Pravafenix (Pravastatin 40 mg / Fenofibrate 160 mg)
Fixed-dose statin–fibrate combination for mixed dyslipidemia in adults at high cardiovascular risk
Quick Facts About Pravafenix
Key Takeaways About Pravafenix
- Two lipid-lowering drugs in one capsule: Pravastatin lowers LDL-cholesterol while fenofibrate reduces triglycerides and raises HDL-cholesterol, tackling mixed dyslipidemia with complementary mechanisms
- Take with the evening meal: Fenofibrate is poorly absorbed without food – taking Pravafenix with dinner maximises effectiveness and consistency of blood levels
- Not a first-line therapy: Pravafenix is reserved for high-risk adults whose lipids are not adequately controlled by pravastatin monotherapy, not as initial treatment
- Muscle and liver monitoring matters: Both statins and fibrates can cause muscle toxicity and transaminase elevations, so your doctor will check liver enzymes and creatine kinase periodically
- Contraindicated with ciclosporin and in pregnancy: Pravafenix must not be combined with ciclosporin, must not be used during pregnancy or breastfeeding, and must not be given to children under 18
What Is Pravafenix and What Is It Used For?
Pravafenix is a fixed-dose oral capsule that combines pravastatin 40 mg (a statin) and fenofibrate 160 mg (a fibrate). It is prescribed to adult patients at high cardiovascular risk who have mixed dyslipidemia – high LDL-cholesterol combined with high triglycerides and/or low HDL-cholesterol – when pravastatin 40 mg alone does not provide adequate control.
Pravafenix contains two complementary active substances in a single hard capsule: pravastatin sodium, which belongs to a class of medicines known as HMG-CoA reductase inhibitors or “statins”, and fenofibrate, which belongs to the class of fibrates (PPAR-alpha activators). The combination was authorised by the European Medicines Agency (EMA) in 2011 following a centralised review and is marketed in the European Union as a treatment for adult patients who require modification of multiple lipid parameters simultaneously.
Pravafenix is prescribed to reduce cardiovascular risk in adults with mixed dyslipidemia (also called combined hyperlipidemia). Mixed dyslipidemia is characterised by raised low-density lipoprotein cholesterol (LDL-C) – the so-called “bad” cholesterol – together with elevated triglycerides and/or low high-density lipoprotein cholesterol (HDL-C) – the “good” cholesterol. This lipid pattern is particularly common in patients with metabolic syndrome, type 2 diabetes mellitus, central obesity, and chronic kidney disease, and is strongly associated with an increased risk of atherosclerotic cardiovascular events such as myocardial infarction and ischaemic stroke.
According to its marketing authorisation, Pravafenix is indicated as an add-on to diet and other non-pharmacological measures (such as exercise and weight loss) in adult patients at high cardiovascular risk with mixed dyslipidemia, to lower triglycerides and raise HDL-C when LDL-C levels are adequately controlled while taking pravastatin 40 mg monotherapy. In clinical practice, this means the drug is generally introduced only after pravastatin 40 mg has successfully brought LDL-C to target but triglycerides remain high and/or HDL-C remains below target.
The two components of Pravafenix act by different mechanisms that are generally regarded as complementary. Pravastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyses the rate-limiting step of hepatic cholesterol biosynthesis. Reduced intracellular cholesterol upregulates hepatic LDL receptors, which increases the clearance of LDL particles from the bloodstream. Fenofibrate, on the other hand, activates the nuclear receptor peroxisome proliferator-activated receptor alpha (PPAR-alpha). Activation of PPAR-alpha increases the expression of lipoprotein lipase (reducing triglycerides), enhances fatty-acid oxidation, decreases production of apolipoprotein C-III (an inhibitor of triglyceride clearance), and increases synthesis of apolipoproteins A-I and A-II, thereby raising HDL-C.
Pravafenix is not a first-line lipid-lowering therapy. It is intended for patients whose lipid profile persists outside target after an adequate trial of pravastatin alone, and always as an adjunct to dietary modification, weight management, smoking cessation, physical activity, and control of underlying conditions such as diabetes or hypothyroidism. Pravafenix is approved for adults aged 18 years and older; it is not authorised for use in children or adolescents.
