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Ferinject (ferric carboxymaltose)

Last Updated on eMC 23-May-2017 View document  | Vifor Pharma UK Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23-May-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)

Date of revision of text on the SPC: 31-Mar-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The following Marketing Authorisation Numbers have been added to section 8 of the Summary of Product Characteristics (SmPC):

MA869/00102 and MA869/00103

 

 

 

Updated on 11-Apr-2017 and displayed until 23-May-2017

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 - Fertility, 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: 29-Mar-2017

Legal Category:POM

Black Triangle (CHM): YES

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 address details regarding ‘The Medicines Authority’ in Malta has been edited

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 ‘March 2017’

Updated on 19-Jul-2016 and displayed until 11-Apr-2017

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jul-2016

Legal Category:POM

Black Triangle (CHM): YES

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 02-Oct-2015 and displayed until 19-Jul-2016

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 01-Sep-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Spelling of "diarrhoea" ammneded

Updated on 18-Sep-2015 and displayed until 02-Oct-2015

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 - Fertility, 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:POM

Black Triangle (CHM): YES

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 10-Jul-2015 and displayed until 18-Sep-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:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Text change in 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 23-Oct-2013 and displayed until 10-Jul-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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC: 01-Oct-2013

Legal Category:POM

Black Triangle (CHM): YES

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 4.3

 

“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

 

The term Lactation has been replaced by “Breast-feeding”

In section 4.7

 

The phrase “Ferinject is unlikely to impair the ability to drive or operate machines” has been replaced by “Ferinject is unlikely to impair the ability to drive and use machines”

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 included.


In section 4.9

 

If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.

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 5.2

 

The acronym for Positron emission tomography has been removed

An acronym for iron deficiency has been added.

In section 5.3

 

The term “Pre-clinical” has been unhyphenated to “Preclinical”

In section 6.3


The term “Shelf-life” has been unhyphenated to “shelf life”

In section 6.5

 

Pack sizes are now listed

 

Details for the 20mL vial (containing 1,000mg of iron) are also listed.

In section 8

 

Details for Malta have been included

In section 9

 

Details for Malta have been included

In section 10

 

Dates of revision has been updated

Details for Malta have been included

Updated on 03-Apr-2013 and displayed until 23-Oct-2013

Reasons for adding or updating:

  • Removal of black triangle

Date of revision of text on the SPC: 29-Sep-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The Medicines and Healthcare products Regulatory Agency (MHRA) has decided that with immediate effect Ferinject® (ferric carboxymaltose) is no longer on the Black Triangle List and is no longer required to display the black triangle.

Updated on 25-Oct-2011 and displayed until 03-Apr-2013

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC: 29-Sep-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.2 (Posology and method of administration) has been amended to reflect an increase in the maximal single dose of Ferinject from 15 to 20mg/kg bodyweight for IV infusion (For IV injection we have the same limitation of 15mg/kg bodyweight)

In section 4.3 (Contraindications), the contraindication for pregnancy in the first trimester has been removed and a more stringent wording included in section 4.6 (Fertility, pregnancy and lactation)

Section 4.6 (Pregnancy and lactation) now reads as follows

Pregnancy

There are no data from the use of Ferinject in pregnant women. A careful risk/benefit evaluation is required before use during pregnancy and Ferinject should not be used during pregnancy unless clearly necessary. Animal data suggest that iron released from Ferinject can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus (see section 5.3).

Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. If the benefit of Ferinject treatment is judged to outweigh the potential risk to the fetus, it is recommended that treatment should be confined to the second and third trimester.

Lactation

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

Fertility

There are no data on the effect of Ferinject on human fertility. Fertility was unaffected following Ferinject treatment in animal studies (see section 5.3).

Updated on 05-Sep-2011 and displayed until 25-Oct-2011

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
  • Change to MA holder contact details

Date of revision of text on the SPC: 01-Jul-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



1.         Name of the Medicinal Product

 

FERINJECTFerinject 50 mg iron/ml solution for injection/infusion.

 

 

2.         Qualitative and Quantitative Composition

 

One milliliterml of solution contains 50 mg of iron as ferric carboxymaltose.

