Shared Care Guideline DRUG: Introduction: LEFLUNOMIDE (Adults) Indication: Disease modifying drug for rheumatoid arthritis and psoriatic arthritis Licensing Information: Disease modifying drug for active rheumatoid arthritis and psoriatic arthritis Formulations: Tablets of 10mg or 20mg. Dosage & administration: 10mg or 20mg once daily swallowed whole with a glass of water. Absorption is unaffected by food. Contraindications Contraindications & Warnings: Severe immunodeficiency states. Impaired bone marrow function including anaemia, leucopenia or thrombocytopenia (contra-indicated if significant) Serious infection. Moderate to severe renal insufficiency or impaired liver function. Severe hypoproteinaemia (e.g. nephrotic syndrome). Pregnancy o Women of child bearing age MUST use reliable contraception during and after treatment for 2 years or 11 days after washout period (plasma concentration of leflunomide must also be checked see SPC for advice) o Men MUST use reliable contraception during and after treatment for at least 3 months or 11 days after washout period (plasma concentration of leflunomide must also be checked see SPC for advice) Breast feeding must be avoided Live attenuated vaccines should be avoided. There may be a reduced response to other vaccines given. Interactions: Co-administration with other hepatotoxic or haematotoxic medicines may increase the incidence of side effects. Methotrexate - Possible risks of additive or synergistic liver toxicity or haematotoxicity. Use with caution Colestyramine, rifampicin, warfarin, phenytoin or tolbutamide avoid co-prescription (unless colestyramine is being used for elimination/washout) Live vaccines - avoid For full list see BNF or SPC at www.medicines.org.uk/emc Adverse Effects: In general, the side effects are considered to be dose related and most will resolve on reduction of leflunomide dose or on cessation of treatment. Common Blood pressure mild increases are common. More severe increases are rare. Monitor as per schedule. Additional antihypertensive therapy may be required or alternatively require cessation of treatment with leflunomide. Name: Leflunamide shared Care Guideline Page 1 of 5
Diarrhoea - If significant stop and refer to specialist Skin itch or rash Nausea/vomiting - If significant stop and refer to specialist Increased hair loss If significant stop and refer to specialist Raised liver enzymes Monitor as per schedule Uncommon / rare Taste disturbance Hepatitis, jaundice Stop and refer to specialist Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme Stop and refer to specialist Pancreatitis Interstitial lung disease Increased susceptibility to infection Impaired bone marrow function Responsibilities of the specialist initiating treatment: For full list see SPC at www.medicines.org.uk/emc General: To assess the suitability of the patient for treatment. As per national, regional and local guidelines, to ensure that the patient/carer has received counselling and understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects, and is aware of actions to take if adverse effects are suspected. Go through patient information leaflet with patient. Inform patients of the long term monitoring requirements and provide a monitoring booklet. Inform the GP of the information provided to the patient. To review the patient at agreed intervals and copy all relevant results to the GP Carry out disease and initial drug monitoring as listed below. Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Prescribing: Issue all prescriptions for 8 weeks minimum until patient is safely established on leflunomide and specialist team are satisfied that it is appropriate to share care. Monitor bloods according to schedule: FBC LFTs U&Es Blood pressure 1 week after initiation then 2 weekly for first 8 weeks whilst under secondary care then as advised by specialist team (see responsibilities of GPs- monitoring). Discuss shared care arrangement with patient. Support and advise GPs as required. Assess response to treatment and initiate any dose changes as Name: Leflunamide shared Care Guideline Page 2 of 5
