Adult Dosing

Type 2 diabetes mellitus

Byetta

• Start 5 mcg SC bid; after 1 month may increase to 10 mcg SC bid (depending on response)
• Give within 1 hr before morning and evening meals
• Do not give after meal if dose is missed

Bydureon

• 2 mg SC qwk with or without meals
• May change the day of weekly administration if required as long as the last dose was given 3 days before

Pediatric Dosing

• Safety and effectiveness have not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• Hypersensitivity to any of the ingredients of the product

Bydureon

• Therapy is not recommended in patients with history of medullary thyroid carcinoma (MTC) and with multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Instruct patient regarding the risk and symptoms of thyroid tumors
• Thyroid C-cell tumors have occurred in rodents at clinically relevant doses, but unknown human relevance

Renal Dose Adjustment (Based on CrCl)

• 50-80 mL/min: No adjustment necessary
• 30-50 mL/min: Caution advised while initiating or escalating dose from 5 mcg to 10 mcg
• < 30 mL/min: Not recommended
• ESRD: Not recommended

Hepatic Dose Adjustment

• Hepatic impairment: No adjustment necessary

• Contraindicated in patients with history of medullary thyroid carcinoma (MTC) and with multiple endocrine neoplasia syndrome type 2 (MEN 2) [FDA Black Box Warning]
• Instruct patient regarding the risk and symptoms of thyroid tumors [FDA Black Box Warning]
• Thyroid C-cell tumors have occurred in rodents at clinically relevant doses, but unknown human relevance [FDA Black Box Warning]
• Exenatide has been associated with acute pancreatitis, including fatal or nonfatal hemorrhagic/necrotizing pancreatitis. Observe patients carefully
• Exenatide has not been studied in severe GI disorders, including gastroparesis
• Risk of hypoglycemia increases when used in combination with sulfonylurea; decrease dose accordingly
• Do not use in patients with severe gastrointestinal disease as therapy is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea
• Alternative antidiabetic therapy should be considered if there is worsening glycemic control or failure to achieve targeted glycemic control
• Suspend therapy and promptly seek medical advice if hypersensitivity reaction occurs. Serious hypersensitivity reactions have been reported.
• Not a substitute for insulin
• Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
• Concurrent use of exenatide with insulin is not recommended
• It should not be used in severe renal impairment/ESRD

Cautions: Use cautiously in

• Dialysis
• GI disorders

Pregnancy Category:C

Breastfeeding: Safety unknown. Due to the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• CV: Dizziness, headache, jitteriness, weakness, asthenia
• GI: Diarrhea, nausea, vomiting, dyspepsia, gastroinestinal reflux, acute hemorrhagic pancreatitis, necrotizing pancreatitis, GERD
• METABOLIC: Severe hypoglycemia, decreased appetite, weight loss
• DERM: Hyperhidrosis
• MISC: Angioedema, anaphylactic reaction

• Incretrin mimetic agent; mimics the action of incretin which promotes endogenous insulin secretion and promotes other mechanisms of glucose-lowering
• Metabolized by kidney
• Renally excreted
• Half-life: 2.4 hrs

US Trade Name(s)

• Bydureon
• Byetta

US Availability

Bydureon

• INJ: 2 mg/vial

Byetta

• INJ: 5 mcg/0.02 mL (1prefilled pen, 1.2 mL)
• INJ: 10 mcg/0.04 mL (1prefilled pen, 2.4 mL)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Byetta

UK Availability

Byetta

• INJ: 5 mcg/0.02 mL (prefilled pen, 1.2 mL)
• INJ: 10 mcg/0.04 mL (prefilled pen, 2.4 mL)

Australian Trade Name(s)

• Byetta

Australian Availability

Byetta

• INJ: 5 mcg/0.02 mL (prefilled pen, 1.2 mL)
• INJ: 10 mcg/0.04 mL (prefilled pen, 2.4 mL)

[Outline]

Endocrine/Metabolic

Antidiabetic Medications

Incretin Mimetics

Pricing data from www.DrugStore.com in U.S.A.

• Byetta 5 MCG Pen 5 MCG/0.02ML SOLN [Pen] (AMYLIN PHARMACEUTICALS)
  1.2 0.02ml = $337
  3.6 0.02ml = $935.98
• Byetta 10 MCG Pen 10 MCG/0.04ML SOLN [Pen] (AMYLIN PHARMACEUTICALS)
  2.4 0.04ml = $281.98
  7.2 0.04ml = $825.01
• Bydureon 2 MG SUSR [Vial] (AMYLIN PHARMACEUTICALS)
  4 mg = $375.99
  8 mg = $751.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.