Adlyxin (Lixisenatide) 100 mcg / ml
Adlyxin
Lixisenatide
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WHAT IS ADLYXIN?

Adlyxin, also known as lixisenatide, is a daily injectable prescription medication. It is used in adults with type 2 diabetes mellitus (T2DM) to better glycemic control in addition to diet and exercise. Controlling hyperglycemia with Adlyxin prevents downstream complications such as kidney damage, limb loss, heart attack, blindness, stroke, or nerve problems. It is important that diabetes remains controlled to lessen the chance of related complications. Adlyxin is provided as a single-patient-use prefilled pen.

Limitations of Use:

  • Adlyxin has not been evaluated in patients with pancreatitis or a history of pancreatitis
  • Adlyxin is not indicated for those with type 1 diabetes mellitus (T1DM)
  • Adlyxin has not been evaluated in those with gastroparesis and is therefore not recommended in these patients

HOW DOES ADLYXIN WORK?

Incretins are peptide hormones originating from the gut that are quickly released after a meal. The two primary incretins in humans include glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1). Incretins such as GLP-1 potentiate glucose-dependent insulin release and exert multiple antihyperglycemic effects after their secretion from the gut into the circulation.

Adlyxin is a GLP-1 receptor agonist that elevates glucose-dependent insulin release by

pancreatic beta-cells, lessening abnormally elevated glucagon release and decreasing gastric emptying. Through this mechanism, it improves glycemic control in patients with type 2 diabetes.

SIDE EFFECTS

Common side effects associated with Adlyxin include:

  • Gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea)
  • Antibody development
  • Injection site reactions such as pain, erythema, and pruritus
  • Headache
  • Dizziness

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Adlyxin has been shown to cause serious hypersensitivity reactions that manifest as anaphylaxis and angioedema. Patients with a history of hypersensitivity reactions with other GLP-1 receptor agonists should be closely observed for allergic reactions. If anaphylaxis or angioedema occur, Adlyxin should be stopped and the patient should seek medical attention.

Acute Pancreatitis

Both fatal and non-fatal hemorrhagic or necrotizing acute pancreatitis cases have been reported in post-marketing data. Patients should be monitored for pancreatitis signs, such as abdominal pain or vomiting. If these symptoms occur, Adlyxin should be stopped immediately and the pancreatitis should be managed appropriately. Therapy with Adlyxin should not be reinitiated in the presence of true pancreatitis.

Never Share Pens

Adlyxin pens should never be shared with others even if changing the needle. If pens are shared, patients are at high risk of transmitting blood-borne pathogens.

Hypoglycemia with Concomitant Use of Insulin Products

Adlyxin can cause hypoglycemia when used concomitantly with products that decrease blood glucose (e.g. insulin). Dose adjustments to insulin may be required to prevent development of hypoglycemia. Patients should be aware of other drugs that can increase the glucose-lowering effects of Adlyxin and cause hypoglycemia. Patients should also be counseled on typical signs and symptoms of low blood sugar.

Acute Kidney Injury

Worsening chronic renal failure and acute kidney injury has occurred in patients treated with Adlyxin. Some reports included patients that did not have awareness of underlying renal disease. Most of these occurrences happened in those experiencing nausea, vomiting, dehydration, or diarrhea. Providers should monitor renal function when starting Adlyxin or increasing the patient’s dose, specifically in those with renal impairment or serious gastrointestinal reactions. Adlyxin should not be used in patients who have end stage renal disease.

Immunogenicity

Patients can have anti-lixisenatide antibodies following treatment with Adlyxin. The presence of antibodies has been associated with an attenuated glycemic response. If glucose control worsens or glycemic targets are not reached, providers should switch patients to another therapy.

DRUG INTERACTIONS

Delayed Gastric Emptying Effects on Oral Medications

Adlyxin slows gastric emptying thus decreasing the absorption rate of other oral medications. Providers should be careful when prescribing oral medications with narrow therapeutic ranges that need close monitoring. If these medications are taken with food, individuals should take them when Adlyxin is not also being taken.

Medicines that rely on threshold concentrations like antibiotics or acetaminophen should be taken a minimum of one hour prior to Adlyxin injection. Patients taking oral contraceptives should ingest the contraceptives at minimum one hour prior to Adlyxin injection or 11 hours post-Adlyxin injection

Hypoglycemia with Concomitant Use of Insulin Products

Adlyxin can cause hypoglycemia when used in combination with other products that lower blood glucose, such as insulin. Dose adjustments to insulin may be required to prevent development of hypoglycemia. Patients should be aware of other drugs that can increase the glucose-lowering effects of Adlyxin and cause hypoglycemia. Patients should also be counseled on typical signs and symptoms of low blood sugar.