 

Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.

Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose.

 

Ferinject contains sodium hydroxide. One milliliterml of solution contains up to 5.5 mg (0.24 mmol (5.5 mg) sodium, see section 4.2.4. For a full list of excipients, see section 6.1.

 

 

3.         Pharmaceutical Form

 

Solution for injection/infusion. Dark brown, non-transparent, aqueous solution.

 

 

4.         Clinical Particulars

 

4.1       Therapeutic indications

 

FERINJECTFerinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.

The diagnosis must be based on laboratory tests.

 

4.2       Posology and method of administration

 

CalculationDetermination of the cumulative iron dose

 

The adequate cumulative dose of FERINJECT must be calculated for each patient individually and must not be exceeded. For overweight patients, a normal body weight/blood volume relation should be assumed when determining the iron requirement. The dose of FERINJECT is expressed in mg of elemental iron.

 

The cumulative dose required for Hb restoration and repletion of iron stores is calculated by the following Ganzoni formula:

 

Cumulative iron deficit [mg] =

body weight [kg] x (target Hb* - actual Hb) [g/dl]** x 2.4*** +

iron storage depot [mg]****

 

*

Target Hb for body weight below 35 kg = 13 g/dl respectively 8.1 mmol/l.

Target Hb for body weight 35 kg and above = 15 g/dl respectively 9.3 mmol/l.

**

To convert Hb [mM] to Hb [g/dl]: multiply Hb [mM] by the factor 1.61145.

***

Factor 2.4 = 0.0034 x 0.07 x 10000;

0.0034: iron content of haemoglobin  0.34%;
0.07: blood volume
 7% of body weight;
10000: conversion factor 1 g/dl =10000 mg/l.

****

Depot iron for body weight below 35 kg = 15 mg/kg body weight.

Depot iron for body weight 35 kg and above = 500 mg.

The cumulative dose for repletion of iron using Ferinject is determined based on the patient’s body weight and haemoglobin level and must not be exceeded. The following table should be used to determine the cumulative iron dose:

 

Hb (g/dL)

 

Patients with body weight
35 kg to <70 kg

Patients with body weight
≥70 kg

 

<10

 

 

1500 mg

 

2000 mg

 

≥10

 

 

1000 mg

 

1500 mg

 

Note: A cumulative iron dose of 500 mg should not be exceeded for patients with body weight

< 35 kg.

For overweight patients, a normal body weight/blood volume relationship should be assumed when determining the iron requirement.

For patients £ 66 kg: the calculated cumulative dose is to be rounded down to the nearest 100 mg.

For patients > 66 kg: the calculated cumulative dose is to be rounded up to the nearest 100 mg.

For patients with an Hb value ≥ 14 g/dL, an initial dose of 500 mg iron should be given and iron parameters should be checked prior to repeat dosing.

Patients may continue to require therapy with FERINJECT at the lowest dose necessary to maintain target levels of haemoglobin, and other laboratory values of iron storage parameters within acceptable limits.

Post repletion, regular assessments should be completed to ensure that iron levels are corrected and maintained.

 

Maximum tolerated single dose

The adequate cumulative dose of FERINJECT must be calculated for each patient individually and must not be exceeded.

A single dose of Ferinject should not exceed 1000 mg of iron (20 ml) per day or 15 mg of iron (0.3 ml) per kg body weight. Do not administer 1000 mg of iron (20 ml) more than once a week.

 

Intravenous bolus injection:

FERINJECTFerinject may be administered by intravenous injection up to a maximum single dose of 4 ml (200 mg of iron) per day but not more than three times a weekusing undiluted solution up to 1000 mg iron. For doses greater than 200 and up to 500 mg iron, Ferinject should be administered at a rate of 100 mg/min. For doses greater than 500 and up to 1000 mg iron, Ferinject should be administered over 15 minutes.

 

Intravenous drip infusion:

FERINJECTFerinject may be administered by intravenous infusion up to a maximum single dose of 20 ml of FERINJECT (1000 mg of iron) but not exceeding 0.3 ml of FERINJECT (15 mg of iron) per kg body weight or the calculated cumulative dose. Do not administer 20 ml (1000 mg of iron) as an infusion more than once a week. (20 ml).

