week of receipt of this framework and
consultants letter. In such cases the GP must inform the
consultant of all relevant medical information regarding the patient
and any changes to the patients medication irrespective of
indication at all times.
Date approved by the HERPC:11/05 Review date:11/07
1. Background
These guidelines aim to provide a framework for the prescribing of
Sirolimus by GPs and to set out the associated responsibilities of
GPs and hospital specialists who enter into the shared care
arrangements.
The guidelines should be read in conjunction with the general
guidance on prescribing matters given in EL (91) 127
“Responsibility for prescribing between hospitals and GPs”.
2. Indication

Sirolimus is a non-calcineurin inhibiting immunosuppressant. It
may be used in patients that are intolerant of calcineurin inhibitors
(e.g. tacrolimus, ciclosporin).
3. Dose
Sirolimus is usually given once a day and doses are titrated
according to trough blood levels. The target range for blood levels
is 5 to12 micrograms/L. The dose to be taken will be advised by
the hospital.
4. Duration of treatment
Treatment is likely to be long term and continued until advised
otherwise by the specialist.
5. Adverse effects
This monitoring will not usually require additional routine
appointments unless a problem is anticipated. It is most likely that,
if they are going to occur, most of these effects will be seen before
the GP is asked to prescribe.
Acne is very common. Doxycycline 100mg daily is the preferred
treatment option for acne (tetracycline and lymecycline should be
avoided in patients with renal impairment). Topical corticosteroid
and oral antihistamines have been used for the rash.
Angioedema and peripheral oedema occur in 10% and generally
require drug withdrawal.
Mouth ulceration is the most frequently seen gastro-intestinal
tract effect. Swab for Herpes simplex before treating established
ulcers with topical triamcinolone 0.1% (Adcortyl in Orabase).
Date approved by the HERPC:11/05 Review date:11/07 Ulceration is usually transient. Abdominal pain and diarrhoea can
occur.
Arthralgias may require dose adjustment or discontinuation of
sirolimus and are an indication for referral to the renal physician.
Interstitial lung disease (including pneumonitis) isseen in
between 1% and 10% and is an indication for drug withdrawal by
the renal physician.
Anaemia and thrombocytopaenia are seen more frequently than
leucopenia or neutropenia, and particularly when co-prescribed
with mycophenolate. Often the dose of mycophenolate is adjusted
first.
Sirolimus is associated with hypokalaemia and
hypophosphataemia. These usually respond to dietary advice.
Most recipients taking sirolimus require a statin for raised
triglycerides and hypercholesterolaemia.
6. Interactions
Drug Interactions
Renal function should be taken into consideration when co-
prescribing for renal transplant patients.
Sirolimus is metabolised by cytochrome P450 and therefore
interacts with several drugs that are also metabolised by this group
of liver enzymes. It is therefore advised that the following drugs are
avoided unless discussed with a renal physician.

The following medicines may increase sirolimus blood levels
The following drugs may decrease sirolimus blood levels
In addition grapefruit juice should be avoided as it may increase
sirolimus levels,
Live vaccines should be avoided in this group of patients.
Always check with BNF or Data Sheet (available electronically at
) for relevant interactions and side effects.
Date approved by the HERPC:11/05 Review date:11/07 7. Monitoring
See section 9
8. Information to patient
The patient will be advised of potential side effects detailed in
section 5. Patient should also be advised to avoid grapefruit juice.
9. Responsibilities of clinicians involved
Stage of
Hospital Specialist
Treatment
Practitioner
-Advise patient of side effects -Accept shared care -Initiate treatment and monitor once the patient is levels accordingly clinical need by the specialist; effects and treat
Contact Details:
During Office hours:
Transplant nurse specialist (01482) 674110
The patients relevant consultant may be contacted via the hospital
switchboard
Out of hours
The on call renal registrar may be contacted via the hospital
switchboard.
Date approved by the HERPC:11/05 Review date:11/07

Source: http://www.hey.nhs.uk/herpc/sirolimus.pdf