Download Leflunomide - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Leflunomide (Arava®) - Hospital monitored
ESCA: For the treatment of rheumatological conditions
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name:
NHS Number:
Date of Birth:
Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
01902 695736
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with
this medicine (*delete as appropriate)
GP Name:
Signature:
Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Rheumatology Nurse Helpline
01902 695491
01902 695492
01902 695495
Rheumatology Secretaries
Hospital Pharmacy Department
Mrs S. Reed
01902 695136
Email address:
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for leflunomide
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Leflunomide (Arava®) - Hospital monitored
ESCA: For the treatment of rheumatological conditions
Patient’s Name:
Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of
leflunomide can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If
GPs are not confident to undertake these roles, then they are under no obligation to do so. In such an event, the total
clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the
GP to prescribe this drug, the GP should reply to this request as soon as practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should
be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the
consequences of its use.
RESPONSIBILITIES and ROLES
Specialist responsibilities
Diagnosis and initiation of leflunomide treatment.
Discuss the benefits and side effects of treatment with the patient.
Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will
discuss the shared care arrangement with the patient.
4. Dose stabilisation: initial dosage adjustment until stable. Thereafter, during maintenance treatment, advice to
the GP on any further dose adjustments required.
5. Monitor FBC and LFT every 2 weeks for six months until stable and then every two months thereafter. If coprescribed with another immunosuppressant or potential hepatotoxic agent blood checks should continue long
term, at least once a month. If ALT/AST 2-3x upper limit normal – reduce dose to 10mg, recheck weekly. If
normalised – continue 10mg; if remains elevated withdraw drug and discuss with specialist team. If ALT/AST
greater than 3 x normal, stop drug, recheck within 72 hours. If still greater than 3 times normal withdraw drug
and consider washout
6. BP should be checked each visit. If BP greater than 140/90 treat in line with NICE guidance. If BP remains
uncontrolled stop leflunomide and consider washout.
7. Weight should be checked at each visit. If more than 10% weight loss with no other cause identified, reduce
dose or stop and consider washout.
8. Communicate promptly with the GP when treatment is changed.
9. Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating
clinical condition.
10. Advise the GP on stopping treatment (if appropriate).
11. Report serious adverse events to the MHRA
12. Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
1. Reply to the request for shared care as soon as practicable.
2. Prescribe leflunomide at the dose recommended.
3. Adjust the dose as advised by the specialist.
4. Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect
treatment.
5. Refer patient to the specialist if his or her condition deteriorates.
6. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises.
7. Report adverse events to the specialist and MHRA.
Patient's role
1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
2. Share any concerns in relation to treatment with leflunomide
3. Report any adverse effects to the specialist or GP whilst taking leflunomide
1.
2.
3.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for leflunomide
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Leflunomide (Arava®) - Hospital monitored
ESCA: For the treatment of rheumatological conditions
SUPPORTING CLINICAL INFORMATION
Indications
Leflunomide is licensed for the treatment of adult patients with active rheumatoid arthritis (RA) as a diseasemodifying anti-rheumatic drug (DMARD) and for the treatment of active psoriatic arthritis (PsA).
Dosage and Administration
The maintenance dose is 10 to 20 mg/day for RA and 20 mg/day for PsA.
A washout period should be followed when switching to another hepato- or haematotoxic drug, or in cases of acute
leflunomide toxicity (see the [SPC] for more details).
Contraindications
Leflunomide must not be used in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema
multiforme. Leflunomide is also contraindicated in patients with impaired immune, liver or bone marrow function;
serious infections, or severe hypoproteinaemia. See the SPC for further details.
Side Effects
The most common adverse events with leflunomide treatment in clinical trials were gastrointestinal effects, pruritus,
rash, hypertension, alopecia and liver enzyme elevations. Postmarketing, there have been rare reports of serious
hepatic reactions and pancytopenia. See the SPC for more details on adverse events.
Monitoring
Monitoring of ALT (SGPT) and a full blood count including differential white blood cell count and a platelet count must
be performed before initiation of leflunomide, every 2 weeks during the first 6 months of treatment, and then every 8
weeks thereafter.
If ALT (SGPT) elevations of 2- to 3-fold the upper limit of normal occur then the dose can be reduced from 20 mg to
10 mg and monitoring must be performed weekly.
If ALT elevations of more than 2-fold the upper limit persist, or more than 3-fold the upper limit of normal are present,
leflunomide treatment must be discontinued and wash-out procedures initiated. The SPC recommends that
monitoring of liver enzymes be continued after discontinuation of treatment until liver enzyme levels have normalised.
Drug Interactions
Recent treatment with hepatotoxic or haematotoxic drugs may result in increased side effects; care should be taken
when initiating leflunomide therapy. The British Society for Rheumatology guideline advises a maximum of
10mg/day if used concomitantly with another potentially hepatotoxic DMARD such as methotrexate. Switching to
another DMARD after leflunomide treatment may raise the possibility of additive risks because of its long half-life. A
washout period is required.
Patients treated with leflunomide should not receive concomitant treatment with cholestyramine or activated
powdered charcoal, because this leads to rapid and significant decreases in plasma leflunomide concentration.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs.
Acknowledgements
Refer to MTRAC VS 04/15.
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for leflunomide
Date approved: May 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Leflunomide (Arava®) - Hospital monitored
ESCA: For the treatment of rheumatological conditions
1.0
1.1
10 June 2013
Uzoma
Ibechukwu
Under ‘specialist responsibilities’; Monitor FBC and LFT changed from
‘every month’ to ‘every 2 weeks’
1.2
25/06/2013
R Eardley
Removal of pharmacy fax numbers
References
1.
2.
3.
BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British
Association of Dermatologists. BSr/DMARD guideline group April 2008, update November 2009.
Electronic Medicines Compendium. Summary of Product Characteristics: Leflunomide. Surrey: eMC 2012. Available from
www.medicines.org.uk
MTRAC guidance VS04/15.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for leflunomide
Date approved: May 2013
Expiry date: 31/12/2017