Statin monotherapy is highly effective at lowering LDL-C but has a more modest effect on triglycerides and HDL-C. In patients with atherogenic dyslipidemia – characterised by small, dense LDL particles, elevated triglyceride-rich lipoproteins, and low HDL-C – residual cardiovascular risk often remains even after LDL-C has been lowered to guideline targets. Adding a fibrate addresses these additional lipid abnormalities. International guidelines (ESC/EAS 2019, AHA/ACC 2018) recognise combined statin-fibrate therapy as an option in selected high-risk patients with persistent hypertriglyceridemia, while emphasising that fenofibrate is the preferred fibrate because gemfibrozil carries a much higher risk of muscle toxicity when combined with statins.
What Should You Know Before Taking Pravafenix?
Do not take Pravafenix if you are allergic to pravastatin, fenofibrate, peanut, soya, or any excipient. It is contraindicated during pregnancy and breastfeeding, in children under 18, and in people with severe liver or kidney disease, gallbladder disease, chronic pancreatitis, or previous photosensitivity to fibrates. Tell your doctor about all medicines you take, especially ciclosporin, warfarin, bile acid binders, and other lipid-lowering drugs.
Contraindications
Pravafenix must not be used in any of the following situations. If any of these apply to you, tell your doctor before starting treatment:
- Hypersensitivity to pravastatin, fenofibrate, peanut, soya (Pravafenix capsules contain soya lecithin), or any of the excipients listed in the product information
- Children and adolescents under 18 years of age – safety and efficacy have not been established in this population
- Severe hepatic impairment, including biliary cirrhosis or active liver disease, and unexplained persistent elevations of serum transaminases
- Known gallbladder disease, including gallstones – fenofibrate can increase cholesterol excretion into bile and promote stone formation
- Chronic or acute pancreatitis, with the exception of acute pancreatitis caused by severe hypertriglyceridemia
- Severe renal impairment, defined as creatinine clearance below 60 mL/min
- Known photoallergic or phototoxic reaction during treatment with fibrates or ketoprofen in the past
- Pregnancy and breastfeeding
- Concomitant use of ciclosporin because of a markedly increased risk of muscle toxicity and renal injury
Warnings and Precautions
Speak with your doctor before taking Pravafenix if any of the following apply:
- Muscle symptoms: Inform your doctor before starting Pravafenix if you have, or have a family history of, inherited muscle disorders, or if you have previously experienced muscle problems on a statin or fibrate. Risk factors for statin/fibrate-induced myopathy include advanced age (above 70), hypothyroidism, kidney disease, alcohol abuse, previous history of muscle toxicity, and certain interacting medicines.
- Liver disease or raised liver enzymes: Pravafenix can cause dose-related, usually reversible, elevations of serum transaminases. Your doctor will measure ALT and AST before treatment, 12 weeks after starting or after any dose change, and periodically thereafter. If ALT or AST exceeds three times the upper limit of normal and remains elevated, Pravafenix should be discontinued.
- Kidney disease: Pravafenix is contraindicated if creatinine clearance is below 60 mL/min. Fenofibrate causes reversible increases in serum creatinine, so your doctor may monitor kidney function during treatment.
- Thyroid disease: Untreated hypothyroidism predisposes to muscle toxicity with both statins and fibrates. Thyroid dysfunction should be excluded or treated before Pravafenix is started.
- Alcohol intake: Excessive alcohol consumption increases the risk of liver injury and muscle problems.
- Previous stroke or transient ischaemic attack: Very rare post-marketing reports suggest a possible increased incidence of haemorrhagic stroke in some populations receiving statins, although the overall stroke risk is reduced. Discuss this with your neurologist if you have had a brain haemorrhage.
- Older age (above 70 years): Requires careful risk assessment due to a higher baseline risk of muscle and kidney toxicity.
