Exenatide (Bydureon Bcise)

Trade Name : BYDUREON BCise

AstraZeneca Pharmaceuticals LP

INJECTION, SUSPENSION, EXTENDED RELEASE

Strength 2 mg/.85mL

EXENATIDE GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Exenatide (Bydureon Bcise) which is also known as BYDUREON BCise and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 2 mg/.85mL per ml. Read more

Exenatide (Bydureon Bcise) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usage, Limitations of Use ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a07/2019
  • Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a02/2020
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a02/2020
  • WARNING: RISK OF THYROID C-CELL TUMORS
  • See full prescribing information for complete boxed warning.
  • Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether BYDUREON BCISE causes 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. (, )
  • BYDUREON BCISE is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors. (u00a0)
  • BYDUREON BCISE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus .
  • Limitations of Use
  • BYDUREON BCISE is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. , n
  • Limitations of Use
  • (1n- 5.2)
  • No data
  • Extended-release injectable suspension: 2 mg of exenatide per 0.85 mL suspension, in a pre-filled single-dose autoinjector. Redispersion by mixing provides a white to off-white, opaque, suspension.
  • Extended-release injectable suspension: 2 mg of exenatide in a 0.85 mL single-dose autoinjector. n
  • BYDUREON BCISE is contraindicated in patients with:
  • History of drug-induced immune-mediated thrombocytopenia from exenatide products (n- ).
  • No data
  • Acute Pancreatitis
  • Hypoglycemia
  • Acute Kidney Injury
  • Gastrointestinal Disease
  • Immunogenicity:
  • Hypersensitivity
  • Drug-induced Immune-mediated Thrombocytopenia:
  • Injection-site Reactions
  • Acute Gallbladder Disease:
  • The following serious adverse reactions are described below or elsewhere in the prescribing information:
  • Most common (u22655%) in clinical trials: injection-site nodule, nausea. ()
  • No data
  • No data
  • u2022
  • Pregnancy:
  • 8.1
  • 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.
  • BYDUREON BCISE (exenatide extended-release) injectable suspension is a GLP-1 receptor agonist supplied as a sterile suspension of exenatide extended-release microspheres in an oil-based vehicle of medium chain triglycerides (MCT), in a single-dose autoinjector. Redispersion by mixing provides a white to off-white-opaque suspension to be administered by subcutaneous injection. Each autoinjector contains sufficient suspension to deliver 2 mg of exenatide extended-release in a volume of 0.85 mL.
  • 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-NHn
  • 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), suspended in the vehicle, MCT (774.4 mg per dose).
  • No data
  • Thyroid C-cell tumors have been observed in rats and mice with GLP-1 receptor agonists.
  • A 2u2011year carcinogenicity study was conducted with exenatide extended-release, the active component of BYDUREON BCISE, in male and female rats at doses of 0.3, 1.0, and 3.0 mg/kg (2-, 10-, and 27-times human systemic exposure at the maximum recommended human dose (MRHD) of 2 mg/week. BYDUREON BCISE based on plasma exenatide AUC, respectively) administered by subcutaneous injection every other week. In this study there was an increased incidence of C-cell adenomas and C-cell carcinomas at all doses. An increase in benign fibromas was seen in the skin subcutis at injection sites of males given 3 mg/kg. No treatment-related injection-site fibrosarcomas were observed at any dose. The human relevance of these findings is currently unknown.
  • Carcinogenicity of exenatide extended-release has not been evaluated in mice.
  • Exenatide, the active ingredient in BYDUREON BCISE, was not mutagenic or clastogenic, with or without metabolic activation, in the Ames bacterial mutagenicity assay or chromosomal aberration assay in Chinese hamster ovary cells. Exenatide was negative in the in vivo mouse micronucleus assay.
  • In mouse fertility studies with exenatide, the active ingredient in BYDUREON BCISE, at twice-daily subcutaneous doses of 6, 68, or 760 mcg/kg/day, males were treated for 4 weeks prior to and throughout mating, and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 760 mcg/kg/day, a systemic exposure 163-times the human exposure resulting from the recommended dose of 2 mg/week, based on AUC.
  • No data
  • How Supplied
  • Storage and Handling
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • Risk of Thyroid C-cell Tumors
  • Inform patients that exenatide extended-release causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician .
  • Risk of Pancreatitis
  • Inform patients treated with BYDUREON BCISE of the potential risk for pancreatitis. Explain that persistent severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue BYDUREON BCISE promptly and contact their healthcare provider if persistent severe abdominal pain occurs .
  • Risk of Hypoglycemia
  • Inform patients that the risk of hypoglycemia is increased when BYDUREON BCISE is used in combination with an agent that induces hypoglycemia, such as a sulfonylurea or insulin . Explain the symptoms, treatment, and conditions that predispose to the development of hypoglycemia. Review and reinforce instructions for hypoglycemia management when initiating BYDUREON BCISE therapy, particularly when concomitantly administered with a sulfonylurea or insulin .
  • Risk of Acute Kidney Injury
  • Inform patients treated with BYDUREON BCISE of the potential risk for worsening kidney function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs n
