Pitavastatin Yarindo Special Precautions

Skeletal Muscle Effects: Myopathy and rhabdomyolysis with acute kidney failure secondary to myoglobinuria have been reported with the use of HMG-CoA reductase inhibitors, including pitavastatin. These risks can occur at any dose level but may increase depending on the dose. Pitavastatin should be used with caution in patients with predisposing factors for myopathy. Predisposing factors include advanced age (>65 years), renal impairment, and poorly treated hypothyroidism. The risk of myopathy may be increased with concomitant administration of fibrates or lipids with niacin. Pitavastatin should be administered with caution in patients with impaired renal function, elderly patients, or when coadministered with fibrates or lipid modifiers with niacin (see Interactions and as follows). Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, has been rarely reported with statin use. IMNM is characterized by proximal muscle weakness. Elevated serum creatine kinase, muscle necrosis without inflammation, and positive anti-HMG-CoA reductase (HMGCR) antibodies that persist despite discontinuation of statin therapy, muscle biopsy demonstrating myopathic necrosis without inflammation, improvement with immunosuppressive agents. Patients should be monitored carefully.
Pitavastatin therapy should be discontinued if elevated creatine kinase (CK) levels occur or if myopathy is diagnosed or suspected. Pitavastatin should be temporarily discontinued in patients with serious acute myopathic conditions or predisposition to secondary renal failure caused by rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disturbances, or uncontrolled seizures). Patients should be advised to report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever, or if muscle pain persists after discontinuation of pitavastatin.
Liver Enzyme Disorders and Monitoring: Elevations in serum transaminases (aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with the use of HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, these elevations are transient and resolve with continued therapy or follow-up therapy. Liver enzyme testing is recommended before using Pitavastatin and if symptoms of liver damage develop. All patients treated with Pitavastatin should be advised to promptly report any symptoms that may indicate liver damage, including fatigue, anorexia, right lower abdominal discomfort, dark urine, or jaundice. Fatal and non-fatal liver failure have been reported rarely in patients using statins, including Pitavastatin. If liver damage accompanied by clinical symptoms or hyperbilirubinemia or jaundice occurs during Pitavastatin use, Pitavastatin should be discontinued immediately. If symptoms do not improve, do not restart pitavastatin. Like other HMG-CoA reductase inhibitors, pitavastatin should be used with caution in patients who consume large amounts of alcohol. Liver disease, which may include persistent transaminase elevations, is a contraindication to pitavastatin use (see Contraindications).
Endocrine Function: Elevated HbA1c and fasting glucose levels have been reported with the use of HMG-CoA reductase inhibitors, including pitavastatin.
Diabetes Mellitus: Some evidence suggests that statins can increase blood glucose levels, leading to hyperglycemia in patients at risk for diabetes. However, this risk is outweighed by the potential benefits of statin therapy, and statin treatment should not be discontinued. Patients at risk for hyperglycemia (fasting glucose 5.6 to 6.9 mmol/L, BMI 2.30 kg/mL, elevated triglycerides, hypertension) should be monitored clinically and biochemically according to guidelines. However, there have been no confirmed reports of a diabetes risk associated with pitavastatin use.
Renal Impairment: Patients with moderate and severe renal impairment (glomerular filtration rate 30-59 mU/1.73 m² and 15-29 mU/1.73 m², respectively, not receiving hemodialysis) and end-stage renal disease receiving hemodialysis should receive an initial dose of pitavastatin 1 mg once daily and a maximum dose of pitavastatin 2 mg once daily. There are no recommended dosage data for pediatric patients with renal impairment (see Dosage & Administration).
Hepatic Impairment: Pitavastatin is contraindicated in patients with active liver disease, which may include persistent, unexplained elevations in liver transaminase levels.
Use in Children: There are no data on long-term use of Pitavastatin in pediatric patients.
The safety and effectiveness of pitavastatin as adjunctive therapy to reduce elevated TC, LDL-C, and ApoB in pediatric patients with HeFH aged 8 years and younger have been established. The safety and effectiveness of pitavastatin in pediatric patients with HeFH aged <8 years or in pediatric patients with other hyperlipidemias (other than HeFH) have not been established.
Use in the Elderly: There are no significant differences in efficacy or safety in elderly patients compared to younger patients. However, the sensitivity of elderly patients may be greater.