Download Bicalutamide 50mg - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 50mg (Casodex®)
ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH
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.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Specialist: Dr Sayers
Bleep
Fax
Email
695220
695624
[email protected]
Specialist: Dr Koh
695201
695624
[email protected]
Specialist: Dr Tirmazy
695204
695624
[email protected]
Hospital Pharmacy Dept: Sandra Tang
695139
1717
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®))
and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed
by MTRAC in April 2004
Date approved: January 2013
Last Reviewed: June 2016
Expiry date: June 2019
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 50mg (Casodex®)
ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH
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 he or she is 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 should be under regular specialist 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
1.
2.
3.
4.
5.
6.
7.
1.
2.
3.
4.
1.
2.
3.
Specialist responsibilities
Discuss the benefits and side effects of treatment with the patient.
Initiate treatment, 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 the response to treatment and communicate promptly with the GP when treatment changes.
Monitor liver function (LFTs) and PSA levels.
Stop treatment when indicated, or advise the GP as to when to stop treatment.
Report adverse events to the MHRA.
Ensure clear backup arrangements exist for GPs for advice and support.
General Practitioner responsibilities
Reply to the request for shared care as soon as practicable.
Refer promptly to the specialist when any loss of clinical efficacy is suspected (e.g. worsening of diseaserelated symptoms, new symptoms suggestive of disease progression such as bone pain) or if intolerance to
therapy occurs.
Report adverse events to the specialist and MHRA.
Stop treatment on the advice of the specialist, or immediately if intolerable side effects occur e.g.
gynaecomastia, clinically significant hepatic changes.
Patient's role
Report to the specialist or GP if he does not have a clear understanding of the treatment.
Share any concerns in relation to treatment with bicalutamide.
Report any adverse effects to the specialist or GP whilst taking bicalutamide.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®))
and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed
by MTRAC in April 2004
Date approved: January 2013
Last Reviewed: June 2016
Expiry date: June 2019
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 50mg (Casodex®)
ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH
SUPPORTING CLINICAL INFORMATION
Indications
Bicalutamide 50mg is indicated for the treatment of advanced prostate cancer in combination with luteinising
hormone releasing hormone (LHRH) analogue therapy or surgical castration.
Dosage and Administration
The recommended dose of bicalutamide is one tablet taken once daily.
Contraindications
Bicalutamide is contra-indicated in women, children, and patients who have shown a hypersensitivity reaction to its
use.
Side Effects
The most frequently reported adverse events with bicalutamide 50mg 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  see 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 dose reductions and monitoring of plasma levels may be
necessary.
Acknowledgements
Refer to MTRAC VS & SS 03/17.
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®))
and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed
by MTRAC in April 2004
Date approved: January 2013
Last Reviewed: June 2016
Expiry date: June 2019
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Bicalutamide 50mg (Casodex®)
ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH
1.0
1.1
25/06/2013
R Eardley
Removal of pharmacy fax numbers
2.0
20/06/2016
S Tang
Updated contact details and confirmed no changes to clinical content
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 50mg (Casodex®))
and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed
by MTRAC in April 2004
Date approved: January 2013
Last Reviewed: June 2016
Expiry date: June 2019