Ferinject (ferric carboxymaltose)
*Company:
Vifor Pharma UK LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 January 2024
File name
230803_SPC FERINJECT_IE.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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)
Updated on 19 January 2024
File name
230803_PIL FERINJECT_IE.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 12 June 2023
File name
IE Ferinject SmPC 120623.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 and 3 - formulation changed from solution to dispersion.
- Section 4.2 - dosing guidance added for children and adolescents aged 1 to 13 years.
- Section 4.4 - 'anaphylactoid' reactions removed under hypersensitivity reactions and only anaphylactic reactions listed. Sentence removed saying Ferinject has not been studied in children.
- Section 4.8 - table of ADRs now represents >9000 (previously 8000) patients including >100 children and adolescents aged 1 to 17 years. Some formatting changes to table 4. MHRA Yellow card scheme website link updated URL.
- Section 5.1 - studies added on use of Ferinject in paediatric population.
- Section 5.2 - pharmacokinetic information for paediatric population added.
- Section 6.5 - formulation changed from solution containing iron to dispersion.
- Section 6.6 - formulation changed to dispersion.
- section 10: date of revision: April 2023
Updated on 12 June 2023
File name
IE Ferinject PIL 120623.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- formulation changed from solution to dispersion.
- dosing guidance added for children and adolescents aged 1 to 13 years.
- "anaphylactoid " reactions removed under hypersensitivity reactions and only anaphylactic reactions listed. Sentence removed saying Ferinject has not been studied in children.
- date of revision: February 2023
Updated on 19 April 2022
File name
Ferinject IE PIL Apr 2022 -Clean.pdf
Reasons for updating
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Text revision date has been updated to February 2022
Updated on 19 April 2022
File name
Ferinject IE SPC Apr 2022.pdf
Reasons for updating
- 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
Text revision date has been updated to February 2022
Updated on 14 February 2022
File name
Ferinject IE SPC Feb 2022 -Clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
the black symbol and the related statement in the product information removed.
Updated on 14 February 2022
File name
Ferinject IE PIL Feb 2022 -Clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
the black symbol and the related statement in the product information removed
Updated on 20 January 2022
File name
Ferinject IE SPC Jan 2022 -Clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Editorial Amendment of SmPC Section 2 to state the active substance name ferric carboxymaltose consistently with other parts of the product information.
Information update regarding the excipient sodium in SmPC Section 4.4 in line with the current European Commission guideline on ’’Excipients in the labelling and package leaflet of medicinal products for human use”
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains ferric carboxymaltose corresponding to 50 mg iron.
Each 2 mL vial contains ferric carboxymaltose corresponding to 100 mg iron.
Each 10 mL vial contains ferric carboxymaltose corresponding to 500 mg iron.
Each 20 mL vial contains ferric carboxymaltose corresponding to 1,000 mg iron.
Excipients
Ferinject contains up to 5.5 mg (0.24 mmol) sodium per mL of undiluted solution, equivalent to 0.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Updated on 20 January 2022
File name
Ferinject IE PIL Jan 2022 -Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Information update regarding the excipient sodium in PIL Section 2 in line with the current European Commission guideline on ’’Excipients in the labelling and package leaflet of medicinal products for human useInformation update regarding the excipient sodium in SmPC Section 4.4 and PIL Section 2 in line with the current European Commission guideline on ’’Excipients in the labelling and package leaflet of medicinal products for human use
' Ferinject contains sodium
This medicine contains up to 5.5 mg sodium (main component of cooking/table salt) in each mL of undiluted solution. This is equivalent to 0.3% of the recommended maximum daily dietary intake of sodium for an adult.'
Updated on 26 August 2021
File name
Ferinject IE SPC Augusr 2021 - Clean.pdf
Reasons for updating
- 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
Date of revision updated to August 2021
Updated on 23 July 2021
File name
Ferinject IE SPC July 2021 -Clean.pdf
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 'distant skin discolouration' within AE table under
Skin and subcutaneous tissue disorders (rare) |
Updated on 23 July 2021
File name
Ferinject IE PIL July 2021- Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
4.8 addtion of ' and skin discoloration at other areas of the body than the administration site.'
