Download Mycophenolate for Interstitial Lung Disease

GMMMG Interface Prescribing
Subgroup
Shared Care Protocol
Shared Care Guideline
Reference Number
Mycophenolate mofetil for Interstitial Lung Disease
Version: 1
Replaces: n/a
Author(s)/Originator(s): (please state author name and
department)
Theresa Garfoot, Respiratory Pharmacist, Pharmacy
Dr Nazia Chaudhuri, ILD Consultant, North West Lung Centre
Dr Colm Leonard, ILD Consultant, North West Lung Centre
Reviewed by: Trafford CCG and South Manchester CCG
Date approved by Interface Prescribing Group:
13/10/2016
Date approved by Commissioners:
dd/mm/yyyy
Issue date: 17/11/2016
To be read in conjunction
with the following
documents:
Current Summary of Product
characteristics
(http://www.medicines.org.uk)
BNF
Date approved by Greater Manchester
Medicines Management Group:
17/11/2016
Review Date:
17/11/2018
Please complete all sections
1. Name of Drug, Brand
Name, Form and
Strength
Mycophenolate mofetil 250mg capsules
Mycophenolate mofetil 500mg tablets
Mycophenolate mofetil (cellcept®) oral suspension 1g/5ml
(N.B. Mycophenolic acid (as mycophenolate sodium) (Myfortic®) should not be prescribed
for this indication).
2. Licensed Indications
3. Criteria for shared
care
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Mycophenolate Mofetil for Interstitial Lung Disease, this is an unlicensed indication.
(NB: not for use in idiopathic pulmonary fibrosis (IPF).
Prescribing responsibility will only be transferred when:
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Treatment is for a specified indication and duration.

Treatment has been initiated and established by the secondary care specialist.

They are deemed stable when:
 They have received at least 2 months of mycophenolate mofetil AND
 Are stabilised on a suitable dose AND
 The blood results have been within acceptable limits AND
 Concordance has been established

The patient’s initial reaction to and progress on the drug is satisfactory.

The GP has agreed in writing in each individual case that shared care is
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 1 of 14
appropriate.
The patient’s general physical, mental and social circumstances are such that
he/she would benefit from shared care arrangements.
 Patient has not been stabilised on treatment.
 Patient does not consent to shared care.
 Patient does not meet criteria for shared care.
 Patient has idiopathic pulmonary fibrosis (IPF).
Mycophenolate mofetil is a pro-drug of the active metabolite of mycophenolic acid. It is a
suppressor of T and B cell proliferation and adhesion and inhibits inosine monophosphate
dehydrogenase and eventually blocks the progression to DNA synthesis and proliferation.

4. Patients excluded
from shared care
5. Therapeutic use &
background
6. Contraindications
(please note this does
not replace the SPC or
BNF and should be
read in conjunction
with it).
Mycophenolate is prescribed as part of the treatment of a number of ILDs (not IPF), in
combination with prednisolone as a steroid sparing agent attempting to halt the
progression of fibrotic disease. In most ILD patients, mycophenolate will be trialed for a
minimum period of three months.
Contraindications:
 Hypersensitivity to mycophenolate mofetil or any excipients
 Pregnancy (see MHRA Drug safety update and Letter sent to healthcare
professionals)).
 Breastfeeding
Cautions:
 Localised or systemic infection
 Very frail or elderly patients
 Patients with suspected lymphoproliferative disorder
 Patients with unexplained anaemia, leucopaenia or thrombocytopaenia
 Active gastrointestinal disease
 As there is a potential increased risk of malignancy, any pre-malignant disease
should be adequately treated before starting therapy and patients should be up to
date with relevant national cancer screening programmes.
 Avoid if previous Hepatitis B or C infection, recurrent herpes / shingles and
caution if marked renal failure (eGFR below 25ml/min).
THIS LIST MAY NOT BE EXHAUSTIVE. CONSULT UP TO DATE SOURCES.
Because of the genotoxic and teratogenic potential of mycophenolate mofetil, women with
childbearing potential should use two reliable forms of contraception simultaneously
before starting treatment with mycophenolate mofetil, during treatment, and for six weeks
after stopping treatment; unless abstinence is the chosen method of contraception.