 

The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years.

 

Method of administration

FERINJECTFerinject must be administered only by the intravenous route: by bolus injection, or during a haemodialysis session undiluted directly into the venous limb of the dialyser, or by drip infusion. In case of drip infusion FERINJECTFerinject must be diluted only in sterile 0.9% m/V sodium chloride solution as follows:

 

Dilution plan of FERINJECTFerinject for intravenous drip infusion

 

FERINJECTFerinject

 

Iron

Maximum amount of
sterile 0.9% m/V sodium chloride solution

Minimum administration time

2

to

< 4 ml

100

to

 < 200 mg

50 ml

 

-

4

to

< 10 ml

200

to

 < 500 mg

100 ml

 

6 minutes

 

10

to

20 ml

500

to

1000 mg

250 ml

 

15 minutes

 

 

Note: For stability reasons, dilutions to concentrations less than 2 mg iron/ml are not permissible.

 

FERINJECTFerinject must not to be administered by the subcutaneous or intramuscular route.

 

Haemodialysis-dependent chronic kidney disease

A single maximum daily injection dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients (see also section 4.4).

 

Paediatric population

The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years.

 

4.3       Contraindications

 

The use of FERINJECTFerinject is contraindicated in cases of:

·         known hypersensitivity to Ferinject or to any of its excipients

·         anaemia not attributed to iron deficiency, e.g. other microcytic anaemia

·         evidence of iron overload or disturbances in utilisation of iron

·         pregnancy in the first trimester

 

4.4       Special warnings and precautions for use

 

Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactoid reactions, which may be potentially fatal (see section 5.34.8). Therefore, facilities for cardio-pulmonary resuscitation must be available. If allergic reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.

 

In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload.

 

No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200 mg iron are available.

 

Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that the administration of FERINJECTFerinject is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis.

 

Caution should be exercised to avoid paravenous leakage when administering FERINJECTFerinject. Paravenous leakage of FERINJECTFerinject at the injection site may lead to brown discolouration and irritation of the skin. In case of paravenous leakage, the administration of FERINJECTFerinject must be stopped immediately.

 

One millilitreml of undiluted FERINJECTFerinject contains up to 5.5 mg (0.24 mmol (5.5 mg) of sodium. This has to be taken into account in patients on a sodium-controlled diet.

 

One ml of undiluted Ferinject contains maximally 75 µg aluminium. This should be considered in the treatment of patients undergoing dialysis.

 

The use of FERINJECTFerinject has not been studied in children.

 

Do not administer 20 ml (1000 mg of iron) as an injection or infusion more than once a week.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

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

 

4.6       Pregnancy and lactation

 

Clinical data on pregnant women are not available. A careful risk/benefit evaluation is required before use during pregnancy.

Animal data suggest that iron released from FERINJECTFerinject can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus

Clinical studies showed that transfer of iron from FERINJECTFerinject to human milk was negligible (£ 1%). Based on limited data on nursing women it is unlikely that FERINJECTFerinject represents a risk to the nursing child.

 

4.7       Effects on ability to drive and use machines

 

FERINJECTFerinject is unlikely to impair the ability to drive or operate machines.

 

4.8       Undesirable effects

 

The most commonly reported ADR is headache, occurring in 3.3% of the patients.

 

System Organ Class

Very common (≥1/10)

Common (≥1/100, <1/10)

Uncommon (≥1/1000, <1/100)

Rare (≥1/10000, <1/1000)

Immune system disorders

 

 

Hypersensitivity including anaphylactoid reactions

 

Nervous system disorders

 

Headache, dizziness

Paraesthesia

 

Vascular disorders

 

 

Hypotension, hypertension, flushing

 

Respiratory, thoracic and mediastinal disorders

 

 

 

Dyspnoea

Gastrointestinal disorders

 

Nausea, abdominal pain, constipation, diarrhoea

Dysgeusia, vomiting, dyspepsia, flatulence

 

Skin and subcutaneous tissue disorders

 

Rash

Pruritus, urticaria

 

Musculoskeletal and connective tissue disorders

 

 

Myalgia, back pain, arthralgia

 

 

General disorders and administration site conditions

 

Injection Site Reactions

Pyrexia, fatigue, chest pain, rigors, malaise, oedema peripheral

 

Investigations

 

 

Transient blood phosphorus decreased, alanine aminotransferase increased

Aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood lactate dehydrogenase increased

 

 

There are no undesirable effects with unknown frequency.

