|
Patients Who May BenefitThose of Asian Descent
|
No Dose Adjustment of Pitavastatin is Needed for Patients of Asian Descent
In pharmacokinetic comparison between Caucasian volunteers and Japanese volunteers, there were no significant differences in Cmax and AUC.2
ACC/AHA Guidelines provide Guidance for Prescribing Statins to Patients of Asian Descent
According to 2018 ACC/AHA Guidelines3:
- Japanese patients may be sensitive to statin dosing3
- In Asian patients, consider a lower starting dose of rosuvastatin. Caution is urged as dose is up-titrated3
- In adults of East Asian descent, other statins should be used preferentially over simvastatin3
Dosage and Administration of ZYPITAMAG2
- The recommended starting ZYPITAMAG dosage is 2 mg once daily. The maximum recommended dosage is ZYPITAMAG 4 mg once daily.
- Lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.
- ZYPITAMAG can be taken orally once daily with or without food.
- ZYPITAMAG should be taken at the same time each day.
Please refer to the Important Safety Information below.
Help your patient find the Right Statin, Right Away
Zypitamag is accessible like a generic statin.
Click another example of a patient group who may benefit from Zypitamag:
|
|
|
|
|
Are of Asian descent |
|
Important Safety Information for Zypitamag® (pitavastatin) tablets
INDICATIONS & USAGE
ZYPITAMAG is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). Limitations of Use: The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.
CONTRAINDICATIONS: ZYPITAMAG is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.
WARNINGS & 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 ZYPITAMAG. ZYPITAMAG is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with ZYPITAMAG may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 g/day), fibrates, and colchicine. Discontinue ZYPITAMAG if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ZYPITAMAG 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 ZYPITAMAG dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
- Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.
- 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 ZYPITAMAG.
- Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including ZYPITAMAG. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
ADVERSE REACTIONS: The most frequent adverse reactions (rate ≥ 2%) are myalgia, back pain, diarrhea, constipation and pain in extremity. This is not a complete list of all reported adverse events.
For additional information, refer to full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
