Ferinject

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Ferinject 50 mg iron/ml injection solution/infusion solution
iron carboxymaltose

Please read the following information carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor immediately. See section 4.

Table of contents

1. What Ferinject is and what it is used for
2. What you should know before receiving Ferinject
3. How Ferinject is administered
4. Possible side effects
5. How to store Ferinject
6. Contents of the package and other information

1. What Ferinject is and what it is used for

Ferinject is an iron-containing medicine.
Iron-containing medicines are used when the patient's body lacks iron. This condition is known as iron deficiency.
Ferinject is used to treat iron deficiency when:

• oral iron medications are not sufficiently effective;
• the patient does not tolerate oral iron medications;
• the physician determines that iron must be rapidly replenished in the body.

Your doctor will confirm the presence of iron deficiency by ordering a blood test.

2. Important information before using Ferinject

When not to use Ferinject

• if the patient is allergic (hypersensitive) to iron carboxymaltose or any of the other ingredients of this medicine (listed in section 6);
• in case of severe allergic reactions (hypersensitivity) to other injectable iron-containing medicines;
• if the patient has anaemia not caused by iron deficiency;
• if the patient has iron overload (excess iron in the body) or disorders of iron metabolism.

Warnings and precautions
Before starting treatment with Ferinject, discuss with your doctor or nurse:

• if the patient has previously had allergies to medicines;
• if the patient has systemic lupus erythematosus;
• if the patient has rheumatoid arthritis;
• if the patient has severe asthma, eczema or other allergies;
• if the patient has an infection;
• if the patient has liver problems;
• if the patient has or has previously had low blood phosphate levels.

Ferinject must not be given to children under 1 year of age.
Improper administration of Ferinject may cause leakage of the product at the injection site, which could lead to skin irritation and potentially long-lasting brown skin discolouration. In such a case, administration must be stopped immediately.

Ferinject with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.
Concomitant use of Ferinject and oral iron-containing medicines reduces the effectiveness of oral iron preparations.

Pregnancy
There is only limited data on the use of Ferinject in pregnant women.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
If pregnancy occurs during treatment, medical advice should be sought to determine whether treatment should be continued.

Breast-feeding
If breast-feeding, consult your doctor before taking Ferinject. It is unlikely that Ferinject poses a risk to breast-fed infants.

Driving and operating machinery
It is unlikely that Ferinject impairs the ability to drive or operate machinery.

Ferinject contains sodium
The medicine contains up to 5.5 mg of sodium (the main component of table salt) in each ml of undiluted dispersion.
Each 2 ml vial contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".
Each 10 ml vial contains up to 55 mg of sodium (the main component of table salt), equivalent to 2.8% of the maximum recommended daily dietary sodium intake for adults.
Each 20 ml vial contains up to 110 mg of sodium (the main component of table salt), equivalent to 5.5% of the maximum recommended daily dietary sodium intake for adults.

3. How Ferinject is administered
Your doctor will determine the dose of Ferinject, how often it should be given, and the duration of treatment. To determine the appropriate dose, your doctor may order blood tests.

Adults and adolescents aged 14 years and older
Ferinject will be administered by your doctor or nurse either undiluted via intravenous injection, diluted as an intravenous infusion, or during dialysis:
The maximum dose of Ferinject administered as a direct intravenous injection is 20 ml (equivalent to 1,000 mg of iron), once weekly.
For intravenous infusion, up to 20 ml of Ferinject (equivalent to 1,000 mg of iron) may be given once weekly. Before administration, Ferinject must be diluted with sodium chloride solution. The volume of the prepared solution may be up to 250 ml; the solution is brown in colour.
Patients undergoing haemodialysis may receive Ferinject administered through the dialysis line.

Children and adolescents aged 1 to 13 years
Ferinject will be administered by your doctor or nurse either undiluted via intravenous injection or diluted as an intravenous infusion.

• The child will receive Ferinject directly into a vein. It will be a brown solution.
• Ferinject must not be given to children undergoing dialysis.

Ferinject may only be administered in settings where immediate and appropriate medical treatment is available in case of hypersensitivity reactions. After each administration, the patient will be observed by a doctor or nurse for at least 30 minutes.