 

Immune System Disorders

Uncommon (>1/1,000, <1/100): Hypersensitivity including anaphylactoid reactions

 

Nervous system disorders

Common (>1/100, <1/10): Headache, dizziness

Uncommon (>1/1,000, <1/100): Paraesthesia

 

Vascular disorders

Uncommon (>1/1,000, <1/100): Hypotension, flushing

 

Respiratory, thoracic and mediastinal disorders 

Rare (>1/10,000, <1/1,000): Dyspnoea

Gastrointestinal disorders

Common (>1/100, <1/10): Nausea, abdominal pain, constipation, diarrhoea

Uncommon (>1/1,000, <1/100): Dysgeusia, vomiting, dyspepsia, flatulence

 

Skin and subcutaneous tissue disorders

Common (>1/100, <1/10): Rash

Uncommon (>1/1,000, <1/100): Pruritus, urticaria

 

Musculoskeletal and connective tissue disorders

Uncommon (>1/1,000, <1/100): Myalgia, back pain, arthralgia

 

General disorders and administration site conditions

Common (>1/100, <1/10): Injection Site Reactions

Uncommon (>1/1,000, <1/100): Pyrexia, fatigue, chest pain, rigors, malaise, oedema peripheral

Investigations

Common (>1/100, <1/10): Transient blood phosphorus decreased, alanine aminotransferase increased

Uncommon (>1/1,000, <1/100): Aspartate aminostransferase increased,  gamma-glutamyltransferase increased, blood lactate dehydrogenase increased

 

4.9       Overdose

 

Administration of FERINJECTFerinject in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising iron accumulation. If iron accumulation has occurred, the use of an iron chelator may be considered.

 

 

5.         Pharmacological Properties

 

5.1       Pharmacodynamic properties

 

Pharmacotherapeutic group: Iron trivalent, parenteral preparation

 

ATC Code: B03A C01

 

Ferinject solution for injection/infusion contains iron in a stable ferric state as a complex of a polynuclear iron-hydroxide core with a carbohydrate polymerligand. The complex is designed to releaseprovide, in a controlled way, utilisable iron tofor the iron transport and storage proteins in the body (ferritin and transferrin and ferritin, respectively). Clinical studies showed that the haematological response and the filling of the iron stores was faster after intravenous administration of Ferinject than with orally administered comparators.

Using positron emission tomography (PET) it was demonstrated that red cell utilisation of 59Fe and 52Fe from FERINJECTradio-labelled Ferinject ranged from 61% to 99%. PatientsAfter 24 days, patients with iron deficiency showed utilisation of radio-labelled iron of 91% to 99% after 24 days, and patients with renal anaemia showed utilisation of radio-labelled iron of  61% to 84% after 24 days.%.

One millilitre of undiluted Ferinject contains less than 75 mg aluminium. This should be considered in the treatment of patients undergoing dialysis.

 

 

5.2       Pharmacokinetic properties

 

Using positron emission tomography (PET) it was demonstrated that 59Fe and 52Fe  from FERINJECTFerinject was rapidly eliminated from the blood, transferred to the bone marrow, and deposited in the liver and spleen.

 

After administration of a single dose of FERINJECTFerinject of 100 to 1000 mg of iron in iron deficient patients, maximum total serum iron levels of 37 µg/ml up to 333 µg/ml after 15 minutes to 1.21 hours respectively are obtained. The volume of the central compartment corresponds well to the volume of the plasma (approximately 3 litres).

The iron injected or infused was rapidly cleared from the plasma, the terminal halflifehalf-life ranged from 7 to 12 hours, the mean residence time (MRT) from 11 to 18 hours. Renal elimination of iron was negligible.

