Aclasta 5 mg solution for infusion
*Company:
Novartis Ireland LimitedStatus:
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 05 September 2023
File name
Aclasta REG PIL PF22-151 Nov 2022_clean IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Change in MAH and local contact for MAH
Updated on 10 May 2023
File name
Aclasta REG SPC November 2022 PF22-151 MAT to Sandoz clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
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MAH changed to Sandoz Pharmaceuticals d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia
Updated on 15 November 2021
File name
Aclasta REG PIL PF21-285 September 2021_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Addition of GB (NI) details for reporting a side effect
Updated on 29 April 2020
File name
Aclasta REG SPC March 2020 PF20-089 clean.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Update Section 4.4 and 4.8 to include wording on acute phase reactions
Update Section 5.1 to include 12-month date for the open-label extension of the paediatric study
Updated on 29 April 2020
File name
Aclasta REG PIL PF20-089 March 2020_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 August 2019
File name
Aclasta REG PIL PF19-135 July 2019 clean TBI 28 April 2020.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
Updated on 14 August 2019
File name
Aclasta REG PIL PF19-135 July 2019 clean.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 14 August 2019
File name
Aclasta REG SPC PF19-135 July 2019 clean IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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- Section 4.2: Updated to include the following recommendation: Aclasta should not be used in children and adolescents below 18 years of age. There are no data available for children under 5 years of age. Currently available data for children aged 5 to 17 years are described in section 5.1.
- Section 5.1: Updated to include detailed results of the study.
Updated on 08 April 2019
File name
Aclasta REG SPC PF18-94 April 2018_IPHA.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 October 2018
File name
Aclasta REG PIL 24_0199_005_6900107 PF18-094 TBI 30 March 2019 IPHA.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 15 May 2018
File name
AclastaREGSPCPF18-94April2018clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2017
File name
PIL_9979_376.pdf
Reasons for updating
- New PIL for new product
Updated on 01 June 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 02 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 May 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 03 February 2016
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 January 2016
Reasons for updating
- Change to side-effects
Updated on 10 December 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 01 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to dosage and administration
Updated on 16 June 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 05 May 2015
Reasons for updating
- Change to MA holder contact details
- Change to improve clarity and readability
Updated on 24 March 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 February 2015
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
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Updated on 03 September 2014
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
Legal category:Product subject to medical prescription which may not be renewed (A)
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· “Anti‑angiogenic medicinal products” has been added to the existing concomitant risk factors in SPC sections 4.4 and 4.8 based on recent publications which demonstrate that anti-angiogenic medicinal products are associated with ONJ
· The current wording on ONJ focuses mainly on cancer patients. A general statement that “Osteonecrosis of the jaw has been reported in patients treated with zoledronic acid” is added in section 4.4. Specific information of ONJ in patients with cancer‑indication is deleted in section 4.4, but maintained in section 4.8.
· The information on hydration and calcium intake, currently under the subheading on Paget`s disease in Section 4.2, has been moved to the beginning of Section 4.2 as hydration intake and calcium intake are important for all patients treated with Aclasta.
Updated on 22 November 2013
Reasons for updating
- Change to improve clarity and readability
Updated on 07 June 2012
Reasons for updating
- Change to dosage and administration
Updated on 01 March 2012
Reasons for updating
- Change of contraindications
Updated on 28 September 2011
Reasons for updating
- Change to side-effects
Updated on 14 July 2011
Reasons for updating
- SPC submitted in error
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.2: Addition of information regarding periodic review of the need for continued treatment
Section 4.4: Addition of information regarding atypical femoral fractures which have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. Patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Section 4.8: Addition of "Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)" as a rare undesirable effect
Updated on 10 June 2010
Reasons for updating
- Change to side-effects
- Change to dosage and administration
Updated on 27 May 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Patients with renal impairment
Use of Aclasta should not be used in patients with creatinine clearance < 35 ml/min is not recommended due to limited clinical experience in this population (see section 4.4).
In Section 4.4 the following warning re use in opatients with renal impairment:
Renal impairment has been observed following the administration of Aclasta (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after Aclasta administration. Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
The following precautions should be taken into account to minimise the risk of renal adverse reactions:
· Creatinine clearance should be measured before each Aclasta dose.
· Aclasta should not be used in patients with creatinine clearance < 35 ml/min (see section 5.2).
· Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
· Monitoring of serum creatinine should be considered in at-risk patients.
· Aclasta should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
· Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Aclasta.
· A single dose of Aclasta should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).The dose of 5 mg zoledronic acid must be administered over at least 15 minutes.
Aclasta is not recommended in patients with severe renal impairment (creatinine clearance < 35 ml/min) due to limited clinical experience in this population. Patients should have their serum creatinine level measured before receiving Aclasta.
Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important in the elderly and for patients receiving diuretic therapy. Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration), see section 4.5.
In Section 4.5 the following text added:
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
In Section 4.8 the following post marketing AEs added (frequency unknown):
Scleritis and orbital inflammation, Hypotension (some of the patients had underlying risk factors), Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects), Renal impairment. Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects), Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
In Section 5.2, the following text added:
Zoledronic acid is not metabolised and is excreted unchanged via the kidney. Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue. This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate. As with other bisphosphonates, the retention time of zoledronic acid in bones is very long. From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney. The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight. The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively. Increasing the infusion time from
Updated on 07 July 2009
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
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: Amended to reflect new indication
Section 4.6: Addition of statement: Aclasta is not recommended in women of childbearing potential.
Section 4.7: Rewording
Section 4.8: Addition of some new adverse events
Section 4.9: Rewording
Section 5.1: Amended to include clinical data from GIO trial
Updated on 13 October 2008
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
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 09 October 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 01 December 2006
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 07 November 2006
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 06 March 2006
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 July 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 June 2005
Reasons for updating
- New PIL for new product