Download Mycophenolate mofetil Shared Care Guideline

PHARMACY DEPARTMENT
DOCUMENT
`
TITLE:
MYCOPHENOLATE MOFETIL TABLETS SHARED CARE GUIDELINE
FILENAME
PHA_Medicines management_Shared Care
guidelines_Mycophenolate Mofetil Shared Care Guideline
VERSION №
2
DATE OF ISSUE
30.11.2010
REVIEW INTERVAL
2 Years
AUTHORISED BY
Area Prescribing Committee
AUTHOR
Dr Shabina Sultan – Consultant Rheumatologist
Dr Raashed – Consultant Respiratory Medicine
Dr Kunc – Consultant Neurologist
Linda Stewart – Lead Pharmacist Clinical Economy
Kelly Hayes-Head – Rheumatology CNS
EMAIL ADDRESS OF AUTHOR
[email protected]
COPY №
2
LOCATION OF COPIES
1. SHAREPOINT
2. PHARMACY NETWORK
ASSOCIATED WORKING INSTRUCTIONS
N/A
LOCATION OF WORKING INSTRUCTIONS
N/A
TO BE VIEWED
TRUST WIDE
X
PHARMACY ONLY
DOCUMENT REVIEW HISTORY
REVIEW DATE
REVIEWED BY
30.11.2012
Expiry extended as under review. To go
to DTC January 2013
18.1.2013
Dr Sultan – Consultant Rheumatologist
Linda Stewart - Pharmacist
19.3.2015
Dr Sultan – Consultant Rheumatologist
CHANGES
Addition of advice against switching brands
added to the prescribing section.
Linda Stewart – Pharmacist
Addition of information from Drug Safety
Update
Area Prescribing Committee April 2015
Addition of patient responsibility section
Updated in line with SPC
4.3.2016
Dr Sultan – Consultant Rheumatologist
Linda Stewart – Pharmacist
Drug and Therapeutics Committee January
2016
Addition of information from Drug Safety
Update regarding pregnancy prevention advice
for men and women
9.3.2018
NB: ONLY SHAREPOINT VERSION OR NUMBERED COPIES IN STATED LOCATIONS
ARE VALID FOR OPERATIONAL USE
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
GENERAL
STATEMENTS
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Mycophenolate mofetil should be initiated in secondary care under
specialist supervision. Once the patient’s dose has been titrated to
the optimum dose they may be considered suitable for shared care
between the consultant and the GP.
Patient’s clinical condition is to be stable or predictable before
contacting the GP to arrange shared care.
The consultant should write to the GP to request the GP to
participate in shared care.
Agreement of GP must be sought before seeking patient
agreement for shared care.
Patients receive supplies of drug from hospital until shared care is
agreed.
Use in Rheumatology if off- license and the dosage in the SPC is
not applicable
The full summary of product characteristics (SPC) should be read before
prescribing.
INDICATIONS FOR
THERAPY
Mycophenolate mofetil is an immunosuppressant licensed for use in
transplantation; the product licence does not cover use in auto-immune
disease. However, the following are disease areas in which it may be
considered:
1. Rheumatology - Usually considered in active SLE or other serious
connective tissue diseases and vasculitides
2. Gastroenterology – considered in very occasional inflammatory
bowel disease patients and autoimmune hepatitis
3. Neurology – usually considered in myasthenia gravis as steroid
sparing agent.
4. Respiratory
a. idiopathic pulmonary fibrosis intolerant to azathioprine often
awaiting lung transplant
b. Pulmonary vasculitides (Wegner’s granulomatosis, CSS and
microscopic polyangitis)
Page: 1 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
CONTRAINDICATIONS
Pregnancy or planned pregnancy and breast feeding see separate
section
AVOID LIVE VACCINATIONS
(BCG, MMR, Poliomyelitis (live oral vaccine), Rotavirus (live oral
vaccine), Typhoid (live oral vaccine), Varicella-Zoster vaccine and Yellow
Fever)
PREGNANCY AND
BREASTFEEDING
For more detail see Vaccinations Rheumatology Guide
Please contact the responsible consultant if patient considering
conceiving or in case of pregnancy.
Mycophenolate mofetil and its active metabolite mycophenolic
acid are associated with a high rate of serious birth defects and
increased risk of spontaneous abortion.