 

5.3              Pre-clinical safety data

 

Pre-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity and genotoxicity. Animal studies indicate that iron released from FERINJECTFerinject does cross the placental barrier and is excreted in milk. In reproductive toxicology studies using iron replete animals FERINJECTFerinject was associated with minor skeletal abnormalities in the fetus. No long-term studies in animals have been performed to evaluate the carcinogenic potential of FERINJECTFerinject. No evidence of allergic or immunotoxic potential has been observed. A controlled in-vivo test demonstrated no cross-reactivity of FERINJECTFerinject with anti-dextran antibodies. No local irritation or intolerance was observed after intravenous administration.

 

 

6.         Pharmaceutical Particulars

 

6.1       List of excipients

 

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

 

6.2       Incompatibilities

 

This medicinal product must not be mixed with other medicinal products thanexcept those mentioned in section 6.6.

The compatibility with containers other than polyethylene and glass is not known.

 

6.3       Shelf-life

 

Shelf-life of the product as packaged for sale:

3 years.

 

Shelf-life after first opening of the container:

From a microbiological point of view, preparations for parenteral administration should be used immediately.

 

Shelf-life after dilution with sterile 0.9% m/V sodium chloride solution:

From a microbiological point of view, preparations for parenteral administration should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.

 

6.4.      Special precautions for storage

 

Store in the original package. Do not store above 30 °C. Do not refrigerate or freeze.

 

6.5.      Nature and contents of container

 

2 ml of solution in a vial (type I glass) with bromobutyl rubber stopper and aluminium cap in pack sizes of 1 and 5 vials.

 

10 ml of solution in a vial (type I glass) with bromobutyl rubber stopper and aluminium cap in pack sizes of 1 and 5 vials.

 

Not all pack sizes may be marketed.

 

6.6       Special precautions for disposal and other handling

 

Inspect vials visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.

 

Each vial of FERINJECTFerinject is intended for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

 

FERINJECTFerinject must only be mixed with sterile 0.9% m/V sodium chloride solution. No other intravenous dilution solutions and therapeutic agents should be used, as there is the potential for precipitation and/or interaction. For dilution instructions, see section 4.2.

 

 

7.         Marketing Authorisation Holder

 

Vifor France SA

7-13, BdBoulevard Paul- Emile Victor

92200 Neuilly-sur-Seine

France

Tel.  +33 (0)1 41 06 58 90

Fax  +33 (0)1 41 06 58 99

e-mail: contact@vifor-france.fr

 

 

8.         Marketing Authorisation Number

 

PL 15240/0002

 

 

9.         Date of First Authorisation/Renewal of THE Authorisation

 

19.07.2007

 

 

10.       Date of Revision of the Text

 

July 201109.07.2009

 

Updated on 27-Jan-2011 and displayed until 05-Sep-2011

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Company name change or merger

Date of revision of text on the SPC: 09-Jul-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:


  • Minor formatting changes have been made to sections 4.2 (Posology and method of administration) and 4.6 (Pregnancy and Lactation)
  • The company contact details have been changed from:
  • Syner-Med (Pharmaceuticals Products) Ltd
    Beech House,
    840 Brighton road,
    Purley,
    Surrey,
    CR8 2BH
    Telephone: +44 (0)845 634 2100
    Fax: +44 (0)845 634 2101

    to

    Vifor Pharma UK Limited
    The Old Stables
    Bagshot Park
    Bagshot
    Surrey
    GU19 5PJ
    Telephone: +44 (0)1276 853600
    Fax: +44 (0)1276 452341

Company contact details

Vifor Pharma UK Limited

Company image
Address

The Old Stables, Bagshot Park, Surrey, GU19 5PJ, UK

Fax

+44 (0)1276 452 341

Medical Information e-mail
Medical Information Fax

+44 (0)1276 452 341

Telephone

+44 (0)1276 853 600

Medical Information Direct Line

+44 (0)1276 853 633

Customer Care direct line

+44 (0)1276 853 633

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

Ferric carboxymaltose

Legal categories

POM - Prescription Only Medicine

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