Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen * Pharmacy Only: Prescription
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 July 2022
File name
62d53037d230f.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects - addition of Hepatobiliary disorders under uncommon frequency of occurrence:
- cholecystitis
- cholelithiasis
Section 10. Date of revision of the text - revision date updated to 14th July 2022.
Updated on 18 July 2022
File name
62d52cfef3400.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4. Possible side effects - addition of 'inflamed gallbladder' and 'gallstones' under Uncommon side effects
Section 6. Contents of the pack and other information - revision date updated to 07/2022
Updated on 03 June 2022
File name
629a10ea5da2c.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 1. What Bydureon is and what it is used for
Section revised to add indication in adolescents and children aged 10 years and above.
Section 2. What you need to know before you use Bydureon - Children and adolescents
Section revised as Bydureon can be used in adolescents and children aged 10 years and above.
Section 6. Contents of the pack and other information
Revision date updated to 05/2022.
Updated on 03 June 2022
File name
629a0c1787935.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 Therapeutic indications
Section revised to add indication for adolescents and children aged 10 years and above.
Section 4.2 Posology and method of administration
Combination therapy with thiazolidinedione was only studied in adult patients. added into Posology section.
Section Paediatric population revised as no dose adjustment is required for adolescents and children aged 10 years and above.
Section 4.4 Special warnings and precautions
Recommendations added for paediatricians to consider alternative antidiabetic therapy if efficacy is not achieved.
Section 4.8 Undesirable effects
Addition of safety results for the paediatric population.
Section 5.1 Pharmacodynamic properties
Addition of efficacy results for the paediatric population.
Section 5.2 Pharmacokinetic properties
Section Paediatric population revised as PK analysis in adolescents and children aged 10 years and above showed similar exposure to adults.
Section 10. Date of revision of the text
Revision date updated to 30th May 2022.
File name
629a0aa4947d1.pdf
Reasons for updating
- Replace File
Updated on 15 January 2021
File name
20210111 Package Leaflet IE MT Bydureon DCP PRAC CV 21 0002_1610712256.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Green = added text
Possible side effects
...
Uncommon side effects
- a delay in the emptying of the stomach
...
Date of revision updated to 01/2021
Updated on 15 January 2021
File name
20210111 SPC IE MT Bydureon DCP PRAC CV 21 0001_1610711780.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Green = Added text
Red = Deleted text
4.8 Undesirable effects
Table 1: Adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports
...
Delayed gastric emptying
...
Rate based on sixteen prolonged-release exenatide completed long term efficacy and safety studies n = 4086 total
...
10. DATE OF REVISION OF THE TEXT
30th January 2020 11th January 2021
Updated on 31 January 2020
File name
20200130 SPC IE MT Bydureon DCP DITP CV 20 0005_1580489360.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 January 2020
File name
20200130 Pakage Leaflet IE MT Bydureon DCP DITP CV 20 0004_1580489223.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 January 2020
File name
20200123-SmPC-IE-MT-Bydureon DCP-Renal Update-CV 19 0032_1580125076.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 January 2020
File name
20200123-Package Leaflet-IE-MT-Bydureon DCP-Renal update-CV 19 0033_1580124832.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
File name
2018-11-27 IFU Bydureon DCP 2mg UIM CV 18 0121_1544044168.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
slight amendment to some diagrams and layout to facilitate readability.
Updated on 02 May 2019
File name
20190424-uim-pl-bydureon-dcp brexit brs update CV 19 0066_1556792711.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 April 2019
File name
20190405_uim_pl_bydureon_dcp_prac_update_CV_19_0045_1554978315.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
Updated on 11 April 2019
File name
20190405_uim_spc_bydureon_dcp_prac_update_CV_19_0044_1554978243.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – Addition of wording related to Diabetic ketoacidosis.
Section 4.4 – Addition of wording related to Diabetic ketoacidosis.
Section 10 – Date of revision.
