Lipfendra (enlicitide decanoate)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*The recommended dosage of enlicitide is one 20 mg tablet taken orally once daily.

*Take enlicitide 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 enlicitide, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

The frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with enlicitide and those receiving placebo. The most common adverse reactions in a study of adults with HeFH treated with enlicitide were diarrhea and dizziness.

There are no severe adverse reactions for this drug.

More Frequent

• Diarrhea
• Dizziness

No enhanced messaging available.

The safety and effectiveness of enlicitide have not been established in pediatric patients.

Discontinue enlicitide when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Alternatively, consider the ongoing therapeutic needs of the individual patient. Enlicitide increases LDL-C uptake and lowers LDL-C levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, enlicitide may cause fetal harm when administered to pregnant patients based on the mechanism of action.

There are insufficient data on the use of enlicitide in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Consider the benefits and risks of enlicitide when prescribing enlicitide to pregnant women.

In animal reproduction studies, no adverse embryofetal developmental effects were observed in pregnant rats and rabbits administered enlicitide subcutaneously during organogenesis (up to 58- and 51-fold, respectively, the human exposure at the recommended human dose (RHD), based on AUC).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is no information on the presence of enlicitide in human milk, the effects on the breastfed infant, or the effects on milk production. Enlicitide was detected at low concentrations in the plasma of nursing pups from lactating rats administered subcutaneous enlicitide.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for enlicitide and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Of the 2,137 patients treated with enlicitide in placebo-controlled trials, 960 (45%) patients were 65 years of age and older, and 252 (12%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.