FERINJECT 50 мг/мл Инъекционная/инфузионная дисперсия

Содержание инструкции

1. Ferinject 50 mg iron/mL injectable dispersion/infusion
   1. What is Ferinject and what is it used for
   2. What you need to know before you are given Ferinject
   3. How Ferinject is administered
   4. Possible side effects
   5. How to store Ferinject
   6. Contents of the pack and other information

Ferinject 50 mg iron/mL injectable dispersion/infusion

ferric carboxymaltose
Read 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 questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Ferinject is and what it is used for
• 2. What you need to know before you are given 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 is Ferinject and what is it used for

Ferinject is a medicine that contains iron.
Medicines that contain iron are used when there is not enough iron in the body.
This condition is called iron deficiency.
Ferinject is used for the treatment of iron deficiency when:

• oral iron is not sufficiently effective.
• you cannot tolerate iron administered orally.
• the doctor decides that you need iron very quickly to build up iron stores.

The doctor will determine if you have iron deficiency by performing a blood test.

2. What you need to know before you are given Ferinject

You must not be given Ferinject

• If you are allergic (hypersensitive) to ferric carboxymaltose or any of the other ingredients of this medicine (listed in section 6).
• If you have had severe allergic (hypersensitivity) reactions to other iron-based injectable preparations.
• If you have anaemia notcaused by iron deficiency.
• If you have iron overload (excess iron in the body) or disorders of iron utilisation.

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Warnings and precautions
Talk to your doctor or nurse before you are given Ferinject

• if you have previously had allergies to medicines
• 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 problems
• if you have or have had low levels of phosphate in the blood

Ferinject should not be administered to children under 1 year of age.
Incorrect administration of Ferinject can cause product leakage at the site of
administration, which can lead to skin irritation and potentially long-lasting brown
discoloration at the site of administration. Administration should be
stopped as soon as this occurs.

Other medicines and Ferinject
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines. If Ferinject is
administered together with oral iron preparations, these oral preparations
may be less effective.

Pregnancy
There are limited data on the use of Ferinject in pregnant women. It is important to tell
your doctor if you are pregnant, suspect you may be pregnant or are planning a pregnancy.
If you become pregnant during treatment, you should ask your doctor for advice.
The doctor will decide whether or not you should be given this medicine.

Breastfeeding
If you are breastfeeding, ask your doctor for advice before you are
given Ferinject.
It is unlikely that Ferinject poses a risk to the infant.

Driving and using machines
It is unlikely that Ferinject will affect your ability to drive or operate machinery.

Ferinject contains sodium
This medicine contains up to a maximum of 5.5 mg of sodium (the main component
of table salt) per mL of undiluted dispersion. This is equivalent to
0.3% of the recommended maximum daily intake of sodium with the diet of an adult.

3. How Ferinject is administered

The doctor will decide the amount of iron to be administered to you, the frequency and the duration of the
administration. The doctor will perform a blood test to determine the necessary dose.

Adults and adolescents aged 14 years or older
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The doctor or nurse will administer Ferinject undiluted by injection, diluted for
infusion or during dialysis:

• For injection, up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, may be administered to you once a week directly into a vein.
• For infusion, up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, may be administered to you once a week directly into a vein. Since Ferinject is diluted with a sodium chloride solution for infusion, it may have a volume of up to 250 mL and will appear as a brown-colored solution.
• If you are undergoing dialysis, you may receive Ferinject during a hemodialysis session through the dialysis machine

Children and adolescents aged between 1 and 13 years
The doctor or nurse will administer Ferinject undiluted by injection or diluted for
infusion:

• Your child will receive Ferinject directly into a vein. It will appear as a brown-colored solution.
• If your child is undergoing dialysis, Ferinject should not be administered.

Ferinject will be administered in a facility where immune-allergic events can receive
appropriate and timely treatment. After each administration, the doctor or
nurse will keep you under observation for at least 30 minutes.

If you are given more Ferinject than you should
This medicine will be administered by experienced medical personnel, therefore it is
unlikely that you will be given an excessive amount.
Overdosage may cause iron accumulation in the body. The doctor will monitor
iron parameters to avoid iron accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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: skin rash (e.g., hives), feeling of
itching, difficulty breathing, wheezing and/or swelling of the lips, tongue, throat or
body, and chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
In some patients, these allergic reactions (which occur in less than 1 in 1,000 people)
can become serious or life-threatening (known as anaphylactic reactions) and may
be associated with heart and circulatory problems and loss of consciousness.
Tell your doctor if you develop worsening fatigue, muscle or bone pain (pain
in the arms or legs, joints or back). This could be a sign
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of a decrease in phosphorus in the blood, which could make the bones soft
(osteomalacia). This condition can sometimes lead to bone fractures. Your doctor may
also check phosphate levels in the blood, especially if you need numerous iron treatments
over time.
Your doctor is aware of these possible side effects and will monitor you
during and after the administration of Ferinject.

