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FERINJECT 50MG IRON/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): FERRIC CARBOXYMALTOSE / FERRIC CARBOXYMALTOSE / FERRIC CARBOXYMALTOSE

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DOCUMENT INFORMATION

Package leaflet: Information for the patient
Ferinject 50 mg iron/mL solution for injection/infusion
Ferric carboxymaltose

Document Name

FJ_Pf_666_02_UK_GP_Version_03

Date

31.10.2016

Article No.

620011, 620012

ARTICLE INFORMATION

medicine is subject to additional monitor   Ting.hisThis
will allow quick identification of new
safety information. You can help by reporting
any side effects you may get. See the end of
section 4 for how to report side effects.

Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor.
– If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Ferinject is and what it is used for
2. What you need to know before you receive Ferinject
3. How Ferinject is given
4. Possible side effects
5. How to store Ferinject
6. Contents of the pack and other information

1. What Ferinject is and what it is used for

Ferinject is an antianaemic preparation, a medicine
that is used to treat anaemia. It contains iron in the
form of an iron carbohydrate. Iron is an essential element required for the oxygen-carrying capacity of
haemoglobin in red blood cells and of myoglobin in
muscle tissue. Moreover, iron is involved in many
other functions necessary for maintenance of life in
the human body.
Ferinject is used for the treatment of patients with
iron deficiency, when oral iron preparations are ineffective or cannot be used. The aim of the therapy is
to replenish body iron stores and to remedy anaemia,
a lack of red blood cells due to iron deficiency.
Before administration, your doctor will perform a
blood test to determine the dose of Ferinject you
require.

2. What you need to know before you
receive Ferinject

You must not receive Ferinject
– if you are allergic (hypersensitive) to the product
or any of the other ingredients of this medicine
(listed in section 6).
– if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
– if you have anaemia not caused by iron deficiency.
– if you have an iron overload (too much iron in your
body) or disturbances in the utilisation of iron.
Warnings and Precautions
Talk to your doctor or nurse before receiving Ferinject:
– if you have a history of medicine allergy
– if you have systemic lupus erythematosus
– if you have rheumatoid arthritis
– if you have severe asthma, eczema or other allergies
– if you have an infection
– if you have liver disorders
Ferinject should not be given to children under 14
years.
Incorrect administration of Ferinject may cause leakage of the product at the injection site, which may
lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. The
administration must be stopped immediately when
this occurs.
How Ferinject is given
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.
Other medicines and Ferinject
Tell your doctor if you are using, have recently used
or might use any other medicines, including medicines obtained without prescription. If Ferinject is
given together with oral iron preparations, then
these oral preparations could be less efficient.
Pregnancy
There is limited data from the use of Ferinject in pregnant women. It is important to tell your doctor if you
are pregnant, think you may be pregnant, or are planning to have a baby.
If you become pregnant during treatment, you must
ask your doctor for advice. Your doctor will decide
whether or not you should be given this medicine.
Breast feeding
If you are breast-feeding, ask your doctor for advice
before you are given Ferinject. It is unlikely that Ferinject represents a risk to the nursing child.
Driving and using machines
Ferinject is unlikely to impair the ability to drive or
operate machines.
Important information about some of the
ingredients of Ferinject
This medicinal product contains 0.24 mmol (or
5.5  mg) sodium per millilitre of undiluted solution.
This has to be taken into account by patients on a
sodium-controlled diet.

