Repatha SureClick
*Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal 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 28 April 2023
File name
ie_xi_repatha_approved_smpc_v61_fourierole.pdf
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)
Updated on 21 June 2022
File name
ie_xi_repatha_approved_smpc_v58_Huygens.pdf
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)
Updated on 06 April 2022
File name
ie_xi_repatha_approved_smpc_v57_HauserOLE.pdf
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)
Updated on 29 March 2022
File name
ie_xi_repatha_approved_smpc_v57_HauserOLE.pdf
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)
Updated on 12 January 2022
File name
ie_xi_repatha_approved_pil_pfp_v49.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - use in children/adolescents
Free text change information supplied by the pharmaceutical company
New information on heterozygous familial hypercholesterolaemia) Homozygous familial hypercholesterolaemia in paediatric patients aged 10 years and over .
Updated on 12 January 2022
File name
ie_xi_repatha_approved_spc_v49.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - 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, 4.2, 4.8, 5.1 and 5.2 Therapeutic Indications - New information on: Hypercholesterolaemia and mixed dyslipidaemia, Homozygous familial hypercholesterolaemia in paediatric population aged 10 years and over.
Updated on 27 April 2021
File name
ie_xi_repatha_approved_spc_pbrer10.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 headache as common side effect
Section 10 Date of reviison of the text
April 2021
Updated on 27 April 2021
File name
ie_xi_repatha_approved_pil_pbrer10.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 headache as a common side effect
Date of revision April 2021
Updated on 13 April 2021
File name
en_repatha_approved_pi_v47 (1).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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SPC |
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Section 4.4 Special warnings and precautions for use |
This medicinal product contains less than 1 mmol sodium (23mg) per dose, |
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Section 4.8 Undesirable Effects |
Myalgia added as common adverse event |
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Section 10 Date of revision of the text |
Feb 2021 |
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PIL |
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Section 2 What you need to know before you use Repatha |
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future. |
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Section 4 Side Effects |
Muscle pain added as common side effect |
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Instructions for Use |
Numerous updates made to the text in this section to clarify the steps. |
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Date of revision of the text |
Feb 2021 |
Updated on 13 April 2021
File name
en_repatha_approved_pi_v47 (1).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 April 2021
File name
en_repatha_approved_Pil_v47.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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SPC |
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Section 4.4 Special warnings and precautions for use |
This medicinal product contains less than 1 mmol sodium (23mg) per dose, |
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Section 4.8 Undesirable Effects |
Myalgia added as common adverse event |
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Section 10 Date of revision of the text |
Feb 2021 |
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PIL |
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Section 2 What you need to know before you use Repatha |
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future. |
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Section 4 Side Effects |
Muscle pain added as common side effect |
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Instructions for Use |
Numerous updates made to the text in this section to clarify the steps. |
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Date of revision of the text |
Feb 2021 |
Updated on 30 March 2021
File name
en_repatha_approved_spc_v47.pdf
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)
Updated on 30 March 2021
File name
en_repatha_approved_Pil_v47.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 December 2020
File name
en_repatha_approved_spc_v43.pdf
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
The following sections have been updated:
Section 5.1 Pharmacodynamic properties - Addition of EVOPACS a single country, multicenter, double-blind, randomized, placebo-controlled, 8-week study.
Section 10 Date of revision of the text – Oct 2020
Updated on 16 April 2020
File name
en_repatha_approved_pil_r40.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
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PIL |
The black triangle has been removed from Repatha
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Section 2 Warnings and Precautions |
Warnings and precautions The needle cover of the glass pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. |
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Date of revision of the text |
April 2020 |
Updated on 16 April 2020
File name
en_repatha_approved_spc_r40.pdf
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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SPC |
The black triangle has been removed from Repatha Repatha has been by evolocumab throughout the SPC
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Section 4.4 Special Warnings and Precautions |
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
Repatha 140 mg solution for injection in pre-filled syringe The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions.
Repatha 140 mg solution for injection in pre-filled pen The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions.
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Section 4.5 Interaction with other medicinal products and other forms of interaction |
No |
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4.7 Effects on ability to drive and use machines |
Repatha has no |
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6.6 Special precautions for disposal and other handling
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Before administration, the solution should be inspected.
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Section 10 Date of revision of the text |
April 2020 |
Updated on 27 February 2020
File name
en_repatha_approved_pil_v38.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2. What you need to know before you use Repatha
Talk to your doctor, pharmacist or nurse before using Repatha if you have:
- liver disease.
, severe kidney problems.
Date of revision of the text
November 2019January 2020
Updated on 27 February 2020
File name
en_repatha_approved_spc_v38.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 5.2 - 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
Deleted text with strikethrough, new text in bold
Section 4.2 Posology and method of administration
Patients with renal impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment (see section 5.2)., see section 4.4 for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Section 4.4 Special Warnings and Precautions
Renal impairment
There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2). Repatha should be used with caution in patients with severe renal impairment.
5.2 Pharmacokinetic properties
Renal impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment. Population pharmacokinetic analysis of integrated dData from the Repatha clinical trials did not reveal a difference in pharmacokinetics of evolocumab in patients with mild or moderate renal impairment relative to non-renally impaired patients. There is limited experience with Repatha in patients with severe renal impairment (see section 4.4).
