"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
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, 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].
- 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].
Last reviewed on RxList: 3/13/2012
Additional Livalo Information
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