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3. How Ferinject is administered

Your doctor can administer Ferinject by three possible routes: undiluted by injection, during dialysis, or
diluted by infusion.
– By injection, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a
week directly into the vein.
– If you are on dialysis, you may receive Ferinject
during a haemodialysis session via the dialyser.
– By infusion, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a
week directly into the vein. Because Ferinject is
diluted with sodium chloride solution for the infusion, it may have a volume of up to 250 mL and
appear as a brown solution.
If you receive more Ferinject than you should
Your doctor will take responsibility for determining
the appropriate dose and choosing the route, frequency and duration of your treatment.
Overdose can cause accumulation of iron in storage
sites. Your doctor will monitor iron parameters such
as serum ferritin and transferrin to avoid iron accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects:
Tell your doctor immediately if you experience any of
the following signs and symptoms that may indicate
a serious allergic reaction: rash (e. g. hives), itching,
difficulty breathing, wheezing and/or swelling of the
lips, tongue, throat or body.
In some patients these allergic reactions (affecting
less than 1 in 1,000 people) may become severe or
life-threatening (known as anaphylactoid reactions)
and can be associated with heart and circulation
problems and loss of consciousness.
Your doctor is aware of these possible side effects
and will monitor you during and after the administration of Ferinject.
Other side effects that you should tell your doctor
about if they become serious:
Common side effects (may affect up to 1 in 10 people): headache, dizziness, feeling hot (flushing), high
blood pressure, nausea and injection/infusion site
reactions (see also section 2).
Uncommon side effects (may affect up to 1 in 100
people): numbness, tingling or prickling sensation on
the skin, a change in your taste sensation, high heart
rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching, hives, redness of the skin, rash, muscle-, joint -and/or back pain, pain in arms or legs,
muscle spasms, fever, tiredness, chest pain, swelling
of the hands and/or the feet, and chills.
Rare side effects (may affect up to 1 in 1,000 people):
inflammation of a vein, a general feeling of discomfort, loss of consciousness, anxiety, fainting, feeling
faint, wheeze, excessive wind (flatulence), rapid
swelling of the face, mouth, tongue or throat which
may cause difficulty in breathing, paleness, swelling
of the face, and flu-like symptoms like fever, headache and/or feeling ill (influenza-like illness).
Some blood parameters may change temporarily,
which could be detected in laboratory tests.
The following change in blood parameters is common: decrease in blood phosphorus.
The following changes in blood parameters are
uncommon: increase in certain liver enzymes called
alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and alkaline phosphatase, and increase in an enzyme called lactate
dehydrogenase.
Ask your doctor for more information.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Ferinject

Keep Ferinject out of the sight and reach of children.
Do not use Ferinject after the expiry date which is
stated on the label. The expiry date refers to the last
day of that month.
Store in the original package in order to protect from
light. Do not store above 30 °C. Do not freeze.
Once the Ferinject vials have been opened, they
should be used immediately. After dilution with sodium chloride solution, the diluted solution should be
used immediately.
Ferinject will normally be stored for you by your doctor or the hospital.

Pf 666-02

31.10.16 08:27

Product

Ferinject

Country

UK/Malta

Language(s)

English

Presentation Form

Vials

Contract Manufacturer

GP

DESIGN AND FONTS
Fonts

Univers

Font Sizes

min: 8.8 pt

max: 10 pt

Logos
Registration Number
COLOUR
Black
MANUFACTURER PACKAGING SPECIFICATIONS
Manufacturer Machine Code
Manufacturer Identification Number
Dimensions

148 x 420 mm

6. Contents of the pack and other information

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovak Republic, Spain, Sweden, United
Kingdom: Ferinject. Belgium, Luxembourg: Injectafer.
Slovenia: Iroprem.

What Ferinject contains
The active substance is iron (as ferric carboxymaltose, an iron carbohydrate compound). The concentration of iron present in the product is 50 mg per
millilitre. The other ingredients are sodium hydroxide
(for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection.
What Ferinject looks like and contents of the pack
Ferinject is a dark brown, non-transparent solution
for injection/infusion.

This leaflet was last revised in November 2016.

Ferinject is supplied in glass vials containing:
– 2 mL solution corresponding to 100 mg iron. Available in pack sizes of 1, 2 and 5 vials.
– 10 mL solution corresponding to 500 mg iron.
Available in pack sizes of 1, 2 and 5 vials.
– 20 mL solution corresponding to 1,000 mg iron.
Available in a pack size of 1 vial.

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.

