pitavastatin and fenofibrate

C10BA14

Forms & Strengths

Adult Dosing

Dyslipidemia/Mixed Dyslipidemia: One tablet daily with or without food
Select tablet strength based on individual component titration and therapeutic goals
Maximum dose: Pitavastatin 4 mg / Fenofibrate 135 mg daily

Pediatric Dosing

Indications

Adjunct to diet for primary hyperlipidemia or mixed dyslipidemia in adults
Reduction of elevated total cholesterol, LDL-C, Apo B, triglycerides, and non-HDL-C
Increase in HDL-C in adult patients

Mechanism of Action

Pitavastatin: Competitive inhibitor of HMG-CoA reductase, halting hepatic cholesterol synthesis and upregulating LDL receptors
Fenofibrate: Activates Peroxisome Proliferator-Activated Receptor Alpha (PPAR-alpha), increasing lipolysis and elimination of triglyceride-rich particles from plasma

Contraindications

Hypersensitivity to pitavastatin, fenofibrate, or any component
Active liver disease or unexplained persistent elevations of serum transaminases
Severe renal impairment, including patients on dialysis
Gallbladder disease
Pre-existing primary biliary cirrhosis or nursing mothers

Adverse Reactions

Myalgia and arthralgia
Elevated liver transaminases
Nasopharyngitis and upper respiratory tract infections
Increased blood creatine phosphokinase (CK)
Diarrhea, dyspepsia, and abdominal pain
Rare: Rhabdomyolysis and severe myopathy (especially when combined with fibrates)

Drug Interactions

Cyclosporine: Significantly increases pitavastatin exposure; concurrent use is contraindicated
Erythromycin: May increase pitavastatin exposure; use with caution
Coumarin anticoagulants: Fenofibrate potentiates coumarin anticoagulant effects; monitor INR closely
Colchicine: Increased risk of myopathy and rhabdomyolysis
Bile acid sequestrants: Decrease absorption of statins and fibrates; administer at least 1 hour before or 4 to 6 hours after sequestrants
Immunosuppressants and protease inhibitors: May increase risk of myopathy

Curated Content: Needs Vetting Before Put to Clinical Use