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GREATER MANCHESTER INTERFACE
PRESCRIBING GROUP
On behalf of the
GREATER MANCHESTER MEDICINES MANAGEMENT
GROUP
SHARED CARE GUIDELINE for Tacrolimus (Prograf®)
Reference Number
Scope: Tacrolimus Post Renal Transplantation for Paediatric Patients
TACP 09 fnl
Classification
SHARED CARE GUIDELINE
Issue date: October 2009
Replaces TACP 07 fnl
Author(s)/Originator(s)
To be read in conjunction with the
following documents
Authorised by
Central Manchester and Manchester Children’s University
Hospitals NHS Trust
Reviewed by: Hong Thoong – Paediatric Medicines Lead
Pharmacist and Denise Roberts – Renal Transplant Specialist
Nurse
Pharmaceutical company’s patient information leaflet (PIL) and
Summary of product characteristics (SPC)
Interface Prescribing Group
Date: March 2010
Review Date
October 2011
Note from the Interface group – This SCG only covers the use of
Prograf® capsules, this product is NOT interchangeable via brand or
formulation due to differences in bioavailability, as per MHRA guidance
(Drug safety update Volume 3, Issue 7 February 2010 from MHRA and CHM Page 3).
This product must be prescribed by brand name, any instances where a
deviation from Prograf® capsules is requested must be referred back to
the Specialist prescriber.
1. Introduction
These guidelines will look at the shared care management of tacrolimus (Prograf®) in
the prevention of kidney allograft rejection.
2. Scope
Prograf® may be considered for shared care arrangements for the treatment of
kidney allograft rejection in renal transplant patients.
3. Clinical condition being treated
Post-transplant treatment.
The first line post-transplant immunosuppressive in children is therapy with Prograf®,
and mycophenolate mofetil. However, other immunosuppressive agents may be used
depending on an individual patient’s circumstances eg. Prograf®, azathioprine,
prednisolone or ciclosporin, azathioprine, prednisolone.
NB a patient would not receive ciclosporin with Prograf®, or azathioprine with
mycophenolate mofetil.
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Licensed indications
Primary immunosuppression in liver and kidney allograft recipients. Treatment of liver
and kidney allograft rejection resistant to conventional immunosuppressive regimens.
4. Product information and treatment regimen to be used
Prograf® capsules are available as 500 micrograms, 1mg and 5mg capsules.
Dose & Duration of Treatment
Treatment is initiated after completion of the kidney transplant surgery at a dose of
0.15mg/kg for patients less than 40kg body weight, 6mg for patients weighing 4060kg, and 0.1mg/kg for patients over 60kg twice a day (12 hours apart). Doses are
then adjusted to reach target blood levels, which vary depending on time after
transplant and other immunosuppressive agents used. Prograf® has a long half-life,
so changes in the dose may take several days to be reflected in the blood levels.
Target trough blood levels (taken immediately prior to next dose) are:
10-15nanograms/ml (0-6 weeks post transplant)
5-10nanograms/ml (> 6 weeks post transplant)
Maintenance doses are based on blood trough levels and clinical assessments of
rejection and tolerability
Note: Prograf® is an immediate release preparation taken twice daily. It is not
interchangeable with Advagraf® (a prolonged release formulation of tacrolimus).
5. Regimen Management
a)
Aspects of care for which the Consultant is responsible
Care Plan for the Patient Post-transplantation
Clinic visits become less frequent as the graft function is stabilised and the drug
therapy is established. An approximate timetable for outpatient visits is detailed
below:
Week 0-6
three times a week to weekly
Week 6-12
weekly to fortnightly
Week 12 onwards fortnightly/monthly
Once stabilised patients are seen every 6-8 weeks.
Specialist Centre
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Initiate treatment and adjust dosage to achieve appropriate therapeutic
levels
The supply of immunosuppressants for the first 3 months posttransplantation, or until the graft function has stabilised
Biochemical monitoring in line with clinic visits
Provide each patient with a patient medication record card and inform
patient of effects / side-effects
Send a letter to the GP with a copy of Shared Care Protocol inviting
shared care for the patient
Annual review of the patient including cancer (skin) screening and kidney
function testing. See Appendix 1 for details of the annual review.
Monitoring – at clinic visits
Blood pressure, weight, height.
Blood sample – haematology, biochemistry, Liver function tests, tacrolimus levels
and cytotoxic antibody screen.
Urine sample – Protein/creatinine ratio and midstream urine
Midstream urine sample – infection, blood, protein, glucose. Frequency of testing
depends on individual circumstances. Further tests are performed as required.
Non-attendance at the clinic will be followed up by the clinic staff. The GP will be
contacted if non-attendance remains a problem.
b) Conditions of assuming responsibility by the GP
Care will be transferred to GP once graft function has stabilised.
c) Aspects of care for which the GP is responsible
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Assessment of continued well-being of patient
Prescribing
ADR / drug interaction monitoring (see section 4.)
