Lixisenatide

Lixisenatide is a prescription medication used to treat the symptoms of Type 2 Diabetes Mellitus.

• Lixisenatide is available under the following different brand names: Adlyxin

Common side effects of Lixisenatide include:

• Nausea,
• Vomiting,
• Diarrhea,
• Headache,
• Dizziness, and
• Low blood sugar

Serious side effects of Lixisenatide include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Itching,
• Severe rash,
• Rapid heartbeats,
• Trouble swallowing,
• Severe pain in the upper stomach spreading to the back,
• Nausea,
• Vomiting,
• Fast heart rate,
• Headache,
• Hunger,
• Sweating,
• Irritability,
• Dizziness,
• Nausea,
• Fast heart rate,
• Anxious,
• Shakiness,
• Little or no urination,
• Painful or difficult urination,
• Swelling in the feet or ankles,
• Tiredness, and
• Shortness of breath

Rare side effects of Lixisenatide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

• SC solution in a prefilled pen
• Starter dose (green pen)
  • 50mcg/mL in 3mL prefilled pen (provides 14 doses of 10mcg/dose)
• The maintenance dose (burgundy pen)
  • 100mcg/mL in 3 mL prefilled pen (provides 14 doses of 20mcg/dose)

Type 2 Diabetes Mellitus

Adult dosage

• Starting dose: 10 mcg Subcutaneous once a day for 14 days
• Maintenance: Increase the dose to 20 mcg subcutaneously once a day starting on Day 15

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lixisenatide has severe interactions with no other drugs.
• Lixisenatide has serious interactions with no other drugs.
• Lixisenatide has moderate interactions with the following drugs
  • acetaminophen
  • chlorpropamide
  • dienogest/estradiol valerate
  • ethinylestradiol
  • glimepiride
  • glipizide
  • glyburide
  • insulin degludec
  • insulin detemir
  • insulin glargine
  • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
  • lonapegsomatropin
  • mestranol
  • somapacitan
  • tolazamide
  • tolbutamide
• Lixisenatide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity: hypersensitivity reactions, including anaphylaxis, have occurred with lixisenatide

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lixisenatide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lixisenatide?”

Cautions

• Anaphylaxis (0.1%) and other hypersensitivity reactions, including angioedema, have been reported; if hypersensitivity occurs, discontinue the drug, and promptly seek medical attention (see Contraindications)
• Acute pancreatitis, including fatal, and nonfatal hemorrhagic or necrotizing pancreatitis reported post-marketing in patients treated with GLP-1 receptor agonists; observe for signs and symptoms (.g, persistent severe abdominal pain that sometimes radiates to the back which may or may not is accompanied by vomiting); promptly discontinue if suspected; if pancreatitis confirmed, do not restart the drug
• Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and post-marketing; if cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
• Do not share pen between patients, even if the needle is changed; pen-sharing poses a risk of transmission of blood-borne pathogens
• The risk for hypoglycemia increases if coadministered with a sulfonylurea or basal insulin; the risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin; inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
• Acute kidney injury and worsening of chronic renal failure (sometimes requiring hemodialysis); some reports were in patients without known underlying renal disease; most of the reports described patients who had experienced nausea, vomiting, diarrhea, or dehydration
• Antibody development to lixisenatide occurred in 70% of patients by week 24; a subset of patients (2.4%) with the highest antibody concentrations (.e, above 100 nmol/L) showed an attenuated glycemic response; a higher incidence of allergic reactions and injection site reactions occurred in antibody-positive patients
• Clinical studies have NOT shown macrovascular risk reduction with lixisenatide or any other antidiabetic drug
• Drug interaction overview
  • Lixisenatide delays gastric emptying, which may affect the absorption of concomitantly administered oral medications
  • Caution if coadministered with drugs that have a narrow therapeutic index or drugs that require careful clinical monitoring; if these medications are to be administered with food, patients should take them with a meal or snack when lixisenatide is not being administered
  • Oral medications that are particularly dependent on minimum serum concentrations (. g, antibiotics) or medications in which a delayed effect may be undesirable (pain medications) should be administered 1 hour before lixisenatide
  • Oral contraceptives should be taken at least 1 hour before lixisenatide administration or 11 hours after lixisenatide
  • Risk of hypoglycemia when coadministered with a sulfonylurea or basal insulin; a dose reduction of sulfonylurea or basal insulin may be required

Pregnancy and Lactation

• 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 controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• 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 the underlying maternal condition