Shared Care Policy and Prescribing Information for General Practitioners
for Leflunomide (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/Lef/MGPG350
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

HOSPITAL
WARD
TELEPHONE NO
CONSULTANT (print name)
ADDRESS
DATE OF BIRTH

Insert patient sticker here

THERAPEUTIC INDICATION FOR THIS PATIENT:
DATE
SIGNATURE
(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); urea, creatinine and
electrolytes (U&E); liver function tests (LTFs);
weight; blood pressure (BP).
 BP should be normal (≤140/90mmHg) on two
separate readings (2 weeks apart). If higher,
treat hypertension before starting leflunomide.
2. Copy of results to be sent to GP.
3. Exclude pregnancy before starting therapy.
 Effective contraception essential for both men
and women during treatment.
 Women are to continue with contraception for at
least two years after treatment.
 Men should use effective contraception for at
least three months after treatment.
4. Initiation of therapy and recommendations on
dose increments.
5. Decision on final dose required for patient.
6. Monitoring clinical response to treatment.
7. Advise patients to report immediately any signs
or symptoms of bone marrow suppression, e.g.
infection, inexplicable bruising or bleeding.
CARE WHICH IS THE RESPONSIBILITY OF THE
GENERAL PRACTITIONER(GP)
1. Prescribing of medication under guidance of consultant.
2. Check before prescribing medication that the monitoring is up
to date and results are within the normal range.
3. The GP should be aware that the drug can cause blood
dyscrasias, hepatotoxicity, increased susceptibility to infections
and increased risk of malignancy.
 Patients should be asked about the presence of sore throat,
rash, itch, oral ulceration at each visit.
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:
 FBC and LFTs (incl. ALT) monthly for six months and if stable,
every two months thereafter.
 Blood checks to be continued long-term, at least monthly if coprescribed with another immunosuppressant.
 Blood pressure (BP) and weight should be checked at every
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 LEFLUNOMIDE - Version 2, August 2010
NHSG/SCPa/Lef/MGPG350
-1-
Shared Care Policy and Prescribing Information for General Practitioners
for Leflunomide (Adults only, non-renal patients)
ABNORMAL MONITORING RESULTS


9
WBC <4.0 x 10 /L
ACTION TO BE TAKEN
Withhold until discussed with consultant
9
Neutrophils <2.0 x 10 /L
9
Withhold until discussed with consultant

Platelets <150x10 /L
Withhold until discussed with consultant

Withhold until discussed with consultant

>2-fold rise in ALT or Alk Phos
(from upper limit of reference range)
BP >140/90

Rash, itch, oral ulceration, malignancies
Withhold until discussed with consultant

Nausea, diarrhoea or anorexia
Reduce dose to 10mg or discontinue if severe

Severe toxicity or severe intercurrent
infection
Consider “washout” regime to rapidly reduce plasma levels.
Discuss with consultant

Weight loss >10 %
Reduce dose, discuss with consultant
Treat BP and if still high 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
 Live vaccines should be avoided in patients taking leflunomide.
 Single pneumococcal vaccination and annual influenza vaccine should be given.
 Varicella Zoster Immunoglobulin should be given to non-immune individuals if exposed to shingles or
chickenpox.
 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:
 Rifampicin may increase plasma leflunomide levels. Caution should be exercised with warfarin
(enhanced effect), phenytoin and tolbutamide.
 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.
 Effective contraception is essential for males and females during treatment and for at least two years
after discontinuation in women, and at least three months after treatment in men.
 Pregnancy must be avoided for two years following withdrawal of treatment unless a ‘washout’ regime is
used (discuss with consultant).
PREGNANCY
Discuss with consultant. Leflunomide is contra-indicated in pregnancy. Effective contraception is essential
during treatment and for at least two years after discontinuation in women (three months in men). Advise to
contact their physician immediately should pregnancy occur.
BREAST-FEEDING
Discuss with Aberdeen Maternity Hospital. Manufacturer advises avoid.
RESPONSIBILITIES OF GPS UNDERTAKING MONITORING
A GP agreeing to monitor leflunomide 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 leflunomide 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 LEFLUNOMIDE - Version 2, August 2010
NHSG/SCPa/Lef/MGPG350
-2-