What is Ranexa?
Ranexa is a medicine that contains the active substance ranolazine. It is available as prolonged-release tablets (blue: 375 mg; orange: 500 mg; green: 750 mg). The expression "prolonged release" means that ranolazine is released from the tablet slowly, within a few hours.
What is Ranexa used for?
Ranexa is used to treat the symptoms of stable angina pectoris (chest pain caused by decreased blood flow to the heart). It is used as an adjunct therapy therapy in patients whose disease is not adequately controlled by other medicines for angina pectoris, such as beta-blockers or calcium channel blockers, or in patients who cannot take these medicines.
The medicine can only be obtained with a prescription.
How is Ranexa used?
The recommended starting dose of Ranexa is 375 mg twice a day. After two to four weeks, the dose can be increased to 500 mg twice a day and then to 750 mg twice a day, depending on the patient's response. The maximum dose is 750 mg twice a day. The dosage may need to be lowered in patients who have some side effects. Dosage increases should be performed with caution in the elderly, in patients weighing less than 60 kg and in patients with kidney, liver or heart disease. Ranexa tablets must be swallowed whole and must not be crushed, crushed or chewed. They can be taken with or without food.
Patients treated with Ranexa must be given a special alert card with the main safety warnings for the medicine.
How does Ranexa work?
The active substance in Ranexa, ranolazine, is thought to work by reducing the flow of sodium ions to the heart muscle cells. This interferes with the activity of special channels present on the cell surface called "sodium-dependent calcium channels" through which calcium ions normally enter cells. This reduces the amount of calcium ions entering the cells. Calcium ions cause contractions of the heart muscle. By reducing the flow of calcium to the cells, it is thought that ranolazine helps the heart relax, improving blood flow to the heart muscle and relieving the symptoms of angina pectoris.
How has Ranexa been studied?
Ranexa has been studied in one main study involving 823 patients with an average age of 64 who had angina pectoris for at least three months. Two doses of Ranexa (750 and 1000 mg twice a day) were compared with a placebo (a dummy treatment) as an adjunct to medicinal products commonly used for angina pectoris (atenolol, amlodipine or diltiazem). The main measure of effectiveness of the medicine was the duration of the patients' physical exercise after 12 weeks of treatment, compared to the duration before the treatment
What benefit has Ranexa shown during the studies?
Ranexa was more effective than placebo in increasing the duration of physical exercise for patients. At the start of the study, patients could exercise for about 7 minutes. After 12 weeks, this time increased, on average, by 1 minute and 56 seconds for patients who added one of two dosages of Ranexa and, on average, 1 minute and 32 seconds for those who added a placebo.
What is the risk associated with Ranexa?
The most common side effects with Ranexa (seen in between 1 and 10 patients in 100) are headache, dizziness, constipation, vomiting, nausea and asthenia (weakness). For the full list of all side effects reported with Ranexa, see the Package Leaflet.
Ranexa should not be used in people who may be hypersensitive (allergic) to ranolazine or any of the other ingredients. The medicine should not be used in patients with severe renal insufficiency or moderate or severe liver disease. Furthermore, Ranexa must not be used in patients who are already taking other medicines that are metabolised in the same way as ranolazine or some other medicines used to correct the heart rhythm. For a complete list of these medicines, see the package leaflet.
Why has Ranexa been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Ranexa for improving the symptoms of stable angina pectoris patients is modest, but that it could be appreciated by patients who have not responded satisfactorily to other medicines. The Committee decided that Ranexa's benefits are greater than its risks as an adjunctive treatment of the symptoms of stable angina pectoris patients who are not adequately controlled or have an intolerance to first-line anti-anginal medicinal products (such as beta-blockers and / or calcium antagonists). The Committee recommended that Ranexa be given marketing authorization.
What measures are being taken to ensure the safe use of Ranexa?
The company that makes Ranexa will express its agreement regarding the patient alert card in each Member State. The card will be inserted in the packs containing the tablets and will contain information for patients and health professionals with explanations on how to use the medicine safely.
More information on Ranexa:
On 9 July 2008, the European Commission issued a marketing authorization valid throughout the European Union for Latixa. The name of the medicine was changed to Ranexa on 11 August 2008. The marketing authorization holder is Menarini International Operations Luxembourg SA
The full EPAR for Ranexa can be found here.
Last update of this summary: 09-2009.