Sexually active men are recommended to use condoms during treatment and for at least
90 days after cessation of treatment. Condom use applies for both reproductively
competent and vasectomised men, because the risks associated with the transfer of
seminal fluid also apply to men who have had a vasectomy. In addition, female partners of
male patients treated with mycophenolate mofetil are recommended to use highly
effective contraception during treatment and for a total of 90 days after the last dose of
mycophenolate mofetil.
Patients should not donate blood during therapy or for at least 6 weeks following
discontinuation of mycophenolate. Men should not donate semen during therapy or for 90
days following discontinuation of mycophenolate.
Live vaccines should be avoided in patients taking MMF.
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 2 of 14
7. Prescribing in
pregnancy and
lactation
This drug cannot be prescribed in the pregnant or breastfeeding patient.
See MHRA Drug safety alert and Letter sent to healthcare professionals
Also see section contraindications and adverse drug reactions
8. Dosage regimen for
continuing care
Route of administration
Preparations available:
Oral
See Section 1.
Mycophenolate is now available in generic form. To be prescribed as mycophenolate
mofetil and not as the brand Cellcept®.
Suspension available for swallowing difficulties and enteral feeding, for use in exceptional
circumstances only.
Please prescribe:
Mycophenolate mofetil 250 - 500mg OD increasing by 250mg per week up to 1 – 1.5g BD
Is titration required
Yes
Titrate dosage up by 250mg every week according to response.
Maintenance dosage up to a maximum 3 gram daily.
Adjunctive treatment regime:
If indicated prednisolone dosed according to response.
Prophylactic co-trimoxazole to prevent infection may be prescribed at the discretion of the
ILD specialist.
Annual flu vaccinations are safe and recommended.
Pneumococcal vaccination is safe and recommended.
In non-immune patients exposed to chickenpox or shingles, passive immunisation should
be carried out using Varicella zoster immunoglobulin (VZIG). It is the specialist’s
responsibility to make the recommendation for vaccination at the appropriate time.
Conditions requiring dose reduction:
e.g. impaired renal/ liver function
Renal and hepatic impairment discuss with consultant. Lower doses should be
considered for frail elderly patients and those with poor renal or hepatic function.
Usual response time : 6 weeks to 3 months
Duration of treatment: Ongoing
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 3 of 14
Treatment to be terminated by: Healthcare professional in consultation with Interstitial
Lung Disease Specialist
NB. All dose adjustments will be the responsibility of the initiating
specialist care unless directions have been specified in the medical letter to
the GP.
9.Drug Interactions
For a comprehensive
list consult the BNF or
Summary of Product
Characteristics
The following drugs must not be prescribed without consultation with the
specialist:
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10. Adverse drug
reactions
For a comprehensive list
(including rare and very
rare adverse effects), or if
significance of possible
adverse event uncertain,
consult Summary of
Product Characteristics
or BNF
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Azathioprine
Antacids (reduced absorption)
Aciclovir / Ganciclovir (causes higher plasma concentrations of both MMF and
acyclovir / ganciclovir)
Cholestyramine (reduced absorption)
Probenecid
Rifampicin
Live vaccines (e.g. oral polio, oral typhoid, MMR, BCG, yellow fever,
varicella zoster) should be avoided in patients taking MMF
Specialist to detail below the action to be taken upon occurrence of a particular
adverse event as appropriate. Most serious toxicity is seen with long-term use
and may therefore present first to GPs.
Adverse event
System – symptom/sign
Action to be taken Include
whether drug should be stopped prior to
contacting secondary care specialist
By whom
Common: nausea and
vomiting, abdominal
cramps, diarrhoea and
dyspepsia
Review for reversible
causes.
Renal: Sterile haematuria,
urinary tract infection, renal
tubular necrosis, proteinuria
See monitoring below.
GP
Hepatic: jaundice/liver
dysfunction
Stop and contact ILD
specialist. See monitoring
below.
GP
GP
Advise patient to take with
food. If no improvement,
reduce the dose/withhold
and contact ILD specialist.
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
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Check with internet that this printed copy of the latest issue
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Gastrointestinal: e.g. GI
ulceration, bleeding and
perforation.
Review for reversible
causes.
GP
Withhold and discuss with
the ILD specialist.
Haematological:
Anaemia, leucopenia,
thrombocytopenia.
