Drug Catalog - Product Detail
BYDUREON SUBCUTANEOUS GER VIAL 2MG 4 X 1
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00310-6520-04 | ASTRAZENECA | 1 | 2MG | SUSPENSION |
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Description
11 DESCRIPTION BYDUREON (exenatide) for extended-release injectable suspension is a GLP-1 receptor agonist supplied as a sterile powder to be suspended in diluent and administered by subcutaneous injection. Exenatide is a 39-amino acid synthetic peptide amide with an empirical formula of C 184 H 282 N 50 O 60 S and a molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH 2 BYDUREON is a white to off-white powder that is available in a dosage strength of 2 mg exenatide per vial or per pen. Exenatide is incorporated in an extended-release microsphere formulation containing the 50:50 poly(D,L-lactide-co-glycolide) polymer (37.2 mg per dose) along with sucrose (0.8 mg per dose). The powder must be suspended in the diluent prior to injection. The diluent for the BYDUREON vial is supplied in a prefilled syringe within each single-dose tray. The diluent for the BYDUREON Pen is contained within each single-dose pen. Each configuration contains sufficient diluent to deliver 0.65 mL. The diluent is a clear, colorless to pale-yellow solution composed of carboxymethylcellulose sodium (19 mg), polysorbate 20 (0.63 mg), sodium phosphate monobasic monohydrate (0.61 mg), sodium phosphate dibasic heptahydrate (0.51 mg), sodium chloride (4.1 mg), and water for injection. Sodium hydroxide may be added during manufacture of BYDUREON Pen for pH adjustment.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How supplied BYDUREON (exenatide) for extended-release injectable suspension is supplied as: ∘ One single dose pen containing 2 mg of exenatide (as a white to off-white powder) and 0.65 mL of diluent. ∘ One custom needle (23G, 9/32") specific to this delivery system. Do not substitute needles or any other components provided with BYDUREON. Storage and Handling • Store BYDUREON in the refrigerator at 36°F to 46°F (2°C to 8°C). BYDUREON can be kept at room temperature not to exceed 77°F (25°C) [see USP Controlled Room Temperature] for no more than a total of 4 weeks, if needed. • Do not freeze BYDUREON. Do not use BYDUREON if it has been frozen. • Protect from light. • Administer immediately after the supplied BYDUREON is reconstituted with the supplied diluent [see Dosage and Administration (2.2) ].
Indications & Usage
1 INDICATIONS AND USAGE BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use : • BYDUREON contains exenatide. Coadministration with other exenatide-containing products is not recommended. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. ( 1 ) Limitations of Use : • Coadministration with other exenatide-containing products is not recommended. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Administer 2 mg by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals. ( 2.1 ) • Administer immediately after the dose is prepared. ( 2.2 ) 2.1 Recommended Dosing • The recommended dose of BYDUREON is 2 mg subcutaneously once every 7 days (weekly). The dose can be administered at any time of day, with or without meals. • Discontinue an immediate- or extended-release exenatide product prior to initiation of BYDUREON. Patients changing from immediate-release exenatide to BYDUREON may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations. • The day of weekly administration can be changed, if necessary, as long as the last dose was administered 3 or more days before the new day of administration. • If a dose is missed, administer the dose as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly). • If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose. 2.2 Administration Instructions • There are two presentations of BYDUREON (i.e., a single dose tray and a single dose pen). Each presentation of BYDUREON requires constitution prior to use to obtain a final concentration of 2 mg of exenatide per 0.65 mL of suspension. • Prior to initiation, train patients and caregivers on proper mixing and injection [see Instruction for Use ] . Instruct caregivers to assist pediatric patients with mixing and administration. • Inspect BYDUREON visually before use. The suspension should appear white to off-white and cloudy. Do not use if particulate matter is present or if discoloration is observed. • Immediately after the dose is prepared, administer BYDUREON subcutaneously to the abdomen, thigh, or upper arm region. Instruct patients to use a different injection site each week when injecting in the same region. • When using BYDUREON with insulin, instruct patients to administer as separate injections and never mix the products. It is acceptable to inject BYDUREON and insulin in the same body region, but the injections should not be adjacent to each other.