We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Vifor Pharma UK Limited

The Old Stables, Bagshot Park, Surrey, GU19 5PJ, UK
Telephone: +44 (0)1276 853 600
Fax: +44 (0)1276 452 341
Medical Information Direct Line: +44 (0)1276 853 633
Medical Information e-mail: medicalinfo_UK@viforpharma.com
Customer Care direct line: +44 (0)1276 853 633
Summary of Product Characteristics last updated on medicines.ie: 20/04/2017
SPC Ferinject (ferric carboxymaltose)

When a pharmaceutical company changes an SPC or PIL, 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 20/04/2017 and displayed until Current
Reasons for adding or 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The following changes have been made in section 4.2 (Posology and method of administration):

·              In the second paragraph the word ‘injection’ has been replaced with ‘administration’

·              Table 1 (Determination of the iron need) has been updated to reflect changes to the symbols in columns 1 and 2 and the wording in column 5.

 

In the third paragraph in section 4.4 (Special warnings and precautions for use) the word ‘injection’ has been replaced with ‘administration’

In section 4.6 (Fertility, pregnancy and lactation) the wording ‘no adequate and well controlled trials’ has been replaced with ‘limited data for the use’

The following changes have been made in section 4.8  (undesirable effects):

·              The number of subjects listed in paragraph 1 has been updated from ‘6755’ to ‘7391’

·              The wording in paragraph 2 has changed from:

 

The most commonly reported ADR is nausea (occurring in 3.1% of the patients), followed by headache, dizziness, and hypertension. Injection site reactions categorised as common in Table 4 are comprised of several ADRs which individually have been reported with a frequency of either uncommon or rare. Hypophosphataemia (common) may occur. In clinical trials the minimum values were obtained after approximately 2 weeks, and 4 to 12 weeks following Ferinject treatment the values had returned to those within the range of baseline. The most serious ADR is anaphylactoid reactions with a frequency of rare. 

To:

The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare. In clinical trials, the minimum serum phosphorous values were obtained after approximately 2 weeks, and 4 to 12 weeks following Ferinject treatment the values had returned to those within the range of baseline. The most serious ADR is anaphylactoid reactions (rare).

·              Table 4 (Adverse drug reactions observed during clinical trials and post-marketing experience) has been updated. Rigors has been removed, pain in extremity has been added as uncommon, flushing is now listed as common, alanine aminotransferase increased is now listed as uncommon.

 

The following changes have been made in section 5.1 (Pharmacodynamic properties):

·              In the second paragraph and under the subheadings ‘Nephrology, Gastroenterology and Women’s health’ the word ‘patients’ has been replaced with ‘subjects’

·              The clinical trial data under the subheadings ‘Cardiology and Pregnancy’ have been updated

·              Under the subheading ‘Gastroenterology’ the Study number has been amend from ‘Study VIT-CL-IV-008’ to Study ‘VIT-IV-CL-008’

 

In section 5.2 (Pharmacokinetic properties) the word ‘patients’ has been replaced with ‘subjects’

In section 10 (Date of Revision of the text) has been updated to ‘April 2017’

Updated on 18/07/2016 and displayed until 20/04/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



7. MARKETING AUTHORISATION HOLDER

Has changed from

Vifor France SA
7-13, Boulevard Paul-Emile Victor
92200 Neuilly-sur-Seine
France
Tel. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99 

To

Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tel.  +33 (0)1 41 06 58 90
Fax  +33 (0)1 41 06 58 99

10. DATE OF REVISION OF THE TEXT

Updated on 23/11/2015 and displayed until 18/07/2016
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Sep-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.1

The diagnosis of iron deficiency must be based on laboratory tests

Section 4.2

Typographical changes to facilitate ease of interpretation:

The posology of Ferinject follows a stepwise approach:

1- determination of the individual iron need

2- calculation and administration of the iron dose(s)

3- post-iron repletion assessments.

Section 4.4

Sub-headings added to categorize nature of warnings and precautions

Section 4.5

The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last injection of Ferinject.

