Download Bicalutamide Prescribing Guidance V2.0

Doncaster & Bassetlaw Area Prescribing Committee February 2017 V2.0
Guidance for the Prescribing of Bicalutamide in the treatment
of Prostate Cancer (Amber-G)
1.0 INTRODUCTION
This document sets out guidance for the assessment and treatment of
patients who are prescribed the antiandrogen Bicalutamide for the treatment
of prostate cancer and delineated responsibilities when care for the patient is
initiated in Secondary Care and transferred to Primary Care for continuation.
It is intended to provide clear guidance to General Practitioners (GPs) and
hospital prescribers regarding the procedures to be adopted when clinical
(and therefore prescribing and financial) responsibility for a patient’s treatment
on bicalutamide is shared between secondary and primary care.
The decision to start a patient on treatment of carcinoma of the prostate
should be taken by a Consultant Urologist.
Green
Traffic light system classification
AmberA
Amber-GAG
RedR
Drug Class
Antiandrogen
Bicalutamide
Amber G (AG) – Drug must be initiated and titrated to stable dosage by specialist before GPs take over
prescribing responsibility. Once medical condition and drug dosage is stable, there is no specific
requirement for ongoing monitoring
This guidance applies only for the indication for which the drugs are
stated to be used for. It should not be used for other indications listed
on the Doncaster & Bassetlaw APC traffic light system or for unlicensed
indications for the drug.
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This Document will be reviewed in the light of new or emerging evidence or by February 2022
Doncaster & Bassetlaw Area Prescribing Committee February 2017 V2.0
2.0 Background Information
Cancer of the prostate usually responds to hormonal treatment aimed at
androgen depletion. Standard treatments include bilateral orchidectomy, use
of a gonadorelin analogue or anti-androgen such as bicalutamide. No entirely
satisfactory therapy exists for disease progression despite this treatment
(hormone-refractory prostate cancer) but occasional patients respond to other
hormone manipulation e.g. with an anti-androgen as additional treatment in
conjunction with an LHRH agonist.
Bicalutamide may be used as monotherapy in advanced disease, or in
conjunction with radiotherapy.
2.1 National Institute for Health and Clinical Excellence (NICE)
In January 2014, the National Institute for Clinical Excellence (NICE)
published a Clinical Guideline on the diagnosis and management of prostate
cancer (CG175).
NICE recommended that anti-androgens should be considered in men with
metastatic disease as an alternative to LHRH agonist therapy in those wishing
to preserve sexual function. Whilst not first line therapy, combined androgen
blockade with LHRH agonist and bicalutamide may be rarely considered. It
may be used as hormone treatment following failure of previous radical
treatment for localised disease.
3.0 Prescribing Details
Refer to Summary of Product Characteristics for full details at
http://www.medicines.org.uk/emc/search
3.1 Dosage
1. Treatment of advanced prostate cancer as monotherapy, or in
combination with radiotherapy, 150mg daily.
2. Treatment of advanced prostate cancer as part of combined androgen
blockade (with orchidectomy or LHRH agonist), 50mg daily.
3.1 Administration
Bicalutamide is taken orally as a single daily dose.
There is no requirement to adjust the dose in patients with renal impairment or
mild hepatic impairment. Increased accumulation may occur in patients with
moderate to severe hepatic impairment, and therefore should be used with
caution in these patients.
3.2 Adverse effects
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This Document will be reviewed in the light of new or emerging evidence or by February 2022
Doncaster & Bassetlaw Area Prescribing Committee February 2017 V2.0
Bicalutamide is generally well tolerated, with a side effect profile of common
reactions similar to placebo in large studies.
Bicalutamide is metabolised by the liver and should be used in caution in
patients with significant hepatic dysfunction. Elevated levels of transaminases
and jaundice may occur, usually in the first few months of use. For this
reason, baseline and 6 monthly liver function testing is required during
treatment in addition to PSA monitoring.
Expected anti antrogenic side effects include hot flushes, pruritis, decreased
libido, breast tenderness and gynaecomastia. The latter is particularly
common and may be ameliorated by the use of breast bud irradiation before
starting bicalutamide treatment.
3.3 Monitoring Requirements
Test: LFT’s – Baseline and 6 monthly
Test: PSA – Baseline and as directed by Secondary Care
Patients will be provided with blood forms by Secondary Care and attend the
GP for the blood test 1 week prior to attending Secondary Care Outpatient
appointment. Blood test results are interpreted by Secondary Care.
3.4 Drug Interactions
Bicalutamide may potentiate the effect of warfarin. Close monitoring of the
INR should be undertaken.
