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Exenatide (Bydureon)

Trade Name : BYDUREON

AstraZeneca Pharmaceuticals LP

KIT

Strength

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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) which is also known as BYDUREON and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of per ml. Read more

Exenatide (Bydureon) 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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About GNH

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
  • Contraindications u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a002/2020
  • Warnings and Precautions u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a002/2020
  • Warnings and Precautions u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a002/2020
  • 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 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 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 (, ).
  • BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus .
  • Limitations of Use
  • 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 with type 2 diabetes mellitus. (n )
  • Limitations of Use:
  • 1n- 5.3
  • No data
  • Extended-release for injectable suspension available as:
  • Extended-release for injectable suspension available as: ()
  • BYDUREON is contraindicated in patients with:
  • No data
  • Acute Pancreatitis:
  • Hypoglycemia:
  • Acute Kidney Injury:
  • Gastrointestinal Disease:
  • Immunogenicity:
  • Hypersensitivity:
  • Drug-induced Immune-mediated Thrombocytopenia:
  • Injection-site Reactions:
  • Acute Gallbladder Disease:
  • Most common (u22655%) and occurring more frequently than comparator in clinical trials: nausea, diarrhea, headache, vomiting, constipation, injection-site pruritus, injection-site nodule, and dyspepsia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .
  • 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 (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-NHn
  • 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.
  • 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, in male and female rats at doses of 0.3, 1.0, and 3.0 mg/kg (2-, 9-, and 26-times human systemic exposure at the maximum recommended human dose (MRHD) of 2 mg/week BYDUREON 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, 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 mouse micronucleus assay.
  • In mouse fertility studies with exenatide, the active ingredient in BYDUREON, 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 148 times the human exposure resulting from the recommended dose of 2 mg/week, based on AUC.
  • BYDUREON has been studied as monotherapy and in combination with metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, a combination of metformin and a thiazolidinedione, in combination with a SGLT2 inhibitor on a background of metformin, and in combination with basal insulin.
  • How supplied
  • BYDUREON (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
  • 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 .
  • Never Share a BYDUREON Pen Between Patients
  • Advise patients that they must never share a BYDUREON pen with another person, because doing so carries a risk for transmission of blood-borne pathogens n n .
  • Risk of Pancreatitis
  • Inform patients treated with BYDUREON 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 promptly and contact their healthcare provider if persistent severe abdominal pain occurs n n .
  • Risk of Hypoglycemia
  • Inform patients that the risk of hypoglycemia is increased when BYDUREON is used in combination with an agent that induces hypoglycemia, such as a sulfonylurea or insulin n n . Explain the symptoms, treatment, and conditions that predispose to the development of hypoglycemia. Review and reinforce instructions for hypoglycemia management when initiating BYDUREON therapy, particularly when concomitantly administered with a sulfonylurea or insulin n n .
  • Risk of Acute Kidney Injury
  • Inform patients treated with BYDUREON 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 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 reactions occur, stop taking BYDUREON and seek medical advice promptly n n .
  • 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 and seek medical advice promptly .
  • 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 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 .
  • Counsel patients that they should never share BYDUREON with another person, even if the needle is changed. Sharing of BYDUREON or needles between patients may pose a risk of transmission of infection.
