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 (Procoralan®)
Reduced Shared Care Guideline for the use of ivabradine for the symptomatic
treatment of chronic stable angina pectoris, and in the management of mild to severe
heart failure.
This Guideline was originally produced in 2007 By Chris Lawson following consultation with specialists at
Barnsley Hospital. The Guideline was subsequently 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).The guideline was further updated by Gillian Smith in December 2014 to include
the use of Ivabradine in the management of mild to severe heart failure.
This guideline has been subject to consultation and endorsement by:
 The Area Prescribing Committee on 14th January 2015.
 The LMC on 10th February 2015
Introduction
Indication/Licensing information
 Treatment of Stable Angina Pectoris:
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. It is also licensed for
use in combination with a beta-blocker in patients who are inadequately controlled with an optimal betablocker dose and whose heart rate is > 60 bpm.

Treatment of Chronic Heart Failure:
Ivabradine is also licensed for use in patients with chronic heart failure (NYHA class II to IV) with
systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with
standard therapy (including beta-blockers) or when beta-blocker therapy is contraindicated or not
tolerated. NICE have issued a positive technology appraisal for the use of ivabradine in heart failure.
(TA267 available at: http://www.nice.org.uk/guidance/TA267)
Pharmacology
Ivabradine selectively and specifically blocks the (If) or funny ion channel which is found in sino-atrial node cells
which results in a reduction in resting heart rate.
Dosage and administration
 Angina: Initially 5 mg twice daily, increased if necessary after 3–4 weeks to 7.5 mg twice daily.
o If, during treatment, 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 below 50
bpm or symptoms of bradycardia persist (see section 4.4 of the SPC).
 Heart failure: Initially 5 mg twice daily, increased if necessary after 2 weeks to 7.5 mg twice daily (Dose
should be reduced to 2.5mg twice daily if not tolerated)
o If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest
or the patient experiences symptoms related to bradycardia, the dose must be titrated
downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. If
heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated
to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily. Treatment
must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist
(see section 4.4 of the SPC).
Elderly
 Angina: Initially 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:December 2014
Review Date:December2016
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.
 To 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) in angina patients (or
75bpm in heart failure patients) at rest or the patient experiences symptoms related to bradycardia such as
dizziness, fatigue or hypotension, the dose must be titrated downward (see above). Treatment must be
discontinued if heart rate falls below 50 bpm (75bpm in heart failure patients) or symptoms of bradycardia
persist.
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 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:December 2014
Review Date:December2016
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
Adverse drug reactions, precautions, contraindications and interactions
BNF therapeutic
class
2.6.3 Other antianginal drugs
Contraindications
and Cautions
Contraindications:
 Hypersensitivity to the active substance or to any of the excipients
 If used for angina: resting heart rate below 60 beats per minute prior to
treatment
 If used for heart failure: resting heart rate below 75 beats per minute
 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
 Congenital QT syndrome
Adverse Drug
Reactions
Monitoring
Interactions
Cautions:
 Mild heart failure
 Monitor for Atrial fibrillation or other arrythmias
 Intraventricular conduction defects
 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 plasma-creatinine 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 in angina patients (75 bpm for heart failure patients) or the patient
experiences symptoms related to bradycardia such as dizziness, fatigue or
hypotension, the dose must be titrated downward (see above). Treatment must be
discontinued if heart rate falls below 50 bpm (75bpm in heart failure patients) or
symptoms of bradycardia persists
Atrial fibrillation and/or other arrythmias
Anti-arrythmics
Cytochrome P450 inhibitors (Macrolides, Azole antifungals, HIV protease inhibitors,
nefazadone)
Beta blockers
Calcium channel blockers
Ivabradine Reduced Shared care Guideline
Date Prepared:December 2014
Review Date:December2016
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 D Zamvar
01226 432572
01226 288614
deoraj.zamvar@nhs.net
Dr U Velupandian
01226 432169
01226 288614
uma.velupandian@nhs.net
Medicines Information
01226 432857
01226 434431
medicinesinformation@nhs.net
or
gilliansmith2@nhs.net
References


BNF December 2014. Available at: www.medicinescomplete.com
SPC. Procolaran®, Servier Laboratories Limited. Available at:
https://www.medicines.org.uk/emc/medicine/17188 Last Accessed: 29th December 2014
Ivabradine Reduced Shared care Guideline
Date Prepared:December 2014
Review Date:December2016
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: (circle as appropriate)
Angina
Heart Failure
(Specify NYHA Stage: I
II
III
IV)
/
Amber-G Drug details
Drug name:
IVABRADINE
Dose: (delete as appropriate)
Date of initiation:
2.5mg BD / 5mg BD / 7.5mg BD
Length of treatment:
The patientnumber(s)
will be reviewed
by the Consultant on:
Telephone
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 (Doctor/Nurse) name:
Specialist (Doctor/Nurse) signature:
Date:
I, Dr …………………………….., can confirm I :
□
accept the request to participate in shared care for the patient named above.
□
reject the request to participate in shared care for the patient named above. The reason for
this being ………………………………………………………………………………………..
GP signature:
Date:
Ivabradine Reduced Shared care Guideline
Date Prepared:December 2014
Review Date:December2016
Page 5 of 5