XGEVA 120 mg solution for injection
*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 22 May 2024
File name
ie_xi_xgeva_approved_pil_vial_v82.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 22 May 2024
File name
ie_xi_xgeva_approved_spc_v82.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
- Change to section 1 - Name of medicinal product
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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)
Updated on 28 July 2022
File name
en_xgeva_approved_pil_v81_IE NI.pdf
Reasons for updating
- Change to section 2 - excipient warnings
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Section 2 Warnings and Precautions
XGEVA contains sorbitol
This medicine contains 78 mg sorbitol in each vial. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420).
XGEVA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially ‘sodium‑free’.
Date of revision of the text
July 2022
Updated on 26 July 2022
File name
en_xgeva_approved_spc_v81_IE NI .pdf
Reasons for updating
- 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)
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Section 4.4 Special Warnings and Precautions
This medicinal product contains sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially 'sodium-free'.
Section 10 Date of revision of the text
July 2022
Updated on 28 April 2022
File name
en_xgeva_approved_pil_v79.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 24 July 2020
File name
en_xgeva_approved_spc_v72.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 22 November 2019
File name
en_xgeva_approved_spc_v69.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
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Section 4.2 Posology and method of administration |
“Paediatric population The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents (aged 12-17 years) with giant cell tumour of bone.
XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents (aged 12-17 years) with giant cell tumour of bone (see section 4.4).”
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Section 4.8 Undesirable Effects |
Per 100 patient-years added to during the first year of treatment
“In a long-term phase II open-label clinical trial in patients with giant cell tumour of bone (Study 6, see section 5.1), ONJ was confirmed in 6.8% of patients, including one adolescent (median number of 34 doses; range 4 – 116). At the completion of the trial, median time on trial including safety follow-up phase was 60.9 months (range: 0 – 112.6). The patient-year adjusted incidence of confirmed ONJ was 1.5 per 100 patient-years overall (0.2 per 100 patient-years during the first year of treatment, 1.5 in the second year, 1.8 in the third year, 2.1 in the fourth year, 1.4 in the fifth year, and 2.2 thereafter). The median time to ONJ was 41 months (range: 11 - 96).”
Paediatric patients changed from 18 to 28 skeletally mature adolescents enrolled with GCT of bone |
Section 5.1 Pharmacodynamic properties |
“Immunogenicity
In clinical studies, neutralising antibodies have not been observed for denosumab in advanced cancer patients or giant cell tumour of bone patients.”
“Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
The safety and efficacy of XGEVA was studied in two phase II open‑label, single‑arm trials (studies 5 and 6) that enrolled
Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone. The main outcome measure of the trial was response rate, defined as either at least 90% elimination of giant cells relative to baseline (or complete elimination of giant cells in cases where giant cells represent < 5% of tumour cells), or a lack of progression of the target lesion by radiographic measurements in cases where histopathology was not available. Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA. All 20 patients (100%) with histology assessments met response criteria. Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion.
Study 6 enrolled
In cohort 1 at the final analysis, 28 of the 260 treated patients (10.8%) had disease progression. In cohort 2, 219 of the 238 (92.0%; 95% CI: 87.8%, 95.1%) evaluable patients treated with XGEVA had not undergone surgery by month 6. Of the 239 subjects in cohort 2 with baseline target lesion location or on-study location not in lungs or soft tissue, a total of 82 subjects (34.3%) were able to avoid on-study surgery.. Overall, efficacy results in skeletally mature adolescents were similar to those observed in adults.”
“Paediatric population
In study 6, XGEVA has been evaluated in a subset of
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Section 5.2 Pharmacokinetic properties |
“Paediatric population
In skeletally-mature adolescents (12-17 years of age) with giant cell tumour of bone who received 120 mg every 4 weeks with a loading dose on days 8 and 15, the pharmacokinetics of denosumab were similar to those observed in adult subjects with GCTB.”
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Section 10 Date of revision of text |
November 2019 |
Updated on 30 May 2019
File name
XGEVA Patient Reminder Card IE fold out-clean.pdf
Reasons for updating
- Replace File
Updated on 24 May 2019
File name
en_xgeva_approved_pil_v68.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 May 2019
File name
en_xgeva_approved_spc_v68.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 16 January 2019
File name
en_xgeva_approved_pil_v65.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 16 January 2019
File name
en_xgeva_approved_SPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
change in frequency of AE, Atypical femur fracture
Change in date of revision to November 2018
removal of black triangle
Updated on 19 October 2018
File name
UKIE-NPC-162x-0515-105725 XGEVA IE ONJ card.pdf
Reasons for updating
- Add New Doc
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This reminder card contains important safety information that patients need to be aware of before and during treatment with denosumab (XGEVA) injections for cancer-related conditions, A side effect called osteonecrosis of the jaw (ONJ, bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving XGEVA injections for cancer-related conditions. 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
File name
en_xgeva_approved_pil-psur11.pdf
Updated on 03 July 2018
File name
en_xgeva_approved_spc_psur11.docx
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
Table 1. Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone
Description of selected adverse reactions New primary malignancy In the primary double blind treatment phases of four phase III active-controlled clinical trials in patients with advanced malignancies involving bone, new primary malignancy was reported in 54/3691 (1.5%) of patients treated with XGEVA (median exposure of 13.8 months; range: 1.0–51.7) and 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; range: 1.0-50.8).