Responsibilities of other prescribers (GP): clinically appropriate including discontinuation of treatment. General and Prescribing: To reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Monitor and prescribe as recommended by the specialist - ensure continued prescribing of leflunomide remains clinically appropriate at dose advised by initiating team. The GP will be typically asked to take up the monitoring and prescribing no earlier than 8 weeks after treatment has been initiated. Ensure there are no drug interactions with any other medications initiated in primary care. (Note Live vaccines avoid. Polio and typhoid are available in killed inactivated form but may not be as effective) Carry out drug monitoring as listed and communicate abnormal results to the Specialist. Urgent drug discontinuation/referral to specialist as clinically appropriate To stop treatment on the advice of the specialist. To refer back to the Specialist if the patient s condition deteriorates. Identify adverse effects to leflunomide and report these to the Specialist and where appropriate to the Commission on Human Medicines/MHRA (Yellow card scheme). Unless otherwise stated by the secondary care Specialist apply the following monitoring frequencies following handover from secondary care: FBC LFTs U&Es Blood pressure At consultations Following handover from the specialist: Monthly for 4 months then every 3 months (unless dose changed or abnormal blood results then follow specialist advice) Ask about oral ulceration, abnormal bruising/bleeding, rash, sore throat Discontinue leflunomide and seek advice from initiating team if: WCC: <3.5 Neutrophils: <2.0 Platelets: <150 AST or ALT: >3 times the normal range Significant Blood Pressure rise or BP >160/95. Pruritus, rash (if possibility of Stevens-Johnsons syndrome) or breathlessness. Significant alopecia, abdominal pain, nausea, diarrhoea or weight loss. NOTE: Due to the long half-life of the active metabolite adverse effects will continue on stopping treatment. A washout procedure may be needed. Refer to initiating physician. Colestyramine 8g three times a day is used for 11 days Name: Leflunamide shared Care Guideline Page 3 of 5
Responsibilities of the Patient / Carer: Communication: Summary: Report any possible side effects to their GP. Ensure they have adequate supply of medication. Attend appointments and take along monitoring book Ensure appropriate contraception; avoid conception for 2 years after stopping leflunomide (females) or 3 months (males) unless approved following washout procedure Avoid breast feeding. Inform GP urgently if unexpected pregnancy is suspected. Limit alcohol intake to within current National guidelines As above contact GP or initiating team if side effects develop (see adverse effects) and attend appointments including those for routine blood tests/investigations Specialist to GP: The specialist will inform the GP when they have initiated leflunomide and when there are any subsequent changes in treatment standard clinic letter. Send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Inform the GP of information provided to the patient GP to Specialist: To reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Irrespective of whether you accept prescribing responsibility or not, you should inform the consultant of relevant medical information regarding the patient and changes to the patient s medication regime irrespective of indication. Notify Consultant if treatment with leflunomide is discontinued. Contact names & details: If you have any concerns regarding individual patients, see consultant letter for medical contact details or contact one of the following: Cost: Name Title/Location Telephone / Bleep / Email Rheumatology advice line 01904 721854 Rheumatology secretaries Dr Isdale Drs Brown and Green Drs Quinn and Saleem 01904 725585 01904 726308 01904 721024 Scarborough Dr Z S S Al-Saffar 01723 342653 Drug Tariff May 2013 (1 month supply) Leflunomide 10mg daily 26.82 Leflunomide 20mg daily 31.54 References: Yorkshire Regional Guidelines on the Monitoring of Adult Patients on Disease Modifying Drugs (DMARDS) Including Biologic Therapies. 5 th Edition. March 2009 BNF 63 Arava SPC last updated 8.1.13 Name: Leflunamide shared Care Guideline Page 4 of 5
Document Control: This information is not inclusive of all prescribing information and potential adverse effects. Please refer to the SPC (data sheet) or BNF for further prescribing information. The original Microsoft Word file of this document is located on: York Teaching Hospital NHS Foundation Trust Pharmacy Department X:\MEDICINES INFORMATION\Shared Care Guidelines\Approved Shared Care Guidelines\LEFLUNOMIDE Shared Care Guideline V1.1 Shared Care Guidelines are also available electronically via http://www.yorkandscarboroughformulary.nhs.uk/ Prepared by: Checked by: Version: Vikki Furneaux Date of Issue / Review: June 2013 Date for next Review: June 2015 Stuart Parkes / Jane Crewe (Pharmacist YH) Clair Ranns (Pharmacist NY and Humber Commissioning Support Unit) 1.1 (Updated August 2013 to include new x drive location) Approved by: Drug & Therapeutics Committee June 2013 Name: Leflunamide shared Care Guideline Page 5 of 5