Download Ciclosporin - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Ciclosporin (Neoral®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant and treatment of nephrotic syndrome
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:
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]
695600
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Ciclosporin (Neoral)
Date approved: Dec 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Ciclosporin (Neoral®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant and treatment of nephrotic syndrome
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
ciclosporin 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 who have undergone renal transplant 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 patient’s 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 regular U and Es (including magnesium), liver function tests, blood count, blood lipids and ciclosporin
levels, with periodic check of blood pressure.
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 ciclosporin (by brand Neoral®) 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.
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 ciclosporin.
Report any adverse effects to the specialist or GP whilst taking ciclosporin.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Ciclosporin (Neoral)
Date approved: Dec 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Ciclosporin (Neoral®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant and treatment of nephrotic syndrome
SUPPORTING CLINICAL INFORMATION
Indications
Ciclosporin is indicated for the prophylaxis of organ rejection in adults at low to moderate immunological risk
receiving a renal transplant.
Dosage and Administration
Ciclosporin is available as capsules containing 10mg, 25mg, 50mg or 100mg or oral solution containing 100mg per
ml. The total daily dose should be taken in 2 divided doses. Grapefruit juice should be avoided for one hour before
the dose.
The usual maintenance dose is 2 to 6mg per kg daily with dose adjusted according to blood ciclosporin concentration
and renal function.
Contraindications
Should be avoided in pregnancy unless potential benefit outweighs risk. Insufficient evidence is available to support
use in breastfeeding.
Patients should be warned to avoid excessive exposure to UV light. Use with caution in patients with porphyria.
Side Effects
Common side effects include abdominal pain, gingival hyperplasia, hepatic dysfunction, anorexia, hypertension,
tremor, headache, paraesthesia, renal dysfunction, hyperuricaemia, hyperkalaemia, hypomagnesaemia,
hyperlipidaemia, hypercholesterolemia, muscle cramps, myalgia, hypertrichosis. Less commonly it causes oedema,
weight gain, encephalopathy, anaemia, thrombocytopenia and rash. It rarely causes pancreatitis, motor
polyneuropathy, menstrual disturbances, gynaecomastia, microangiopathic haemolytic anaemia, haemolytic uraemia
syndrome, hyperglycaemia, muscle weakness, myopathy; visual disturbances secondary to benign intracranial
hypertension (indication to stop drug).
Serious suspected reactions (even if well recognised or causal link uncertain) should be reported to the MHRA.
Monitoring
Monitor regular U and Es (including magnesium), LFTs, blood count and blood lipids. Blood pressure should be
regularly monitored.
Plasma concentrations of ciclosporin should be monitored if there are changes in renal function or to detect changes
with interacting drugs.
Drug Interactions
Should be avoided in combination with lercanidipine, rosuvastatin (increased risk of myopathy) and tacrolimus.
There is an increase risk of hyperkalaemia when ciclosporin is given with ACE inhibitors, Angiotensin –II receptor
antagonists, potassium sparing diuretics, alderosterone antagonists and potassium salts
There is an increased risk of nephrotoxicity and possible hypermagnaesaemia with thiazide diuretics.
Ciclosporin increases plasma concentration of aliskiren, caspofungin (monitor LFTs), nifedipine (increased risk of
gingival hyperplasia), and digoxin (increased risk of toxicity)
There is increased nephrotoxicity when used with non steroidal anti-inflammatory drugs and ciclosporin doubles
diclofenac plasma levels. There is also increased risk of nephrotoxicity with aminoglycosides, polymixins, quinolones,
sulphonamides, vancomycin, trimethoprim, amphotericin, aciclovir, bezafibrate, fenofibrate.
Increased risk of myopathy with daptomycin (prefer to avoid combination), statins
Absorption of ciclosporin is increased by ursodeoxycholic acid and possibly by orlistat.
Plasma level of ciclosporin is increased by clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole,
posaconazole, Voriconazole, miconazole, chloroquine, hydroxychloroquine, carvedilol, Diltiazem, nicardipine,
verapamil, danazoll, metoclopramide. The plasma level is possibly increased by chloramphenicol, doxycycline
Metabolism is accelerated by rifampicin, carbamazepine, phenytoin, primidone, barbiturates. Concentration is
reduced by St Johns Wort and this should be avoided in combination. Plasma concentration possibly reduced by
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Ciclosporin (Neoral)
Date approved: Dec 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Ciclosporin (Neoral®)
ESCA: For the prophylaxis of organ rejection in adult patients at low to moderate immunological
risk receiving a renal transplant and treatment of nephrotic syndrome
sulfadiazine, griseofulvin, terbinafine
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 Ciclosporin (Neoral)
Date approved: Dec 2012
Expiry date: 31/12/2017