- Venous thromboembolism: Fenofibrate has been associated with a small increase in the risk of pulmonary embolism and deep-vein thrombosis, particularly in patients with additional risk factors.
- Unexplained muscle pain, tenderness or weakness, particularly when accompanied by fever, general malaise or dark-coloured (tea- or cola-coloured) urine – these may be signs of rhabdomyolysis
- Yellowing of the skin or eyes (jaundice), dark urine, pale stools, persistent nausea or right-upper-abdominal pain – possible hepatitis
- Severe, persistent upper abdominal pain radiating to the back – possible pancreatitis or gallstone disease
- Sudden severe breathlessness, chest pain or calf swelling – possible pulmonary embolism or deep-vein thrombosis
- Widespread rash with blistering, peeling skin or mucosal ulcers, especially after sun exposure
- Swelling of the face, lips, tongue or throat, difficulty breathing or swallowing – severe allergic reaction
Pregnancy and Breastfeeding
Pravafenix must not be used during pregnancy. Cholesterol and other products of the cholesterol biosynthesis pathway are essential for fetal development. Statins have been associated with teratogenic effects in some preclinical studies, and there is limited human experience with fenofibrate during pregnancy. Women of childbearing potential should use effective contraception throughout treatment.
If you become pregnant, or think you might be pregnant, while taking Pravafenix, stop the medicine immediately and contact your doctor for advice.
Pravafenix must not be used during breastfeeding. It is not known whether pravastatin or fenofibrate is excreted in human breast milk, but both substances are known to pass into the milk of animals. Because of the potential for serious adverse reactions in the nursing infant, a decision must be made whether to discontinue breastfeeding or to discontinue the medicine, taking into account the importance of the therapy to the mother.
Driving and Operating Machinery
Pravafenix has no or negligible influence on the ability to drive and use machines. However, some patients have reported dizziness, visual disturbances or muscle pain with either of the individual components. If you experience these symptoms, do not drive or operate machinery until you know how Pravafenix affects you.
Pravafenix capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. The capsules also contain soya lecithin – do not take Pravafenix if you are allergic to peanut or soya. The product is essentially sodium-free, containing less than 1 mmol sodium (23 mg) per capsule.
How Does Pravafenix Interact with Other Drugs?
Pravafenix is contraindicated with ciclosporin because of severe muscle and kidney toxicity. It enhances the effect of warfarin and other oral anticoagulants, and interacts with bile acid binders, other statins and fibrates, colchicine, rifampicin, and certain antibiotics and antifungals. Always give your doctor and pharmacist a complete list of medicines, supplements and herbal products you use.
Pravafenix contains two different active substances and can therefore interact through two distinct routes: the statin (pravastatin) is affected by drugs that influence the OATP1B1 transporter and, to a small degree, CYP3A4, while the fibrate (fenofibrate) interacts mainly with drugs metabolised via CYP2C9 or with other lipid-active drugs. Some interactions are potentially serious and require dose adjustment or avoidance.
