Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 150mg (Casodex®)
ESCA: For the treatment of localised or locally advanced prostate cancer
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.
Specialist: Dr M Churn
Bleep
Fax
Email
695202
695624
mark.churn@nhs.net
Specialist: Dr C Brammer
695201
695624
caroline.brammer@nhs.net
Specialist: Dr Mehra
695205
695624
rakesh.mehra@nhs.net
Specialist: Dr Ramachandra
696460
695624
p.ramchandra@nhs.net
Hospital Pharmacy Dept: Sandra Tang
695139
1717
sandra.tang@nhs.net
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 150mg
(Casodex®)
Date approved: January 2013
Expiry date: January 2016
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 150mg (Casodex®)
ESCA: For the treatment of localised or locally advanced prostate cancer
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
bicalutamide for men with prostate cancer 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 they are under no obligation to do
so. In such an event, 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 prostate cancer are under regular follow-up, which provides an
opportunity 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
1.
2.
3.
4.
5.
6.
7.
1.
2.
3.
Specialist responsibilities
Confirm diagnosis.
Discuss benefits and side effects of treatment with the patient.
Initiate treatment and ask the GP whether they are willing to participate in shared care, or advise the GP to
initiate treatment.
Prompt communication with the GP of any changes in treatment.
Monitor response to treatment.
Monitor liver function (LFTs) and PSA levels.
Stop treatment when indicated, or advise the GP on when to stop treatment.
Report adverse events to the MHRA.
Ensure clear arrangements for back-up, advice, and support.
General Practitioner responsibilities
Initiate treatment ONLY on the advice of a specialist, and thereafter continue prescribing bicalutamide.
Ensure that shared care arrangements are in place before initiating treatment.
If the specialist initiates treatment, reply to the request for shared care as soon as practicable.
Seek specialist advice if signs/symptoms of hepatic changes occur.
Prompt referral to specialist when any clinical suspicion of loss of efficacy (disease progression) is noted, e.g.
worsening of disease related symptoms, new symptoms suggestive of disease progression such as bone
pain.
Report adverse events to specialist and MHRA.
Stop treatment on advice of specialist, or immediately if intolerable side effects occur e.g. gynaecomastia,
clinically significant hepatic changes.
Patient's role
Report any adverse effects to their specialist or GP whilst taking bicalutamide.
Share any concerns they have in relation to treatment with bicalutamide.
Report to the specialist or GP if they do not have a clear understanding of their treatment.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 150mg
(Casodex®)
Date approved: January 2013
Expiry date: January 2016
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 150mg (Casodex®)
ESCA: For the treatment of localised or locally advanced prostate cancer
SUPPORTING CLINICAL INFORMATION
Indications
Bicalutamide 150mg:

‘In patients with locally advanced prostate cancer (T3-T4, any N, MO; T1-T2,N+, MO),’ bicalutamide 150mg
‘is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or
radiotherapy’

‘The management of patients with locally advanced, non-metastatic prostate cancer for whom surgical
castration or other medical intervention is not considered appropriate or acceptable.’
Dosage and Administration
Bicalutamide 150mg is taken orally as a single daily dose. No dosage adjustments are necessary in patients with
renal impairment. In patients with moderate to severe hepatic impairment, accumulation may occur.
Contraindications
Bicalutamide 150mg is contraindicated in women and children; patients with known hypersensitivity to the active
substance or any of the excipients; and patients taking terfenadine or astemizole.
Side Effects
The most frequently reported adverse events with bicalutamide 150mg are gynaecomastia and breast pain. Hepatic
changes (elevated transaminase levels, cholestasis and jaundice) have been seen in patients taking bicalutamide
(see Monitoring). Refer to the SPC for a full list of adverse effects.
Monitoring
Parameter
Liver function test due to
the possibility of hepatic
changes. (Most cases
are expected to occur
within the first 6 months of
therapy  SPC)
Frequency of monitoring
As indicated according to the
individual patient's
requirements, or as
recommended by the specialist
(can be measured at the same
time as PSA levels)
Action
Depends on the profile of results. It may be
necessary to repeat test, monitor more frequently, or
discontinue treatment. Consult with specialist if
uncertain about threshold for discontinuing
treatment.
(The SPC notes that changes seen with
bicalutamide therapy were frequently transient,
resolving or improving with continued therapy or
following withdrawal of therapy.)
Prostate Specific Antigen
(PSA) levels
According to specialist's
recommendation (can be
measured at the same time as
LFTs)
Consult with specialist. High or increasing levels
may indicate disease progression, and the need to
re-evaluate patient's treatment needs.
Drug Interactions
In vitro studies show that bicalutamide inhibits enzymes of the cytochrome P450 system, and may displace warfarin
from plasma protein binding sites. Concomitant use of other enzyme inhibitors e.g. cimetidine could theoretically
increase plasma concentrations of bicalutamide with the potential for increased adverse effects. In clinical practice
drug interactions are not generally seen (expert opinion). Caution is advised when drugs with a narrow therapeutic
index are given with bicalutamide e.g. ciclosporin, where dosage reductions and monitoring of plasma levels may be
necessary.
Acknowledgements
Refer to MTRAC VS & SS 03/17.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 150mg
(Casodex®)
Date approved: January 2013
Expiry date: January 2016
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 150mg (Casodex®)
ESCA: For the treatment of localised or locally advanced prostate cancer
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
References
MTRAC guidance VS03/17.
AstraZeneca. Casodex. Summary of Product Characteristics 2004.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 150mg
(Casodex®)
Date approved: January 2013
Expiry date: January 2016