Atorvaliq
Generic Name: atorvaliq
Brand Names:
Atorvaliq
11 DESCRIPTION ATORVALIQ (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33 H 34 FN 2 O 5 ) 2 Ca∙3H 2 O and its molecular weight is 1209.42.
Overview
11 DESCRIPTION ATORVALIQ (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33 H 34 FN 2 O 5 ) 2 Ca∙3H 2 O and its molecular weight is 1209.42.
Uses
1 INDICATIONS AND USAGE ATORVALIQ is indicated: • 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, 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: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
Dosage
2 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 ).
Side Effects
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] 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.
Interactions
7 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 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with ATORVALIQ Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP).
Warnings
5 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 ). 4 CONTRAINDICATIONS ATORVALIQ is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] • Hypersensitivity to atorvastatin or any excipients in ATORVALIQ.
Pregnancy
8.1 Pregnancy Risk Summary Discontinue ATORVALIQ when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, ATORVALIQ may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy.
Storage
Storage Store at 20° C – 25° C (68° F–77° F); excursions permitted to 15° C to 30° C (59° F to 86° F). [See USP Controlled Room Temperature]. Store and dispense ATORVALIQ in its original bottle. Use within 60 days of first opening the bottle, then discard any remainder.
Frequently Asked Questions
What is Atorvaliq used for?▼
1 INDICATIONS AND USAGE ATORVALIQ is indicated: • 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, 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: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
What are the side effects of Atorvaliq?▼
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] 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.
Can I take Atorvaliq during pregnancy?▼
8.1 Pregnancy Risk Summary Discontinue ATORVALIQ when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, ATORVALIQ may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy.
What are the important warnings for Atorvaliq?▼
5 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 ). 4 CONTRAINDICATIONS ATORVALIQ is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] • Hypersensitivity to atorvastatin or any excipients in ATORVALIQ.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.