Aclasta 5 mg solution for infusion

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 29 April 2020

File name

Aclasta REG SPC March 2020 PF20-089 clean_1588159359.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)

Free text change information supplied by the pharmaceutical company

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_1588159240.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_1565856984.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_1565773969.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_1565774052.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)

Free text change information supplied by the pharmaceutical company

  • 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_1554725933.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_1540381421.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

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Addition of hypophosphataemia as rare ADR

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 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)

Free text change information supplied by the pharmaceutical company

Update Section 4.4 & 4.8 to implement PRAC recommendations regarding osteonecrosis of the external auditory canal

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)

Free text change information supplied by the pharmaceutical company

Section 4.2, 4.4 and 4.8 updated to reflect the current knowledge of osteonecrosis of the jaw.

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

Change in address of Novartis Europharm

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

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

Free text change information supplied by the pharmaceutical company

Changes due to renewal.

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)

Free text change information supplied by the pharmaceutical company

·         “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)

Free text change information supplied by the pharmaceutical company



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)

Free text change information supplied by the pharmaceutical company

In Section 4.2 the following change re use in patients with renal impairment:

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 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.

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 4.1: New indication: Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.

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)

Free text change information supplied by the pharmaceutical company

Section 4.1: added new indication for male osteoporosis, including those with a recent low-trauma hip fracture
Section 4.2: Included detail on new indication above
Section 4.4: changed the creatinine clearance from <40ml/min to <35ml/min
Section 4.8: included new data from clinical trials and added various new uncommon, rare and unknown adverse drug reactions to Table 1
Section 5.1: Added new data from clinical trials
Section 5.2: changed the creatinine clearance from 40ml/min to 35ml/min

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)

Free text change information supplied by the pharmaceutical company

New indication (post menopausal osteoporisis)
Safety update related to atrial fibrillation

Updated on 01 December 2006

Reasons for updating

  • Change to section 6.3 - Shelf life

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Free text change information supplied by the pharmaceutical company

Shelf life (unopened bottle) has changed from 30 months to 3 years

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)

Free text change information supplied by the pharmaceutical company

Safety update to include osteonecrosis of the jaw (Section 4.4)
Update to align SmPC with CCDS (changes to 4.3 and 4.8)

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