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Pravafenix is a brand name for Fenofibrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment…
Verbatim from this product's EMA label. Tap a section to expand.
Prior to initiating Pravafenix, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment. Posology The recommended dose is one capsule per day.
Dietary restrictions instituted before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.
Special populations Elderly patients (≥ 65 years old) Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section
Summary of the safety profile The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders. Tabulated list of adverse reactions In clinical trials, over 1,566 patients received Pravafenix.
Adverse reactions have usually been mild and transient.
The frequencies of adverse reactions are ranked according to the following:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000). System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity reactions Uncommon Metabolism and nutrition disorders Diabetes mellitus aggravated, Obesity Uncommon Psychiatric disorders Sleep disturbance including insomnia and nightmares Uncommon Nervous system disorders Dizziness, headache, paraesthesia Uncommon Cardiac disorders Palpitations Uncommon Gastrointestinal disorders Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Common Hepatobiliary disorders Transaminases increased. Common Hepatic pain, gammaglutamyl transferase increased. Uncommon Skin and subcutaneous tissue disorders Pruritus, urticaria Uncommon 9 Musculoskeletal, connective tissue and bone disorders Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Uncommon Renal and urinary disorders Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure Uncommon General disorders and administration site conditions Asthenia, fatigue, influenza like illness Uncommon Investigation Blood cholesterol increased, blood triglycerides increased, low- density lipoprotein increased, weight increased.
4 Renal and urinary disorders). ) No modification of posology should be necessary in patients with mild renal impairment. ). No posology adjustment is required in patients with mild hepatic impairment. 3). Method of administration Oral use.
The recommended dose is one capsule taken daily during the evening meal. 5. 2). 1. 4). - Children and adolescents (age below 18 years). - Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min). - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
4). 4). 6). 4). 4 Special warnings and precautions for use The pharmacokinetics properties of Pravafenix are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state. ).
8). Pravafenix should be discontinued in case of aggravation of symptoms. Recurrences when the same or a different statin was (re-) administered have been reported. Musculoskeletal and connective tissue disorders As with other lipid lowering substances, pravastatin or fenofibrate have been associated with the onset of myalgia, myopathy and very rarely rhabdomyolysis with or without secondary renal insufficiency.
Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
The risk of muscle toxicity is increased when a fibrate and a 3-hydroxy-3-methyl-glutaryl- Coenzyme A (HMG-CoA) reductase inhibitor are administered together. Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps.
In such cases CK levels should be measured (see below). 4 Consequently, the potential benefit/risk ratio of Pravafenix should be closely assessed before treatment initiation and patients should be monitored for any signs of muscle toxicity.
1. 4). - Children and adolescents (age below 18 years). - Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min). - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
4). 4). 6). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fenofibrate in European Union.
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Uncommon Description of selected adverse reactions Skeletal muscle:
Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently. 92% for patients treated with Pravafenix. 38% of the patients treated with Pravafenix. 06% of the patients treated with Pravafenix. 4).
Liver reactions:
Marked and persistent increases of serum transaminases have been reported infrequently. 83% for patients treated with Pravafenix. 38% of the patients treated with Pravafenix. 4). Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and post- marketing experience that may potentially occur with Pravafenix are listed below.
Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU. g cholecystitis, cholangitis, biliary colic, etc). g. 4); myositis, polymyositis. Isolated cases of tendon disorders, sometimes complicated by rupture.
Erythematous lupus like syndrome. 4). 031). 074). The following adverse events have been reported with some […]
Certain predisposing factors such as age > 70, renal impairment, hepatic impairment, hypothyroidism, personal history of muscular toxicity with a statin or fibrate, personal or familial history of hereditary muscular disorders or alcohol abuse may increase the risk of muscular toxicity and therefore CK measurement is indicated before starting the combination therapy in these patients (see below).
Statins including pravastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
5). The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. , for the treatment of severe infections, the need for co-administration of Pravafenix and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Before treatment initiation CK levels should be measured prior to initiation of therapy. The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy. When measured, CK levels should be interpreted in the context of other potential factors that can cause transient muscle damage, such as strenuous exercise or muscle trauma and repeated if necessary.
If CK levels are significantly elevated > 5 times the ULN at baseline, the results should be controlled after 5-7 days. 3). During treatment Routine monitoring of CK is systematically recommended every 3 months during the first 12 months of the combination therapy and let to the appreciation of the clinician beyond this initial period.
Patients should be advised to report […]