Interação entre Ciclosporina e Rosuvastatina

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin tablets with cyclosporine or gemfibrozil is not recommended. rosuvastatin tablets dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see Dosage and Administration ( 2.6 )] .

Cyclosporine Prevention or Management: In patients taking cyclosporine, do not exceed a dosage of rosuvastatin tablets 5 mg once daily.

Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold.

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.

Treatment with immunosuppressive agents may be required.

Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs.

HMG-CoA Reductase Inhibitors (Statins) Literature and postmarketing cases of myotoxicity, including muscle pain and weakness, myositis, and rhabdomyolysis, have been reported with concomitant administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and rarely fluvastatin.

When concurrently administered with cyclosporine, the dosage of these statins should be reduced according to label recommendations.

Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis.