Fact Sheet - CATENA

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Contact: Bureau of Cardiology Allergy and Neurological Sciences

What is CATENA®?

CATENA® is a medicine containing 150 mg of idebenone per tablet, an analogue of coenzyme Q10 that participates in the production of energy in body cells.

Health Canada has authorized CATENA® with conditions, under the Notice of Compliance with Conditions (NOC/c) Policy. CATENA® is indicated for the symptomatic management of patients with Friedreich's Ataxia. This authorization reflects the promising nature of the clinical evidence of efficacy and safety which must be verified and/or extended with a further study. Products authorized under Health Canada's NOC/c Policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.

What is CATENA® used for?

This authorization with conditions for CATENA® is for the symptomatic management of patients with Friedreich's Ataxia.

What is Friedreich's Ataxia?

Ataxia is the general term for lack of muscular coordination. Friedreich's Ataxia is an inherited, progressive neuromuscular disease. Patients with Friedreich's Ataxia suffer from reduced energy production in the body as well as increased oxidative stress. As a result, most sensitive cells, such as nerves and heart cells are damaged. Patients experience abnormal gait, clumsiness and slurred speech, which first becomes apparent in childhood or early adolescence. These abnormalities will in turn lead to skeletal changes such as twisting of the spine (scoliosis), distortion of the feet (pes cavus), and enlargement of the heart.

How does CATENA® work?

CATENA® is thought to improve energy production by body cells. It may also scavenge (mopup) substances that can cause oxidative stress and damage to cells.

What other treatments have been approved for use in Freidreich's Ataxia?

CATENA® is the first drug approved in Canada for use in Friedreich's Ataxia.

What do patients need to know about using CATENA®?

CATENA® may decrease the number of certain blood cells or it may increase levels of liver enzymes. Your doctor will check these values by taking a blood sample at regular intervals.

You should tell your doctor if you are taking any other medications/treatments. You should also tell your doctor if you have liver or kidney problems.

What are the common side effects and how serious are they?

Side effects are typically mild to moderate and mainly consist of gastrointestinal effects such as diarrhoea, nausea and abdominal pain. There have been some rare reports of reductions in blood cell counts, increases in levels of liver enzymes, coloured urine or increased Blood Urea Nitrogen.

You should report all new symptoms after beginning to use CATENA® to your doctor. Not all new symptoms are caused by CATENA®, but CATENA® may be responsible for some of them.

Can CATENA® be taken with other drugs?

While you are taking CATENA®, do not start any new medicines, including natural or herbal medicines, without talking to your doctor first. Your doctor or pharmacist will know which medicines are safe for you to take together with CATENA®.

Who can be treated with CATENA®?

Patients that are diagnosed with Friedreich's Ataxia can be treated with CATENA®.

Who should not take CATENA®?

• Patients with known or suspected allergy to idebenone or azo-dyes (color of the coating of the tablet) or to any ingredient of the tablet, or patients with an intolerance to lactose.
• Patients with moderate or severe liver problems.
• Patients with severe kidney problems. Pregnant women should ask the advice of their doctor. The use of CATENA® is not recommended in nursing women.

Pregnant women should ask the advice of their doctor. The use of CATENA® is not recommended in nursing women.

How is CATENA® taken?

CATENA® is a tablet that should be swallowed whole with water and taken with food. The daily dose will depend on your weight and the decision of your doctor. Your doctor will tell you how many tablets of CATENA® to take.

What else should patients know about taking CATENA®?

Consult your physician at any time if you have a cold or flu-like symptom(s) suggestive of another infectious disease or if you feel particularly lacking in energy or you bruise more readily or longer than usual.

If a dose of CATENA® has been forgotten, do not try to compensate by taking a double dose. Continue treatment at the next scheduled time and dose amount and try not to forget any other dose.

CATENA® tablets should be stored at a temperature between 15-30°C.

Where can I learn more about CATENA®?

For medical enquiries or additional information, contact the Canadian Importer, GMD Distributing Inc. at 1-866-270-1733 or speak to your doctor.