  • If a patient is currently taking BYETTA, it should be discontinued upon starting BYDUREON. Inform patients formerly on BYETTA who start BYDUREON that they may experience transient elevations in blood glucose concentrations, which generally improve within the first 2 weeks after initiation of therapy .
  • Treatment with BYDUREON may also result in nausea, particularly upon initiation of therapy .
  • Inform patients about the importance of proper storage of BYDUREON .
  • Instruct the patient to review the BYDUREON 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
  • BYDUREON is a registered trademark of the AstraZeneca group of companies.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: February 2020
  • BYDUREON (by-DUR-ee-on) Single-Dose Tray
  • Before using Bydureon, your healthcare provider should show you how to use it the right way.
  • Read these Instructions for Use before you start using BYDUREON Single-Dose Tray and each time you get a refill.
  • Getting ready
  • Never share your BYDUREON vials or needles with anyone else. You may give an infection to them or get an infection from them.
  • BYDUREON Single-Dose Tray is not for self-injection by people who are blind or cannot see well.
  • Supplies needed to give your BYDUREON Single-Dose Tray injection (not all supplies are included):
  • Your guide to your BYDUREON Single-Dose Tray
  • Keep this flap open so you can refer to it as you go through the steps.
  • Your guide to the parts
  • What is Inside
  • To take the correct dose, read page so that you do step in order.
  • This step-by-step guide is divided into 4 sections:
  • For see page X.
  • How to store your Single-Dose Trays of BYDUREON
  • 1. Getting Started
  • 1a) Take a Single-Dose Tray from the refrigerator.
  • 1b) Wash your hands.
  • 2. Connecting the Parts
  • 3. Mixing the Medicine and Filling the Syringe
  • 4. Injecting the Medicine
  • Please keep these Instructions for Use for your next dose.
  • Common Questions and Answers
  • Where to learn more about BYDUREON
  • These Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • BYDUREON is a registered trademark of the AstraZeneca group of companies.
  • Manufactured for:AstraZeneca Pharmaceuticals LPWilmington, DE 19850
  • By:Amylin Ohio LLCWest Chester, OH 45071
  • Approved: October 2017
  • BYDUREON (by-DUR-ee-on) Penn- (exenatide extended-release) for injectable suspension
  • Before using Bydureon Pen, your healthcare provider should show you how to use it the right way.
  • Read the Instructions for Use before you start using Bydureon Pen and each time you get a refill.
  • Getting ready
  • Never share your Bydureon Pen or needles with anyone else. You may give an infection to them or get an infection from them.
  • Bydureon Pen is not for self-injection by people who are blind or cannot see well.
  • Supplies needed to give your Bydureon Pen injection (not all supplies are included):
  • How should I store Bydureon?
  • Keep Bydureon Pen, and all medicines, out of the reach of children.
  • Step 2: Mix your dosen- Combine the medicine.
  • Firmly tap your Pen to mix.
  • Check the Bydureon mix.
  • Stop. Do Not proceed unless your medicine is mixed well.
  • To get your full dose the medicine must be mixed well. If itu2019s not mixed well, tap longer and more firmly.
  • Check the Bydureon mix again.
  • If you have any questions or are not sure if your Bydureon is mixed well, call 1-877-700-7365 for help.
  • Step 3: Inject your dose
  • Important: After the medicine is mixed well, you must inject your dose right away.
  • Common Questions and Answers:
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • BYDUREON is a registered trademark of the AstraZeneca group of companies.
  • Manufactured for:AstraZeneca Pharmaceuticals LPWilmington, DE 19850
  • By:Amylin Ohio LLCWest Chester, OH 45071
  • Approved: October 2017
  • NDC 0310-6520-04n n
  • Once-weekly
  • Bydureon
  • exenatide extended-releasefor injectable suspension
  • 2 mg/vial
  • Subcutaneous use only.
  • Dispense the enclosed
  • Medication Guide to each patient.
  • Total quality: 4 single-dose trays.
  • Each tray includes supplies to deliver a 2 mg dose.
  • Use 1 tray every week.
  • Store refrigerated: 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C). Do not freeze.
  • Package Not Child-Resistant. Keep out of reach of children.
  • NDC 0310-6530-04Rx Only
  • Once-Weekly
  • Bydureon
  • exenatide extended-release
  • for injectable suspension
  • 2 mg/pen
  • Subcutaneous use only.
  • Dispense the enclosed Medication Guide to each patient.
  • Follow the enclosed Instructions for Use to prepare and inject your dose.
  • For more information about BYDUREON, call n
  • or visit .
  • Store refrigerated: 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C). Do not freeze.
  • Package Not Child-Resistant. Keep out of reach of children.

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