Accidental overdose of Ferinject
Since this medicine will be administered by trained medical personnel, it is unlikely that the patient will receive too high a dose.
Overdose may lead to excessive accumulation of iron in the body. To prevent iron overload, your doctor will regularly monitor iron metabolism parameters.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
Inform the doctor immediately if the patient experiences any of the following symptoms, which may
indicate a serious allergic reaction: rash (e.g. urticaria), itching, shortness of breath, wheezing, and (or)
swelling of the lips, tongue, throat or entire body, as well as chest pain, which may be a symptom of
the sometimes severe allergic reaction called Kounis syndrome.
In some patients, the aforementioned allergic reactions (occurring less frequently than in 1 out of 1,000
people) may intensify into severe or life-threatening allergic reactions (called anaphylactic
reactions) and may be accompanied by heart and circulatory problems and loss of consciousness.
If the patient experiences increased fatigue or muscle or bone pain (pain in arms or legs, joints or
back), they should inform the doctor. This may be a sign of decreased phosphate levels in the blood,
which may lead to softening of the bones (osteomalacia). Such a condition may occasionally lead to
bone fractures. The doctor may also order blood phosphate level testing, especially if the patient
requires repeated iron treatment over a prolonged period.
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The patient's doctor is aware of the possibility of the aforementioned adverse reactions and will
therefore monitor the patient's condition during and after administration of Ferinject.
Other adverse reactions, which should be reported to the doctor if they become severe:
Common (may affect up to 1 in 10 people): headache, dizziness, hot flushes, high blood pressure,
nausea, and reactions at the injection/infusion site (see also section 2).
Uncommon (may affect up to 1 in 100 people): numbness, tingling or pricking sensation of the skin,
altered taste sensation, rapid heartbeat, low blood pressure, shortness of breath, vomiting,
indigestion, abdominal pain, constipation, diarrhoea, skin itching, urticaria, skin redness, rash,
muscle, joint or back pain, pain in arms and legs, muscle cramps, fever, feeling of fatigue, chest pain,
swelling of hands or feet, chills and general feeling of discomfort.
Rare (may affect up to 1 in 1,000 people): phlebitis, feeling of anxiety, fainting, feeling of impending
faint, wheezing, excessive gas (flatulence), sudden swelling of the face, lips, tongue or throat, which
may cause breathing difficulties, pallor and skin discoloration in areas of the body other than the
injection site.
Frequency not known (frequency cannot be estimated from the available data): loss of
consciousness and facial swelling.
Flu-like symptoms (may affect up to 1 in 1,000 people) may occur within a few hours to several days
after injection; typical symptoms include high body temperature and muscle and joint pain.
Some blood test results may undergo transient changes. These can be detected by laboratory tests.
The following blood parameter change commonly occurs: decreased blood phosphate levels.
The following blood parameter changes occur uncommonly: increased activity of certain liver
enzymes known as alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl
transferase and alkaline phosphatase, and increased activity of the enzyme lactate dehydrogenase.
If further information is needed, consult the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the
doctor, pharmacist or nurse.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
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5. How to store Ferinject

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the specified month.
Do not store above 30°C. Do not freeze. For storage conditions after dilution or first opening of the container, see section "Information intended exclusively for medical professionals".
Ferinject is most commonly stored by a physician or in a hospital.

6. Contents of the package and other information

What Ferinject contains
The active substance is iron carboxymaltose — an iron-carbohydrate complex. The concentration of iron in this product is 50 mg/ml. Each 2 ml vial contains iron carboxymaltose equivalent to 100 mg of iron. Each 10 ml vial contains iron carboxymaltose equivalent to 500 mg of iron. Each 20 ml vial contains iron carboxymaltose equivalent to 1 000 mg of iron. Other ingredients of the medicinal product are: sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Ferinject looks like and contents of the pack
Ferinject is a dark brown, opaque dispersion for injection/infusion.
Ferinject is supplied in glass vials containing:
2 ml dispersion. Pack sizes: 1, 2 or 5 vials.
10 ml dispersion. Pack sizes: 1, 2 or 5 vials.
20 ml dispersion. Pack sizes: 1 vial of 20 ml.
Not all pack sizes may be marketed.

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]

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Netherlands, Ireland, Iceland, Latvia, Germany, Norway, Poland, Portugal, Slovak Republic, Romania, Sweden, Hungary, United Kingdom (Northern Ireland), Italy: Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.

For further information, please contact the local representative of the Marketing Authorisation Holder:

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Poland
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
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Information intended exclusively for medical professionals:

Patients must be carefully monitored for potential objective and subjective symptoms of hypersensitivity reactions during and after each administration of Ferinject.
Ferinject should only be administered when trained medical personnel, capable of assessing and managing anaphylactic reactions, are immediately available, and in a setting fully equipped with resuscitation equipment. Patients should be observed for adverse reactions for at least 30 minutes after each administration of Ferinject.
Step 1: Determining iron requirement
The individual iron requirement for correcting iron deficiency with Ferinject is based on the patient's body weight and hemoglobin (Hb) concentration. To determine the total iron requirement, refer to Table 1. Two doses may be required to meet the total iron requirement; see Step 2 for maximum single iron doses.
Table 1: Determining total iron requirement

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

Adults and adolescents aged 14 years and older
Single administration of Ferinject should not exceed:

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

The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL of Ferinject) per week. If the total iron requirement is higher, additional doses should be administered no sooner than 7 days after the first dose.

