exenatide acetate

exenatide acetate

Byetta

Pharmacologic class: Incretin mimetic

Therapeutic class: Hypoglycemic

Pregnancy risk category C

Action

Mimics enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins

Availability

Solution for injection: 250 mcg/ml as 60 doses in 5-mcg-per-dose/1.2-ml prefilled pen, 250 mcg/ml as 60 doses in 10-mcg-per-dose/2.4-ml prefilled pen

⊘Indications and dosages

➣ Adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but who haven't achieved adequate glycemic control

Adults: 5 mcg injected subcutaneously in thigh, abdomen, or upper arm twice daily within 60 minutes before morning and evening meals. Dosage can be increased to 10 mcg after 1 month of therapy, based on clinical response.

Dosage adjustment

• Concurrent sulfonylurea use

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• severe renal impairment or end-stage renal disease, acute pancreatitis, severe GI disease
• concurrent use of insulin, thiazolidinediones, D-phenylalanine derivatives, meglitinides, or alpha-glucosidase inhibitors
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Administer oral drugs 1 hour before exenatide. For oral drugs that must be taken with food, administer these with a light meal or snack when exenatide isn't given.
• Discard pen 30 days after first use, even if some drug remains. Don't freeze, and don't use drug if it has been frozen.

Route	Onset	Peak	Duration
P.O.	Unknown	2.1 hr	Unknown

Adverse reactions

CNS: dizziness, headache, asthenia, jitteriness

GI: nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease

Metabolic: hypoglycemia (especially with concurrent sulfonylurea)

Skin: excessive sweating

Other: decreased appetite, general injection site reaction, hypersensitivity reaction

Interactions

Drug-drug. Anti-infectives, hormonal contraceptives: possible slowing of GI transit time

Drug-behaviors. Alcohol use: reduced blood glucose level

Patient monitoring

• Monitor serum glucose level frequently, especially in patients also receiving sulfonylureas.
• Monitor renal function tests periodically.

Patient teaching

• Instruct patient to take drug 1 hour before morning and evening meals.
• Teach patient how to self-administer drug with prefilled pen.
• Tell patient to do a new pen set-up one time only, when starting a new prefilled pen.
• Advise patient to discard pen 30 days after first use, even if some drug remains.
• Caution patient not to freeze drug and not to use it if it has been frozen.
☞ Teach patient to recognize and immediately report signs and symptoms of hypoglycemia and diabetic ketoacidosis.
• Advise patient to avoid alcohol during therapy.
• Instruct breastfeeding patient to either discontinue breastfeeding or stop taking drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.