Download Tacrolimus - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Tacrolimus (Prograf®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant.
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name:
NHS Number:
Date of Birth:
Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
01902
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with
this medicine (*delete as appropriate)
GP Name:
Signature:
Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Bleep:
Fax:
Email address:
Specialist: Dr P Carmichael
01902 696134
7865
695734
[email protected]
Specialist: Dr J Nicholas
01902 696133
695734
[email protected]
Specialist: Dr P Rylance
01902 696131
695734
[email protected]
Specialist: Dr K Sandhu
01902 696145
695734
[email protected]
Specialist: Dr S Cherukuri
01902 695452
695734
[email protected]
Hospital Pharmacy Dept:
Fiona McKean
01902 695137
3963
Other: Sr Jean Shears (INP)
01902 695454
7645
1410
[email protected]
695734
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Tacrolimus (Prograf®)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Tacrolimus (Prograf®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant.
Patient’s Name:
Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of
tacrolimus for adults can be shared between the specialist and general practitioner (GP). GPs are invited to
participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In that
case, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a
specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should
be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it. Patients with interstitial pulmonary fibrosis are under regular follow-up, which
provides opportunities to discuss drug therapy.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the
consequences of its use.
RESPONSIBILITIES and ROLES
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Specialist responsibilities
Receive details of patients care from transplant centre.
Dose stabilisation: initial dosage adjustment until stable. Thereafter, during maintenance treatment, advice to
the GP on any further dose adjustments required to be made.
Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will
discuss the shared care arrangement with the patient.
Monitor U and Es, liver function tests and blood count on a regular basis dependent on frequency of follow up.
Communicate promptly with the GP when treatment is changed.
Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating
clinical condition.
Advise the GP on stopping treatment (if appropriate).
Report all adverse events to the MHRA
Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
Reply to the request for shared care as soon as practicable.
Prescribe tacrolimus by brand (Prograf®) at the dose recommended by the specialist.
Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect
treatment.
Check for drug interactions before initiating any acute treatments, either on the ESCA, Summary of Products
Characteristics (SPC) or with specialist clinician/pharmacist input.
If appropriate, ensure patient is aware of the need to use non-hormonal contraception
Refer patient to the specialist if his or her condition deteriorates.
Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises.
Report adverse events to the specialist and MHRA.
Patient's role
Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
Share any concerns in relation to treatment with tacrolimus.
Take tacrolimus(Prograf®) at least one hour before or 2-3 hours after a meal. Avoid grapefruit or grapefruit
juice while taking tacrolimus (Prograf®).
Report any adverse effects to the specialist or GP whilst taking tacrolimus.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Tacrolimus (Prograf®)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Tacrolimus (Prograf®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant.
SUPPORTING CLINICAL INFORMATION
Indications
Tacrolimus is indicated for the prophylaxis of organ rejection in adults at low to moderate immunological risk
receiving a renal transplant.
Dosage and Administration
Tacrolimus is available as capsules containing 500micrograms, 1mg or 5mg.
The usual dose is 200 to 300mcograms per kg daily in two divided doses.
May affect the performance of skilled task e.g. driving. Plasma concentrations are increased by grapefruit juice so
this is best avoided.
Contraindications
Should be avoided in patients having hypersensitivity to macrolides. It is contraindicated in combination with
ciclosporin. Should be avoided in pregnancy unless potential benefit outweighs risk as there a danger of premature
delivery and hyperkalaemia. Avoid in breastfeeding as it is present in milk.
Side Effects
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Common side effects are gastrointestinal and include dyspepsia, and inflammatory and ulcerative disorders,
hepatic dysfunction, jaundice, bile duct and gall bladder abnormalities. It can also cause hypertension (less
frequently hypotension) tachycardia, angina, arrhythmias, thromboembolic and ischaemic events, rarely
causes myocardial hypertrophy, cardiomyopathy, dyspnoea, pleural effusion, tremor, headache, insomnia,
paraesthesia, confusion, depression, dizziness, anxiety, convulsions, incoordination, encephalopathy,
psychosis, visual and hearing abnormalities, haematological effects including anaemia, leucopenia,
thrombocytopenia, coagulation disorders, altered acid-base balance and glucose metabolism, electrolyte
disturbances including hyperkalaemia, altered renal function including increased serum creatinine,
hypophosphataemia, hypercalcaemia, hyperuricaemia, muscle cramps, arthralgia, pruritis, alopecia, rash,
sweating, acne, photosensitivity, susceptibility to lymphoma and other malignancies of the skin.
Less commonly causes ascites, pancreatitis, atelectasis, kidney damage and renal failure, myasthenia,
hirsuitism.
Rarely cause Stevens Johnson syndrome.
Serious suspected reactions (even if well recognised or causal link uncertain) should be reported to the
MHRA.
Monitoring
Regular U and Es, LFTs and full blood count.
Neurological parameters
Visual status
Blood glucose
Whole blood ‘trough’ concentrations (especially during periods of diarrhoea) or when prescribing drug which interact
Drug Interactions
Non hormonal methods of contraception needed if contraception required.
There is an increased risk of nephrotoxicity if tacrolimus is given with non steroidal anti-inflammatory drugs,
vancomycin, aciclovir and ganciclovir.
The plasma concentration of Tacrolimus is increased by clarithromycin, erythromycin, fluconazole, itraconazole,
ketoconazole, Voriconazole, posaconazole (reduce dose of Tacrolimus), saquinavir (consider reducing dose of
Tacrolimus), diltiazem and nifedipine.
Plasma concentration possibly increased by imidazoles and triazoles, atazanivir, lefinavir, Ritonavir, felodipine,
nicardipine, verapamil
The plasma concentration is decreased by St Johns Wort, caspofungin, phenobarbital
Tacrolimus should not be used in combination with droperidol as there is a risk of ventricular arrhythmias. It should
not be used with ciclosporin as there is increased risk of nephrotoxicity.
There is an increased risk of hyperkalaemia when given with potassium salts, potassium sparing diuretics and
alderosterone antagonists.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Tacrolimus (Prograf®)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Tacrolimus (Prograf®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs. This section
may be excluded if the shared care agreement related to a drug which is not an immunosuppressant.
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
25/06/2013
R Eardley
Removal of pharmacy fax numbers
1.0
1.1
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Tacrolimus (Prograf®)
Date approved: 30 Dec 12
Expiry date: 31/12/2017