Prolia
- Name:
Prolia
- Company:
Amgen Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/11/20
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Amgen Ireland Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AMGEVITA prefilled pen | Active Ingredients adalimumab |
| Medicine Name AMGEVITA prefilled syringe | Active Ingredients adalimumab |
| Medicine Name Aranesp PFS | Active Ingredients Darbepoetin alfa |
| Medicine Name ARANESP PFS with needle guard | Active Ingredients Darbepoetin alfa |
| Medicine Name Aranesp SureClick | Active Ingredients Darbepoetin alfa |
| Medicine Name Blincyto | Active Ingredients Blinatumomab |
| Medicine Name Imlygic | Active Ingredients Talimogene laherparepvec |
| Medicine Name KANJINTI | Active Ingredients Trastuzumab |
| Medicine Name Kyprolis | Active Ingredients Carfilzomib |
| Medicine Name Mimpara Granules | Active Ingredients cinacalcet hydrochloride |
| Medicine Name Mimpara tablets | Active Ingredients cinacalcet hydrochloride |
| Medicine Name MVASI | Active Ingredients Bevacizumab |
| Medicine Name Neulasta On Body Injector | Active Ingredients Pegfilgrastim |
| Medicine Name Neulasta Pre-Filled Syringe | Active Ingredients Pegfilgrastim |
| Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection | Active Ingredients Filgrastim |
| Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) | Active Ingredients Filgrastim |
| Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) | Active Ingredients Filgrastim |
| Medicine Name Nplate reconstitution kit | Active Ingredients Romiplostim |
| Medicine Name Nplate vial | Active Ingredients Romiplostim |
| Medicine Name Otezla 10mg, 20mg, 30mg | Active Ingredients Apremilast |
| Medicine Name Parsabiv | Active Ingredients etelcalcetide |
| Medicine Name Prolia | Active Ingredients Denosumab |
| Medicine Name Repatha SureClick | Active Ingredients Evolocumab |
| Medicine Name Vectibix | Active Ingredients Panitumumab |
| Medicine Name XGEVA | Active Ingredients Denosumab |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 12 November 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 28 August 2020 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date change to August 2020
Update to section 3 'How to use Prolia' and 'If you stop using Prolia'
Updated on 20 January 2020 SPC
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2020 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 9 July 2019 PIL
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 9 July 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Addtion of 2 new AEs, update to revision date
Updated on 19 October 2018 Ed-Ptnt
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This reminder card contains important safety information that patients need to be aware of before and during treatment with denosumab (Prolia), which is used to treat osteoporosis and bone loss. A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Prolia for osteoporosis. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions patients should take. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441
Updated on 11 June 2018 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- 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
Addition of GIOP indication
Updated on 8 June 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- 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 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 25 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 25 September 2017 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Editorial changes throughout
- deletion of introductory sentence on overall safety profile from section 4.8
- deletion of "excessively" from "do not shake excessively" in section 6.6
Updated on 25 September 2017 PIL
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 5 - how to store or dispose
Updated on 15 September 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 September 2017 SPC
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
Updated on 15 August 2017 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Updated on 15 August 2017 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 27 July 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 27 July 2017 SPC
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 4.8 - 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
|
Section 4.2 Posology and method of administration |
New paragraph added: The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4). |
|
Section 4.4 Special warnings and precautions for use |
New paragraph added: Long-term antiresorptive treatment Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2). |
|
Section 4.8 Undesirable effects |
Addition of final sentence to paragraph on ONJ: Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of Prolia treatment. The risk of ONJ increased with duration of exposure to Prolia. |
|
Section 5.1 Pharmacodynamic effects |
Amendments to information on the Freedom Extension: In patients treated with Prolia for up to 10 years, BMD increased from the pivotal study baseline by 21.7% at the lumbar spine, 9.2% at the total hip, 9.0% at the femoral neck, 13.0% at the trochanter and 2.8% at the distal 1/3 radius. The mean lumbar spine BMD T-score at the end of the study was - 1.3 in patients treated for 10 years.
Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design. |
|
Section 10 Date of revision of the text |
June 2017 |
Updated on 24 July 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 July 2017 SPC
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 4.8 - 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
|
Section 4.2 Posology and method of administration |
New paragraph added: The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4). |
|
Section 4.4 Special warnings and precautions for use |
New paragraph added: Long-term antiresorptive treatment Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2). |
|
Section 4.8 Undesirable effects |
Addition of final sentence to paragraph on ONJ: Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of Prolia treatment. The risk of ONJ increased with duration of exposure to Prolia. |
|
Section 5.1 Pharmacodynamic effects |
Amendments to information on the Freedom Extension: In patients treated with Prolia for up to 10 years, BMD increased from the pivotal study baseline by 21.7% at the lumbar spine, 9.2% at the total hip, 9.0% at the femoral neck, 13.0% at the trochanter and 2.8% at the distal 1/3 radius. The mean lumbar spine BMD T-score at the end of the study was - 1.3 in patients treated for 10 years.
Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design. |
|
Section 10 Date of revision of the text |
June 2017 |
Updated on 30 June 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 June 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4 new paragraph added
Osteonecrosis of the external auditory canal
Osteonecrosis of the external auditory canal has been reported with denosumab. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving denosumab who present with ear symptoms including chronic ear infections
Section 4.8 new adverse reaction added
Addition of osteonecrosis of the external auditory canal as an adverse reaction with frequency “not known”
Section 10 update to date of revision of text
June 2017
Updated on 31 March 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 3 January 2017 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 3 January 2017 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Date of revision updated
Updated on 20 October 2016 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 20 October 2016 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Change from joint to individual SPCs
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 June 2016 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
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 addition of 10-year data from the open label extension study (previously 8-year data)
Joint SPC for all authorised presentations
Updated on 7 July 2015 SPC
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 4.8 – 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
4.4: Update to section on Osteonecrosis of the jaw
4.8 Update to section on Osteonecrosis of the jaw
Updated on 7 July 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 28 January 2015 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 27 January 2015 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.8 addition of introductory sentence regarding most common side effects
Updated on 26 August 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 26 August 2014 SPC
Reasons for updating
- 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
Section 4.4 Special warnings and precautions for use
· Updated recommendations for monitoring of calcium levels
· Strengthened recommendations for precautions for ONJ
· Addition of renal impairment subheading to clarify greater risk of hypocalcaemia and accompanying PTH elevation
Section 4.8 Undesirable Effects
· Addition of musculoskeletal pain as a very common adverse reaction and descriptive text
· Clarification and addition of descriptive text for symptoms of hypocalcaemia
Section 5.1: Pharmacodynamic Properties
· Addition of information from 8 year OLE study including incidence of ONJ and AFF
Section 10 Date of revision of the text
· July 2014
Updated on 18 June 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Change to section 4.8 to include adverse reaction abdominal pain
Update to date of revision of text
Updated on 18 June 2014 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
Updated on 4 September 2013 SPC
Reasons for updating
- 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 4.8: Updated method for calculation for ADR frequencies resulting in change in frequency for pain in extremity and ezcema; updated text for ADR reporting
Section 6: Update to date of revision
Updated on 30 August 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 August 2013 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 6 June 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 5 June 2013 SPC
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
In Section 10 (Date of revision of the text) - Updated date of revision of the text
Updated on 15 February 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
In section 4.4 - New sub headings for special warnings and precautions and addition of atypical femoral fracture text
In section 4.8 - Addition of atypical femoral fracture text
In section 10 – Date of revision
Updated on 15 February 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 6 December 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 6 December 2012 SPC
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 4.8 - 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 4.4
-Addition of text around severe symptomatic hypocalcaemia
Section 4.5
-Addition of text to incorporate result from an interaction study with midazolam
Section 4.8
-Addition of text for rare cases of severe symptomatic hypocalcaemia reported in patients at increased risk of hypocalcaemia receiving Prolia
Section 10
-Updated date of revision of the text
Updated on 14 September 2012 PIL
Reasons for updating
- Addition of manufacturer
Updated on 30 April 2012 SPC
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)
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In section 10: Date of revision of text
Updated on 22 March 2012 PIL
Reasons for updating
- Change to, or new use for medicine
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 22 March 2012 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 2 – Text changes to improve readability
In Section 4.2 – Injection site clarification
In Section 4.4 – Warning for concomitant medication
In Section 4.6 – Updates to pregnancy, breastfeeding and non-clinical reproductive toxicity text
In Section 4.8 – Updates to undesirable effects
In Section 5.2 – Updates to pharmacokinetic properties
In Section 5.3 – Updates to preclinical safety data
In Section 10 – Updated date of revision
Updated on 8 March 2012 SPC
Reasons for updating
- 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)
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In section 10: Date of revision
Updated on 10 February 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 13 October 2010 SPC
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
In section 10, the date of revision has been changed from 26 May 2010 to 20 September 2010.
Updated on 22 September 2010 SPC
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 22 September 2010 PIL
Reasons for updating
- New PIL for new product
Prolia patient reminder cardRisk Minimisation Materials
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