SPECIFIC POPULATIONS

Pregnancy

There is not much data available on Adlyxin in patients who are pregnant and the drug’s potential to cause birth defects and miscarriage. However, there are many risks associated with poorly controlled diabetes during pregnancy. The risk-benefit should be considered by the provider, as poorly controlled diabetes during pregnancy can lead to birth defects, stillbirth, or complications.

Lactation

No data is available on Adlyxin’s presence in human milk, effects on breastfed infants, or milk production. Lixisenatide is present in rat milk. Providers should consider the benefits of breastfeeding and weigh them with the risks of potential adverse events of breastfeeding while on Adlyxin.

Pediatrics

Adlyxin has not been studied in pediatrics. Thus, efficacy and safety has not been established in younger patients.

Geriatrics

In clinical trials, there was no difference in safety or effectiveness between younger patients and patients older than 65 years of age. However, increased sensitivity in geriatric patients cannot be discounted.

Renal Impairment

Adlyxin should not be dose-adjusted in patients with mild or moderate renal impairment. Those with serious renal impairment should be monitored for symptoms of adverse gastrointestinal reactions and for alterations in renal function. Adlyxin is not recommended in end stage renal disease (eGFR <15 mL/min/1.73 m2).

FREQUENTLY ASKED QUESTIONS

Adlyxin should be taken once daily within 60 minutes of your first meal. It should be administered at the same time each day. You have to activate Adlyxin every time you use a new pen before administering it for the first time. Adlyxin should be injected under the skin into the abdomen, upper arm, or thigh. Do not inject Adlyxin under the vein. You should rotate injection sites every time you administer a new dose. Do not use the same site for every injection. Check the pen label every time you administer Adlyxin to ensure you are using the right medication. Never use the same needle or give your pen to other people. This can lead to serious infections.

If you miss a dose of Adlyxin, administer it within 1 hour prior to your next meal.

Adlyxin can be taken long-term to control type 2 diabetes mellitus.

Adlyxin should be taken once daily within 60 minutes of your first meal.

If you overdose with Adlyxin, you should immediately go to the emergency room or contact the Poison Control Center.

Common side effects associated with Adlyxin include:

  • Gastrointestinal symptoms, such as nausea, vomiting, and diarrhea
  • Antibody development
  • Injection site reactions such as pain, erythema, and pruritus
  • Headache
  • Dizziness

Serious side effects that may occur with Adlyxin include:

  • Serious allergic reactions
  • Kidney problems
  • Low blood sugar

It is important that you tell your doctor all of the medications, vitamins, and supplements that you take, especially if you are taking:

  • antibiotics or acetaminophen. These medicines should be taken at least 1 hour prior to administering Adlyxin. When taking these medications, take them with food. Do not take these at the same time as Adlyxin.
  • birth control pills. Adlyxin may interact with your birth control and decrease their efficacy in preventing pregnancy. Take birth control a least 1 hour prior to administering Adlyxin or a minimum of 11 hours after injecting Adlyxin.
  • other diabetes medications, including sulfonylureas or insulin products

It is also important to let your doctor know if you:

  • have had problems with your pancreas, gallbladder, or kidneys
  • have a history of alcoholism
  • have serious stomach problems, such as gastroparesis or issues with food digestion
  • are pregnant or may become pregnant
  • are breastfeeding or plan to breastfeed

New and unused Adlyxin pens should be kept in the refrigerator at 36°F to 46°F (2°C to 8°C). Never freeze Adlyxin pens. Do not use Adlyxin pens if they have been frozen. After you activate an Adlyxin pen, they can be stored at room temperature. Temperatures should not exceed greater than 86°F (30°C), and pens should be protected from light. Additionally, Adlyxin should never be stored with the needle attached. If it is, you are at increased risk of needle contamination and air bubbles. Keep Adlyxin out of reach from children.

Post-activation, Adlyxin can be used for up to 14 days. After 14 days, Adlyxin should be disposed regardless of if there’s medication left. Used pens should be disposed of in FDA-cleared sharps containers. Loose needles should never be left in household trash. Adlyxin should not be used after the expiration date has passed.