Other side effects that your doctor needs to be informed about if they worsen:
Common(may affect up to 1 in 10 people): headache, dizziness, feeling of warmth
(hot flushes), high blood pressure, nausea and reaction at the injection/infusion site
(see also section 2).

Uncommon(may affect up to 1 in 100 people): numbness, tingling or
pins and needles on the skin, changes in taste, fast heart rate,
low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, feeling of itching, hives, redness of the skin,
skin rash, muscle pain, joint and/or back pain, pain in the arms
or legs, muscle spasms, fever, fatigue, chest pain, swelling of the
hands and/or feet, chills and a general feeling of being unwell.

Rare(may affect up to 1 in 1,000 people): inflammation of a vein, anxiety,
fainting, feeling of fainting, wheezing, excessive abdominal gas (flatulence), rapid
swelling of the face, mouth, tongue or throat that can cause difficulty
breathing, paleness and changes in skin color in areas of the body other than
the injection site.

Not known(frequency cannot be estimated from the available data): loss of
consciousness and facial swelling.
A flu-like illness (may affect up to 1 in 1,000 people) can occur
several hours to several days after the injection and is usually characterized by symptoms such as
high temperature and muscle and joint pain.
Some blood parameters may be temporarily altered, as can be detected in
laboratory tests.
The following change in blood parameters is common: reduction in blood phosphorus level.
The following changes in blood parameters are uncommon: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma glutamyl
transferase and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.
For more information, please contact your doctor.

Reporting of side effects
If you get any side effect, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system
at:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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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.
Do not store at a temperature above 30°C. Do not freeze. For storage conditions
after dilution or the first opening of the medicine, see the paragraph “The
following information is intended exclusively for healthcare professionals”.
As a rule, Ferinject is stored by the doctor or the hospital.

6. Contents of the pack and other information

What Ferinject contains
The active ingredient is ferric carboxymaltose, an iron carbohydrate complex. The
concentration of iron present in the product is 50 mg per millilitre. Each vial
containing 2 mL contains ferric carboxymaltose corresponding to 100 mg of iron. Each vial
containing 10 mL contains ferric carboxymaltose corresponding to 500 mg of iron. Each
vial containing 20 mL contains ferric carboxymaltose corresponding to 1,000 mg of iron. The
other ingredients are sodium hydroxide (for pH adjustment), hydrochloric acid (for
pH adjustment) and water for injections.

Description of the appearance of Ferinject and contents of the pack
Ferinject is a non-transparent, dark brown-coloured injectable/infusion dispersion.
Ferinject is supplied in glass vials containing:

• 2 mL of dispersion. Packs of 1, 2 or 5 vials.
• 10 mL of dispersion. Packs of 1, 2 or 5 vials.
• 20 mL of dispersion. Packs of 1 vial.

Not all pack sizes may be marketed.
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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: [email protected]
Sales representative:
Vifor Pharma Italia Srl
Via Paolo di Dono 73
00142 Rome
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland):
Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.
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The following information is intended exclusively for healthcare professionals:
Carefully monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of Ferinject. Ferinject must be
administered only if qualified personnel are immediately available to assess and manage anaphylactic reactions, in a setting where resuscitation equipment can be
guaranteed. The patient must be kept under observation for adverse reactions for at least 30 minutes after each
administration of Ferinject.
Step 1: Determination of iron requirement
The individual iron requirement for replenishment with the help of Ferinject is determined on the
basis of the patient's body weight and haemoglobin (Hb) level. Refer to
Table 1 to determine the total iron requirement. 2 doses may be needed
to replenish the total iron requirement, see step 2 for individual maximum iron doses:

Table 1: Determination of total iron requirement

Step 2: Calculation and administration of the maximum individual iron dose(s)
Based on the total iron requirement determined, the appropriate dose(s) of Ferinject
must be administered taking into account the following:

Adults and adolescents aged 14 years and over
A single administration of Ferinject must not exceed:

• 15 mg of iron/kg of body weight (intravenous injection) or 20 mg iron/kg of body weight (intravenous infusion)
• 1,000 mg of iron (20 mL of Ferinject)

The recommended maximum cumulative dose of Ferinject is 1,000 mg of iron (20 mL of
Ferinject) per week. If the total iron requirement is higher, the administration of
an additional dose must occur at least 7 days after the first dose.