In a clinical trial of 18 patients with either normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m2, n = 6), severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2, n = 6), or end-stage renal disease (ESRD) receiving haemodialysis (n = 6), exposure to unbound evolocumab as assessed by Cmax after a single 140 mg subcutaneous dose was decreased by 30% in patients with severe renal impairment and by 45% in patients with ESRD receiving haemodialysis. Exposure as assessed by AUClast was decreased by approximately 24% in patients with severe renal impairment and by approximately 45% in patients with ESRD receiving haemodialysis. The exact mechanism of PK differences is unknown; however, differences in body weight could not explain these differences. Some factors including small sample size and large inter-subject variability should be considered when interpreting the results. The pharmacodynamics and safety of evolocumab in patients with severe renal impairment and ESRD were similar to patients with normal renal function, and there were no clinically meaningful differences in LDL-C lowering. Therefore, no dose adjustments are necessary in patients with severe renal impairment or ESRD receiving haemodialysis.
Section 10 Date of revision of the text
November 2019 January 2020
Updated on 27 November 2019
File name
en_repatha_approved_spc_PSURv7.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 hypersensitivity as a common Adverse Event
Section 10 Date of revision of the text - Updated to November 2019
Updated on 27 November 2019
File name
en_repatha_approved_pil_PSURv7.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 Side Effects - Updated to state “Allergic reactions including rash” as a common side effect
Date of revision of the text - Updated to November 2019
Updated on 16 October 2019
File name
en_repatha_approved_ pil_v33.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Section 2 What you need to know before you use Repatha
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.i.e. it is essentially ‘sodium- free’ and should not affect a sodium-controlled diet.
Section 4 Side Effects
Flu like symptoms
Date of revision of the text
September 2019
Updated on 16 October 2019
File name
en_repatha_approved_ spc_v33.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
Additon of Influenza-like illness as an uncommon adverse reaction
Section 10 Date of revision of teh text
September 2019
Updated on 14 August 2019
File name
en_repatha_approved_spc_v35.pdf
Reasons for updating
- 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 5.1 Pharmacodynamic properties - update to information relating to the OSLER trials
Section 10 Date of revision of the text - July 2019
Updated on 24 July 2019
File name
en_repatha_approved_spc_TAUSSIG.pdf
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
5.1 Pharmacodynamic properties
Information relating to the TAUSSIG trial has been updated.
Information in Tables 5 and 7 relating to the TAUSSIG trial has been updated.
10. DATE OF REVISION OF THE TEXT
Date of revision has been updated to June 2019
Updated on 09 May 2019
File name
en_repatha_approved_pil_PBRER06_new images.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to improve clarity and readability
Updated on 07 May 2019
File name
en_repatha_approved_pil_PBRER06.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to improve clarity and readability
Updated on 07 May 2019
File name
en_repatha_approved_spc_PBRER06.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
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Section 4.8 Undesirable Effects
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Tabulated summary of adverse reactions Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Table 1. Adverse reactions with Repatha
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Section 10 Date of revision of the text |
April 2019 |
File name
en_repatha_approved_pil_v17.pdf
Updated on 29 May 2018
File name
en_repatha_approved_pil_v17.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 May 2018
File name
en_repatha_approved_smpc_ireland_v17.docx
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
Addition of new indication "Established atherosclerotic cardiovascular disease" and subsequently changes made to sections 4.2, 5.1 and 5.2
Changes to section 4.4 regarding patients with renal impairment
Changes to section 4.8 injection site reactions
Updated on 21 May 2018
File name
en_repatha_approved_smpc_ireland_v17.docx
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
4.1 Therapeutic indications
Addition of new indication Established atherosclerotic cardiovascular disease
4.2 Posology and method of administration
Update to the posology sub-section with information on Established atherosclerotic cardiovascular disease in adults
4.4 Special Warnings and Precautions
Update to the renal impairment sub-section
4.8 Undesirable Effects
Update to the Summary of the safety profile, Injection site reactions, Elderly population and Immunogenicity sub-sections
5.1 Pharmacodynamic properties
Update to the Clinical efficacy in primary hypercholesterolaemia and mixed dyslipidaemia sub-section
New information - Effect on atherosclerotic disease burden & Cardiovascular risk reduction in adults with established atherosclerotic cardiovascular disease
Section 5.2 Pharmacokinetic properties
Update to sub section renal impairment
10 Date of revision of the text
May 2018
Updated on 18 May 2018
File name
en_repatha_approved_pil_v17.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 March 2018
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
The shelf life of the Repatha® pre-filled syringe and the Repatha® pre-filled pen (SureClick®) has been extended to 3 years.
Please note that the Repatha® pre-filled syringe is not marketed in Ireland
Section 6.3 Shelf life
Repatha 140 mg solution for injection in pre-filled syringe
3 years.
Repatha 140 mg solution for injection in pre-filled pen
3 years.
Repatha 420 mg solution for injection in cartridge
2 years.
Section 10. DATE OF REVISION OF THE TEXT
Updated to March 2018
Updated on 11 April 2017
File name
PIL_16434_184.pdf
Reasons for updating
- New PIL for new product
Updated on 11 April 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 February 2017
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change from individual to joint SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The Repatha Summary of Product Characteristics has been updated to now incorporate three presentations:
1) Solution for injection in pre-filled syringe
2) Solution for injection in pre-filled pen (SureClick)
3) Solution for injection in cartridge (automated mini-doser)
Please note that the Repatha solution for injection in pre-filled syringe and cartridge (automated mini-doser) are not available in Ireland.
Updated on 24 February 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 September 2016
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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
The following sections of the SmPC have been updated:
Section 6.4 Special precautions for storage:
Previous text:
If removed from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 week.
New text:
If removed from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.
10. DATE OF REVISION OF THE TEXT
Previous text:
July 2015
New text:
September 2016
Updated on 30 September 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 29 June 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 31 July 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 31 July 2015
Reasons for updating
- New PIL for new product