See monitoring below.
GP
Bruising with or without sore
throat.
Mouth ulcers
Check FBC immediately
and discuss with the ILD
specialist as risk on bone
marrow suppression. See
monitoring below.
GP
Other: Opportunistic
infections, neurological
symptoms, malignancy risk
Review for reversible
causes.
GP
Withhold and discuss with
ILD specialist.
The patient should be advised to report any of the following signs or symptoms to
their GP without delay:
Rash
Sore throat / oral ulceration
Abnormal bruising or bleeding
Signs of infection
Abdominal pain or jaundice
These may suggest bone marrow suppression. Stop the drug and obtain an urgent FBC /
other bloods as appropriate.
Please note that, 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 the patient has not previously had chicken pox and they come into contact with
someone who has chicken pox or shingles or the patient develops chicken pox or
shingles.
Other important co morbidities (e.g. Chickenpox exposure). Include advice on
management and prevention and who will be responsible for this in each case:
Pneumovax and annual ‘flu vaccine should be given.
Passive immunisation should be carried out using varicella zoster immunoglobulin (VZIG)
in non-immune patients if exposed to chickenpox or shingles.
The Green Book (February 2016):
The risk and severity of shingles is considerably higher amongst immunosuppressed
individuals and therefore eligible patients (patients aged 70 – 79) anticipating
immunosuppressive therapy should ideally be assessed for vaccine eligibility before
starting treatment that may contraindicate future vaccination. Eligible patients who have
not received Zostavax® should receive a single dose of vaccine at the earliest opportunity
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 5 of 14
and wait at least 14 days before starting immunosuppressive therapy, although leaving
one month would be preferable if a delay is possible.
Sunscreens should be encouraged to reduce sunlight exposure.
Mycophenolate is contraindicated in pregnancy and breastfeeding. Contraception should
be used for 6 weeks after stopping the treatment (see section 7).
Male patients (plus female partners) should avoid fathering children for 90 days after
stopping the treatment (see section 7).
Any adverse reaction to a black triangle drug or serious reaction to an established
drug should be reported to the MHRA via the “Yellow Card” scheme.
11.Baseline
List of investigations / monitoring undertaken by secondary care
investigations
FBC
U&E
LFTs
Chest X-Ray
Consider hepatitis B and C and HIV.
Consider VZV serology (if no history of varicella)
Pregnancy test
12. Ongoing
monitoring
requirements to be
undertaken by GP
Is monitoring required?
Monitoring
Frequency
FBC
During dose
titration:
weekly until
dose stable for
4 weeks then
every 2 weeks
for 2 months
Maintenance:
monthly
WBC < 3.5 x
109 / L
During dose
titration:
weekly until
dose stable for
4 weeks then
every 2 weeks
for 2 months
Maintenance:
monthly
>2-fold rise in
AST, ALT or
Alk Phos
(from upper
limit of
reference
range)
LFT
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Yes or No (if yes complete following section) Yes
Results
Action
Withhold and
discuss with
ILD Team
Neutrophils
<2.0 x 109 / L
Platelets <150
x 109 / L
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Withhold and
discuss with
ILD team
By whom
Initial
monitoring
during dose
stabilisation to
be completed
by the ILD
specialist
(typically 3
months) then
on going
monitoring by
GP
Initial
monitoring
during dose
stabilisation to
be completed
by the ILD
specialist
(typically 3
months) then
on going
monitoring by
GP
Page 6 of 14
U&E
13. Pharmaceutical
aspects
14. Responsibilities
of initiating specialist
Initial
monitoring
during dose
stabilisation to
be completed
Potassium >
by the ILD
5.5mmol/L
specialist
(typically 3
months) then
on going
monitoring by
GP
Mycophenolate mofetil is now available in generic form. To be prescribed as
mycophenolate mofetil and not as the brand Cellcept®.
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Version: 1
Date: 17/11/2016
Review: 17/11/2018
During dose
titration:
weekly until
dose stable for
4 weeks then
every 2 weeks
for 2 months
Maintenance:
monthly
Creatinine
increase by >
30% of
baseline value
Withhold and
discuss with
ILD team
Initiate treatment and prescribe until dose is stable
Full information about the teratogenic risk and the pregnancy prevention
measures should be given to women of childbearing potential and, as
appropriate, to men. (See MHRA Drug safety alert for details)
Undertake baseline monitoring.