The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively.
No treatment-related pattern in individual cancers or cancer groupings was apparent.
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Section 10: June 2018
Updated on 03 July 2018
File name
en_xgeva_approved_pil-psur11.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 May 2018
File name
en_xgeva_approved_spc_v59.docx
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 May 2018
File name
en_xgeva_approved_pil-v59.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 06 April 2018
File name
PIL_15079_938.pdf
Reasons for updating
- New PIL for new product
Updated on 06 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2018
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 update to indication
Section 4.2 update to reflect change in indication
Section 4.8 updated to reflect new data from Multiple myeloma CTs
Section 5.1 Updated with Multiple myeloma clinical trial data
Section 5.2 Updated with Multiple myeloma clinical trial data
Section 10 Date of revision updated to March 2018
Updated on 06 April 2018
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 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 21 September 2017
File name
PIL_15079_472.pdf
Reasons for updating
- New PIL for new product
Updated on 21 September 2017
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
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Additional of polysorbate 20 as an excipient
Updated on 21 September 2017
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
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 28 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)
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Change of revision date to June 2017
Updated on 23 June 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 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)
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Date of revision
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 12 April 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4 - Addition of text to “Warning for excipients”
Section 4.8 - Addition of new paragraph on the overall safety profile
Updated on 12 April 2016
Reasons for updating
- Change of contraindications
- Change to date of revision
Updated on 18 December 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4 - new section on patients with growing sections
Updated on 18 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 29 July 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.8 - addition of information on ONJ events over time in patients with non-metastatic prostate cancer
Updated on 20 July 2015
Reasons for updating
- 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 4.8 - 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)
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Section 4.3 - addition of contraindication "unhealed lesions from dental or oral surgery"
Section 4.4 - update to section on ONJ
Section 4.8 - update to section on ONJ
Updated on 20 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 16 September 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 10 September 2014
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 4.6 - Pregnancy and lactation
- 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
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Clarification to warnings and precautions for ONJ
Update to pregnancy information
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4 Special warnings and precautions for use
· Updated recommendations for monitoring of calcium levels
· Addition of renal impairment subheading to clarify greater risk of hypocalcaemia and accompanying PTH elevation
· Strengthened recommendations for precautions for ONJ
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
· Clarification on exclusion of patients with ONJ risk factors from P3 trials and incidence of ONJ in extension phases
· Addition of subheading on renal impairment special population
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 03 December 2013
Reasons for updating
- Addition of black triangle
- 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)
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Addition of symptoms of hypocalcaemia to section 4.8
Frequency of durg hypersensitivity adverse reaxtion decreased to rare in section 4.8
Update to date of revision
Addition of black triangle and reporting for adverse events
Updated on 03 December 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 06 June 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)
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In Section 4.4 (Special warnings and precautions for use) – Addition of text regarding atypical fracture of the femur
In Section 4.8 (Undesirable effects) - Addition of atypical fracture of the femur and anaphylaxis as rare adverse reaction
In Section 10 (Date of revision of the text) - Updated date of revision of the textUpdated on 06 June 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 01 March 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 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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Section 4.8 update to ONJ inofrmation to reflect open label extension phase to P3 studies
Section 5.1 update to ONJ inofrmation to reflect open label extension phase to P3 studies
Section 10 update to date of revision of text
Updated on 01 March 2013
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 31 August 2012
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)
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-Addition of text relating to recommendations for the monitoring of calcium
Section 4.4
-Addition of text for hypocalcaemia manifestation
-Addition of text for severe symptomatic hypocalcaemia reported in the post-marketing setting
Section 4.8
-Addition of text for severe symptomatic hypocalcaemia in the post-marketing setting
Section 10
-Updated date of revision of the text
Updated on 13 July 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
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Updated on 13 July 2012
Reasons for updating
- Change to date of revision
Updated on 25 January 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Presentation currently not marketed.
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 23 January 2012
Reasons for updating
- Introduction of new pack/pack size
- Presentation currently not marketed.
Updated on 21 July 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 21 July 2011
Reasons for updating
- New PIL for new product