LIVALO Film-coated tablet Ref.[11118] Active ingredients: Pitavastatin

Source: FDA, National Drug Code (US)  Revision Year: 2019 

1. Indications and Usage

LIVALO is indicated as an adjunctive therapy to diet in:

  • Adult patients with primary hyperlipidemia or mixed dyslipidemia 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).
  • Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

Limitations of Use:

  • The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.

2. Dosage and Administration

2.1 General Dosage and Administration Information

  • Take LIVALO orally once daily with or without food at the same time each day.
  • Individualize the dose of LIVALO according to patient characteristics, goal of therapy, and response.
  • After initiation or upon titration of LIVALO, analyze lipid levels after 4 weeks and adjust the dosage accordingly.

2.2 Recommended Dosage for Adults and Pediatric Patients Aged 8 Years and Older

  • The recommended starting LIVALO dosage is 2 mg once daily.
  • The maximum recommended dosage is LIVALO 4 mg once daily [see Warnings and Precautions (5.1)].

2.3 Recommended Dosage in Patients with Renal Impairment

  • The recommended starting dose for adults with moderate and severe renal impairment (estimated glomerular filtration rate 30–59 mL/minute/1.73 m² and 15–29 mL/minute/1.73 m², respectively) and patients with end-stage renal disease receiving hemodialysis is LIVALO 1 mg once daily.
  • The maximum recommended dose for these patients is LIVALO 2 mg once daily [see Use in Specific Populations (8.6)].
  • A recommended dosage for pediatric patients with renal impairment has not been established.

2.4 LIVALO Dosage Adjustments Due to Drug Interactions

  • In patients taking erythromycin, do not exceed LIVALO 1 mg once daily [see Drug Interactions (7)].
  • In patients taking rifampin, do not exceed LIVALO 2 mg once daily [see Drug Interactions (7)].

10. Overdosage

No specific treatment for LIVALO overdose is known. Contact Poison Control (1-800-222-1222) for latest recommendations. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of LIVALO.

16.2. Storage and Handling

Store at room temperature between 15°C and 30°C (59° to 86°F) [see USP]. Protect from light.

< Previous: Overview
Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