Dose adjustments.
Monitor patient’s initial reaction to and progress on the drug.
Ensure that the patient has an adequate supply of medication until GP supply can
be arranged.
Patients will be considered suitable for transfer to GP prescribing ONLY when
they meet the criteria listed in section 3 above.
Continue to monitor and supervise the patient according to this protocol, while the
patient remains on this drug, and agree to review the patient promptly if contacted
by the GP.
Provide GP with diagnosis, relevant clinical information and baseline results,
treatment to date and treatment plan, duration of treatment before consultant
review.
Provide GP with details of outpatient consultations, ideally within 14 days of
seeing the patient or inform GP if the patient does not attend appointment.
Provide GP with advice on when to stop this drug.
Act upon communication from the GP in a timely manner.
Provide patient with relevant drug information to enable Informed consent to
therapy.
Provide patient with relevant drug information to enable understanding of potential
side effects and appropriate action.
Provide patient with relevant drug information to enable understanding of the role
of monitoring.
Provide patient with monitoring booklet where appropriate.
Be available to provide patient specific advice and support to GPs as necessary.
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
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Check with internet that this printed copy of the latest issue
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15. Responsibilities
of the GP
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Version: 1
Date: 17/11/2016
Review: 17/11/2018
Continue treatment as directed by the specialist.
Act upon communication from the specialist in a timely manner.
Ensure no drug interactions with concomitant medicines.
To monitor and prescribe in collaboration with the specialist according to this
protocol.
To ensure that the monitoring and dosage record is kept up to date (if applicable).
To undertake vaccination as directed by the initiating consultant, the BNF or
Green Book.
Symptoms or results are appropriately actioned, recorded and communicated to
secondary care when necessary.
If the GP does not feel it is appropriate to take on the prescribing then the
prescribing responsibilities will remain with the specialist. The GP should indicate
the reason for declining.
Enter a READ code (8BM5.00) on to the patient record to highlight the existence
of shared care for the patient.
Undertake more frequent tests if there is evidence of clinical deterioration,
abnormal results, or other risk factors. Contact consultant team for advice on
monitoring in these circumstances if required.
Check all monitoring results prior to issuing a repeat prescription to ensure it is
safe to do so.
Monitor the patient’s general wellbeing.
Physicians should ensure that women and men taking mycophenolate understand
the risk of harm to the baby, the need for effective contraception, and the need to
immediately consult a physician if there is a possibility of pregnancy (see MHRA
Drug Safety alert )
Inform the consultant immediately if a patient has become pregnant or is planning
to become pregnant for treatment options to be considered.
Notify the consultant of any circumstances that may preclude the use of
mycophenolate for example, the use of illicit drugs or contraindications to
treatment.
Seek urgent advice from secondary care if:
 Toxicity is suspected.
 Non-compliance is suspected.
 The GP feels a dose change is required.
 There is marked deterioration in the patient’s condition.
 The GP feels the patient is not benefiting from the treatment.
The shared care agreement will cease to exist, and prescribing responsibility will
return to secondary care, where:
 The clinical situation deteriorates such that the shared care criterion of
stability is not achieved.
 The clinical situation requires a major change in therapy.
 GP feels it to be in the best stated clinical interest of the patient for
prescribing responsibility to transfer back to the Consultant. The
Consultant will accept such a transfer within a timeframe appropriate to
the clinical circumstances.
There must be discussion between the consultant team and GP on this matter
and agreement from the consultant team to take back full prescribing
responsibility for the treatment of the patient. The consultant team should be
given 14 days’ notice in which to take back prescribing responsibilities from
primary care.
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 8 of 14
16. Responsibilities
of the patient
17.Additional
Responsibilities
e.g. Failure of patient to
attend for monitoring,
Intolerance of drugs,
Monitoring
parameters
outside
acceptable
range, Treatment failure,
Communication failure

To take medication as directed by the prescriber, or to contact the GP if not taking
medication.
 To attend hospital and GP clinic appointments, bring monitoring booklet (if
issued).
 Failure to attend will result in medication being stopped (on specialist advice).
 To report adverse effects to their Specialist or GP.