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Mycophenolate mofetil or mycophenolic acid should not be used in
pregnancy unless there is no suitable alternative treatment to prevent
transplant rejection
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Physicians should ensure that women and men taking mycophenolate
mofetil and mycophenolic acid understand: the risk of harm to a baby; the
need for effective contraception; the need to plan for pregnancy and
change treatment as necessary; and the need to immediately consult a
physician if there is a possibility of pregnancy
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Mycophenolate mofetil or mycophenolic acid treatment should only be
initiated in women of child bearing potential when there is a negative
pregnancy test result to rule out unintended use in pregnancy
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Mycophenolate mofetil or mycophenolic acid should only be given to
women of childbearing potential who are using highly effective
contraception
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Women should use 2 forms of effective contraception during treatment and
for 6 weeks after stopping treatment
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Men (including those who have had a vasectomy) should use condoms
during treatment and for at least 90 days after stopping treatment. This
advice is a precautionary measure due to the genotoxicity of these
products
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Female partners of male patients treated with mycophenolate mofetil or
mycophenolic acid should use highly effective contraception during
treatment and for 90 days after the last dose
Page: 2 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
CAUTIONS
Intercurrent infections: check FBC & withhold drug until FBC result known
to ensure WCC within range
Chicken pox/varicella zoster can be fatal in immunosuppressed
patients: varicella zoster immunoglobulin should be given to susceptible
patients (not known to be immune to chicken pox) where contact occurs,
preferably within 3 days but up to 10 days after exposure. Systemic
antivirals should be given if infection is suspected.
When using mycophenolate mofetil or any other medicines containing
mycophenolic acid (MPA) as its active ingredient:
 Measure serum immunoglobulin levels if recurrent infection
develops
 In cases of sustained, clinically relevant
hypogammaglobulinaemia, consider appropriate clinical action.
Take into account the potent cytostatic effects of MPA on Blymphocytes and T-lymphocytes
 Consider bronchiectasis or pulmonary fibrosis if patient develops
persistent respiratory symptoms, such as cough and dyspnoea
POTENTIAL DRUG
INTERACTIONS
Aciclovir/ ganciclovir, azathioprine, antacids and PPIs ( levels),
probenecid, rifampicin. Care if GFR <25ml/min
Please refer to the current BNF and Summary of Product Characteristics
for updated information before prescribing new medicines. Antacids
decrease the absorption of mycophenolate mofetil
INITIAL SCREENING
FBC, LFTs, ESR, CRP, U&E, eGFR, lipids checked in clinic
Baseline Hepatitis B and C
Varicella immune status (if no history of chickenpox), consider alternative
if history of recurrent herpes/shingles
Pregnancy test if premenopausal – see separate section on pregnancy
and breastfeeding
Page: 3 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
PRESCRIBING
Initial prescribing and monitoring will be carried out by the
specialist for the first three months. Thereafter if the patient is on a
stable dose the GP will continue prescribing and monitoring.
Switching patients between brands and preparations is dangerous.
The specialist will normally commence a generic brand and consider
switching if there are issues regarding tolerance. All changes in product /
brand should only be done in consultation with specialist.
Mycophenolate mofetil (Non-proprietary) is available as - 250mg
capsules, 500mg tablets and 1g/5ml oral powder for reconstitution.
Brands include Cellcept and Arzip.
(It is also available as mycophenolic acid Myfortic. Mycophenolic acid
720 mg is approximately equivalent to mycophenolate mofetil 1 g)
Doses below are for Rheumatology and are off-license
Reduce dose if GFR <25ml/min – starting with 250mg BD and do not
exceed 1g bd GFR >25ml/min then start at 500mg daily, dose increased
to 1g BD over 2-8 weeks period (max 3g/day)
Take with/ after food in divided doses if preferred
Pneumovax and annual ‘flu vaccine should be given
MONITORING
FBC weekly for 4 weeks then every two weeks for 2 months, then
monthly for first year.
U&Es, LFTs two weekly for 2 months, monthly for 4 months, then 2
monthly for the first year.