Children and adolescents aged 1 to 13 years
Single administration of Ferinject should not exceed:

• 15 mg of iron per kg of body weight
• 750 mg of iron (15 mL of Ferinject)

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The maximum recommended cumulative dose of Ferinject is 750 mg of iron (15 mL of Ferinject) per week. If the total iron requirement is higher, additional doses should be administered no sooner than 7 days after the first dose.

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

Patients with chronic kidney disease requiring hemodialysis
Adults and adolescents aged 14 years and older: in patients with chronic kidney disease requiring hemodialysis, the maximum single daily dose should not exceed 200 mg of iron.

Ferinject is not recommended for use in children aged 1 to 13 years with chronic kidney disease requiring hemodialysis.

Method of administration
Ferinject is intended exclusively for intravenous use: as an injection, infusion, or during hemodialysis as an undiluted dispersion administered directly via the venous line leading to the dialyzer. Ferinject must not be administered subcutaneously or intramuscularly.

Care must be taken during administration of Ferinject to avoid extravasation of the medicinal product into the perivascular space. Extravasation of Ferinject into the perivascular space may cause skin irritation and long-lasting brown skin discoloration at the injection site. If extravasation occurs, administration of Ferinject must be stopped immediately.

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

Table 2: Administration rate for Ferinject in intravenous bolus injection

Intravenous infusion
Ferinject can be administered as an intravenous infusion. In such cases, it must be diluted.
In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg of iron per kg of body weight, but must not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg of iron per kg of body weight, but must not exceed 750 mg of iron.
For infusion, Ferinject must be diluted only with sterile 0.9% m/V sodium chloride solution, according to the scheme given in Table 3. Note: Due to the stability of the solution, Ferinject must not be diluted to concentrations below 2 mg of iron/ml (excluding the volume of iron carboxymaltose dispersion).
Table 3: Dilution scheme for Ferinject for intravenous infusion

Monitoring actions
The physician should reassess based on the individual patient's condition. Reassessment of haemoglobin (Hb) concentration should not be performed earlier than 4 weeks after the last administration of Ferinject to allow sufficient time for erythropoiesis and iron utilization in the body.
If the patient requires further iron deficiency correction, the iron requirement should be recalculated using Table 1 above.

Pharmaceutical incompatibilities
Parenterally administered iron-containing products reduce the absorption of iron administered orally at the same time. Therefore, if oral iron therapy is necessary, it should not be initiated earlier than 5 days after the last administration of Ferinject.

Overdose
Administration of Ferinject in amounts exceeding the dose required to correct iron deficiency at the time of administration may lead to iron accumulation in the body's storage pool and, consequently, to hemosiderosis. In diagnosing iron overload, monitoring of iron metabolism parameters, such as serum ferritin concentration and transferrin saturation, may be useful. In case of iron accumulation, standard treatment for such conditions should be initiated, e.g., consideration of iron-chelating agents.

Stability ensuring suitability for use
Shelf-life after first opening of the container:
From a microbiological standpoint, parenteral preparations should be used immediately after preparation.
If not used immediately, the user is responsible for ensuring compliance with storage duration and conditions ensuring suitability for use. The product must be administered under controlled and verified aseptic conditions. Chemical and physical stability ensuring suitability for use has been demonstrated for up to 7 days when stored at 30°C.

Stability in polyethylene and polypropylene containers after dilution in sterile 0.9% sodium chloride solution:
From a microbiological standpoint, the parenteral preparation should be used immediately after dilution with sterile 0.9% sodium chloride solution.
If not used immediately, the user is responsible for ensuring compliance with storage duration and conditions ensuring suitability for use, which typically means storage for up to 24 hours at a temperature of 2°C to 8°C.
Chemical and physical stability ensuring suitability for use has been demonstrated for up to 72 hours at 30°C for concentrations of 2 mg/ml and 5 mg/ml.
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Stability in polypropylene syringe (undiluted):
From a microbiological standpoint, the product should be used immediately after preparation.
If not used immediately, the user is responsible for ensuring compliance with storage duration and conditions ensuring suitability for use, which typically means storage for up to 24 hours at a temperature of 2°C to 8°C.
Chemical and physical stability ensuring suitability for use has been demonstrated for up to 72 hours at 30°C.
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