Cyclosporine significantly increased pitavastatin exposure. Co-administration of cyclosporine with LIVALO is contraindicated [ see Contraindications (4), and Clinical Pharmacology (12.3)].
Based on data with another HMG-CoA reductase inhibitor that has a similar pharmacokinetic profile to that of pitavastatin, co-administration of the protease inhibitor combination, lopinavir/ritonavir, with LIVALO may significantly increase pitavastatin exposure. Therefore, LIVALO should not be used with this combination of protease inhibitors.
[ see Limitations of Use (1.2)].
Erythromycin significantly increased pitavastatin exposure. In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded [see Dosage and Administration and Clinical Pharmacology].
Rifampin significantly increased pitavastatin exposure. In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded [see Dosage and Administration and Clinical Pharmacology].
Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors may be increased with concurrent administration of fibrates, LIVALO should be administered with caution when used concomitantly with gemfibrozil or other fibrates [see Warnings and Precautions and Clinical Pharmacology].
The risk of skeletal muscle effects may be enhanced when LIVALO is used in combination with niacin; a reduction in LIVALO dosage should be considered in this setting [see Warnings and Precautions ].
LIVALO had no significant pharmacokinetic interaction with R- and S- warfarin. LIVALO had no significant effect on prothrombin time (PT) and international normalized ratio (INR) when administered to patients receiving chronic warfarin treatment [see Clinical Pharmacology]. However, patients receiving warfarin should have their PT and INR monitored when pitavastatin is added to their therapy.