Then 3 monthly FBC, U&Es, LFTs
No monitoring of Mycophenolate mofetil blood levels is necessary
Lipids to be checked annually (if any specific concerns, consider 3
monthly lipids check)
If any increase in dose revert to initial monitoring advice
STOP MYCOPHENOLATE MOFETIL & CONTACT AGH IF:
WCC
<3.5 x 109/l
Neutrophils
<2 x 109/l
Platelets
<150 x 109/l
AST/ALT
>2 x upper limit of normal
Throat or oral ulceration,
Unusual bruising or bleeding, abdominal pain/ diarrhoea
Measure serum immunoglobulin levels if recurrent infections develop
Page: 4 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
ADVERSE EVENTS
As with all immunosupressants, mycophenolate mofetil increases
susceptibility to infection, especially those caused by cytomegalovirus.
Vaccines may not give full protection against disease and live vaccines
need to be avoided.
The most frequent side-effects include neutropenia and gastrointestinal
disturbances including diarrhoea, constipation, vomiting and indigestion.
Less common side-effects include gastrointestinal haemorrhage,
hypertension, oedema, hyper- and hypokalaemia, hyperglycaemia,
hypophosphataemia, hypercholesterolaemia, dyspnoea, headache,
dizziness, insomnia, tremor. Recent isolated reports of progressive
multifocal leukoencephalopathy.
Risk of hypogammaglobulinaemia
Risk of bronchiectasis
RESPONSIBILITY OF
THE ORGAN
TRANSPLANT TEAM
If the product is being used pre or post transplant, it is the overall
responsibility of the transplant centre to advise on dose changes and to
decide when the treatment should start and stop,
RESPONSIBILITY OF
THE HOSPITAL
SPECIALIST
INITIATING
TREATMENT
Summary
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To ask the GP whether they are willing to participate in shared
care (mycophenolate mofetil)
Inform the patient of side effects and long term monitoring before
initiating treatment
Advise women of child bearing potential to practice effective
contraception before starting treatment and to continue practising
effective contraception throughout treatment period and for 6
weeks after. Breast feeding not recommended
Review patient in clinic
Disease and drug monitoring as listed
Inform GP of results of blood tests if abnormal
Prescribe for the first 3 months and until the immunosuppression
regime is stable
If the dose is increased the hospital specialist will monitor for a
further two months
To monitor the patient for adverse events and report to the GP and
where appropriate the Commission on Human Medicines/MHRA
(Yellow card scheme) https://www.gov.uk/report-problemmedicine-medical-device
Page: 5 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
RESPONSIBILITY OF
OTHER
PRESCRIBERS
Summary
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PATIENT
RESPONSIBILITY
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To inform the specialist in writing if they are not willing to
participate in Shared care
Prescribe the mycophenolate product identified at a dose advised
by the hospital specialist
Arrange blood tests as advised by the hospital specialist and if the
patient is stable, then the GP needs to do blood tests as detailed
above – contact hospital specialist if there is a problem.
Identify adverse effects and treat or report to hospital specialist
and Commission on Human Medicines/MHRA (Yellow card
scheme) where appropriate https://www.gov.uk/report-problemmedicine-medical-device
Avoid drug interactions
Avoid live vaccines
Ensure smear tests are up to date for female patients. Advice on
the frequency of screening is contradictory, however, the NHS
Cervical Screening Programme recommends that females taking
maintenance immunosuppression post transplant should be
offered regular screening with frequency in line with national
guidance (i.e. 3 yearly for females aged 25-49, and 5 yearly for
females aged 50-65).
If the medication needs to be stopped contact the hospital
specialist on the next working day
Minimise exposure to sunlight and wear sunscreen with a high
protection factor which can be bought
Avoid live vaccines
Use appropriate contraception during therapy and for 6 weeks
after stopping treatment.
Undertake blood testing at appropriate intervals as recommended
by hospital specialist or GP
Page: 6 of 7
MYCOPHENOLATE MOFETIL TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE
CONTACTS
A patient information leaflet has been issued to your patient.
If any problems occur please contact relevant specialist:
Consultant Respiratory Physicians Secretary:
Consultant Gastroenterology secretary:
For Rheumatology Patients ONLY:
Consultant Rheumatologists’s secretary:
Rheumatology Nurse Specialist:
Rheumatology Helpline:
Pharmacy (for all patients):
01535 292064
01535 292037
01535 292368
01535 292067
01535 292084
01535 292084
01535 293503
Access to shared care guidelines is available via the internet at
Airedale NHS Trust at: http://www.airedaletrust.nhs.uk/GPs/SharedGuide.html
Page: 7 of 7