Feriniect

PATIENT INFORMATION LEAFLET

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Patient Information Leaflet: Information for the Patient

Ferinject 50 mg iron/ml dispersion for injection/infusion

Carboxymaltose iron

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

• Please keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Ferinject and what is it used for
• 2. Important information before using Ferinject
• 3. How to use Ferinject
• 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 an iron-containing medicine.
Iron-containing medicines are given when the patient's body lacks iron. This condition is called iron deficiency.
Ferinject is used to treat iron deficiency when:

• oral iron medicines are not effective enough;
• the patient does not tolerate oral iron medicines;
• the doctor has determined that it is necessary to quickly replenish the patient's iron stores.

The doctor will check if the patient has 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 carboxymaltose iron or any of the other ingredients of this medicine (listed in section 6);
• in case of severe allergic reactions (hypersensitivity) to other intravenously administered iron-containing medicines; if the patient has anemia that is not caused by iron deficiency; if the patient has excessive iron accumulation (iron overload) or iron absorption disorders.

Warnings and precautions

Before starting treatment with Ferinject, the patient should discuss with their doctor or nurse:

• if the patient has a history of allergy 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;

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if the patient has liver disorders;
if the patient has or has had low phosphate levels in the blood.
Ferinject should not be given to children under 1 year of age.
Incorrect administration of Ferinject may cause the product to leak at the injection site, which can lead to skin irritation and potentially long-lasting discoloration of the skin at the injection site. In such a case, administration of Ferinject should be stopped immediately.

Ferinject and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription.
Concomitant use of Ferinject and oral iron medicines reduces the effectiveness of oral iron medicines.

Pregnancy

There are limited data on the use of Ferinject in pregnant women.
If the patient is pregnant, thinks she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
If the patient becomes pregnant during treatment, she should consult her doctor, who will decide whether to continue using Ferinject.

Breast-feeding

During breast-feeding, the patient should consult her doctor before taking Ferinject. It is unlikely that Ferinject poses a risk to breast-fed infants.

Driving and using machines

It is unlikely that Ferinject will affect the patient's ability to drive or use machines.

Ferinject contains sodium

The medicine contains up to 5.5 mg of sodium (the main component of common salt) per ml of undiluted dispersion. This corresponds to 0.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ferinject

The doctor will determine the dose of Ferinject to be administered to the patient, the frequency of administration, and the duration of treatment. To determine the dose of Ferinject for the patient, the doctor will order a blood test.
Adults and adolescents aged 14 and over
The doctor or nurse will administer Ferinject as an undiluted injection into a vein, as a diluted infusion, or during dialysis:
The maximum dose of Ferinject administered as an injection directly into a vein is 20 ml (equivalent to a dose of 1,000 mg of iron), once a week.
Up to 20 ml of Ferinject (equivalent to 1,000 mg of iron) can be administered as an intravenous infusion, once a week. Before administering Ferinject as an infusion, it must be diluted with a sodium chloride solution. The volume of the prepared solution may be up to 250 ml; the solution is brown in color.
Patients undergoing hemodialysis may receive Ferinject administered into the dialysis line.
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Children and adolescents aged 1 to 13
The doctor or nurse will administer Ferinject as an undiluted injection into a vein or as a diluted infusion.

• The child will receive Ferinject directly into a vein. It will be in the form of a brown solution.
• If the child is undergoing dialysis, Ferinject should not be administered.

Ferinject may only be administered in places where immediate and adequate medical assistance is available in case of an allergic reaction. After each administration of Ferinject, the patient will be monitored by a doctor or nurse for at least 30 minutes.

Overdose of Ferinject

Since this medicine will be administered to the patient by medical staff, it is unlikely that the patient will receive too much of the medicine.
Overdose may cause excessive iron accumulation in the body. To avoid excessive iron accumulation, the doctor will regularly check the patient's iron metabolism parameters.

