Lixisenatide

Pregnancy

Limited data available are not sufficient to inform a drug-associated risk of major birth defects and miscarriage

Use during pregnancy only if the benefit justifies the potential risk to the fetus

Clinical considerations

• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications
• Poorly control diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity

Animal data

• Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1x and 6x higher than the 20-mcg/day clinical dose, respectively, based on plasma AUC

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Animal data

• A study in lactating rats showed low (9.4%) transfer of lixisenatide and its metabolites into milk and negligible (0.01%) levels of unchanged lixisenatide peptide in the gastric contents of weaning offspring

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Lixisenatide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

• If you also take acetaminophen (Tylenol), take it at least 1 hour before you use lixisenatide.

• If you also take any type of antibiotic, take it at least 1 hour before you use lixisenatide.

• If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use lixisenatide.

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Lixisenatide has the following uses:

Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.1

Lixisenatide has the following limitations of use:

Has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.1

Not for treatment of type 1 diabetes or diabetic ketoacidosis.1

Has not been studied in combination with short acting insulin.1

Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.1

General

Lixisenatide is available in the following dosage form(s) and strength(s):

• Injection: 50 mcg/mL in 3 mL in green prefilled pen (for 14 pre-set doses; 10 mcg per dose).1

• Injection: 100 mcg/mL in 3 mL in burgundy prefilled pen (for 14 pre-set doses; 20 mcg per dose).1

Dosage

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

• Initiate at 10 mcg once daily for 14 days. On day 15, increase dosage to 20 mcg once daily. 1

• Administer once daily within one hour before the first meal of the day. 1

• Inject subcutaneously in the abdomen, thigh or upper arm.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Pen-injector Kit, Subcutaneous:

Adlyxin Starter Pack: 10 mcg/0.2 mL & 20 mcg/0.2 mL (3 mL) [contains metacresol]

Solution Pen-injector, Subcutaneous:

Adlyxin: 20 mcg/0.2 mL (3 mL) [contains metacresol]

Lixisenatide is a selective glucagon-like peptide-1 (GLP-1) receptor agonist. Acting on the same receptor as the endogenous hormone incretin, lixisenatide increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, and slows gastric emptying.

Distribution

Vz/F: ~100 L

Metabolism

Presumed to undergo proteolytic degradation

Excretion

Urine

Time to Peak

1 to 3.5 hours

Half-Life Elimination

~3 hours

Refer to adult dosing.