Clinical Information
Gen. Code and Des.
84377 atorvastatin calcium ORAL ORAL SUSP 20 MG/5 ML
GCN and Des.
53672 atorvastatin calcium ORAL ORAL SUSP 20 MG/5 ML
Strength
20MG/5ML
Dose Form
SUSPENSION, ORAL (FINAL DOSE FORM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24060800 HMG-COA REDUCTASE INHIBITORS
Active Ingredients
6322 atorvastatin calcium 134523038
Inactive Ingredients
3203 paraben 99967
6364 magnesium aluminum silicate 132743
These highlights do not include all the information needed to use ATORVALIQ safely and effectively. See full prescribing information for ATORVALIQ.
ATORVALIQ® (atorvastatin calcium) oral suspension
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
ATORVALIQ is an HMG-CoA reductase inhibitor (statin) indicated (1):
•
To reduce the risk of:
o
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
o
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
o
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, congestive heart failure (CHF), and angina in adults with clinically evident CHD.
•
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
o
Adults with primary hyperlipidemia.
o
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
•
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
•
As an adjunct to diet for the treatment of adults with:
o
Primary dysbetaliproteinemia.
o
Hypertriglyceridemia.
DOSAGE AND ADMINISTRATION
•
Take orally once daily, only on an empty stomach (2.1).
•
Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ATORVALIQ, and adjust dosage if necessary (2.1).
•
Adults (2.2):
o
Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily.
o
Patients requiring LDL-C reduction >45% may start at 40 mg once daily.
•
Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily (2.3).
•
Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily (2.4).
•
See full prescribing information for ATORVALIQ dosage modifications due to drug interactions (2.5).
DOSAGE FORMS AND STRENGTHS
Oral suspension: 20 mg/5mL (3).
CONTRAINDICATIONS
•
Acute liver failure or decompensated cirrhosis (4).
•
Hypersensitivity to atorvastatin or any excipient in ATORVALIQ (4).
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 (2.5, 5.1, 7.1, 8.5, 8.6).
•
Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue ATORVALIQ if IMNM is suspected (5.2).
•
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 (5.3).
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).
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 (2.5, 7.1).
•
Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with ATORVALIQ (7.2).
•
Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive (7.3).
•
Digoxin: May increase digoxin plasma levels; monitor patients appropriately (7.3).
USE IN SPECIFIC POPULATIONS
•
Pregnancy: May cause fetal harm. (8.1).
•
Lactation: Breastfeeding not recommended during treatment with ATORVALIQ (8.2).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2023
