LIPFENDRA Film-coated tablet Ref.[116750] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2026 

1. Indications and Usage

LIPFENDRA is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.

2. Dosage and Administration

2.1 Recommended Dosage

  • The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily.
  • Assess LDL-C when clinically appropriate. The LDL-C-lowering effect of LIPFENDRA may be measured as early as 4 weeks after initiation.

2.2 Important Administration Instructions

  • Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea.
  • Swallow the tablet whole. Do not split, crush, or chew the tablet.
  • After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea [see Clinical Pharmacology (12.3)].
  • LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3)].
  • If a dose is missed, take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea). Do not take 2 doses on the same day.

10. Overdosage

There is no specific treatment for overdose with LIPFENDRA. In the event of an overdose of LIPFENDRA, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

16.2. Storage and Handling

Store LIPFENDRA at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store and dispense LIPFENDRA in the original bottle and keep the bottle tightly closed to protect from moisture. Do not remove the desiccant.

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