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Exenatide Dosage

Applies to the following strength(s): 5 mcg/0.02 mL ; 2 mg ; 10 mcg/0.04 mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Diabetes Type 2

Immediate-release:
-Initial dose: 5 mcg subcutaneously twice a day for at least 1 month
-Maintenance dose: Based on clinical response, may increase to 10 mcg subcutaneously twice a day
-Maximum dose: 10 mcg twice a day
-Administer within the 60-minute period before the morning and evening meals; alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart; do not administer after a meal.

Extended-release:
-Dose: 2 mg subcutaneously once every seven days; administer at any time of day, with or without meals
-Patients may switch from immediate-release to extended-release, although prior treatment with immediate-release exenatide is not necessary.
-For patients who do switch, discontinue immediate-release exenatide on initiation of extended-release; transient elevations in blood glucose may occur and generally improve within the first 2 weeks of initiation.

Comments:
-For patients concomitantly receiving a sulfonylurea, a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Renal Dose Adjustments

Byetta(R):
-Mild renal impairment (CrCl 50 to 80 mL/min): No adjustment recommended
-Moderate renal impairment (CrCl 30 to 50 mL/min): Dose adjustments from 5 mcg to 10 mcg should be made with caution.
-End-stage renal disease or severe renal impairment (CrCl less than 30 mL/min): Not recommended
-Renal transplantation: Use with caution

Bydureon(R):
-Moderate renal impairment (CrCl 30 to 50 mL/min): Use with caution
-End-stage renal disease or severe renal impairment (CrCl less than 30 mL/min): Not recommended
-Renal transplantation: Use with caution

Liver Dose Adjustments

Data not available

Dose Adjustments

-Patients receiving a sulfonylurea in combination with exenatide may require a lower dose of the sulfonylurea to reduce the risk of hypoglycemia.
-When exenatide is used in combination with insulin, the dose of insulin should be evaluated. In patients at increased risk of hypoglycemia consider reducing the dose of insulin.
-The concurrent use of exenatide with prandial insulin has not been studied and cannot be recommended.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Bydureon(R). It includes a communication plan. For additional information:
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

BOXED WARNING(S):
-Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether this drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide-extended-release-induced rodent thyroid C-cell tumors has not been determined.
-This drug is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients should be counseled regarding the potential risk for MTC and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring for serum calcitonin or using thyroid ultrasounds is of uncertain value for detection of MTC in patients treated with exenatide extended-release.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer subcutaneously in abdomen, thigh, or upper arm region; do not administer IV or IM
-Never share a pen between patients, even if the needle is changed, as this presents a risk for transmission of blood-borne pathogens

Immediate-release (Byetta(R):
-Administer within 60-minute of the morning and evening meals; alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart.
-Do not administer after a meal; if a dose is missed, resume with next scheduled dose.
Extended-release (Bydureon(R):
-Administer once every 7 days, at any time of the day and with or without meals.
-Administer dose immediately after it is prepared; do not substitute needles or any other components provided with the tray.
-If a dose is missed, administer as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later; then resume usual dosing schedule of once every 7 days (weekly).
-If a dose is missed and the next regularly scheduled dose is 1 or 2 days later, skip the missed dose and resume with the next regularly scheduled dose.
-If necessary, the day of weekly administration can be changed as long as the last dose was administered 3 or more days before.

Storage requirements:
Immediate-release Pens:
-Unopened (not in use): Store in refrigerator 2C to 8C (36F to 46F), do not freeze, protect from light; discard if frozen
-Opened (in-use): May keep unrefrigerated for up to 30 days after opening; keep away from direct heat and light; temperature should not exceed 25C (77F)); discard 30 days after opening.

Extended-release Trays:
-Store in refrigerator 2C to 8C (36F to 46F), do not freeze, protect from light; discard if frozen
-If needed, the tray may be kept out of the refrigerator at 20C to 25C (68F to 77F) for up to 4 weeks

Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. See product labeling for specific instructions.

General:
-This drug has not been studied in patients with a history of pancreatitis, consider alternative therapy.
-This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus.
-This drug is not a substitute for insulin.

Monitoring:
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy.
-Observe for signs and symptoms of pancreatitis.

Patient advice:
-Patients should be advised to never share a pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
-Counsel patients to report symptoms of thyroid tumors such as a lump in their neck, persistent hoarseness, dysphagia, or dyspnea.
-Patients should be aware that they may experience a reduction in appetite, food intake, and/or weight loss and there is no need to modify the dose due to these effects; nausea may occur early in therapy and generally resolves.
-Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.

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