Ketek

telithromycin

This is a summary of the European public assessment report (EPAR) for Ketek. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ketek.

What is Ketek?

Ketek is a medicine that contains the active substance telithromycin. It is available as orange, oblong tablets (400 mg).

What is Ketek used for?

Ketek is used to treat adults with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).

It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic):

• acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs);
• acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes).

Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes. It is used when beta-lactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.

Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.

The medicine can only be obtained with a prescription.

How is Ketek used?

The recommended dose of Ketek is 800 mg (two tablets) once a day. The tablets should be swallowed whole with water. Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness. For pneumonia, the tablets should be taken for seven to 10 days. For the other infections, they are taken for five days.

A lower dose may be needed in patients who have severe kidney problems. For more information, see the package leaflet.

How does Ketek work?

The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ketolides’. These are closely related to the macrolides. Telithromycin works by blocking the bacteria’s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria. The full list of bacteria against which Ketek is active can be found in the summary of product characteristics (also part of the EPAR).

How has Ketek been studied?

Ketek has been studied in 10 main studies involving a total of over 4,000 patients. Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis. All but two of the studies compared Ketek with other antibiotics. The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘satisfactory’ reductions in the amount of bacteria detected in samples taken from the throat.

What benefit has Ketek shown during the studies?

Ketek was as effective as the comparator antibiotics. For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment. In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/clavulanic acid. For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels in samples taken from the throat.

What is the risk associated with Ketek?

The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea. For the full list of all side effects reported with Ketek, see the package leaflet.

Ketek should not be used in people who may be hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients. It must not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness), or who have had hepatitis (inflammation of the liver) or jaundice when they have taken telithromycin in the past. Ketek must also not be used in patients who are taking any of the following medicines:

• cisapride (used to relieve certain stomach problems);
• ‘ergot alkaloid derivatives’, such as ergotamine and dihydroergotamine (used to treat migraine headache);
• pimozide (used to treat mental illness);
• astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);
• simvastatin, atorvastatin or lovastastin (used to lower cholesterol in the blood).

Ketek must not be taken by patients with a history or a family history of ‘long QT syndrome’ or with ‘acquired QT interval prolongation’ (disruption of the heartbeat). In patients with severe kidney or liver problems, Ketek must not be used with some medicines that may affect the way that telithromycin is broken down, including protease inhibitors (used in HIV infection) and ketoconazole (an antifungal medicine).

Why has Ketek been approved?

The CHMP concluded that Ketek’s benefits are greater than its risks and recommended that it be given marketing authorisation. However, the Committee noted that Ketek is associated with a greater risk of certain side effects than other antibiotics. Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision. Therefore, the Committee decided that its use should be reserved to the treatment of community-acquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics cannot be used.

Other information about Ketek

The European Commission granted a marketing authorisation valid throughout the European Union for Ketek to Aventis Pharma S.A. on 9 July 2001. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Ketek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 03/05/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

06/12/2011  Ketek -EMEA/H/C/000354 -IB/0052/G

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).

Ketek is indicated for the treatment of the following infections:

In patients of 18 years and older:

• Community-acquired pneumonia, mild or moderate (see section 4.4).
• When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):

• Acute exacerbation of chronic bronchitis
• Acute sinusitis

In patients of 12 years and older:

• Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).

Changes since initial authorisation of medicine

Initial marketing-authorisation documents