English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Exjade (deferasirox) – Conditions or restrictions regarding supply and use - V03AC03

Updated on site: 06-Oct-2017

Medication nameExjade
ATC CodeV03AC03
Substancedeferasirox
ManufacturerNovartis Europharm Limited
o o o o o o

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and and any subsequent updates published on the European medicines web-portal.

D.CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

The MAH must inform the European Medicines Agency and the CHMP of the results of the surveillance programme in each Member State.

As well as the requirements in the legislation, the following serious ADRs should be forwarded on an expedited basis to the appropriate competent authority as well as summarised in the above reports:

Increase in hepatic enzymes >10x ULN Serious rise in creatinine

Results of renal biopsies, if available Cataracts

Hearing loss Gallstones

Prior to launch of EXJADE in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.

The educational programme is aimed to inform healthcare professionals and patients to minimise the risks of:

Non-compliance of the posology and biological monitoring

Medication errors due to switching between formulations (dispersible and film-coated tablets).

The MAH shall ensure that, at launch, in each Member State where EXJADE is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use EXJADE are provided with the following educational package for both formulations and on all indications:

Physician educational material

Patient information pack

Additional periodic distributions after launch should be performed, notably after safety substantial product information modifications justifying educational material updates.

The MAH shall use distinct outer cartons, blisters and tablets for both formulations (dispersible and film-coated tablet).

The physician educational material should contain:

The Summary of Product Characteristics

Guide for healthcare professionals

The Guide for healthcare professionals shall contain the following key elements:

Description of available deferasirox formulations o Different posology regimen

o Different conditions of administration

o Dose conversion table when switching from one formulation to another

The recommended doses and the rules for starting treatment

The need to monitor serum ferritin monthly

That deferasirox causes rises in serum creatinine in some patients

oThe need to monitor serum creatinine

On two occasions prior to initiation of treatment

Every week during the first month of initiation of treatment or after therapy modification

Monthly thereafter

oThe need to reduce by 10 mg/kg the dose if serum creatinine rises:

Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min)

Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits.

oThe need to interrupt treatment after a dose reduction if serum creatinine rises:

Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min)

oThe need to consider renal biopsy:

When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).

The importance of measuring creatinine clearance

Brief overview of methods of measuring creatinine clearance

That rises in serum transaminases may occur in patients treated with EXJADE

o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated

o Not to prescribe to patients with pre-existing severe hepatic disease

oThe need to interrupt treatment if persistent and progressive increase in liver enzyme were noted.

The need for annual auditory and ophthalmic testing

The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:

Before initiating treatment

 

Serum creatinine at Day - X

Value 1

Serum creatinine at Day - Y

Value 2

X and Y are the days (to be determined) when pre-treatment measurements should be performed.

Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes:

o Information that only one course of treatment is proposed for NTDT patients o The recommended doses and the rules for starting treatment

o The rules for stopping when target liver iron concentration and serum ferritin are reached

o A warning to minimise the risk of over-chelation

o A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population

o A warning on the currently unknown safety consequences of long-term treatment in the paediatric population

Prior to launch of deferasirox film-coated tablets, healthcare professionals will receive introductory notification letters as follows:

Pharmacists - a detailed letter explaining the switch between the two formulations

Prescribers - a letter including the following dossiers:

oA prescribers’ guide informing about the switch between the two formulations in order to address the important potential risk of medication error for deferasirox

oA patient’s guide informing about the possibility of two co-existing formulations in the EU market, and the differences concerning their administration, in order to

address the important potential risk of medication error for deferasirox

Additionally, prescribers and pharmacists will be informed via a specific letter regarding the timelines for removing EXJADE dispersible tablets from the EU market.

The patient information pack should contain:

Patient information leaflet

Patient guide

Patient guide should contain the following key elements:

oInformation on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin

oInformation that renal biopsy may be considered if significant renal abnormalities occur

oAvailability of several oral formulations and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

Non-interventional post-authorisation safety study (PASS): In order to assess the

June 2021

long-term exposure and safety of deferasirox dispersible and film-coated tablets,

 

the MAH should conduct an observational cohort study in paediatric

 

non-transfusion-dependent thalassaemia patients over 10 years old for whom

 

deferoxamine is contraindicated or inadequate conducted according to a

 

CHMP-agreed protocol. The clinical study report should be submitted by

 

Interventional post-authorisation safety study (PASS): In order to assess the safety

June 2021

of deferasirox film-coated tablets in the paediatric population (especially when the

 

tablets are crushed), the MAH shall conduct and submit the results of a safety study

 

conducted according to an agreed protocol. The clinical study report should be

 

submitted by

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed