| | FARMVILLE, N.C., June 23, 2023 /PRNewswire/ -- CMP Pharma, Inc. announced today that Atorvaliq (atorvastatin calcium) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid of atorvastatin, is now available. Atorvaliq is a ready-made liquid oral suspension of atorvastatin approved for patients 10 years of age and older. Atorvaliq is indicated for the treatment of high cholesterol and certain risk factors for heart disease or stroke. FDA-approved Atorvaliq does not require special preparation and does not require refrigeration. Atorvaliq comes in a pleasant tasting citrus orange-flavored suspension and is available in a 150 mL bottle with a 24-month shelf. Atorvaliq offers convenience and addresses inconsistencies that may exist with unapproved crushed or compounded tablet formulations. “Atorvaliq is intended for a subset of the patient population that needs atorvastatin but has dysphagia or difficulty swallowing tablets. The availability of Atorvaliq gives healthcare providers and appropriate patients a convenient, safe, and FDA-approved liquid formulation,” said Gerald Sakowski, CEO of CMP Pharma, Inc. Atorvaliq (atorvastatin calcium) Oral Suspension is now available. For more information, contact CMP Pharma at 252-753-7111 or visit atorvaliq.com. About CMP Pharma, Inc.
CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including oral liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients. www.cmppharma.com Important Safety Information
Indications and Usage
ATORVALIQ is indicated: - To reduce the risk of:
- Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
- MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
- Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
- As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
- As an adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
- As an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia.
Contraindications - Acute liver failure or decompensated cirrhosis.
- Hypersensitivity to atorvastatin or any excipients in ATORVALIQ.
Warnings and Precautions - Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher ATORVALIQ dosage. Discontinue ATORVALIQ if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ATORVALIQ in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing ATORVALIQ dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
- Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue ATORVALIQ if IMNM is suspected.
- Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ATORVALIQ.
Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in the extremity, and urinary tract infection. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Drug Interactions - See full prescribing information for details regarding concomitant use of ATORVALIQ with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis.
- Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with ATORVALIQ.
- Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive.
- Digoxin: May increase digoxin plasma levels; monitor patients appropriately.
See full prescribing information for ATORVALIQ dosage modifications due to drug interactions. To see the Full Prescribing Information, visit https://atorvaliq.com/prescribing-information Atorvaliq® and the stylized Atorvaliq logo are registered trademarks of CMP Development LLC. Atorvaliq is marketed by CMP Pharma, Inc. © 2023 CMP Pharma, Inc. All rights reserved.
ATV-00006 06/2023  View original content:https://www.prnewswire.com/news-releases/cmp-pharma-inc-announces-that-atorvaliq-the-first-and-only-fda-approved-liquid-suspension-of-atorvastatin-is-now-available-301858707.html
SOURCE CMP Pharma, Inc. | |
