Names and pronunciation
(ex-en′a-tide) Bydureon, Bydureon BCise, Byetta
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Drug reference
(ex-en′a-tide) Bydureon, Bydureon BCise, Byetta
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Func. class.: Antidiabetic
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Chem. class.: Incretin mimetic
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ACTION: Binds and activates known human GLP-1 receptor, mimics natural physiology for self-regulating glycemic control
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USES: Type 2 diabetes mellitus given in combination with metFORMIN, a sulfonyl- urea, thiazolidinedione, insulin glargine
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CONTRAINDICATIONS: Hyper- E sensitivity
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Black Box Warning: Medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN-2), thyroid cancer Precautions: Pregnancy, geriatric patients, severe renal/hepatic/GI disease, pancreatitis, vit D deficiency Black Box Warning: Increased risk of thyroid tumors (medullary C-cell tumors) • Anaphylaxis, angioedema: product should be discontinued immediately • Renal studies: urinalysis, creatinine • Hypo/hyperglycemic reaction that can occur soon after meals; for severe hypo- glycemia, give IV D50W, then IV dextrose solution • Nausea, vomiting, diarrhea, ability to tolerate product, may cause dehy- dration • Pregnancy/breastfeeding: use only if benefits clearly outweigh risks; if pregnant, enroll in the Exenatide Pregnancy Registry (800-633-9081); do not breastfeed
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SIDE EFFECTS CNS: Headache, dizziness, feeling jit- tery, restlessness, weakness ENDO: Hypoglycemia, thyroid hyperplasia GI: Nausea, vomiting, diarrhea, dyspep- sia, anorexia, gastroesophageal reflux, weight loss, pancreatitis SYST: Angioedema, anaphylaxis INTEG: Serious injection site reactions (cellulitis, abscess, skin necrosis)
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INTERACTIONS • May decrease effect of acetaminophen • Do not use with erythromycin, meto- clopramide Increase: hypoglycemia—ACE inhibi- tors, disopyramide, sulfonylureas, andro- gens, fibric acid derivatives, alcohol Increase: hyperglycemia—phenothi- azines, corticosteroids, anabolic steroids Decrease: action of digoxin, lovastatin, acetaminophen (elixir) Decrease: efficacy—niacin, dextrothyrox- ine, thiazide diuretics, triamterene, estro- gens, progestins, oral contraceptives, MAOIs
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DOSAGE AND ROUTES • Adult: SUBCUT 5 mcg bid 1 hr prior to morning and evening meal; may increase to 10 mcg bid after 1 mo; extended release SUBCUT (Bydureon) 2 mg q7days Renal dose • Adult: PO CCr 30-50 mL/min, use cau- tion when increasing dose
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Available forms: Injection 5, 10 mcg pen; extended-release powder for sus- pension for injection 2 mg; Injection: 2 mg/dose single-dose pen
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Administer: Store in refrigerator for unopened pen; may store at room temperature after opening for up to 30 days SUBCUT route (regular release—Byetta) • May be used as monotherapy or com- bined with other products • SUBCUT only, do not give IV/IM • Pen needles must be purchased sepa- rately, compatible; prime prior to use; inject into thigh, abdomen, upper arm; rotate sites • Product 1 hr prior to meals, approxi- mately 6 hr apart; if patient is NPO, may need to hold dose to prevent hypoglyce- mia • If added to insulin glargine, insulin, or detemir, a dosage reduction in these products may be required SUBCUT route (extended release—By- dureon) • Give every 7 days (weekly); the dose can be given at any time of day without regard to meals • Available as a single-dose tray con- taining a vial of 2 mg, a prefilled sy- ringe delivering 0.65 mL diluent, a vial connector, and 2 custom needles (23G × 5/169) specific to this delivery sys- tem (one is a spare needle); do not substitute needles or any other compo- nents • Inject immediately after the white to off-white powder is suspended in the di- luent and transferred to the syringe • Inject SUBCUT into the thigh, abdo- men, or upper arm, rotate sites to pre- vent lipodystrophy
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Assess: • Fasting blood glucose, A1c levels, postprandial glucose during treatment to determine diabetes control • Pancreatitis: severe abdominal pain with or without vomiting, product should be discontinued
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Evaluate: • Therapeutic response: decrease in polyuria, polydipsia, polyphagia, clear sensorium, improving A1c, weight; ab- sence of dizziness, stable gait
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the symptoms of hypo/hypergly- cemia, what to do about each; to have glucagon emergency kit available; to carry a glucose source (candy, sugar cube) to treat hypoglycemia • That product must be continued on a daily or weekly basis (extended release); about consequences of discontinuing product abruptly • That diabetes is a lifelong illness; that product will not cure disease; to carry emergency ID with prescriber and medi- cation information • To continue weight control, dietary restrictions, exercise, hygiene • That regular blood glucose monitor- ing and A1c testing are needed • To notify prescriber if pregnant or in- tending to become pregnant • About the importance of reading “In- formation for the Patient” and “Pen User Manual”; about self-injection • Pancreatitis: if severe abdominal pain with or without vomiting occurs, seek medical attention immediately • To review injection procedure; to store product in refrigerator, room temperature after first use; discard 30 days after first use; do not freeze; to protect from light (Byetta)
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PHARMACOKINETICS Absorption well, immediate release: peak 2.1 hr, elimination by glomerular filtra- tion, half-life 2.4 hr; extended release: peak 2 wk
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• Adult: SUBCUT 5 mcg bid 1 hr prior to morning and evening meal; may increase to 10 mcg bid after 1 mo; extended release SUBCUT (Bydureon) 2 mg q7days Renal dose
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• Adult: PO CCr 30-50 mL/min, use cau- tion when increasing dose
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