Livalo (Pitavastatin Calcium) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Cyclosporine

Cyclosporine significantly increased pitavastatin exposure. Co-administration of cyclosporine with LIVALO is contraindicated [ see Contraindications (4), and Clinical Pharmacology (12.3)].

Lopinavir/Ritonavir

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

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

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].

Fibrates

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].

Niacin

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 ].

Warfarin

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.

OVERDOSAGE

There is no known specific treatment in the event of overdose of pitavastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of pitavastatin.

CONTRAINDICATIONS

The use of LIVALO is contraindicated in the following conditions:

• Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with LIVALO [see Adverse Reactions ].
• Patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.2), Use in Specific Populations].
• Women who are pregnant or may become pregnant. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, LIVALO may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy [see Use in Specific Populations and Nonclinical Toxicology (13.2)].
• Nursing mothers. Animal studies have shown that LIVALO passes into breast milk. Since HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, LIVALO, like other HMG-CoA reductase inhibitors, is contraindicated in pregnant or nursing mothers [see Use in Specific Populations and Nonclinical Toxicology].
• Co-administration with cyclosporine [see Drug Interactions and Clinical Pharmacology].