Patient Journeys: An Individualized Approach to Statin Treatment for Adult Patients

Contraindications
LIVALO is contraindicated in the following conditions:

• Concomitant use of cyclosporine [see Drug Interactions (7)].
• Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)].
• Hypersensitivity to pitavastatin or any excipients in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO.

Warnings and Precautions

• Myopathy and Rhabdomyolysis: Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, concomitant use of certain drugs, and higher doses of LIVALO. LIVALO is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with LIVALO may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 grams/day), fibrates, and colchicine. Discontinue LIVALO if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue LIVALO in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the LIVALO dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
• Immune-Mediated Necrotizing Myopathy: There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. 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. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue LIVALO if IMNM is suspected.
• Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO.

Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including LIVALO. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

Adverse Reactions
In short-term controlled studies, the most frequent adverse reactions reported by ≥2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate ≥ placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). Other serious adverse reactions include rhabdomyolysis, immune-mediated necrotizing myopathy, hepatic dysfunction, and increases in HbA1c and fasting serum glucose. In adult HIV-infected patients with dyslipidemia, the safety profile of LIVALO was generally consistent with that observed in the short-term controlled studies described above. In pediatric patients with HeFH, the safety profile was similar to that observed in the adult population. This is not a complete listing of all reported adverse events.

For additional information please see the full Prescribing Information.

^© Kowa Pharmaceuticals America, Inc. (2022) – LIV-RA-1043 PI of 09/2022
LIVALO is a registered trademark of the Kowa group of companies.
^© Kowa Pharmaceuticals America, Inc. (2022)
All rights reserved. LIV-MIT-4775 January 2022