Children and adolescents aged 1 to 13 years
A single administration of Ferinject must not exceed:

• 15 mg iron/kg of body weight

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• 750 mg of iron (15 mL of Ferinject)

The recommended maximum cumulative dose of Ferinject is 750 mg of iron (15 mL of Ferinject)
per week. If the total iron requirement is higher, the administration of an additional dose
must occur at least 7 days after the first dose.

Children under 1 year of age
The use of Ferinject is not recommended in children under 1 year of age.

Patients with chronic kidney disease dependent on haemodialysisIn adult and
adolescent patients aged 14 years and over with chronic kidney disease dependent on
haemodialysis, a single maximum daily dose of 200 mg of iron must not be
exceeded.
The use of Ferinject in children aged 1 to 13 years with chronic kidney disease
dependent on haemodialysis is not recommended.
Route of administration
Ferinject must be administered exclusively by the intravenous route: by
injection, infusion or during haemodialysis undiluted directly into the venous access of the dialyser. Ferinject must not be administered by subcutaneous or
intramuscular route.
During the administration of Ferinject, care must be taken to avoid paravenous leakage.
Paravenous leakage of Ferinject at the administration site can
cause skin irritation and potentially long-lasting dark discolouration at the administration site. If paravenous leakage occurs, the administration of Ferinject must
be stopped immediately.

Intravenous injection
Ferinject can be administered by intravenous injection using the undiluted dispersion.
In adults and adolescents aged 14 years and over, the single maximum dose
is 15 mg of iron/kg of body weight, but must not exceed 1,000 mg of iron. In children
aged 1 to 13 years, the single maximum dose is 15 mg iron/kg of body weight,
but must not exceed 750 mg of iron. The administration rates are shown in
Table 2:

Table 2: Ferinject intravenous injection administration rates

Intravenous infusion
Ferinject can be administered by intravenous infusion; in this case it must
be diluted. In adults and adolescents aged 14 years and over, the single dose
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maximum is 20 mg of iron/kg of body weight, but must not exceed 1,000 mg of iron. In
children aged 1 to 13 years the single maximum dose is 15 mg iron/kg of body
weight, but must not exceed 750 mg of iron.
For infusion, Ferinject must be diluted exclusively in sterile sodium chloride solution
0.9% w/v as shown in Table 3. Note: for stability reasons, Ferinject
must not be diluted to concentrations lower than 2 mg of iron/mL (excluding the volume of the
ferric carboxymaltose dispersion).

Table 3: Ferinject dilution plan for intravenous infusion
Monitoring measures
The doctor must perform a reassessment based on the individual patient's condition. The
Hb level must be reassessed no earlier than 4 weeks after the last administration
of Ferinject to allow sufficient time for erythropoiesis and iron utilization. In the
event that the patient requires further iron replenishment, the requirement must be recalculated
using Table 1, above.
Incompatibilities
The absorption of iron by the oral route is reduced in case of concomitant administration of
parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of
Ferinject.
Overdose
The administration of Ferinject in quantities greater than those necessary to correct the
iron deficiency at the time of administration can lead to iron accumulation in the
storage sites, eventually leading to haemosiderosis. Monitoring of iron parameters, such as
serum ferritin and transferrin saturation, can facilitate the detection of iron accumulation.
If iron accumulation occurs, treat it according to standard medical practice, for
example consider the use of an iron chelator.
Stability in use

Period of validity after first opening of the container:
From a microbiological point of view, parenteral preparations must
be used immediately.
If not used immediately, the storage times and conditions are the responsibility of the user. The administration of the product must take place under controlled and validated aseptic conditions.
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The chemical and physical stability of the product in use has been demonstrated for 7 days at 30°C.

Period of validity in polyethylene and polypropylene containers after dilution with sterile solution

of sodium chloride 0.9% w/v:
From a microbiological point of view, parenteral preparations must
be used immediately after dilution with sterile sodium chloride solution
0.9% w/v.
If not used immediately, the storage times and conditions before
use are the responsibility of the user and generally do not exceed 24 hours between 2 and
8°C.
The chemical and physical stability in use of the product in use has been demonstrated for 72 hours at 30°C at
concentrations of 2 mg/mL and 5 mg/mL.

Period of validity in polypropylene syringe (undiluted):
From a microbiological point of view, the product must be used immediately.
If not used immediately, the storage times and conditions before
use are the responsibility of the user and generally do not exceed 24 hours between 2 and
8°C.
The chemical and physical stability of the product in use has been demonstrated for 72 hours at 30°C.
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