Major Interactions
Tell your doctor or pharmacist immediately if you are taking, or have recently taken, any of the following:
| Drug | Interaction | Severity | Clinical Advice |
|---|---|---|---|
| Ciclosporin | Increases plasma levels of both pravastatin and fenofibrate; markedly raises the risk of rhabdomyolysis and nephrotoxicity. | Contraindicated | Do not co-administer. If urate- or lipid-lowering therapy is essential in a transplant patient, use an alternative regimen selected by a specialist. |
| Other fibrates (e.g., gemfibrozil, bezafibrate) | Additive risk of myopathy and rhabdomyolysis; gemfibrozil also markedly increases statin exposure via OATP1B1 inhibition. | Avoid | Do not combine Pravafenix with another fibrate. Gemfibrozil with any statin is generally contraindicated. |
| Other statins | Duplication of HMG-CoA reductase inhibition with no additional benefit and increased muscle toxicity. | Avoid | Do not use Pravafenix together with any other statin. |
| Oral anticoagulants (warfarin, acenocoumarol, phenprocoumon) | Fenofibrate potentiates the anticoagulant effect by displacing the coumarin from albumin binding sites and by impairing vitamin K metabolism. | Major | Reduce the anticoagulant dose by about one-third when starting Pravafenix and adjust according to INR. Monitor INR frequently during initiation, dose changes and discontinuation. |
| Colchicine | Additive risk of neuromuscular toxicity, including myopathy and rhabdomyolysis, particularly in elderly patients or those with renal impairment. | Major | Use with caution; monitor for muscle symptoms. Avoid combination in patients with kidney disease. |
| Bile acid sequestrants (cholestyramine, colestipol, colesevelam) | Bind pravastatin and fenofibrate in the gut, substantially reducing their absorption. | Moderate | Take Pravafenix at least 1 hour before or 4–6 hours after the bile acid sequestrant to avoid loss of efficacy. |
| Rifampicin | Reduces plasma concentrations of pravastatin by inducing hepatic uptake transporters and metabolism. | Moderate | Lipid control may deteriorate; monitor lipid levels closely or consider an alternative regimen. |
| Erythromycin, clarithromycin | Macrolide antibiotics can inhibit hepatic uptake of pravastatin, modestly increasing exposure. | Moderate | Monitor for muscle symptoms, especially with prolonged courses. Azithromycin is generally preferred when possible. |
Minor Interactions and Other Considerations
Several other medicines interact modestly with Pravafenix and may require monitoring but not routine dose changes:
- Glitazones (e.g., pioglitazone, rosiglitazone): Concomitant administration with fenofibrate has led to reversible, paradoxical reductions in HDL-cholesterol in some cases; HDL-C should be monitored and Pravafenix discontinued if a marked decrease occurs.
- CYP2C9 substrates: Fenofibrate is a mild inhibitor of CYP2C9 and can raise plasma concentrations of substrates such as warfarin, some sulfonylureas (glipizide, glimepiride) and phenytoin.
- Alcohol: Heavy alcohol use increases the risk of hepatotoxicity and triglyceride variability.
- Grapefruit juice: Has little effect on pravastatin (which is minimally metabolised by CYP3A4) but interactions vary with other statins; no strict avoidance is required for Pravafenix.
- Niacin (nicotinic acid): Can increase the risk of muscle toxicity when combined with statin-fibrate therapy; use with caution and monitor for muscle symptoms.
- Oestrogens: Oestrogens and oestrogen-containing oral contraceptives can raise triglycerides; this is a pharmacological effect rather than a pharmacokinetic interaction and may require monitoring.
Herbal products such as St John’s wort (Hypericum perforatum) are strong inducers of CYP3A4 and hepatic transporters. Although pravastatin is only modestly affected, overall lipid control should be reviewed if patients begin herbal inducers during therapy.
What Is the Correct Dosage of Pravafenix?
The recommended dose of Pravafenix is one capsule (40 mg pravastatin / 160 mg fenofibrate) taken once daily with the evening meal. Swallow the capsule whole with water. Treatment is long-term and should be combined with a low-fat diet and regular physical activity. Do not use in children, during pregnancy, or in people with severe liver or kidney disease.
Always take Pravafenix exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Before starting Pravafenix, secondary causes of dyslipidemia (poorly controlled diabetes, hypothyroidism, nephrotic syndrome, obstructive liver disease, certain drugs, alcoholism) should be identified and treated, and the patient should be established on a standard cholesterol-lowering diet that should continue throughout therapy.
Adults
Standard Dosing for Mixed Dyslipidemia
- Dose: One capsule of Pravafenix 40 mg / 160 mg once daily
- Timing: Take with the evening meal; fenofibrate absorption is poor on an empty stomach
- Administration: Swallow the capsule whole with a glass of water; do not open, crush or chew
- Duration: Long-term, alongside diet and lifestyle measures; continue indefinitely unless stopped by your doctor
- Monitoring: Lipid profile, liver enzymes (ALT/AST), creatinine and creatine kinase as judged necessary by your doctor
Response to treatment should be evaluated by measuring serum lipid values a few weeks (usually 4–6) after initiation and periodically thereafter.
