Exenatide Injectable Solution

Exenatide Injectable Solution is a prescription medicine used to treat the symptoms of type 2 diabetes mellitus. 

• Exenatide Injectable Solution is available under the following different brand names: Byetta

Adult dosage

Injectable Solution, prefilled pen

• 250mcg/mL (1.2mL vial)
• 250mcg/mL (2.4mL vial)

Diabetes Mellitus, Type 2

Adult dosage

• Immediate-release (Byetta): 5 mcg SC every 12 hours within 60 minutes before meal initially; after 1 month, may increase to 10 mcg every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Exenatide Injectable Solution include:

• heartburn,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• headache,
• dizziness,
• weakness, and
• feeling jittery.

Serious side effects of Exenatide Injectable Solution include:

hives,

• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• rapid heartbeats,
• lightheadedness,
• itching,
• severe pain in the upper stomach spreading to the back,
• nausea,
• vomiting,
• fast heart rate,
• little or no urination,
• painful or difficult urination,
• swelling in the feet or ankles,
• feeling tired,
• shortness of breath,
• headache,
• hunger,
• sweating,
• irritability,
• dizziness,
• anxiety, and
• shaking.

Rare side effects of Exenatide Injectable Solution include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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.

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.

• Exenatide Injectable Solution has severe interactions with no other drugs.
• Exenatide Injectable Solution has serious interactions with no other drugs.
• Exenatide Injectable Solution has moderate interactions with at least 105 other drugs.
• Exenatide Injectable Solution has minor interactions with the following drugs: 
  • acetaminophen rectal
  • digoxin
  • lovastatin

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 of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• ESRD, severe renal impairment (CrCl less than 30 mL/min)
• History of drug-induced immune-mediated thrombocytopenia from drug or related products
• Family or current history of medullary thyroid carcinoma

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Exenatide Injectable Solution?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Exenatide Injectable Solution?”

Cautions

• Never share a pen between patients even if the needle is changed
• Not a Substitute for insulin
• Not a first-line therapy for patients inadequately controlled on diet and exercise alone
• Evaluate insulin dose when added on to long-acting insulin (ie, insulin glargine); in patients with increased risk of hypoglycemia, consider decreasing insulin dose
• Not recommended for patients experiencing severe gastrointestinal disease, including gastroparesis
• Not recommended for type 1 diabetes
• Do not take with short- and/or rapid-acting insulins
• Animal studies show an association of extended-release dosage form with the formation of thyroid tumors (effects in humans unknown)
• Always administer before a meal and never after a meal
• Weight loss resulting from reduced intake reported
• Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) are reported; if a hypersensitivity reaction occurs, discontinue therapy and other suspect medications and promptly seek medical advice; inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions; unknown whether such patients will be predisposed to anaphylaxis with drug
• Risk of acute pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis; after initiation and after dose increases, observe patients for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting); if pancreatitis suspected, discontinue drug promptly and initiate appropriate management; if pancreatitis confirmed, do not restart therapy; consider antidiabetic therapies other than exenatide in patients with a history of pancreatitis
• When therapy is used in combination with insulin, evaluate the dose of insulin; the risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or another concomitantly administered insulin secretagogue) or insulin in patients at increased risk of hypoglycemia; concurrent use with prandial insulin not studied and cannot be recommended; also possible that use with other glucose-independent insulin secretagogues (eg, meglitinides or sulfonylureas) or insulin could increase risk of hypoglycemia
• Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
• Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia is reported in a postmarketing setting; drug-induced thrombocytopenia is an immune-mediated reaction, with exenatide-dependent anti-platelet antibodies; in presence of exenatide, these antibodies cause platelet destruction; if drug-induced thrombocytopenia suspected, discontinue therapy immediately and do not re-expose patient to exenatide
• Antibody formation to exenatide is likely; up to 4% of patients may have worsening glycemic control and require alternative antidiabetic therapy
• Acute kidney injury
  • Altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis or kidney transplantation reported
  • Some events reported in patients receiving one or more pharmacologic agents known to affect renal function or hydration status
  • Reversibility of altered renal function is observed in many cases with supportive treatment and discontinuation of potentially causative agents; the drug is not directly nephrotoxic in preclinical or clinical studies
  • Because the drug may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function; exercise caution when initiating or escalating doses from 5 to 10 mcg in patients with moderate renal impairment (creatinine clearance 30-50 mL/min)

Pregnancy and Lactation

• Limited data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
• Based on animal reproduction studies, there may be risks to the fetus from exposure to therapy during pregnancy; the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
• Lactation
  • There is no information regarding the presence of the drug, in human milk, effects on the breastfed infant, or milk production; the drug was present in the milk of lactating mice; however, due to species-specific differences in lactation physiology, the clinical relevance of data is not clear; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or underlying maternal condition