Exenatide Injectable Suspension

Exenatide Injectable Suspension is a prescription medication used to treat the symptoms of type 2 Diabetes Mellitus. 

• Exenatide Injectable Suspension is available under the following different brand names: Bydureon BCise 

Common side effects of Exenatide Injectable Suspension include:

• Indigestion,
• Nausea,
• Vomiting,
• Diarrhea,
• Constipation,
• Headache,
• Itching, and
• Small bump where an injection was given

Serious side effects of Exenatide Injectable Suspension include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Unusual bleeding,
• Bruising,
• Severe ongoing nausea,
• Vomiting,
• Pain,
• Warmth,
• Swelling,
• Open wound or scab,
• Skin changes at the injection site,
• Swelling in the neck or throat (enlarged thyroid),
• Hoarse voice,
• Trouble swallowing,
• Pain in the upper stomach spreading to the back,
• Nausea,
• Fever,
• Fast heart rate,
• Yellowing of the skin or eyes (jaundice),
• Headache,
• Hunger,
• Sweating,
• Irritability,
• Dizziness,
• Fast heart rate,
• Anxiety,
• Shakiness,
• Little or no urination,
• Painful or difficult urination,
• Swelling in the feet or ankles,
• Tiredness, and
• Shortness of breath

Rare side effects of Exenatide Injectable Suspension 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 and pediatric dosage

Injectable Suspension, autoinjector

• 2 mg/0.85 mL (Bydureon BCise)

Type 2 Diabetes Mellitus

Adult dosage

• 2 mg Subcutaneously every week

Pediatric dosage

• Children below 10 years: Safety and efficacy not established
• Children above 10 years: 2 mg subcutaneously every week

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.

• Exenatide Injectable Suspension has severe interactions with no other drugs.
• Exenatide Injectable Suspension has serious interactions with no other drugs.
• Exenatide Injectable Suspension has moderate interactions with at least 104 other drugs.
• Exenatide Injectable Suspension 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 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

• Hypersensitivity to exenatide or any of the product components
• Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome types 2 (see Black Box Warnings)

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Avoid concurrent use of extended-release (Bydureon BCise) and immediate-release exenatide (Byetta) formulations
• Serious injection-site reactions (.g, abscess, cellulitis, and necrosis) were reported, with or without SC nodules; some required surgical intervention
• Thyroid C-cell tumors in animals observed; human relevance unknown (see Black Box Warnings)
• Pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis; discontinue promptly if pancreatitis is suspected; do not resume therapy unless alternative etiology of pancreatitis is confirmed; consider alternative antidiabetic therapy in patients with a history of pancreatitis
• Reports of serious hypersensitivity reactions (.g, anaphylaxis and angioedema); inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions; it is unknown whether such patients will be predisposed to anaphylaxis (see Contraindications)
• Antibodies to exenatide following treatment may develop; anti-exenatide antibodies were measured in controlled studies; patients with higher titer antibodies may have an attenuated HbA1c response; if glycemic control worsens, consider alternative antidiabetic therapy
• Not recommended with severe gastrointestinal disease (.g, gastroparesis)
• Evaluate the patient further if serum calcitonin is measured and found to be elevated
• Evaluate further patients with thyroid nodules noted on physical examination or neck imaging
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction
• Pen-shaped injection devices should not be used by more than one person, even if the needle is changed as it increases the risk of infection
• Not for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis
• Acute events of gallbladder disease were reported in GLP-1 receptor agonist trials; if cholelithiasis was suspected, gallbladder studies and appropriate clinical follow-up indicated
• Acute kidney injury
  • Renal impairment reported, including some instances requiring hemodialysis and kidney transplantation; not recommended if severe renal impairment or ESRD exist
  • Caution in patients with renal transplantation or moderate renal impairment
  • Not recommended for use in patients with severe renal impairment (creatinine clearance below 30 mL/min) or end-stage renal disease; should be used with caution in patients with renal transplantation
  • Therapy may induce nausea and vomiting with transient hypovolemia and may worsen renal function; not recommended for use in patients with an eGFR below 45mL/min/1.73 m²
• Drug interactions overview
  • Use caution when administering oral medications with Bydureon and Bydureon BCise where a slower rate of oral absorption may be clinically meaningful
  • Postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding; monitor INR
  • The risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (.g, sulfonylureas) or insulin; a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia; inform patients using these concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia

Pregnancy and Lactation

• Limited data with exenatide in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage
• Based on animal reproduction studies, there may be risks to the fetus from exposure to exenatide injection during pregnancy
• Use exenatide injection during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy or exposure to exenatide during pregnancy and lactation, in association with maternal effects
• Lactation
  • There is no information on the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production
  • Exenatide was present in the milk of lactating mice; exenatide concentration in milk was up to 2.5% of the concentration in maternal plasma after administering SC injection twice a da