Exjade Film-Coated Tablets
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 16 October 2024
File name
Exjade_REG PIL_PF24-0079_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
File name
A352222 Novartis Exjade A5 RMP HCP Brochure-D5.pdf
Reasons for updating
- Add New Doc
File name
A352122 Novartis Exjade Patient Handbook-D6.pdf
Reasons for updating
- Add New Doc
File name
A346722 Novartis Exjade RMP Physicians checklist D6.pdf
Reasons for updating
- Add New Doc
Updated on 09 September 2022
File name
Exjade_REG SPC_PF22-0165_25 Aug 2022_English_Clean.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)
Updated on 09 September 2022
File name
Exjade_REG PIL_PF22-0165_clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 22 January 2022
File name
Exjade FCT_REG SPC_PF22-0007_Dec 2021_clean.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)
Updated on 22 January 2022
File name
Exjade FCT_REG PIL_PF22-0007_clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 03 September 2021
File name
Exjade FCT_REG PIL_PF21-0208_09.08.2021_clean_TBI 06May2022 .pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 28 April 2021
File name
Exjade FCT_REG PIL_PF21-0094_11.03.2021_clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
Updated on 28 April 2021
File name
EXJADE FCT_SMPC PF 21-0094_11.03.2021_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 August 2020
File name
Exjade FCT REGSPC_PF 20-0108 Clean_July 2020.pdf
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)
Updated on 29 November 2019
File name
Exjade FCT REGPIL PF 19-0165 July 2019 clean IPHA.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 03 September 2019
File name
Exjade FCT REGSPC_ PF 19-0188_July 2019_Clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 July 2019
File name
Exjade FCT REGSPC_Clean_July 2019.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 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2019
File name
Exjade FCT 2215403_R91_WEH_p1_LFT_X-4 RA approved 12.09.2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
Updated on 18 September 2018
File name
Exjade SmPCs September 2018_Clean.pdf
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018
File name
Exjade FCT REGSPC_Clean May 2018.docx
Reasons for updating
- 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
Address change -BREXIT
Updated on 22 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 August 2017
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
In Section 4.4 Special warnings and precautions for use additional information has been added on Skin disorders
In Section 4.8 Undesirable effects Severe cutaneous adverse reactions (SCARs) has been added under summary of safety profile, Drug reaction with eosinophilia and systemic symptoms (DRESS) has been added as a rare side effect.
Updated on 20 February 2017
File name
PIL_17093_776.pdf
Reasons for updating
- New PIL for new product
Updated on 15 February 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 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- Joint SPC superseded by SPCs for individual presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2
Patients with hepatic impairment
EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE must be used with caution in such patients. Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month and then every month (see section 4.4).
Section 4.4
The third paragraph under hepatic function:
(Child-Pugh Class C) (see section 5.2).
Section 5.2
At the end of this section:
Renal or hepatic impairment
The pharmacokinetics of deferasirox have not been studied in patients with renal impairment. The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
In a clinical study using single doses of 20 mg/kg deferasirox, the average exposure was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function. The average Cmax of deferasirox in subjects with mild or moderate hepatic impairment was increased by 22%. Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Section 9
Date of latest renewal: 28.08.2011
Updated on 12 October 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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
In Section 4.5 inclusion of statement re. interaction with iron chelators, concomitant administration of Exjade with NSAIDs , corticosteroids or oral bisphosphonates..... cholestyramine effect described alos in Section 4.5
In Section 4.8 - addition of "tubulointerstitial nephritis" as an unknown undesirable effect.
Updated on 09 February 2011
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 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 4.5 updated to include interaction with theophylline....
Updated on 14 December 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Elderly patients (≥65 years of age)
The dosing recommendations for elderly patients are the same as described above. In clinical trials, elderly patients experienced a higher frequency of adverse reactions than younger patients (in particular, diarrhoea) and should be monitored closely for adverse events that may require a dose adjustment.
The causes of the rises in serum creatinine have not been elucidated. Particular attention should therefore be paid to monitoring of serum creatinine in patients who are concomitantly receiving medicinal products that depress renal function, and in patients who are receiving high doses of EXJADE and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or <2 units/month for an adult). While no increase in renal adverse events was observed after dose escalation to doses above 30 mg/kg in clinical trials, an increased risk of renal adverse events with EXJADE doses above 30 mg/kg cannot be excluded.
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with EXJADE. Tests for proteinuria should be performed monthly. As needed, additional markers of renal tubular function (e.g. glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria) may also be monitored. Dose reduction or interruption may be considered if there are abnormalities in levels of tubular markers and/or if clinically indicated.
Changes to Section 4.8
|
Immune system disorders |
|||||||||||||||||||||||||||||||
|
|
Not known: |
Hypersensitivity reactions (including anaphylaxis and angioedema)1 |
|||||||||||||||||||||||||||||
|
Psychiatric disorders |
|||||||||||||||||||||||||||||||
|
|
Uncommon: |
Anxiety, sleep disorder
|
|||||||||||||||||||||||||||||
Updated on 24 July 2009
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)