Adlyxin (lixisenatide)

• Lixisenatide is an injectable drug that reduces the level of sugar (glucose) in the blood. It is used for the treatment type 2 diabetes and is similar to
  • exenatide (Byetta),
  • liraglutide (Victoza),
  • dulaglutide (Trulicity), and
  • abliglutide (Tanzeum).
• Lixisenatide belongs in a class of drugs called incretin mimetics because these drugs mimic the effects of incretins. Incretins, such as human-glucagon-like peptide-1 (GLP-1), are hormones that are produced and released into the blood by the intestine in response to food. GLP-1 increases the secretion of insulin from the pancreas, slows absorption of glucose from the gut, and reduces the action of glucagon. (Glucagon is a hormone that increases glucose production by the liver.) All three of these actions reduce levels of glucose in the blood. In addition, GLP-1 reduces appetite. Lixisenatide is a synthetic (man-made) hormone that resembles and acts like GLP-1. In studies, lixisenatide treated patients achieved lower blood glucose levels and experienced weight loss.

What brand names are available for lixisenatide?

Adlyxin is the brand name available for lixisenatide available in the US.

Is lixisenatide available as a generic drug?

No

Do I need a prescription for lixisenatide?

Yes

• Adlyxin is used with diet and exercise to improve control of blood sugar in adults with type 2 diabetes.
• It should not be used for the treatment of diabetic ketoacidosis or type 1 diabetes.

Common side effects of include:

• Nausea
• Vomiting
• Diarrhea
• Headache
• Diarrhea
• Dizziness
• Hypoglycemia (when combined with insulin or sulfonyrea)

Other possible side effects of include:

• Indigestion (dyspepsia)
• Constipation
• Upper abdominal pain
• Abdominal distension
• Abdominal pain
• Injection site reactions (pain, redness, itching)

Possible serious side effects of include:

• Severe allergic reactions (anaphylaxis, angioedema [hives])
• Pancreatitis
• Acute kidney failure
• Antibodies to lixisenatide

• The recommended starting dose of Adlyxin is 10 mcg injected under the skins (subcutaneously) once daily for 14 days.
• The dose should be increased on day 15 to the maintenance dose of 20 mcg once daily.

• Adlyxin slows down transit of food and drugs through the intestine and, therefore, may reduce the absorption of drugs that are taken by mouth. Caution should be used when combining Adlyxin with oral medications that have a narrow therapeutic ratio or that require careful monitoring. If these medications are to be taken with food they should be taken with a meal or snack when Adlyxin is not administered.
• Oral medications such as antibiotics, or medications, for example acetaminophen (Tylenol) whose effects shouldn't be delayed should be taken at least 1 hour before Adlyxin injection.
• Oral contraceptives should be taken at least 1 hour before Adlyxin administration or at least 11 hours after an injection of Adlyxin.
• Combining Adlyxin with insulin or drugs that stimulate release of insulin, for example, glyburide (Micronase, Diabeta, Glynase, Prestab) may increase the occurrence of low blood sugar (hypoglycemia). The dose of insulin or the insulin release stimulating drug should be reduced.

• There are no adequate studies of lixisenatide in pregnant women. Most experts agree that insulin is the drug of choice in pregnant women with diabetes.
• There are no adequate studies of lixisenatide in nursing mothers, and it is not known whether this drug is excreted in human breast milk.

What preparations of lixisenatide are available?

• Injection (Prefilled Pen): 50, 100 mcg/mL

How should I keep lixisenatide stored?

• Adlyxin pen should be kept in the package to protect it from light and it should be stored in a refrigerator at 2 C to 8 C (36 F to 46 F) prior to use.
• It should not be frozen.
• After first use, it should be stored below 30 C (86 F).
• The pen cap should be replaced after each use to protect it from light.
• The pen should discarded 14 days after first use.

When was lixisenatide approved by the FDA?

• The FDA approved lixisenatide in July 2016.