Fenostat

Adjunct to diet to reduce elevated total-C, LDL-C, apo B & triglyceride levels & to increase HDL-C in patients w/ mixed dyslipidemia; reduce elevated total-C, LDL-C, apo B & increase HDL-C in patients w/ primary hypercholesterolemia.

Adult & elderly Initially atorvastatin 10 mg + fenofibrate 160 mg (or atorvastatin 10 mg + fenofibrate 200 mg) once daily, can be titrated upwards depending on patients' response & tolerability to treatment. Max: Atorvastatin 40 mg + fenofibrate 160 mg (or atorvastatin 40 mg + fenofibrate 200 mg).

Should be taken with food.

Hypersensitivity. Gallbladder disease; chronic or acute pancreatitis w/ exception of acute pancreatitis due to severe hypertriglyceridemia; photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen. Hepatic insufficiency (including biliary cirrhosis & unexplained persistent liver function abnormality); active liver disease or unexplained persistent elevations of serum transaminases exceeding 3x ULN. Severe renal insufficiency (estimated GFR <30 mL/min/1.73 m²). Pregnancy & lactation. Women of child-bearing potential not using appropriate contraceptive measures.

Perform LFTs before initiation of treatment & every 3 mth during the 1st 12 mth of treatment & periodically thereafter. Monitor transaminase levels; if increase in transaminases of >3x ULN persist, dose reduction or w/drawal is recommended. May cause myalgia, myositis, & myopathy that may progress to rhabdomyolysis. Measure creatine kinase level before starting treatment in patients w/ renal impairment, hypothyroidism, personal/familial history of hereditary muscular disorders, previous history of muscular toxicity w/ statin or fibrate, previous history of liver disease &/or where substantial quantities of alcohol are consumed, elderly (>70 yr) according to the presence of other predisposing factors for rhabdomyolysis, situations where an increase in plasma levels may occur. Not recommended in childn & adolescents <18 yr. Atorvastatin: Patients who consume substantial quantities of alcohol &/or have history of liver disease. Patients w/ prior hemorrhagic stroke or lacunar infarct; increased risk of hemorrhagic stroke. Concomitant use w/ potent inhibitors of CYP3A4 or transport proteins (eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir). Risk of myopathy w/ gemfibrozil & other fibric acid derivates, boceprevir, erythromycin, niacin, ezetimibe, telaprevir, or combination of tipranavir/ritonavir. Do not administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Discontinue statin therapy if patient has developed ILD. Monitor patients at risk of hyperglycemia & DM. Fenofibrate: Secondary cause of hypercholesterolemia eg, uncontrolled type 2 DM, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease or alcoholism should be treated prior to therapy. Determine if the hyperlipidemia is of primary or secondary nature (possible elevation of lipid values caused by the therapeutic agents). Discontinue therapy when symptoms indicative of hepatitis occur (eg, jaundice, pruritus), & diagnosis is confirmed by lab testing. Pancreatitis. Mild to moderate renal insufficiency.

Nausea, diarrhea, flatulence. Atorvastatin: Nasopharyngitis; allergic reactions; hyperglycemia; headache; pharyngolaryngeal pain, epistaxis; constipation, dyspepsia; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain; abnormal LFT, increased blood creatine kinase. Fenofibrate: GI signs & symptoms (abdominal pain, vomiting); increased transaminases; increased blood homocysteine level.

Atorvastatin: Increased plasma conc & increased risk of myopathy w/ CYP3A4 or transport protein inhibitors (eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir), moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil & fluconazole). Concomitant use w/ gemfibrozil/fibric acid derivatives, ezetimibe, fusidic acid, colchicine may induce myopathy & increased risk of muscle related events, including rhabdomyolysis. Increased exposure w/ amiodarone & verapamil, transport protein inhibitors (eg, ciclosporin). Decreased plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin, St. John's wort). Decreased plasma conc w/ colestipol. Increased steady-state conc of digoxin. Increased plasma conc of OCs (norethindrone & ethinyl estradiol). Determine prothrombin time prior treatment w/ coumarin anticoagulants. Fenofibrate: Increased risk of bleeding w/ oral anticoagulants. Concomitant administration w/ cyclosporin may cause reversible renal function impairment. Increased muscle toxicity w/ HMG-CoA reductase inhibitors & other fibrates. Concomitant administration w/ glitazones may cause reversible paradoxical reduction of HDL-C. Carefully monitor patients co-administered w/ CYP2C19, CYP2A6, & especially CYP2C9 metabolised drugs w/ narrow therapeutic index.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
C10BA - Combinations of various lipid modifying agents ; Used in the treatment of hyperlipidemia.

Rx