Shared Care Policy and Prescribing Information for General Practitioners
for oral Ciclosporin (Neoral®) (Adults only, non-renal patients)
Publish public
Applies to: NHS Grampian
Coordinator
Medicines Information
pharmacist
Signature:
I Mweemba
Authorised for issue by
Medicines Guidelines
and Policies Group
Signature:
C Hind
Version 2
Document no:
NHSG/SCPa/Cic/MGPG418
Effective date:
August 2010
Review Date: August 2012
Supersedes: version 1
Please keep this document in the patients notes
PATIENT NAME
UNIT NUMBER
CHI NUMBER

WARD
TELEPHONE NO
CONSULTANT (print name)
ADDRESS
DATE OF BIRTH

Insert patient sticker here
HOSPITAL

DATE
SIGNATURE
THERAPEUTIC INDICATION FOR THIS PATIENT: (to be completed by consultant)
DOSAGE/PREPARATION/ROUTE/FREQUENCY OF ADMINISTRATION: (to be completed by consultant)
SAFE PRACTICE IS THAT THE CLINICIAN WHO ORDERS THE TEST MUST ACT ON THE RESULT
CARE WHICH IS THE RESPONSIBILITY OF THE
HOSPITAL CONSULTANT
1. Baseline:
 Full blood count (FBC); liver function tests
(LFTs); urea, creatinine and electrolytes (U&Es)
(x 2); lipids, urinalysis and blood pressure (BP).
 BP should be normal (≤140/90) on two separate
occasions (2 weeks apart).
 Creatinine levels to be checked twice, (2 weeks
apart) and results clearly recorded. Baseline
will be the average of the two immediate pretreatment values.
Creatinine 1:
Creatinine 2:
Average:
2. Exclude pregnancy before starting therapy.
 If contraception needed non-hormonal methods
should be used.
 Advise to contact physician immediately should
pregnancy occur.
3. Copy of results to be sent to GP.
4. Initiation of therapy and recommendations for
dose increments.
5. Decision on final dose required for patient.
6. Monitoring clinical response to treatment.
7. Advise patients to immediately report any signs
or symptoms of bone marrow suppression, e.g.
infection, inexplicable bruising or bleeding.
CARE WHICH IS THE RESPONSIBILITY OF THE GENERAL
PRACTITIONER
1. Prescribing of medication (by brand name as different brands
are not bioequivalent) under guidance of consultant.
2. Check before prescribing medication that the monitoring is up
to date and results are within the normal range.
3. GP should be aware that the drug can cause nephrotoxicity,
increase in BP, increased risk of infection and lymphoma.
 Patients should be asked about the presence of sore throat,
abnormal bruising or bleeding at each visit.
 Check for development of lymphomas and other malignancies
particularly of the skin.
When the patient has an intercurrent illness a FBC, U&E and
LFTs should be done and any abnormal results including
those noted above should be reported to the consultant.
4. The General Practitioner has primary responsibility for
monitoring therapy according to the schedule below:
 U&Es (incl. creatinine and potassium) fortnightly until dose and
results have been stable for three months, then monthly
thereafter.
 FBC and LFTs (incl. ALT & Alk Phos) monthly until dose and
results stable for three months, then three monthly.
 Fasting lipids should be checked every six months.
 BP should be checked at each monitoring visit.
When writing laboratory request forms always include
details of the patient’s medication
NOTE: in addition to absolute values for haematological indices a
rapid fall or a consistent downward trend in any value should
prompt caution and extra vigilance.
If something unexpected occurs contact consultant.
Notify the consultant if the drug is stopped.
UNCONTROLLED WHEN PRINTED Review Date August 2012 (sooner if recommendations change)
SCP and Prescribing Information for GPs for oral CICLOSPORIN - Version 2, August 2010
NHSG/SCPa/Cic/MGPG418
-1-
Shared Care Policy and Prescribing Information for General Practitioners
for oral Ciclosporin (Neoral®) (Adults only, non-renal patients)
Abnormal Monitoring Results
Action To Be Taken
 Platelets <150 x 109/L
Withhold until discussed with consultant
 >2-fold rise in ALT or Alk Phos
(from upper limit of reference range)
Withhold until discussed with consultant
 Potassium rises to above normal range
Withhold until discussed with consultant
 Creatinine rises ≥30% from baseline
Discuss with consultant
 Abnormal bruising, sore throat, rash, oral ulceration
Withhold until discussed with consultant. Check FBC
 Significant rise in lipids
Withhold until discussed with consultant
 Malignancies
Withhold until discussed with consultant
 BP rise to >140/90 on two consecutive readings,
2 weeks apart
Treat BP and if not controlled, withhold and discuss with
consultant
For specific product information please consult the current summary of product characteristics
(http://emc.medicines.org.uk/) and the BNF (http://www.bnf.org/bnf/)
Other information





Neoral® soft gelatin capsules and Neoral® oral solution are bioequivalent so can be interchanged
Live vaccines should be avoided in patients taking ciclosporin.
Single pneumococcal vaccination and annual influenza vaccine should be given.
There are a number of drug interactions that must be considered. When a new drug is prescribed please
refer to Summary of Product Characteristics, BNF or contact Medicines Information.
Some important interactions to consider include the following:
 Do not give with tacrolimus due to increased risk of nephrotoxicity.
 Potassium sparing diuretics, ACE inhibitors, Angiotensin-II receptor antagonists and potassium salts should be
used with caution as co-administration may lead to hyperkalaemia
 Colchicine, statins and digoxin levels can be increased by ciclosporin. Monitor response and use the lowest
effective dose. Rosuvastatin is specifically contra-indicated with ciclosporin.
 Drugs that decrease ciclosporin levels include barbiturates, Antiepileptics, hypericum perforatum ( St John’s
Wort).
 Drugs that increase ciclosporin levels include grapefruit, macrolide antibiotics (mainly erythromycin and
clarithromycin) and azole Antifungals (ketoconazole, fluconazole, itraconazole and voriconazole) and oral
contraceptives. Close monitoring is essential.
 Concurrent use of NSAIDs and ciclosporin need not be avoided but use lower doses and monitor renal function.
Diclofenac dose must be reduced by 50%.
To minimize the risk of skin cancer, exposure to sunlight and Ultra Violet light should be limited by wearing protective
clothing and using sunscreen with a high protection factor.
Pregnancy
Discuss with consultant. Ciclosporin should not be given to patients who are pregnant or likely to become pregnant
without careful assessment of risk versus benefit.
Breast-feeding
Discuss with Aberdeen Maternity Hospital or contact Medicines Information. Manufacturer advises avoid.
Responsibilities of GPs undertaking monitoring
A GP agreeing to monitor ciclosporin should:
 Ensure that the relevant monitoring requirements are undertaken at the correct frequency.
 Ensure that the test results are checked for any abnormality as soon as the results are available.
 Ensure abnormal results are acted upon.
 Only continue to prescribe ciclosporin if it is being satisfactorily monitored.
 Contact the consultant in the event of a drug reaction or monitoring abnormality or anything you are unhappy about.
 Be alert for any of the known adverse reactions.
** The patient should be encouraged to ensure blood tests are taken at the correct intervals. **
UNCONTROLLED WHEN PRINTED Review Date August 2012 (sooner if recommendations change)
SCP and Prescribing Information for GPs for oral CICLOSPORIN - Version 2, August 2010
NHSG/SCPa/Cic/MGPG418
-2-