Co-administration with terfenadine, astemizole or cisapride is contraindicated. (NB Terfenadine and cisapride are no longer available in the UK but
may be available outside of the UK).
Bicalutamide inhibits enzymes of the cytochrome p450 system, therefore
caution is advised when co-administering enzyme inhibitors such as
cimetidine and ketoconazole.
Caution is also advised when co-administering bicalutamide with drugs
metabolised predominantly by CYP 3A4. (ciclosporin, calcium channel
blockers – these drugs may need dosage reductions and plasma ciclosporin
levels should be monitored)
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This Document will be reviewed in the light of new or emerging evidence or by February 2022
Doncaster & Bassetlaw Area Prescribing Committee February 2017 V2.0
4.0 ARRANGEMENTS
All patients receiving bicalutamide will be under the ongoing care (minimum of
6 month review) of a Consultant Urologist or Clinical Oncologist.
4.1 Aspects of care for which Secondary Care Team is responsible
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Diagnosis and assessment
Inform GP of the intention to start therapy
Initiation of drug therapy
Patient/guardian/carer education
Ensure patient/guardian/carer is fully informed of potential benefits and
side effects of treatment
Ensure patient’s parents/guardian/carer is fully informed of the treatment (if
required)
Provide a comprehensive treatment package in addition to medications
including appropriate information/monitoring sheet(s)
Write to the GP after every clinic visit detailing whether the medication
regime should remain the same or be changed. Specify any products /
dose or frequency changes.
Extra monitoring needed for dose changes will be organised by specialist
team and conveyed to patient.
Monitor side effects of medication.
Monitor patient’s response to treatment
Report adverse events via the Yellow Card reporting system in the BNF or
at https://yellowcard.mhra.gov.uk/
4.2 Aspects of care for which Primary Care Team is responsible
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Ensure that the patient/guardian/carer is clear what is being monitored and
by whom
Ensure that the patient/guardian/carer knows what significant adverse
effects/events to report urgently and to whom they should report (specialist
or GP)
Confirm that proposed therapy is not contra-indicated because of
concurrent therapy for other conditions the patient may be suffering from
e.g. check drug-contraindications and drug-interactions. Contact specialist
team if possible interactions found.
Confirm the specialists have provided the patient/carer with appropriate
information sheet(s) for monitoring and/or to alert other clinical staff to the
treatment they are receiving. If appropriate information has not been
provided by the specialist, the GP must ensure the information is provided
Ensure patient’s parents/guardian/carer is fully informed of the treatment (if
required)
Monitor treatment as stated in the guidance
Amend prescription as per requests from secondary care
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This Document will be reviewed in the light of new or emerging evidence or by February 2022
Doncaster & Bassetlaw Area Prescribing Committee February 2017 V2.0
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Confirm with specialist which changes in these or other parameters should
trigger urgent referral back to the specialist
Seek specialist advice promptly as advised in the guidance or if
signs/symptoms of changes occur
Report adverse events via the Yellow Card reporting system in the BNF or
at https://yellowcard.mhra.gov.uk/
Report adverse events to the consultant sharing the care of the patient
Stop treatment on advice of specialist, or immediately if intolerable side
effects occur provided that it is safer to do so than to continue this therapy
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4.3 Patient (or Carer’s) Responsibilities
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Discuss potential benefits and side effects of treatment with the specialist
and GP. Identify whether they have a clear picture of these from the
specialist and to raise any outstanding queries
Check that where possible the specialists have provided a patient-held
record or information sheet for monitoring and/or to alert other clinical
staff to the treatment they are receiving
Share any concerns they have in relation to treatment with the medicine
Report any adverse effects to their specialist or GP whilst taking the
medicine
Report to the specialist or GP if they do not have a clear understanding
of their treatment
Participate in the monitoring of therapy and the assessment of outcomes,
to assist health professionals to provide safe, appropriate treatment
5.0 REFERENCES
NICE CG175 The diagnosis and management of prostate cancer January
2014
BNF 72 September 2016
Casodex 50mg Summary of Product Characteristics – revised February 2015
Casodex 150mg Summary of Product Characteristics – revised December
2015
Guidance Development
Written By:
Mr J Leveckis, Consultant Urological Surgeon,
Doncaster & Bassetlaw Hospitals NHS Foundation Trust.
January 2012
Reviewed By:
Doncaster & Bassetlaw Area Prescribing Committee January 2012
Mr J Leveckis, Consultant Urological Surgeon
Ms T Soar Urological Specialist Nurse
Doncaster & Bassetlaw Hospitals NHS Foundation Trust February 2017
Approved by:
Doncaster & Bassetlaw Area Prescribing Committee February 2017
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This Document will be reviewed in the light of new or emerging evidence or by February 2022