Patients Who May Benefit

Those who are currently taking Pravastatin

Are your patients who are taking pravastatin meeting their LDL-C goal?

Pravastatin is a low- to moderate intensity statin that is a great option for those who are on
multiple medications with high cholesterol. ZYPITAMAG offers similar benefits of reduced potential
for drug interactions but with clinically superior LDL-C lowering ability.

About ZYPITAMAG

  • Similar metabolism to pravastatin†
  • Taken once daily, with or without food
  • Reduces LDL-C up to 45% and increases HDL-C up to 7%
  • Superior in LCL-C reduction compared to pravastatin
  • Compatible with grapefruit juice

Filled as easily as generic pravastatin

  • No insurance needed, no prior authorization, and no step-therapy required.
  • Your patient will pay $34.50/month - no surprises - free home delivery

Both ZYPITAMAG and Pravastatin have Reduced Potential to Interact with Other Medications


Most statins are processed by our body through an enzyme family called cytochrome 450, or CYP450 for short. 70-80% of drugs are also metabolized by this pathway.


Both ZYPITAMAG and pravastatin bypass this pathway. As a result, both ZYPITAMAG and pravastatin have reduced potential to interact with other medications compared to the other statins.


Both ZYPITAMAG and pravastatin can safely be taken with grapefruit juice.

 

The principal route of pitavastatin metabolism is glucuronidation via liver uridine 5'-diphosphate glucuronosyltransferase (UGT) with subsequent formation of pitavastatin lactone. There is only minimal metabolism by the cytochrome P450 system. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8. Pravastatin is processed by CYP3A4 (part of CYP450), but unlike other statins it's not extensively metabolized by this enzyme. Instead, it's mostly excreted unchanged in the bile. Because CYP450 isn't significantly involved in pravastatin's metabolism, pravastatin also has a decreased risk of drug interactions.
*CYP2C9 isoenzyme is primarily involved in the metabolism of fluvastatin (approximately 75%), while CYP2C8 and CYP3A4 isoenzymes are involved to a much less extent, i.e., approximately 5% and approximately 20%, respectively.

ZYPITAMAG Significantly Reduced LDL-C Compared to Pravastatin:

Three clinical studies have shown ZYPITAMAG significantly reduced LDL-C compared to pravastatin in various patient populations.1-4

Adults with High Cholesterol: Pitavastatin significantly lowered LDL-cholesterol compared to pravastatin in adults with high cholesterol1-2

PREVAIL-US, 12-week phase IV, multicenter, randomized, double-blind, double-dummy, active-control superiority study.

In those >65 Years Old with High Cholesterol: Pitavastatin significantly reduced LDL-cholesterol compared to pravastatin in those with high cholesterol who were >65 years of age.3

 

Study 306: 12-week randomized, multicenter, double-blind, double-dummy, active-controlled non-inferiority (NI) study. NI was met if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.
Pitavastatin was not studied against pravastatin 80 mg.
1 mg pitavastatin and 10 mg pravastatin experimental groups were removed from the data presented. Results were consistent with what is presented here.

 

In those living with HIV who have High Cholesterol: Pitavastatin 4mg has shown to significantly reduce LDL-cholesterol compared to pravastatin 40mg in those with high cholesterol who were living with HIV.4

INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs pravastatin for Dyslipidemia) randomised, double-blind, active-controlled, phase , 52-week trial. 252 HIV-infected patients with dyslipidemia were treated with either pitavastatin 4 mg once daily (n=126) or another statin (n=126). All patients were taking antiretroviral therapy (excluding darunavir) and had HIV-1 RNA less than 200 copies/mL and CD4 count greater than 200 cell/μL for at least 3 months prior to randomization.

 

Help your patient find the Right Statin, Right Away

Zypitamag is accessible like a generic statin.

Learn about Access

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 Sponseller CA et al. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clinical Therapeutics. 2014;36(8):1211-1222.
2 Miller PE et al. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia. Clinical Therapeutics. 2016;38(3):603-609.
3 Stender S et al. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolemia or combined (mixed) dyslipidemia. European Journal of Preventative Cardiology. 2013;20(1):40-53.
4 Aberg JA et a. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidemia (INTREPID): 12 week and 52 week results of a phase 4, multicenter, randomized, double-blind, superiority trial. Lancet HIV. 2017;4:e284-94.

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.

Unite Interactive