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Prolia

*
Pharmacy Only: Prescription

  • Company:

    Amgen Ireland Ltd

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Denosumab

    *Additional information is available within the SPC or upon request to the company

Updated on 14 November 2024

File name

ie_xi_prolia_approved_spc_v100.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 27 February 2024

File name

ie_xi_prolia_approved_pil_v99_CDSv29.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 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 27 February 2024

File name

ie_xi_prolia_approved_spc_v99_CDSv29.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 6.3 - Shelf life
  • 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)

Updated on 18 August 2023

File name

ie_xi_prolia_approved_spc_v98_CDSv28.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - 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)

Updated on 17 May 2022

File name

ie_xi_prolia_approved_pil_v93_CDSv26.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 17 May 2022

File name

ie_xi_prolia_approved_spc_v93_CDSv26.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 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 25 August 2021

File name

en_prolia_spc_latexremoval_IE & NI.pdf

Reasons for updating

  • 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 6.5 - Nature and contents of container
  • 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 25 August 2021

File name

en_prolia_pil_latexremoval_IE & NI.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

Updated on 12 November 2020

File name

en_prolia_pil_cdsv24.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 November 2020

File name

en_prolia_approved_spc_cdsv24.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 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

File name

en_prolia_pil_psur13.pdf

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

File name

en_prolia_spc_r82.pdf

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

File name

en_prolia_pil_r82.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 July 2019

File name

en_prolia_approved_pil_psur12.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 09 July 2019

File name

en_prolia_approved_spc_psur12.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 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

EDM Updated on 19 October 2018

File name

UKIE-NPC-162-0515-105723 PROLIA IE ONJ card.pdf

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

File name

en_prolia_approved_spc_v68.docx

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 08 June 2018

File name

en_prolia_approved_pil_v68.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 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

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

File name

PIL_14797_643.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 September 2017

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

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

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

Deletion of cataracts as an adverse reaction (4.8 Table 1 and text)

Updated on 15 September 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 August 2017

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

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 27 July 2017

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. In years 4 through 10, the rates of new vertebral and non-vertebral fractures did not increase over time; annualised rates were approximately 1.0% and 1.3% respectively. The cumulative incidence of new vertebral and nonvertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1,278). Patients who did not complete the study of any reason had higher on-treatment fracture rates.

Section 10 Date of revision of the text

June 2017

Updated on 27 July 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 July 2017

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. In years 4 through 10, the rates of new vertebral and non-vertebral fractures did not increase over time; annualised rates were approximately 1.0% and 1.3% respectively. The cumulative incidence of new vertebral and nonvertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1,278). Patients who did not complete the study of any reason had higher on-treatment fracture rates.

Section 10 Date of revision of the text

June 2017

Updated on 24 July 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 30 June 2017

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 30 June 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 March 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 03 January 2017

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

Removal of PSP/LSP wording  
Date of revision updated

Updated on 03 January 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 20 October 2016

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

SPC updated to reflect deregistration of the vial presentation for Prolia

Updated on 20 October 2016

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 June 2016

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 4.8 update to information on osteonecrosis of the jaw
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 07 July 2015

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

4.2: Instruction to give patients the package leaflet and reminder card
4.4: Update to section on Osteonecrosis of the jaw
4.8 Update to section on Osteonecrosis of the jaw

Updated on 07 July 2015

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

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

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

4.4 explicit clarification that Prolia contains sorbitol
4.8 addition of introductory sentence regarding most common side effects

Updated on 26 August 2014

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 26 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 18 June 2014

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 sections 4.1, 4.8, 5.1 to reflect approval of indication for male osteoporosis
Change to section 4.8 to include adverse reaction abdominal pain
Update to date of revision of text

Updated on 18 June 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 04 September 2013

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

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 August 2013

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 06 June 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 05 June 2013

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 4.8 (Undesirable effects) - Addition of anaphylactic reaction as a rare reaction observed in the post-market setting 

In Section 10 (Date of revision of the text) -  Updated date of revision of the text

Updated on 15 February 2013

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

Reasons for updating

  • Change to side-effects

Updated on 06 December 2012

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 06 December 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 14 September 2012

Reasons for updating

  • Addition of manufacturer

Updated on 30 April 2012

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

In section 5.1: Addition of data
In section 10: Date of revision of text

Updated on 22 March 2012

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 22 March 2012

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 08 March 2012

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 5.3 (Preclinical Safety Data) New non-clinical data regarding the potential reversibility of effects on bone growth and tooth eruption
In section 10:  Date of revision

Updated on 10 February 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 13 October 2010

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 6.3, the shelf-life has been changed from 30 months to 3 years
In section 10, the date of revision has been changed from 26 May 2010 to 20 September 2010.

Updated on 22 September 2010

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

None provided

Updated on 22 September 2010

Reasons for updating

  • New PIL for new product