Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Ivabradine(Procoloran®)
Reduced Shared Care Guideline for the use of ivabradine for the symptomatic
treatment of chronic stable angina pectoris.
This Guideline was originally produced in 2007 By Chris Lawson following consultation with specialists at
Barnsley Hospital. The Guideline has been updated by Caron Applebee (Prescribing Support Pharmacist) with
input from Gillian Smith (Medicines Information Pharmacist BHNFT) and the Cardiologists (Dr Tahir, Dr Etorki
and Dr Yousaf). This guideline has been subject to consultation and endorsement by:
 The Area Prescribing Committee on 14th November 2012.
 The LMC on 11th December 2012.
Introduction
Indication/Licensing information
Ivabradine is licensed for the symptomatic treatment of chronic stable angina pectoris in patients with normal
sinus rhythm, who have a contra-indication or intolerance to beta-blockers.
Pharmacology
Ivabradine blocks a specific ion channel, the (If) or funny channel which is found in sino-atrial node cells which
results in a reduction in resting heart rate.
Dosage and administration
Starting dose;
5mg twice daily. After three to four weeks of treatment the dose may be increased to 7.5mg twice daily
depending on therapeutic response.
If heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences
symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward
including the possible dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). Treatment must be
discontinued if heart rate falls below 50 bpm or symptoms of bradycardia persists (see section 4.4 of the SPC
http://emc.medicines.org.uk/).
Elderly:Patients over 75yrs should commence on 2.5mg twice daily. Dose reduction or cessation should be considered
if the heart rate drops below 50bpm.
Ivabradine Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 1 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Responsibilities of the specialist initiating treatment
Summary
 To assess the suitability of the patient for treatment, including undertaking baseline echocardiography.
 To discuss the benefits and side effects of treatment with the patient/carer and the need for long term
monitoring if applicable.
 To perform baseline tests and if appropriate routine tests until the patient is stable.
 To prescribe until the patient is stabilised on ivabradine (minimum of 4 weeks).
 To explain shared care to the patient and gain acceptance from them
 To ask the GP whether they are willing to participate in shared care.
 To provide the GP with a summary of information relating to the individual patient to support the GP in
undertaking shared care (See Shared care request form in Appendix A).
 To advise the GP of any dosage adjustments required, monitoring required, when to refer back, and when
and how to stop treatment (if appropriate).
 To advise the GP when the patient will next be reviewed by the specialist.
 To monitor the patient for adverse events and report to the GP and where appropriate Commission on
Human Medicines/MHRA (Yellow card scheme).
 To provide the GP with contact details in case of queries.
 To review the patient if indicated or requested by the GP.
 T o inform the GP if patient misses repeated follow up appointments.
Baseline Tests
Resting heart rate.
Routine Tests
Resting heart rate. If heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient
experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be
titrated downward including the possible dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Treatment must be discontinued if heart rate falls below 50 bpm or symptoms of bradycardia persists
Disease monitoring
The patient will be reviewed in Secondary Care within 3 months of discharge from hospital then every 4-6
months until the patient is stable.
Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for reduced shared care for the patient. GPs will
take on shared care only if they are willing and able.
Summary
 To reply to the request for reduced shared care as soon as possible.
 To prescribe and adjust the dose as recommended by the specialist.
 To ensure there are no interactions with any other medications initiated in primary care.
 To continue monitoring as agreed with secondary care (guideline should include details of monitoring
requirements and what to do when each of the defined parameters alters).
 To refer back to the specialist where appropriate. For example:
o
Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects.
o
Advice in respect of concordance.
o
Special situations, (e.g. Pregnancy)
 Discontinue the drug as directed by the specialist if required or immediately should the patient’s condition
seriously deteriorate (e.g. severe hypotension, cardiogenic shock, symptomatic bradycardia)
 To identify adverse events if the patient presents with any signs and liaise with the hospital specialist
where necessary. To report adverse events to the specialist and where appropriate the Commission on
Human Medicines/MHRA (Yellow card scheme).
Ivabradine Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 2 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Clinical Particulars
BNF therapeutic
class
2.6.3 Other antianginal drugs
Contraindications
and Cautions
Contraindications:
 Hypersensitivity to the active substance or to any of the excipients
 Resting heart rate below 60 beats per minute prior to treatment
 Cardiogenic shock, Acute myocardial infarction
 Severe hypotension (< 90/50 mmHg)
 Severe hepatic insufficiency
 Sick sinus syndrome, Sino-atrial block, Unstable or acute heart failure
 Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
 Unstable angina
 AV-block of 3rd degree
 Combination with strong cytochrome P450 3A4 inhibitors such as azole
antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin,
erythromycin), HIV protease inhibitors and nefazodone
 Pregnancy, lactation
Adverse Drug
Reactions
Monitoring
Interactions
Cautions:
 Mild heart failure
 Monitor for Atrial fibrillation or other arrythmias
 Hypotension
 Retinitis pigmentosa
 Elderly
Bradycardia, first-degree heart block, ventricular extrasystoles, headache, dizziness,
visual disturbances including phosphenes and blurred vision; less commonly nausea,
constipation, diarrhoea, palpitations, supraventricular extrasystoles, dyspnoea,
angioedema, vertigo, muscle cramps, eosinophilia, hyperuricaemia, raised plasmacreatinine concentration, rash; very rarely atrial fibrillation, second- and third-degree
heart block, sick sinus syndrome
Resting heart rate. If heart rate decreases persistently below 50 beats per minute
(bpm) at rest or the patient experiences symptoms related to bradycardia such as
dizziness, fatigue or hypotension, the dose must be titrated downward including the
possible dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). Treatment must
be discontinued if heart rate falls below 50 bpm or symptoms of bradycardia persists




Anti-arrythmics
Cytochrome P450 inhibitors (Macrolides, Azole antifungals, HIV protease
inhibitors, nefazadone)
Beta blockers
Calcium channel blockers
Ivabradine Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 3 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Communication
Specialist to GP
The specialist will inform the GP when they have initiated Ivabradine. When the patient is near completing the
satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and where
possible give an indication as to the expected length of treatment. The Specialist will also send a Reduced
Shared care request form to support the GP in undertaking shared care. (Appendix A)
GP to specialist
If the GP has concerns over the prescribing of Ivabradine, they will contact the specialist as soon as possible.
Contact Details
Consultant Cardiologists
Telephone No
Fax No
Email
Dr M Tahir
01226 432572
01226 288614
naeem.tahir@nhs.net
Dr S Yousaf
01226 432572
01226 288614
sajjad.yousaf@nhs.net
Dr M Etorki
01226 432169
01226 288614
mohamed.etorki@nhs.net
Medicines Information
01226 777875
01226 320425
gilliansmith2@nhs.net
References


BNF September 2012. Available at: www.bnf.org
SPC. Inspra®. Available at:
http://www.medicines.org.uk/EMC/medicine/16746/SPC/Inspra+25mg+%26+50+mg+filmcoated+tablets/ Accessed <24.9.12>
Ivabradine Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 4 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Appendix A – Reduced Shared Care (Amber-G) request form



Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosed condition:
Amber-G Drug details
Drug name:
Dose:
Date of initiation:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone number(s) for contact:
The patient should be reviewed by the GP by:
Consultant:
Date:
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist name:
Specialist signature:
Date:
GP name:
GP signature:
Date:
Ivabradine Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 5 of 5