Children and Adolescents
Pravafenix is not recommended for children and adolescents under 18 years of age. The safety and efficacy of the combination have not been established in this age group, and the individual components are not routinely used together in paediatrics.
Elderly Patients
No routine dose adjustment is required in elderly patients with normal renal function. However, because older adults are more likely to have reduced kidney function, hypothyroidism, polypharmacy and a higher baseline risk of myopathy, your doctor will check creatinine clearance before treatment and may monitor creatine kinase more closely. Pravafenix is contraindicated if creatinine clearance is below 60 mL/min.
Patients with Kidney Impairment
Pravafenix must not be used in patients with severe renal impairment (creatinine clearance <60 mL/min). For patients with mild impairment, both components accumulate to a lesser extent; however, lipid-lowering therapy in kidney disease should be individualised, and alternative regimens may be preferred.
Patients with Liver Impairment
Pravafenix is contraindicated in patients with active liver disease, unexplained persistent transaminase elevations, or severe hepatic impairment. Before starting treatment and periodically thereafter, liver function tests (ALT/AST) will be checked. If transaminases rise to more than three times the upper limit of normal and remain elevated, Pravafenix should be discontinued.
Missed Dose
If you forget to take your Pravafenix capsule with dinner, take it as soon as you remember with some food, provided it is still the same day. If you only remember the next day, skip the missed dose and continue with your normal schedule. Do not take a double dose to make up for a forgotten one.
Overdose
If you take more Pravafenix than prescribed, contact your doctor, poison control centre, or nearest emergency department immediately. There is no specific antidote. Treatment is supportive and focuses on standard measures for statin overdose (observation, symptomatic care) and fenofibrate overdose (gastric decontamination if recent and clinically appropriate; haemodialysis is not effective because fenofibrate is highly protein-bound).
Stopping lipid-lowering therapy suddenly can cause LDL-cholesterol and triglycerides to rebound and cardiovascular risk to rise again. If you experience side effects, speak with your doctor before discontinuing the medicine; many patients can be switched to an alternative statin-fibrate combination or have the dose adjusted rather than stopping therapy altogether.
What Are the Side Effects of Pravafenix?
Common side effects include abdominal pain, indigestion, diarrhoea, nausea, and increases in liver enzymes (ALT, AST, gamma-GT), creatinine or creatine kinase. Muscle aches can occur. Rare but serious reactions include rhabdomyolysis, hepatitis, pancreatitis, gallstones, venous thromboembolism, photosensitivity and severe hypersensitivity. Stop Pravafenix and seek urgent medical advice for unexplained muscle pain with dark urine, yellowing of the skin or severe abdominal pain.
Like all medicines, Pravafenix can cause side effects, although not everybody gets them. Most adverse reactions are mild to moderate and resolve spontaneously or after discontinuation. The frequencies listed below are based on clinical trial data and post-marketing reports for the combination product and the individual components.
