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BYDUREON
Overview
What is BYDUREON?
BYDUREON (exenatide extended-release) for 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 CHNOS 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
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.
What does BYDUREON look like?
What are the available doses of BYDUREON?
Extended-release for injectable suspension available as: ()
What should I talk to my health care provider before I take BYDUREON?
How should I use BYDUREON?
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of Use:
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.
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.
What interacts with BYDUREON?
Sorry No Records found
What are the warnings of BYDUREON?
Sorry No Records found
What are the precautions of BYDUREON?
Sorry No Records found
What are the side effects of BYDUREON?
Sorry No records found
What should I look out for while using BYDUREON?
BYDUREON is contraindicated in patients with:
What might happen if I take too much BYDUREON?
Effects of overdoses with BYETTA, another formulation of exenatide, included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations, including severe hypoglycemia requiring parenteral glucose administration. In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
How should I store and handle BYDUREON?
Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.How suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and HandlingHow suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and HandlingHow suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and HandlingHow suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and HandlingHow suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and HandlingHow suppliedBYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:Do substitute needles or any other components provided with BYDUREON.Storage and Handling
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Incretins, such as glucagon-like peptide-1 (GLP-1), enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. BYDUREON is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.
The amino acid sequence of exenatide partially overlaps that of human GLP-1. Exenatide is a GLP-1 receptor agonist that has been shown to bind and activate the human GLP-1 receptor . This leads to an increase in both glucose-dependent synthesis of insulin and secretion of insulin from pancreatic beta cells, by mechanisms involving cyclic AMP and/or other intracellular signaling pathways. Exenatide promotes insulin release from pancreatic beta-cells in the presence of elevated glucose concentrations.
Non-Clinical Toxicology
BYDUREON is contraindicated in patients with:ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Aspirin
When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Diuretics
Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
Lithium
Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Warfarin-type anticoagulants
Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
H-2 Antagonists
In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
In both genders of rats, exenatide extended-release caused a dose-related and treatment-duration–dependent increase in the incidence of thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures compared to controls A statistically significant increase in malignant thyroid C-cell carcinomas was observed in female rats receiving exenatide extended-release at 25-times clinical exposure compared to controls and higher incidences were noted in males above controls in all treated groups at ≥2-times clinical exposure. The potential of exenatide extended-release to induce C-cell tumors in mice has not been evaluated. Other GLP-1 receptor agonists have also induced thyroid C-cell adenomas and carcinomas in male and female mice and rats at clinically relevant exposures. It is unknown whether BYDUREON will cause 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.
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
BYDUREON is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk of MTC with the use of BYDUREON and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with BYDUREON. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin testing for MTC and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
The following serious adverse reactions are described below or elsewhere in the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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