Drugplain

Livalo 2.09 mg/1

pitavastatin calcium · TABLET, FILM COATED · Kowa Pharmaceuticals America, Inc.

2 Recalls on Record
Plain English

Livalo is a prescription tablet taken by mouth that contains pitavastatin calcium, a statin medication used to help lower cholesterol levels in the blood. It belongs to a class of drugs commonly used to reduce the risk of heart disease and stroke.

Key Facts

Brand Name
Livalo
Generic Name
pitavastatin calcium
NDC Code (Product)
66869-204
Manufacturer
Kowa Pharmaceuticals America, Inc.
Strength
2.09 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA022363
Marketing Start
05/16/2019

Recall History

2 Recalls on Record
Class III02/24/2025

Kowa Pharmaceuticals America

Presence of foreign tablets/capsules

CompletedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

myalgia467 reports
diarrhoea382 reports
nausea359 reports
fatigue347 reports
anaemia296 reports
headache289 reports
arthralgia288 reports
dizziness285 reports
rash275 reports
off label use255 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food at the same time each day. ( 2.1 ) For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving LIVALO 4 mg daily, prescribe alternative LDL-C-lowering treatment. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of LIVALO, and adjust the dosage if necessary. ( 2.1 ) Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) See full prescribing information for LIVALO dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take LIVALO orally once daily with or without food at the same time each day. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving LIVALO 4 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating LIVA…

Contraindications

4 CONTRAINDICATIONS LIVALO is contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions (7) ]. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ]. Hypersensitivity to pitavastatin or any excipents in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO [see Adverse Reactions (6) ] . Cyclosporine ( 4 , 7 ) Active liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to pitavastatin or any excipients in LIVALO ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with LIVALO and instructions for preventing or managing drug interactions [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ]. Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with LIVALO Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis . Intervention: Concomitant use of cyclosporine with LIVALO is contraindicated [see Contraindications (4) ]. Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including LIVALO. Intervention: Avoid concomitant use of gemfibrozil with LIVALO. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis . Intervention: In patients taking erythromycin, do not exceed LIVALO 1 mg once daily [see Dosage and Administration (2.4) ]. Rifampin Clinical Impact: Rifampin signi…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in other sections of the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warning and Precautions (5.2) ] Hepatic Dysfunction [see Warning and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warning and Precautions (5.4) ] The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, , diarrhea, back pain, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceuticals America, Inc. at 1-877-334-3464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hyperlipidemia In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia were administered LIVALO 1 mg to 4 mg da…

Frequently Asked Questions

What is Livalo used for?

Livalo is a prescription tablet taken by mouth that contains pitavastatin calcium, a statin medication used to help lower cholesterol levels in the blood. It belongs to a class of drugs commonly used to reduce the risk of heart disease and stroke.

Is Livalo a controlled substance?

Livalo is not classified as a controlled substance by the DEA.

What is the generic name for Livalo?

The generic name for Livalo is pitavastatin calcium. There are 11 other brand versions of pitavastatin calcium.

What is the NDC code for Livalo 2.09 mg/1?

The NDC (National Drug Code) for Livalo 2.09 mg/1 is 66869-204, listed by Kowa Pharmaceuticals America, Inc..

Product NDC

66869-204

Package NDC

66869-204-90

Other Pitavastatin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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