Fluvastatin

Increases in HbA1c and fasting blood glucose have been reported with HMG-CoA reductase inhibitors; however, the benefits of statin therapy (eg, reduction in the risk of MI or stroke) far outweigh the risk of dysglycemia. If a patient develops diabetes mellitus during therapy, continue use of fluvastatin and encourage patient to adhere to healthy lifestyle regimens (eg, heart healthy dietary pattern, engage in physical activity, achieve and maintain a healthy body weight) (ACC/AHA [Stone 2013]).

Increased AST or ALT has been reported; in most cases, elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy. Postmarketing reports of fatal and nonfatal hepatic failure have been reported and are rare. If serious hepatotoxicity with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, interrupt therapy promptly. If an alternate etiology is not identified, do not restart fluvastatin. Possible drug-related hepatitis (rare) was observed that resolved upon discontinuation of treatment. Liver enzyme tests should be obtained at baseline and as clinically indicated and if signs/symptoms of liver injury occur. Ethanol may enhance the potential of adverse hepatic effects; instruct patients to avoid excessive ethanol consumption. Use has been found to be safe in those with active hepatitis C (Kondo 2012; Kurincic 2014).

Rhabdomyolysis with acute renal failure secondary to myoglobinuria and/or myopathy has been reported; patients should be monitored closely. This risk is dose related and is increased with concurrent use of cyclosporine, erythromycin, or other lipid-lowering medications (eg, fibrates, niacin at doses ≥1 g/day). Use caution in patients with inadequately treated hypothyroidism, and those taking other drugs associated with myopathy (eg, colchicine); these patients are predisposed to myopathy. Uncomplicated myalgia immune-mediated necrotizing myopathy (IMNM) associated with HMG-CoA reductase inhibitors use has also been reported. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine, particularly if accompanied by malaise or fever. Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed/suspected. Disease-related concerns:

Use caution in patients with conditions or on medications that reduce steroidogenesis.

Use with caution in patients who consume large amounts of ethanol or have a history of liver disease. Use is contraindicated in patients with active liver disease or unexplained transaminase elevations.

Use with caution in patients with renal impairment; these patients are predisposed to myopathy. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution in patients with advanced age; these patients are predisposed to myopathy.

The manufacturer recommends temporary discontinuation for elective major surgery, acute medical or surgical conditions, or in any patient experiencing an acute or serious condition predisposing to renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, trauma, uncontrolled seizures, severe metabolic, endocrine, or electrolyte disorders). Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Hillis 2011]; ACC/AHA [Fleisher 2014]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality. Other warnings/precautions:

Drug therapy should be only one component of multiple risk factor intervention in patients at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. In patients with CHD or multiple risk factors for CHD, initiate therapy simultaneously with diet.

Secondary causes of hyperlipidemia should be ruled out prior to therapy.