Section 4.6

Clinical studies showed that transfer of iron from Ferinject to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Ferinject represents a risk to the breast-fed child

Section 4.8

Inclusion of “influenza like illness” as a rare adverse drug reaction

Section 5.1

Inclusion of the following data:

Ferritin monitoring after replacement therapy

There is limited data from study VIT-IV-CL-008 which demonstrates that ferritin levels decrease rapidly 2-4 weeks following replacement and more slowly thereafter. The mean ferritin levels did not drop to levels where retreatment might be considered during the 12 weeks of study follow up. Thus, the available data does not clearly indicate an optimal time for ferritin retesting although assessing ferritin levels earlier than 4 weeks after replacement therapy appears premature.  Thus, it is recommended that further re-assessment of ferritin should be made by the clinician based on the individual patient’s condition.

 

Section 6.4

Store in the original package in order to protect from light. Do not store above 30 °C. Do not freeze

Section 6.5

Typographical changes ml to mL

Section 10

Date of revision of text has been update to September 2015

Updated on 13/07/2015 and displayed until 23/11/2015
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to

5.1 Pharmacodynamic properties

From:
Pharmacotherapeutic group: Iron trivalent, parenteral preparation, ATC code: B03A C01

To:
Pharmacotherapeutic group: Iron trivalent, parenteral preparation, ATC code: B03AC

Updated on 05/12/2013 and displayed until 13/07/2015
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 2

 

“Each 20 mL vial contains 1000 mg of iron as ferric carboxymaltose.” Has now been added.
volumes are now listed in mL


In section 4.2

 

“For doses up to 200 mg iron, there is no prescribed administration time.” Has now been added under “Intravenous injection”

 

The term “intravenous drip infusion” has now been replaced with “intravenous infusion”

 

Dilution plan of Ferinject for intravenous infusion has been clarified to confirm which dose ranges require what volume of sterile 0.9% m/V sodium chloride solution.

 

In section 4.8

 

The following text has been incorporated:

 

“The most commonly reported ADR is nausea (occurring in 3.1% of the patients), followed by headache, dizziness, and hypertension. Injection site reactions categorised as common in Table 3 are comprised of several ADRs which individually have been reported with a frequency of either uncommon or rare. Hypophosphataemia (common) may occur. In clinical trials the minimum values were obtained after approximately 2 weeks, and 4 to 12 weeks following Ferinject treatment the values had returned to those within the range of baseline. The most serious ADR is anaphylactoid reactions with a frequency of rare.”

 

Hypertension and hypophosphataemia are now listed as “common”

 

Dysgeusia, tachycardia, dyspnoea, abdominal pain, constipation, diahorrea, , erythema, rash, muscle spasms and chills are now “uncommon”

 

Anaphylactoid reactions, loss of consciousness, anxiety, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise are now “rare”.

Detail on how to report Adverse events have also been revised.

 

In section 5.1

 

Data has been added on clinical efficacy and safety on Ferinject in in different therapeutic areas necessitating intravenous iron to correct iron deficiency.

In section 10

 

Dates of revision has been updated

Updated on 13/11/2013 and displayed until 05/12/2013
Reasons for adding or updating:
  • Addition of black triangle
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Sep-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.2

Details on post-dose monitoring have been included.

In section 4.3

 

“hypersensitivity to the active substance, to Ferinject or any of its excipients listed in section 6.1.” has replaced “known hypersensitivity to Ferinject or to any of its excipients”

 

“known serious hypersensitivity to other parenteral iron products.” Has been added

In section 4.4

 

The following text has been incorporated:

 

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.

 

The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.

There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).

 

Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each Ferinject injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.

In section 4.6

 

This section has been revised and re-written for clarity

In section 4.8

 

Details of the reporting authority have been included

In section 10

 

Dates of revision has been updated

Updated on 05/12/2011 and displayed until 13/11/2013
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Ferric carboxymaltose