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Ivabradine (Coralan)

Safety advisory - risk of cardiovascular events in patients with angina

9 July 2015

Consumers and health professionals are advised that the TGA has completed a safety review of ivabradine, marketed as Coralan. Subsequently, the Product Information (PI) for ivabradine has been updated to reduce the risk of cardiovascular events in patients who take the medicine for angina.

Ivabradine is a heart rate lowering agent that can be used to treat the symptoms of chronic stable angina or treatment of symptomatic chronic heart failure.

The changes to the PI, which are based on a phase III clinical study, include updated indications and contraindications and other information to reduce the risk of cardiovascular events in patients with angina.

In particular, patients who take ivabradine for angina must now have a resting heart rate equal to or above 70 beats per minute (bpm) prior to treatment. This has been increased from 60 bpm.

The PI has been updated to include additional medicines that ivabradine should not be taken in combination with, including diltiazem and verapamil, which are used to treat high blood pressure or angina. An existing warning regarding a potential interaction with grapefruit juice has also been strengthened to advise that drinking grapefruit juice should be avoided (rather than 'restricted').

The Consumer Medicine Information (CMI) for ivabradine has been updated to reflect the changes made to the PI.

Information for consumers

If you or someone you are caring for takes ivabradine for angina, you are encouraged to read the updated CMI.

You should continue taking your medicine until advised otherwise by your health professional. However, if you are taking ivabradine and have angina, check with your health professional to make sure that this medicine is still appropriate for you.

If you experience a slow heart rate (less than 60 bpm) or any related symptoms, such as palpitations, dizziness, fatigue or low blood pressure, seek medical attention.

You should avoid drinking grapefruit juice, as it can interact with this medicine.

If you have any questions or concerns about this issue, speak to your health professional.

Information for health professionals

If you are treating a patient who is taking ivabradine for angina, you are encouraged to read the updated PI.

In particular, review the updated indications, contraindications, precautions and interactions sections.

Ivabradine must not be used in patients who have a pre-treatment resting heart rate below 70 bpm or concomitantly with potent cytochrome P450 3A4 [CYP3A4] inhibitors or moderate CYP3A4 inhibitors with heart rate reducing properties.

The PI also includes other information relating to cardiovascular risks for patients with angina.

You should discuss the benefits and risks of ivabradine treatment with patients who are taking, or for whom you may prescribe, this medicine.

Educate patients regarding the signs and symptoms of the cardiovascular events identified in the PI and instruct them to seek medical attention if any are suspected.

Further information about this issue is provided in an article which was published in the June 2015 issue of the TGA's Medicines Safety Update.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.