UK—The Rubidium (Rb82) Generator (RUBY-FILL) has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) as a diagnostic tool for cardiac imaging.

As a closed system for producing rubidium Rb 82 chloride injections for intravenous usage, RUBY-FILL requires one or two injections administered by a professional doctor at least 10 minutes apart, with scans performed within 5 minutes of each other

This rubidium Rb 82 chloride injection is used for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress to assess regional myocardial perfusion in adult patients with suspected or established coronary artery disease.

This radiopharmaceutical substance contains a small amount of radioactivity and temporarily collects in certain parts of the body, which can be detected from outside of the body with special cameras.

A healthcare professional will then take an image, which can provide valuable information about blood flow to the heart.

This radiopharmaceutical will deliver low amounts of ionizing radiation, which is associated with a very low risk of cancer and hereditary abnormalities (passing on faulty genes).

The doctor will have considered that the clinical benefit obtained from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

Coronary heart disease (CHD) is a major cause of death worldwide, responsible for 68,000 deaths in the UK each year.

CHD occurs when the blood supply to the heart is blocked by a buildup of fatty material in the coronary arteries, which could in some cases lead to a heart attack.

With 2.3 million people living with the disease, CHD is the most common form of heart and circulatory disease in the UK.

While speaking during the ceremony, Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, noted that keeping patients safe and providing access to high-quality, safe, and effective medical items are top priorities for the MHRA.

He went on to say that the required regulatory standards for approval of this diagnostic had been satisfied and that the MHRSA will continue to monitor the safety of all goods.

The MHRA will closely monitor the safety and efficacy of the Rubidium (Rb82) Generator, just as it would any other drug. 

Anyone who feels they are experiencing an adverse effect from this medicine should consult their doctor, pharmacist, or nurse and report it directly to the MHRA Yellow Card initiative, which can be found on the website or by searching the Google Play or Apple App stores for MHRA Yellow Card.

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