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CARDIOVASCULAR SYSTEM › LIPID MODIFYING AGENTS › LIPID MODIFYING AGENTS, COMBINATIONS › Combinations of various lipid modifying agents
rosuvastatin and fenofibrate
C10BA09
Forms & Strengths
- Rosuvastatin 5 mg / Fenofibrate 160 mg oral tablet
- Rosuvastatin 10 mg / Fenofibrate 160 mg oral tablet
- Rosuvastatin 20 mg / Fenofibrate 160 mg oral tablet
Adult Dosing
- One tablet daily taken with food
- Select dose based on individual risk factors, baseline lipid levels, and treatment goals
- Maximum recommended dose is Rosuvastatin 20 mg / Fenofibrate 160 mg daily
- Reduce starting dose in severe renal impairment (CrCl < 30 mL/min)
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Not recommended for use in patients under 18 years of age
Indications
- Adjunct to diet in adult patients with mixed dyslipidemia characterized by elevated LDL-C, high triglycerides, and low HDL-C
- Reduction of cardiovascular events in high-risk patients when diet and lifestyle measures are insufficient
Mechanism of Action
- Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, upregulating hepatic LDL receptors and increasing LDL clearance
- Fenofibrate is a peroxisome proliferator-activated receptor alpha (PPAR-alpha) activator, increasing lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III
Contraindications
- Hypersensitivity to rosuvastatin, fenofibrate, or any component of the formulation
- Active liver disease, including unexplained persistent elevations of hepatic transaminases
- Severe renal impairment (CrCl < 30 mL/min)
- Pre-existing gallbladder disease
- Nursing mothers
- Concomitant use with ciclosporin
Adverse Reactions
- Myalgia and arthralgia
- Elevated liver transaminases
- Increased blood creatinine kinase
- Gastrointestinal upset (abdominal pain, nausea, diarrhea)
- Headache and dizziness
- Rare risk of rhabdomyolysis and myopathy
Drug Interactions
- Coumarin anticoagulants (increases INR and bleeding risk; monitor closely and adjust dose)
- Ciclosporin (significantly increases rosuvastatin exposure; contraindicated)
- Colchicine (increased risk of myopathy and rhabdomyolysis)
- Gemfibrozil (increases risk of severe myopathy/rhabdomyolysis; avoid co-administration)
- Bile acid sequestrants (may bind rosuvastatin/fenofibrate; administer at least 1 hour before or 4 to 6 hours after sequestrants)
Curated Content: Needs Vetting Before Put to Clinical Use