Section 6 updated following brexit : This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: UK(NI) etc
Updated on 10 February 2021
File name
Ferinject IE SPC February 2021 -Clean.pdf
Reasons for updating
- 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
Date of revision changed to Jan 2021
Updated on 10 February 2021
File name
Ferinject IE PIL February 2020-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of revision changed to Jan 2021
Updated on 30 October 2020
File name
Ferinject IE PIL October 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Added: Tell your doctor if you develop worsening of tiredness, muscle or bone pain (pain in your arms or legs, joints or back). That may be a sign of a decrease in blood phosphorus which might cause your bones to become soft (osteomalacia). This condition may sometimes lead to bone fractures. Your doctor may also check the levels of phosphate in your blood, especially if you need a number of treatments with iron over time.
Updated on 30 October 2020
File name
Ferinject IE SPC October 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)
Free text change information supplied by the pharmaceutical company
4.4 Special Warnings and precautions for use |
Hypophosphataemic osteomalacia Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain.Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated.
|
4.8 Undesirable effects |
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.
Addition of Hypophosphataemic osteomalacia as “frequency not known” under the System Organ Class (SOC) of Musculoskeletal and connective tissue disorders |
Updated on 28 July 2020
File name
Ferinject IE SPC July 2020 -Clean.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)
Free text change information supplied by the pharmaceutical company
Sections 4.4 Special warnings and precautions for use and 4.8 undesirable effects table have been updated to include additional wording regarding Kournis syndrome and is highlighted in the blue text below.
4.4. Special warnings and precautions for use
|
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. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8). |
|
4.8. Undesirable effects |
Cardiac disorders (frequency unknown) - Kounis syndrome
Please also note the below side effects have been updated from frequency ‘rare’ to frequency ‘unknown’;
Nervous system disorders (frequency unknown) - Loss of consciousness Skin and subcutaneous tissue disorders (frequency unknown) - face oedema |
|
Updated on 28 July 2020
File name
Ferinject IE PIL July 2020-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Please also note the below side effects have been updated from frequency ‘rare’ to frequency ‘unknown’;
Nervous system disorders (frequency unknown) - Loss of consciousness
Skin and subcutaneous tissue disorders (frequency unknown) - face oedema
Updated on 17 June 2020
File name
Ferinject IE SPC June 2020 -Clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
The following changes were approved within the SmPC and are highlighted in the blue text below:
1) Section 4.1: new indication “when there is a clinical need to deliver iron rapidly”
2) Section 4.2: minor editorial change in safety section
3) Section 5.1: Study EFFECT-HF
4.1 Therapeutic indications |
Ferinject is indicated for the treatment of iron deficiency when (see section 5.1): – oral iron preparations are ineffective. – oral iron preparations cannot be used. – there is a clinical need to deliver iron rapidly. |
4.2 Posology and method of administration |
For infusion, Ferinject must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferinject should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxymaltose solution). For further instructions on dilution of the medicinal product before administration, see section 6.6.
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5.1 Pharmacodynamic properties |
Ferinject treatment of patients results in an increase in reticulocyte count, and serum ferritin levels and TSAT levels to within normal ranges.
Study EFFECT-HF was an open-label (with blinded endpoint evaluation), randomised, 2 arm study comparing Ferinject (n=86) vs. standard of care (n=86) in subjects with chronic heart failure and ID for a treatment period of 24 weeks. At Day 1 and Week 6 (correction phase), subjects received either Ferinject according to a simplified dosing grid using baseline Hb and body weight at screening (see section 4.2) or standard of care. At Week 12, (maintenance phase) subjects received Ferinject (500 mg iron) or standard of care if serum ferritin <100 ng/ml or 100 to 300 ng/ml and TSAT <20%. The treatment benefit of Ferinject vs. standard of care was demonstrated with the primary efficacy endpoint, the change in weight-adjusted peak VO2 from baseline to Week 24 (LS Mean 1.04 ±0.44, p=0.02). |
Updated on 17 June 2020
File name
Ferinject IE PIL June 2020-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
section 1: Ferinject is a medicine that contains iron.
Medicines that contain iron are used when you do not have enough iron in your body. This is called iron deficiency.
Ferinject is used to treat iron deficiency when:
- oral iron is not effective enough.
- you cannot tolerate oral iron.