Be aware of the drug interactions with immunosuppressive therapy, and
report any evidence of interactions to the patient’s named consultant.
Be aware of the increased incidence of skin and other cancers in patients
receiving long-term immunosuppressive therapy and ensure female
patients receive their cervical smear test at the GP practice each year
Encourage the patient to carry an up to date medication record card,
encourage compliance and recommend not to use OTC medications
without seeking medical advice
Inform the patient’s named consultant of any patient consultations or
changes made to drug therapy
Report any lack of communication about dosage and progress to the
patient’s named consultant
Individual consideration of each case between consultant and GP
Any additional information necessary for the care of the patient
6. Summary of cautions, contra indications, side-effects
NB: this will not replace the SPC and should be read in conjunction with it
Possible side effects of treatment
There are a significant number of drug interactions with Prograf®. For full details
consult the Summary of Product Characteristics.
Drugs and other agents may affect plasma concentrations of tacrolimus (Prograf®)
through competitive inhibition or induction of the hepatic enzymes involved in the
metabolism of tacrolimus, in particular cytochrome P450. These drugs are detailed
below:
Note from the Interface Group – The following table does not provide a complete
list of interactions and must be read in conjunction with the SPC and the BNF.
Drugs that increase Prograf® levels
Drugs that decrease Prograf® levels
Omeprazole
Rifampicin
Clotrimazole
Carbamazepine
Clarithromycin
Phenobarbital
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Erythromycin
Fluconazole
Ketoconazole
Voriconazole
Grapefruit juice
Diltiazem
Nicardipine
Verapamil
Itraconazole
Phenytoin
St John’s wort
Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood
levels.
If it is necessary to prescribe any of the above drugs, (or to initiate dosage
adjustments), the patient’s named consultant should be informed so that the
effects on the plasma tacrolimus levels can be monitored.
Care should also be taken for other types of drug interactions involving Prograf®,
including:
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Increased risk of hyperkalaemia with ACE inhibitors and potassiumsparing diuretics
Increased risk of nephrotoxicity with other nephrotoxic drugs such as
NSAIDs, aminoglycosides, amphotericin, ciprofloxacin, co-trimoxazole
(and trimethoprim alone)
Other drug interactions, such as: possible reduced effectiveness of
vaccinations, possible reduced efficacy of oral contraceptives
Management of Adverse Events by the General Practitioner
Adverse Event
Nausea & vomiting, diarrhoea
Hyperglycaemia, diabetes
Hypertension
Tremor
Headache
Management
Continue medications if possible.
If necessary – refer to patient’s named
consultant
Inform patient’s named consultant –
possible adverse effect of Prograf®
Treat with appropriate antihypertensives.
Refer to patient’s named consultant
May indicate Prograf® toxicity.
Refer to patient’s named consultant.
Treat with appropriate analgesia
(paracetamol). Refer to patient’s named
consultant if necessary.
See the BNF for other side-effects of Prograf®.
Precautions
Be aware of the reduced effectiveness of vaccination and that live vaccines
must be avoided.
Be aware of the possible reduced efficacy of oral contraceptives.
7. Special considerations
No information provided
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8. Back-up care available to GP from Hospital, including emergency contact
procedures and help line numbers
For local decision
9. Statement of agreement
Shared care is an agreement between the GP and the Consultant. This form is a
request by the consultant to share the suggested care pathway of your patient. If you
are unable to agree to the sharing of care and initiating the suggested medication,
please make this known to the consultant within 14 days, ideally stating the nature of
your concern.
10. Written information provided to the patient
Information is provided in Manchester Children’s Hospital “Patient Education
Programme for Children” filofax.
11. Supporting References
BNF 57th Edition. March 2009
BNF for Children 2009
Summary of Product Characteristics: Prgraf® 0.5mg,1mg,5mg Hard capsules. Last
updated on the eMC: 26th May 2009
TACP 09 fnl
Appendix 1. Transplant Annual Review
Every transplant patient receiving follow up care at the RMCH will be offered a
Transplant Annual Review. The patient will be seen by the Paediatric Renal Transplant
Nurse Specialist.
Investigations on that clinic visit:
 Routine blood screens: full blood count, renal screen, liver screen.
 Fasting lipid screen
 Parathyroid Hormone (PTH)
 Fasting blood sugar
 Formal assessment of GFR
 Body Mass Index measurement
Nurse Practitioner responsibilities:
 Cardiovascular health: blood pressure, cholesterol, smoking, BMI, exercise
activity, alcohol intake, diet
 Infection
 Dental health – assessment and advice
 Female health: breast examination, menstruation, contraception, infertility, advice
regarding cervical smears, urinary and sexual health
 Male health: TSE, urinary and sexual health
 Assessment of growth, bone age and growth velocity
 Medication review and patient compliance
 Skin care advice
 Identification of current health problems and / or enquiries for the doctor
Medical Staff responsibilities:
 Addressing identified health problems
 Reviewing medical problems from the previous year
 Routine renal review
 Referrals where appropriate
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