Medicure announces availability of ZYPITAMAG (pitavastatin) in the U.S.
Published: May 01, 2018
WINNIPEG, May 1, 2018 /PRNewswire/ - Medicure (TSXV:MPH) today announced that pitavastatin magnesium (ZYPITAMAGTM) tablets are now available in retail pharmacies throughout the United States. ZYPITAMAGTM, a statin (HMG-CoA reductase inhibitor) medication approved by the U.S. Food and Drug Administration (FDA) in July 2017, is available in strengths of 1 mg, 2 mg and 4 mg. ZYPITAMAGTM is indicated for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet, 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). (Refer to the annexure appended below for the complete indication statement and important safety information.)
"Medicure is pleased to partner with Cadila Healthcare Ltd., India (Zydus group) and add ZYPITAMAGTM to its cardiovascular commercial operation. This partnership offers a cost effective pitavastatin alternative and fits with Medicure's mission of being a significant, value based, cardiovascular pharmaceutical company focused on the U.S. market," commented Medicure's President and CEO, Dr. Albert D. Friesen.
As previously announced Medicure entered into an agreement with Zydus to commercialize ZYPITAMAGTM for a term of seven years, with extensions to the term available. ZYPITAMAGTM was developed by Zydus via a 505(b)(2) New Drug Application procedure. Medicure is a U.S. pharmaceutical company and has a proven track-record of successful commercialization of products in the therapeutic segments of cardiovascular and metabolic diseases. As a part of this agreement, Zydus will hold the NDA and Medicure will be responsible for the sales and marketing of ZYPITAMAGTM.
Medicure is a pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. cardiovascular market. The primary focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAGTM (pitavastatin magnesium) in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
About Zydus Cadila
Cadila Healthcare Ltd., India is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 21000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020. For more information, please visit www.zyduscadila.com
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IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG (pitavastatin)
INDICATIONS & USAGE: Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.
Primary Hyperlipidemia and Mixed Dyslipidemia: ZYPITAMAG is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Limitations of Use: Doses of ZYPITAMAG greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of ZYPITAMAG. The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined. ZYPITAMAG has not been studied in Fredrickson Type I, III, and V dyslipidemias.
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
Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including pitavastatin.
- These risks can occur at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.
- Advise patients to promptly report unexplained and/or persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; discontinue ZYPITAMAG.
- If muscle signs and symptoms persist after discontinuation, this may be a sign of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated with statin use, requiring immediate medical attention. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
- ZYPITAMAG should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. ZYPITAMAG should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).
Liver Enzyme Abnormalities:
- Persistent elevation in hepatic transaminases can occur. Check liver enzymes before initiating therapy and if signs or symptoms of liver injury occur; advise patients to report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
- Fatal and non-fatal hepatic failure can occur. Interrupt ZYPITAMAG if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. If an alternate etiology is not found do not restart ZYPITAMAG.
- Use ZYPITAMAG with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use ZYPITAMAG if patient has active liver disease, which may include unexplained persistent transaminase elevations.
- Increases in HbA1c and fasting serum glucose levels have been reported.
COMMON ADVERSE REACTIONS: myalgia, back pain, diarrhea, constipation and pain in extremity (rate ≥ 2% in at least one marketed dose). 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.
James Kinley, Chief Financial Officer, Tel. 888-435-2220, Fax 204-488-9823, E-mail: email@example.com, www.medicure.com
SOURCE Medicure Inc.
Company Codes: OTC-PINK:MCUJF, TorontoVE:MPH