- your doctor decides you need iron very quickly to build up your iron stores.
The doctor will determine whether you have iron deficiency by performing a blood test.
section 2: ( part removed from here and placed below)
section 3: How Ferinject is administered
Your doctor will decide how much Ferinject to give you, how often you need it and for how long. Your doctor will perform a blood test to determine the dose you need. Your doctor or nurse will administer Ferinject undiluted by injection, during dialysis, or diluted by infusion:
Ferinject will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment. You will be observed for at least 30 minutes by your doctor or nurse after each administration.
If you receive more Ferinject than you should
As this medicine will be given to you by trained medical staff it is not likely that you will be given too much of this medicine
Updated on 24 April 2020
File name
FCM IE PIL April 2020-CLEAN.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6 - contents of the pack and other information has been updated to remove the local representative from the PIL, highlighted in blue in the text below.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park, Bagshot, Surrey, GU19 5PJ UK
Updated on 24 April 2020
File name
FCM IE PIL January 2019-CLEAN.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6 - contents of the pack and other information has been updated to remove the local representative from the PIL, highlighted in blue in the text below.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park, Bagshot, Surrey, GU19 5PJ UK
Updated on 23 April 2020
File name
FCM IE PIL January 2019-CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 April 2020
File name
Venofer IE PIL April 2020 -clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Foetal bradycardia.
Updated on 23 April 2020
File name
Venofer IE PIL April 2020 -clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6 - contents of the pack and other information has been updated to remove the local representative from the PIL, highlighted in blue in the text below.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park
Bagshot
Surrey
GU19 5PJ
United Kingdom
Tel: +44 1276 853600
Fax: +44 1276 452341
Updated on 11 November 2019
File name
Ferinject IE SPC October 2019 - Clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6 Fertility, pregnancy and lactation has been updated to include additional wording regarding foetal bradycardia and is highlighted in the blue text below
Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.
Updated on 21 January 2019
File name
FCM IE PIL January 2019-CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 21 January 2019
File name
FCM IE SPC January 2019 -CLEAN.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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
4.2 - Posology and method of administration:
- Special population: "injection" removed.
- Table 3 Dilution Plan of Ferinject for intravenous infusion - added "no minimal prescribed time" to minimum administration time.
4.4 Special Warnings and Precautions for use:
- Added paragraph on Hypophosphataemia.
- Extravasation: "injection" replaced with administration.
4.5 Interaction with other medicinal products and other forms of interaction:
- "injection" replaced with administration.
4.8 Undesirable effects:
- "7,391" replaced with >8,000.
-
Paragraph re worded from: "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)." to: "For subjects in clinical trials that showed a decrease in serum phosphorous, the minimum values were obtained after approximately 2 weeks, and in most cases returned to baseline values by 12 weeks following Ferinject treatment . The most serious ADR is anaphylactoid/anaphylactic reactions (rare); fatalities have been reported. See section 4.4 for further details.
-
Table 4: "Anaphylactoid reactions" replaced with Anaphylactoid/anaphylactic reactions. Added (whose onset may vary from a few hours to several days) following "Malaise,influenza like illness". Table footnote: 2. "were" replaced with are. 4. added: but is not limited to.
5.1 Pharmacodynamic properties:
- Cardiology: Abbriviation "(CHF)" removed.
Updated on 03 December 2018
File name
Ferinject November 2018 IE PIL Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 03 December 2018
File name
Ferinject SPC November 2018 IE Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2017
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 4.6 - 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 April 2017
File name
PIL_15142_123.pdf
Reasons for updating
- New PIL for new product
Updated on 18 April 2017
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 18 July 2016
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
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 15 July 2016
Reasons for updating
- Change to MA holder contact details
Updated on 23 November 2015
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 4.5 - 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
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
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 02 November 2015
Reasons for updating
- Change to storage instructions
- Change to side-effects
Updated on 13 July 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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
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 December 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic 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 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 27 November 2013
Reasons for updating
- Change to side-effects
- Change to improve clarity and readability
- Introduction of new pack/pack size
Updated on 13 November 2013
Reasons for 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
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
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 11 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 05 December 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 05 December 2011
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 26 September 2011
Reasons for updating
- New PIL for medicines.ie
- PIL retired pending re-submission