Exjade Film-Coated Tablets

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *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 28 April 2021

File name

Exjade FCT_REG PIL_PF21-0094_11.03.2021_clean_1619611051.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_1619610606.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_1596624639.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_1575027898.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 September 2019

File name

Exjade FCT REGSPC_ PF 19-0188_July 2019_Clean_1567512038.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_1564069555.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_1548157904.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 18 September 2018

File name

Exjade SmPCs September 2018_Clean_1537272580.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 4.1, there has been a change to wording of indication.
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 2 updated to include lactose statement.

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

Change to Section 4.2 - dose extended to 40mg/kg

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.
Change to Section 4.4

 

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

Hepatobiliary disorders

Common:

Transaminases increased

Uncommon:

Hepatitis, cholelithiasis

Not known:

Hepatic failure1

Skin and subcutaneous tissue disorders

Common:

Rash, pruritus

Uncommon:

Pigmentation disorder

Not known:

Leukocytoclastic vasculitis1, urticaria1, erythema multiforme1, alopecia1

Renal and urinary disorders

Very common:

Blood creatinine increased

Common:

Proteinuria

Uncommon:

Renal tubulopathy (acquired Fanconi’s syndrome), glycosuria

Not known:

Acute renal failure1

 

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)

Free text change information supplied by the pharmaceutical company

None provided