Common Side Effects
- Abdominal pain, abdominal distension
- Dyspepsia (indigestion)
- Diarrhoea
- Nausea
- Flatulence
- Constipation
- Elevated liver enzymes (ALT, AST)
- Elevated gamma-glutamyltransferase (gamma-GT)
- Elevated serum creatinine
- Elevated creatine kinase (CK)
- Muscle pain (myalgia)
- Headache
Uncommon Side Effects
- Dizziness, vertigo, sleep disturbance, fatigue
- Paraesthesia (tingling, numbness)
- Muscle weakness, muscle cramps
- Rash, pruritus (itching), urticaria (hives)
- Skin reactions such as erythema, photosensitivity
- Sexual dysfunction, loss of libido, erectile dysfunction
- Visual disturbances, blurred vision
- Heartburn, vomiting
- Chest pain (non-cardiac)
- Anaemia, decreased haemoglobin
- Reduction in white blood cells or platelets
- Raised blood urea
- Gallstones (cholelithiasis)
Rare Side Effects
- Rhabdomyolysis – severe muscle breakdown that may lead to acute kidney injury; contact a doctor immediately if you experience unexplained muscle pain, tenderness or weakness, especially with fever or dark urine
- Hepatitis (inflammation of the liver), including cholestatic and autoimmune forms, and jaundice
- Severe hypersensitivity reactions, including angioedema, anaphylaxis and skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis
- Pulmonary embolism and deep-vein thrombosis
- Pancreatitis (inflammation of the pancreas)
- Severe photosensitivity reactions triggered by sun or UV exposure
- Peripheral neuropathy
- Interstitial lung disease (very rare with statins)
- Immune-mediated necrotising myopathy (very rare, persistent muscle weakness after stopping the statin)
- Depression, memory problems or confusional states (reported with statins)
- Tendon disorders, occasionally complicated by rupture
- Decline in haemoglobin or white cell count leading to clinical symptoms
- Unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine
- Yellowing of the skin or eyes, dark urine or severe upper-right abdominal pain
- Severe, persistent pain in the upper abdomen radiating to the back (possible pancreatitis)
- Sudden chest pain, breathlessness, swelling or pain in one leg (possible blood clot)
- Rash with blistering, peeling skin or mucosal ulcers, particularly after sun exposure
- Swelling of the face, lips, tongue or throat; difficulty breathing or swallowing
Reporting side effects: If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the patient information leaflet. Reports of suspected adverse drug reactions in your country (for example to the EMA EudraVigilance database, the UK Yellow Card Scheme, or the US FDA MedWatch programme) help ensure the continued safety of this medicine.
How Should You Store Pravafenix?
Store Pravafenix below 30°C in the original package to protect it from moisture. Keep it out of the sight and reach of children. Do not use after the expiry date printed on the blister and carton. Return any unused capsules to a pharmacy for safe disposal; do not put them down the sink or in household waste.
Keep this medicine out of the sight and reach of children. Store the capsules in the original package to protect them from moisture; no specific temperature requirements apply below 30°C for most pack sizes, but always follow the storage instructions printed on the carton supplied in your country.
Do not use Pravafenix after the expiry date (EXP) stated on the blister foil and outer carton. The expiry date refers to the last day of the month shown. Do not use any capsules that appear damaged, discoloured or have broken blister seals.
Do not throw any medicines away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure.
What Does Pravafenix Contain?
Each Pravafenix hard capsule contains two active ingredients: 40 mg of pravastatin sodium and 160 mg of fenofibrate. The capsule also contains lactose, microcrystalline cellulose, soya lecithin, and a gelatin shell with titanium dioxide and iron oxide colourants. People with peanut, soya or galactose intolerance should not take Pravafenix.
Active Ingredients
Each hard capsule contains:
- Pravastatin sodium 40 mg
- Fenofibrate 160 mg (in micronised form for improved absorption)
Inactive Ingredients (Excipients)
Capsule contents: Lactose monohydrate, microcrystalline cellulose, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, soya lecithin, and related pharmaceutical-grade excipients required to formulate the two active ingredients as a stable combination within one capsule.
Capsule shell: Gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), and printing ink.
Appearance and Pack Sizes
Pravafenix is supplied as a hard capsule with a light-green cap and light-brown body, imprinted with the corresponding identification marking by the manufacturer. Inside the capsule are powder and granules containing the two active substances. Pack sizes typically available include blister packs of 30, 60 or 90 capsules; not all pack sizes may be marketed in every country.
Marketing authorisation holder: Laboratoires SMB S.A., Rue de la Pastorale 26-28, B-1080 Brussels, Belgium. The product is authorised through the centralised European procedure and the EMA European Public Assessment Report (EPAR) provides further technical detail.
Frequently Asked Questions About Pravafenix
Medical References and Sources
This article is based on current medical research, regulatory information, and international guidelines. All claims are supported by scientific evidence from peer-reviewed sources and official regulatory documents.
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Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians with expertise in cardiology, lipidology, clinical pharmacology and internal medicine.
iMedic Medical Editorial Team
Specialists in Clinical Pharmacology and Lipidology
iMedic Medical Review Board
Independent medical expert panel
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