Pravafenix
Authorised
This medicine is authorised for use in the European Union
fenofibrate / pravastatin
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Pravafenix. 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 Pravafenix.
Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate. It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.
Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein’ (LDL or ‘bad’) cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).
The medicine can only be obtained with a prescription.
Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient’s abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.
The recommended dose is one capsule a day taken during the evening meal. The medicine should always be taken with food as it is less well absorbed from an empty stomach. The patient’s blood should be monitored regularly to see how the medicine is working. The doctor should stop treatment if an adequate response is not seen within three months.
The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.
Pravastatin belongs to the group called ‘statins’. It reduces total blood cholesterol by blocking the action of 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA) reductase, an enzyme in the liver involved in the production of cholesterol. As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further. The cholesterol drawn out of the blood in this way is the LDL, or ‘bad’ cholesterol.
Fenofibrate is a ‘peroxisome-proliferator-activated-receptor (PPAR) agonist’. It activates a type of receptor called the ‘PPAR alpha’, which is involved in breaking down fat from the diet, especially triglycerides. When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Because pravastatin and fenofibrate have been used in medicines for a number of years, the company presented information from the scientific literature in addition to results from its own studies.
The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats. The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks (excluding HDL or ‘good’ cholesterol).
In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing non-HDL-cholesterol levels. Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.
The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes. For the full list of all side effects reported with Pravafenix, see the package leaflet.
Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients. Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo-allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen. It must also not be used in patients with gall-bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate. It must not be given to women who are pregnant or breastfeeding.
The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate. The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol. The Committee therefore decided that Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: PSUSA/00001363/202304
22/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Pravafenix
- Active substance
- fenofibrate
- Pravastatin
- International non-proprietary name (INN) or common name
- fenofibrate
- pravastatin
- Therapeutic area (MeSH)
- Dyslipidemias
- Anatomical therapeutic chemical (ATC) code
- C10BA03
Pharmacotherapeutic group
Lipid modifying agentsTherapeutic indication
Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.
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