Updated on 27 February 2019
File name
2019-02-14_PIL_Bydureon_DCP_2_mg_UIM_CV_19_0030_1551279602.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 27 February 2019
File name
2019-02-14_SmPC_Bydureon_DCP_2_mg_UIM_CV_19_0029_1551279928.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - footnote to Table 1 has been corrected with updated data for Study 7.
Section 5.1 - data corrected with the data from updated CSR/CO for study 7.
Section 5.3 – Deletion of ‘exenatide’.
Section 6.6 – Addition of text for instructions of use.
Updated on 02 October 2018
File name
2018-09-20 SmPC Bydureon DCP 2 mg UIM CV 18 0063_1538475004.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 – refer to sections 4.4, 4.5 and 5.1 for information on glycaemic control and cardiovascular events
Section 4.2 – removal of text on limited information available on renal patients over 75 years
Section 5.1 – additional information on clinical trial on Type 2 diabetes patients with any level of CV risk
Section 10 – date of revision of the text 20th September 2018
Updated on 06 September 2018
File name
2018-08-27 PIL Bydureon DCP 2 mg UIM CV 18 0055_1536225948.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 September 2018
File name
2018-08-27 SmPC Bydureon DCP 2 mg UIM CV 18 0054_1536226151.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Bydureon 2mg PFP user manual.pdf
Reasons for updating
- Add New Doc
Updated on 27 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 November 2017
File name
PIL_16223_343.pdf
Reasons for updating
- New PIL for new product
Updated on 23 November 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 06 September 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1- Indication re written to state use in combination with other glucose-loweing medicinal products when the therapy in use together with diet and exercise does not provide adequate glycaemic control.
Section 4.4- minor editorial changes
Section 4.8-minor editorial changes and update to UK reporting details
Section 5.1-Information on clinical efficacy and safety information updated with new figures, information and result data from clinical study on combination of prolonged-release exenatide and dapagliflozin added and minor editorial changes.
Section 5.2 minor editorial changes
Section 5.3 minor editorial changes
Section 9- error in date of first authorisation corrected
Section 10- date of revision updated
Updated on 05 September 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 04 August 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
section 10 Update to revision date
Updated on 28 November 2016
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 Updated information within the Glycaemic control section, data on uncontrolled study extension updated to reflect final data of study
Section 10 revision date amended
Updated on 08 March 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 – editorial
Secton 4.2 – editorial
Section 4.3 – editorial
Section 4.4 – editorial
Section 4.5 – editorial
Section 4.6 – editorial
Section 4.7 – editorial
Section 4.8 – editorial
Section 4.9 – editorial
Section 5.1 – editorial
Section 5.2 – editorial
Section 5.3 – editorial
Section 6.1 – editorial
Section 6.3 – editorial
Section 6.4 – editorial
Section 6.6 – editorial
Section 9 – editorial
Section 10 – date of revision
Updated on 07 March 2016
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 11 January 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – editorial updates.
Section 4.4 – reported frequencies updated for renal impairment, acute pancreatitis and interaction with warfarin.
Section 4.5 – reported frequencies updated for interaction with warfarin.
Section 4.8 – frequency of adverse events updated
Section 5.2 – editorial updates.
Section 10 – Date of revision updated.
Updated on 08 January 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 04 February 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.4 adding cholelithiasis as example of rapid weight loss.
- Section 4.8 Combine side effects into one table namely moving the following from one table to another; dehydration, dysgeusia, hyperhidrosis, alopecia, asthenia, feeling jittery and International normalised ratio investgation.
- Section 4.8 updating Malta adverse event reporting information.
- Section 10 Change to date of revision
Updated on 03 February 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 02 February 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 February 2015
Reasons for updating
- New PIL for new product
Product Notice
Discontinued Strength Notice
Bydureon 2 mg Powder and Solvent for Prolonged-Release Suspension for Injection in Pre-Filled Pen has been discontinued. It is expected that stock will be depleted by September 2022.