 To understand the need for effective contraception and the need to immediately
consult a physician if there is a possibility of pregnancy.
List any special
Action required
By whom
Date
considerations
Patients are advised if the dose of mycophenolate is increased and experience GI side
effects, reduce dose by 1 tablet and wait a further week before attempting to increase the
dose again. If side effects occur once more on increasing the dose then remain on the
highest dose without experiencing side effects.
Patients commenced on mycophenolate should be instructed to report immediately any
evidence of infection, unexpected bruising or bleeding or other manifestations of bone
marrow suppression.
Increased risk of developing lymphomas and other malignancies particularly skin, to
minimise the risk patients should be advised to limit exposure to sunlight and UV light by
wearing protective clothing and using a high factor sunscreen.
18. Supporting
documentation
19. Patient monitoring
booklet
(may not be applicable
for all drugs)
20. Shared care
agreement form
21. Contact details
Version: 1
Date: 17/11/2016
Review: 17/11/2018
The SCG must be accompanied by a patient information leaflet. (Available from
http://www.medicines.org.uk/emc OR http://www.mhra.gov.uk/spc-pil/)
The patient must receive a monitoring booklet from the specialist upon initiation of
treatment. The patient must bring this booklet to all specialist and GP appointments
where it will be updated by the health professional conducting the appointment. The
patient must also produce the booklet to any health professional involved in other
aspects of their care e.g. pharmacists and dentists.
The patient must receive information on the risks of pregnancy and the need for effective
contraception.
Attached below
See Appendix 1
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 9 of 14
Appendix 1 – Local Contact Details
Lead author contact
information
Name: Theresa Garfoot
Email: [email protected]
Contact number: 0161 291 2453
Organisation: University Hospital of South Manchester, Wythenshawe Hospital
Commissioner contact
information
Name: [insert text here]
Email: [insert text here]
Contact number: [insert text here]
Organisation: [insert text here]
Secondary care contact
information
If stopping medication or needing advice please contact:
Dr Nazia Chaudhuri or Dr Colm Leonard
Contact number: 0161 291 5054
Fax: 0161 291 5602
Hospital: University Hospital of South Manchester, Wythenshawe Hospital
Dr Nazia Chaudhuri, ILD Physician via secretary 0161 291 5054
Dr Colm Leonard, ILD Physician via secretary 0161 291 5054
Helen Morris, ILD specialist nurse 0161 291 4936
Tracy Marshall, ILD specialist nurse 0161 291 4936
Theresa Garfoot, Respiratory Pharmacist 0161 291 2453
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 10 of 14
Shared Care Agreement Form
Specialist request
*IMPORTANT: ACTION NEEDED
Dear Dr
[insert Doctors name here]
Patient name: [insert Patients name here]
Date of birth: [insert date of birth]
NHS Number: [insert NHS Number]
Diagnosis:
[insert diagnosis here]
This patient is suitable for treatment with [insert drug name] for the treatment of
[insert indication]
This drug has been accepted for Shared Care according to the enclosed protocol
(as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement
to share the care of this patient.
The patient has been fully counselled on the medication.
Treatment was started on [insert date started] [insert dose].
If you are in agreement, please undertake monitoring and treatment from [insert
date]
NB: date must be at least 1 month from initiation of treatment.
Baseline tests:
[insert information]
Next review with this department:
[insert date]
You will be sent a written summary within 14 days. The medical staff of the
department are available at all times to give you advice. The patient will not be
discharged from out-patient follow-up while taking [insert text here].
Please use the reply slip overleaf and return it as soon as possible.
Thank you.
Yours
[insert Specialist name]
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
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Check with internet that this printed copy of the latest issue
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Shared Care Agreement Form
GP Response
Dear Dr [insert Doctors name]
Patient
[insert Patients name]
NHS Number [insert NHS Number]
Identifier
[insert patient date of birth/address]
I have received your request for shared care of this patient who has been
advised to start [insert text here]
A
I am willing to undertake shared care for this patient as set out in the
protocol
B
I wish to discuss this request with you
C
I am unable to undertake shared care of this patient.