Not all pack sizes may be marketed.

The following information is intended for
healthcare professionals only:

Vifor Pharma UK Limited
The Old Stables, Bagshot Park · Bagshot Surrey
GU19 5PJ UK

Marketing Authorisation Holder and Manufacturer
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
e-mail: contact-fr@viforpharma.com

Monitor patients carefully for signs and symptoms of
hypersensitivity reactions during and following each
administration of Ferinject. Ferinject should only be
administered when staff trained to evaluate and
manage anaphylactic reactions is immediately available, in an environment where full resuscitation
facilities can be assured. The patient should be
observed for adverse effects for at least 30 minutes
following each Ferinject administration.
Determination of the iron need
The individual iron need for repletion using Ferinject
is determined based on the patient’s body weight and
haemoglobin (Hb) level (see Table 1):

Table 1: Determination of the iron need
Hb

Patient body weight

g/dL

mmol/L

below 35 kg

35 kg to <70 kg

70 kg and above

<10

<6.2

500 mg

1,500 mg

2,000 mg

10 to <14

6.2 to <8.7

500 mg

1,000 mg

1,500 mg

≥14

≥8.7

500 mg

500 mg

500 mg

Iron deficiency must be confirmed by laboratory
tests.
Calculation and administration of the maximum
individual iron dose(s)
Based on the iron need determined above the appropriate dose(s) of Ferinject should be administered
taking into consideration the following:
A single Ferinject administration should not exceed:
• 15 mg iron/kg body weight (intravenous injection)
or 20 mg iron/kg body weight (intravenous infusion)
• 1,000 mg of iron (20 mL Ferinject)
The maximum recommended cumulative dose of
Ferinject is 1,000 mg of iron (20 mL Ferinject) per
week.
A single maximum daily injection dose of 200 mg iron
should not be exceeded in haemodialysis-dependent
chronic kidney disease patients.
The use of Ferinject has not been studied in children,
and therefore is not recommended in children under
14 years.

Method of administration
Ferinject must only be administered by the intravenous route: by injection, by infusion, or
during a haemodialysis session undiluted directly
into the venous limb of the dialyser. Ferinject must
not be administered by the subcutaneous or intramuscular route.
Caution should be exercised to avoid paravenous
leakage when administering Ferinject. Paravenous
leakage of Ferinject at the injection site may lead to
irritation of the skin and potentially long lasting
brown discolouration at the site of injection. In case
of paravenous leakage, the administration of Ferinject must be stopped immediately.
Intravenous injection
Ferinject may be administered by intravenous injection using undiluted solution. The maximum single
dose is 15 mg iron/kg body weight but should not
exceed 1,000 mg iron. The administration rates are as
shown in Table 2:

Table 2: Administration rates for intravenous injection of Ferinject
Volume of Ferinject
required

Equivalent iron dose

Administration rate /
Minimum administration time

2 to 4 mL

100 to 200 mg

No minimal prescribed time

>4 to 10 mL

>200 to 500 mg

100 mg iron/min

>10 to 20 mL

>500 to 1,000 mg

15 minutes

Intravenous infusion
Ferinject may administered by intravenous infusion, in which case it must be diluted. The maximum single
dose is 20 mg iron/kg body weight but should not exceed 1,000 mg iron. 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).
Table 3: Dilution plan of Ferinject for intravenous infusion
Volume of Ferinject
required

Equivalent iron dose

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 1,000 mg

250 mL

15 minutes

Monitoring measures
Re-assessment should be performed by the clinician
based on the individual patient’s condition. The Hb
level should be re-assessed no earlier than 4 weeks
post final Ferinject administration to allow adequate
time for erythropoiesis and iron utilisation. In the
event the patient requires further iron repletion, the
iron need should be recalculated using Table 1
above.
Incompatibilities
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.
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Overdose
Administration of Ferinject 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,
treat according to standard medical practice, e.g.
consider the use of an iron chelator.

Pf 666-02

31.10.16 08:27

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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