Download Administration and Preparations available Drug Interactions Patient

SHARED CARE PROTOCOL
for SOUTH EAST ESSEX
Drug Name
MYCOPHENOLATE MOFETIL
Clinical Indication: ‘Off- licence’ mycophenolate has been used in many disorders including rheumatoid arthritis, other autoimmune disorders
including connective tissue diseases like SLE, scleroderma and inflammatory muscle disease and dermatological conditions where standard treatment
has failed. It is used in adults and children.
Date approved: December 2014
Due for review: December 16
Author(s)/Originator(s): Esther Trillo-Gallo / Dr W M Wong
Administration and Preparations available
Tablets administrating orally. Please prescribe generically.
Dose is started low and gradually titrated 500mg daily increased weekly by 500mg to optimal
dose. Maximum 3g per day.
Drug Interactions
For Mycophenolate drug interactions follow the link Mycophenolate drug interactions.
Patient Information
Renal impairment no data available
Pregnancy avoid—congenital malformations reported; effective contraception required before treatment, during treatment, and for 6 weeks after discontinuation of treatment; manufacturer of Myfortic® also
advise that men should use condoms during treatment and for 13 weeks after last dose.
Breast-feeding avoid—present in milk in animal studies.
Annual flu vaccination recommended.
Live vaccines should not be given.
Side Effects
Taste disturbance, gingival hyperplasia, nausea, constipation, flatulence, anorexia, weight loss, vomiting, abdominal pain, gastro-intestinal inflammation, ulceration, and bleeding, hepatitis, jaundice, pancreatitis,
stomatitis, oedema, tachycardia, hypertension, hypotension, vasodilatation, cough, dyspnoea, insomnia, agitation, confusion, depression, anxiety, convulsions, paraesthesia, myasthenic syndrome, tremor,
dizziness, headache, influenza-like syndrome, infections, hyperglycaemia, renal impairment, malignancy (particularly of the skin), blood disorders (including leucopenia, anaemia, thrombocytopenia, pancytopenia,
and red cell aplasia) disturbances of electrolytes and blood lipids, arthralgia, alopecia, acne, skin hypertrophy, and rash; also reported intestinal villous atrophy, progressive multifocal leucoencephalopathy,
interstitial lung disease, pulmonary fibrosis
Precautions
Exclude pregnancy before starting treatment; elderly (increased risk of infection, gastro-intestinal haemorrhage and pulmonary oedema; active serious gastro-intestinal disease (risk of haemorrhage, ulceration
and perforation); delayed graft function; increased susceptibility to skin cancer (avoid exposure to strong sunlight);
Bone marrow suppression Patients should be warned to report immediately any signs or symptoms of bone marrow suppression e.g. infection or inexplicable bruising or bleeding.
Mycophenolate. For full prescribing information refer to the latest BNF and SPC
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Criteria for shared care. Prescribing responsibility will only be transferred when:
 Treatment is for a specified indication.
 Treatment has been initiated and established by the secondary care specialist.
 The patient’s initial reaction to and progress on the drug is satisfactory.
 The patient’s general physical, mental and social circumstances are such that he/she would benefit from shared care arrangements.
Responsibilities of initiating specialist
 Initiation of treatment
 3 month worth of treatment will be supplied or until patient is stable and does not require blood tests for three months.
 Monitoring tests as required before and during treatment as agreed in Summary of Monitoring and Responsibilities document.
 Discussion with the patient regarding benefits and side effects of treatment
 Prompt communication with the GP of any changes in treatment (including dose adjustments) and assessments of adverse events
 Advice to GPs about all aspects of treatment
 Reporting adverse events to the CSM
 Ensure clear arrangements for back-up, advice and support.
Responsibilities of the GP
 To prescribe on going therapy to patients after treatment has been established in Secondary Care, usually three months.
 To report any adverse events to the consultant.
 Prompt referral to specialist if there is any change in patient’s status.
 Reporting to and seeking advice from the specialist on any aspect of patient care which is of concern to the GP and may affect treatment.
 To monitor overall health and wellbeing of the patient.
 To review that blood tests are performed within the last 3 months before issuing a new prescription. For best practice it is recommended that GPs check that blood tests’ results are in
range and contact specialist as detailed in Summary of Monitoring and Responsibilities document or as below.
Results that require specialist team input:
>1+ on 2 occasions or > 150mg/d
Proteinuria
Treat, if unresponsive, discuss with specialist
Persistent or severe GI upset
Hypertension
WCC
< 3.5 x 109/l
Significant reduction in renal function
Platelets
< 100 x 109/l
Flu-like symptoms, sore throat, infection, rash, ulceration, bruising
AST/ALT
> 2 times the upper limit of normal
MCV
Increased > 105. Check for other causes (B12, folate and alcohol consumption). A high MCV is not an indication to stop treatment.
Secondary Care contact information
If stopping medication or needing advice please contact:
Dr / nurse
Contact number:
Department
Patient’s named Consultant or Clinical Nurse Specialist team in Rheumatology
01702 385128 Nurse Specialist live telephone service Mon, Tues, Wed, Fri 9am – 11am. . Alternatively Rheumatology secretaries on 01702 435555, extension
numbers 5616 or 6721 or Email: [email protected].
Rheumatology
Mycophenolate. For full prescribing information refer to the latest BNF and SPC
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