My reasons for not accepting are:
(Please complete this section)
GP signature
Date
GP address/practice stamp
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
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Check with internet that this printed copy of the latest issue
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Shared Care Guideline Summary
Mycophenolate for the treatment of Interstitial Lung
Disease
Drug
Indication
Overview
Specialist’s
Responsibilities
Mycophenolate mofetil
Interstitial Lung Disease (not Idiopathic Pulmonary Fibrosis)
Mycophenolate mofetil is prescribed as part of the treatment of a number of ILDs (not IPF),
in combination with prednisolone as a steroid sparing agent attempting to halt the
progression of fibrotic disease. In most ILD patients, mycophenolate will be trialled for a
minimum period of three months.
Initial investigations: Assessment and diagnosis of ILD by the MDT. Discuss the benefits
and side effects of treatment. FBC, U&E, LFTs, Chest X-Ray. Consider hepatitis B and C,
HIV. Consider VZV serology (if no history of varicella). Pregnancy test.
Initial regimen: Mycophenolate mofetil 250 - 500mg OD increasing by 250mg per week up
to 1 – 1.5g BD
Clinical monitoring: Specialist review to ensure continued benefit. FBC, U&E, LFTs.
Review of side effects and skin examination.
Frequency: During dose titration: weekly until dose stable for 4 weeks then every 2
weeks for 2 months Maintenance: monthly
Safety monitoring:
Adverse event
System – symptom/sign
WBC<3.5 x 109/l
Neutrophils< 2.0 x 109/l
Platelets<150 x 109/l
Bruising with or without sore
throat
Action to be taken Include
By whom
whether drug should be stopped
prior to contacting secondary
care specialist
Withhold until discussion
with ILD Team
Specialist during initiation
Check FBC immediately
and discuss with ILD Team
as risk of bone marrow
suppression
Specialist during initiation
Prescribing duration: On-going, started in secondary care and supplied by hospital for the
initial 2 – 3 months of treatment, thereafter transferred to the GP.
Prescribing details: Initiated by specialist, prescribed and monitored by the specialist for
the first 2 – 3 months and then care transferred over to the GP. To stop the drug or provide
information to the GP on when to stop the drug.
Documentation: Patients will only be transferred to the GP once the GP has agreed via
signing copies of the shared care agreement form. Provide GP with diagnosis, relevant
clinical information, treatment plan, duration of treatment within 14 days of seeing the patient
or inform the GP if the patient does not attend.
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
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Check with internet that this printed copy of the latest issue
Page 13 of 14
GP’s
Responsibilities
Maintenance prescription: prescribe and monitor mycophenolate mofetil 2 – 3 months
after initiation in accordance with the specialist’s recommendations.
Clinical monitoring: To report to and seek advice from the specialist on any aspect of
patient care which is of concern to the GP and may affect treatment. Review of side effects.
Safety monitoring:
FBC, LFTs, and U&E, during dose titration: weekly until dose stable for 4 weeks then
every 2 weeks for 2 months (undertaken by specialist) Maintenance: monthly.
Adverse event
System – symptom/sign
WBC<3.5 x 109/l
Neutrophils< 2.0 x 109/l
Platelets<150 x 109/l
Bruising with or without sore
throat
Action to be taken Include
whether drug should be
stopped prior to
contacting secondary
care specialist
Withhold until discussion
with ILD Team
By whom
GP
Check FBC immediately
and discuss with ILD Team
as risk of bone marrow
suppression
GP
Duration of treatment: On-going, stop treatment on advice of specialist.
Documentation: Formally reply to the consultant’s request to shared care within 14 days of
receipt, using the shared care agreement forms. Monitoring booklet.
Adverse Events
Contraindications
Cautions
Drug
Interactions
Other
Information
Contact Details
Adverse events
Gastrointestinal symptoms
(e.g.: nausea, diarrhoea, vomiting,
abdominal discomfort)
Jaundice / liver dysfunction
Bone marrow suppression
(leucopenia, thrombocytopenia)
Action
Advise patient to take with food. If no
improvement, reduce the
dose and contact specialist.
Stop and contact specialist for advice
Contact specialist for advice.
Please refer to the BNF and/or SPC for information.
See above
Name: [insert text here]
Address: [insert text here]
Telephone: [insert text here]
Version: 1
Date: 17/11/2016
Review: 17/11/2018
Shared Care Guideline for mycophenolate mofetil for
Interstitial Lung Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
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