Patients Who May Benefit

Those of Asian Descent


The efficacy and safety of pitavastatin was studied in approximately 20,000 patients of East
Asian descent with hypercholesterolemia.1

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.

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About Zypitamag

  • ZYPITAMAG is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia.

  • ZYPITAMAG is a moderate-intensity statin available in 2mg and 4mg tablets.

  • ZYPITAMAG 4mg lowers LDL-C by a mean of 44% and raises HDL-C by a mean of 7%*

  • Compared to most statins, ZYPITAMAG has a reduced potential to interact with certain medications and foods.

  • At ZYPITAMAG's highest dose, only 3.1% of patients experienced muscle pain vs. 1.4% taking placebo.

  • 0.5% of patients discontinued ZYPITAMAG due to myalgia.

* Mean percent change from baseline at week 12 in randomized clinical study (NK- 104-304) with 4 mg pitavastatin
1 Yokote K et al. Efficacy and safety of pitavastatin in Japanese patients with hypercholesterolemia: LIVES study and subanalysis. Expert Review of Cardiovascular Theray. 2011 May;9(5):555-62.
2 ZYPITAMAG® [prescribing information]. Ahmedabad, India: Cadila Healthcare Ltd; September 2020
3 Grundy SM et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology. 2019;73(24):e285-e350

Click another example of a patient group who may benefit from Zypitamag:

Have type II diabetes

Are ≥ 65 years old

Are taking multiple medications

Are currently taking Pravastatin

Are of Asian descent

Are living with HIV

IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG™ (pitavastatin) tablets

INDICATIONS & USAGE

ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia.

Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.

CONTRAINDICATIONS

ZYPITAMAG is contraindicated in the following conditions:

  • Concomitant use of cyclosporine.
  • Acute liver failure or decompensated cirrhosis.
  • Hypersensitivity to pitavastatin or any excipients in ZYPITAMAG. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin.

WARNINGS & PRECAUTIONS

  • Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher ZYPITAMAG dosage. 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 if myopathy is either 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, 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 ZYPITAMAG 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 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, constipation, diarrhea, back pain, 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.

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