  • Risk of Hypersensitivity Reactions
  • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of exenatide. Inform patients that if symptoms of hypersensitivity reaction occur, stop taking BYDUREON BCISE and seek medical advice promptly .
  • Risk of Drug-Induced Thrombocytopenia
  • Inform patients that drug-induced immune mediated thrombocytopenia has been reported during use of exenatide. Inform patients that if symptoms of thrombocytopenia occur, e.g. bleeding, stop taking BYDUREON BCISE and seek medical advice promptly n
  • Risk of Injection-Site Reactions
  • Inform patients that there have been postmarketing reports of serious injection-site reactions with or without subcutaneous nodules, with the use of BYDUREON. Isolated cases of injection-site reactions required surgical intervention. Advise patients to seek medical advice if symptomatic nodules occur, or for any signs or symptoms of abscess, cellulitis, or necrosis n n .
  • Acute Gallbladder Disease
  • Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up n n
  • Instructions
  • Train patients on how to use BYDUREON BCISE properly prior to self-administration. Instruct patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer patients to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • Inform patients formerly on BYETTA who start BYDUREON BCISE may experience transient elevations in blood glucose concentrations, which generally improve within the first 4 weeks after initiation of therapy .
  • Treatment with BYDUREON BCISE may also result in nausea, particularly upon initiation of therapy .
  • Inform patients about the importance of proper storage of BYDUREON BCISE .
  • Instruct the patient to review the BYDUREON BCISE Medication Guide and the Instructions for Use each time the prescription is refilled.
  • Manufactured for:
  • AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • By:
  • Amylin Ohio LLC
  • West Chester, OH 45071
  • and
  • Vetter Pharma-Fertigung GmbH & Co. KG
  • 88214 Ravensburg
  • Germany
  • BYDUREON, BCISE and BYETTA are trademarks of the AstraZeneca group of companies.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: February 2020
  • Once-weeklyBYDUREON BCISEn
  • (exenatide extended-release), injectable suspensionn n
  • 2 mg
  • Read the Instructions for Use before you start using BYDUREON BCISE.Before using BYDUREON BCISE, talk to your healthcare provider about how to use it the right way.
  • Before You Begin
  • The autoinjector:
  • Before Use
  • Supplies needed to give your injection:
  • BYDUREON BCISE autoinjector, Alcohol swab, A clean, flat surface, Sharps container (see u201cdisposalu201d instructions at the end of these instructions)
  • Step 1: Prepare for Injection
  • A. Let your autoinjector come to room temperature.n
  • B. Check the expiration date (labeled EXP) printed on the autoinjector label.n
  • C. Wash your hands.
  • D. Choose your injection site.n
  • Each week you can use the same area of your body, but choose a different injection site in that area of your body.Clean the area with an alcohol swab.
  • Step 2: Mix the medicine
  • A. Look in the window.
  • B. Shake the autoinjector hard,n
  • C. Check the mix.
  • Do not
  • Step 3: Prepare the Autoinjector
  • Important: n- right away
  • Only unlock the autoinjector when you are ready to inject
  • A. Unlock the autoinjector.n
  • B. While still holding the autoinjector straight up, firmly unscrew the orange cap.
  • It is normal to see a few drops of liquid inside the cap. recap the autoinjector.Throw away the cap.
  • Step 4: Inject the Dose
  • A. Inject and hold:
  • B. Make sure you received your full dose.n
  • Step 4: Inject the Dose
  • C. Disposal.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDAu2019s website at: .
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. See u201cCommon Questions and Answersu201d for additional disposal information.
  • Please keep these instructions to use for your next dose.
  • Common Questions and Answers
  • 1. Where is the needle?
  • 2. How do I know if the medicine is fully mixed?
  • 3. Why do I need to hold the autoinjector upright while removing the orange cap?n
  • 4. Why should I inject my medicine right away after mixing it?n
  • 5. How do I know I gave myself the full dose of medicine?n
  • 6. Why should I store my autoinjectors flat in the refrigerator?
  • 7. What if I do not have an FDA-cleared sharps disposal container?n- Do not
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and autoinjectors.
  • For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDAu2019s website at: .
  • 8. What if I cannot unlock the autoinjector?
  • 9. What if I cannot remove the orange cap from the autoinjector?
  • 10. For other questions about BYDUREON BCISE:
  • How to Store BYDUREON BCISE Autoinjector
  • NDC 0310-6540-01n single-dose autoinjector
  • Medication requires mixing before use
  • Store FLAT in a refrigerator 36-46u00b0F
  • (2-8u00b0C)
  • Once-weekly
  • BYDUREON BCisen (exenatide extended-release)
  • injectable suspension
  • For subcutaneous use only
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0AstraZeneca
  • NDC 0310-6540-04Once-Weekly
  • BYDUREON BCiseu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a02 mg single-dose autoinjector(exenatide extended-release)
  • injectable suspension
  • For subcutaneous use only
  • Dispense with enclosed Medication Guide
  • to each patient.
  • Store FLAT in refrigerator 36-46u00b0F (2-8u00b0C).
  • Total Quantity: 4 x Single-Dose AutoinjectorsUse one autoinjector every week
  • Each autoinjector delivers a 2 mg dose
  • Rx only

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