4. Possible side effects

Like all medicines, Ferinject can cause side effects, although not everybody gets them.
Severe side effects:
The patient should immediately inform their doctor if they experience any of the following symptoms that may indicate a severe allergic reaction: rash (e.g., hives), 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 sign of a sometimes severe allergic reaction called Kounis syndrome.
In some patients, the aforementioned allergic reactions (occurring less frequently than in 1 in 1,000 people) may worsen to severe or life-threatening allergic reactions (called anaphylactic reactions) and may be accompanied by heart and circulation problems and loss of consciousness.
If the patient experiences increased fatigue or muscle or bone pain (pain in the arms or legs, joints, or back), they should inform their doctor. This may be a sign of decreased phosphate levels in the blood, which can lead to softening of the bones (osteomalacia). This condition can sometimes lead to bone fractures. The doctor may also order a blood test to check phosphate levels, especially if the patient needs repeated iron therapy for a longer period.
The doctor treating the patient is aware of the possibility of these side effects and will therefore monitor the patient's condition during and after administration of Ferinject.
Other side effects that the patient should inform their doctor about if they worsen to severe side effects:
Frequent(may occur in up to 1 in 10 people): headache, dizziness, feeling of heat (flushing), high blood pressure, nausea, and reactions at the injection site/infusion (see also section 2).
Uncommon(may occur in up to 1 in 100 people): feeling of numbness, tingling, or prickling of the skin, change in taste, rapid heartbeat, low blood pressure, shortness of breath, vomiting, indigestion, abdominal pain, constipation, diarrhea, itching of the skin, hives, redness of the skin, rash, muscle pain, joint or back pain, pain in the arms and legs, muscle cramps, fever, feeling of fatigue, chest pain, swelling of the hands or feet, chills, and general feeling of discomfort.
Rare(may occur in up to 1 in 1,000 people): vein inflammation, feeling of anxiety, fainting, feeling of impending fainting, wheezing, excessive gas (bloating), sudden swelling of the face, lips, tongue, or throat, which may cause difficulty breathing, paleness, and discoloration of the skin in areas 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 occur in up to 1 in 1,000 people) may occur within a few hours to a few days after injection; typical symptoms include high body temperature and muscle and joint pain.
Some blood test results may temporarily change. This can be detected by performing laboratory tests.
Frequent changes in blood parameters include decreased phosphate levels in the blood.
Uncommon changes in blood parameters include increased activity of certain liver enzymes, such as alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltranspeptidase, and alkaline phosphatase, as well as increased activity of the enzyme lactate dehydrogenase.
If additional information is needed, the patient should consult their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ferinject

The medicine should be stored 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 month.
Do not store above 30°C. Do not freeze. Storage conditions after dilution or opening of the pack, see section "Information intended for healthcare professionals only".
Ferinject is usually stored by the doctor or in a hospital.
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6. Contents of the pack and other information

What Ferinject contains

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

What Ferinject looks like and contents of the pack

Ferinject is a dark brown, non-transparent dispersion for injection/infusion.
Ferinject is supplied in glass vials containing:
2 ml of dispersion. Pack sizes: 1, 2, or 5 vials.
10 ml of dispersion. Pack sizes: 1, 2, or 5 vials.
20 ml of dispersion. Pack sizes: 1 vial of 20 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Phone: +33 (0)1 41 06 58 90
Fax: +33 (0)1 41 06 58 99
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area and in 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, Slovakia, Romania, Sweden, Hungary, United Kingdom (Northern Ireland), Italy: Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.

Date of last revision of the leaflet: November 2024

For more detailed information, the patient should contact their local representative of the marketing authorization holder:

Poland

Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Phone: +33 (0)1 41 06 58 90
Fax: +33 (0)1 41 06 58 99
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Information intended for healthcare professionals only:

The patient's condition should be carefully monitored for signs of subjective and objective hypersensitivity reactions during each administration of Ferinject and after administration.
Ferinject should only be administered when personnel trained in the evaluation and treatment of anaphylactic reactions are immediately available, in a fully equipped resuscitation facility. The patient should be monitored for adverse reactions for at least 30 minutes after each administration of Ferinject.

Step 1: Determining iron requirements

The individual iron requirement for treating iron deficiency with Ferinject is determined based on the patient's body weight and hemoglobin (Hb) concentration. To determine the total iron requirement, refer to Table 1. To meet the total iron requirement, two doses may be required, see Step 2, which provides the maximum individual iron doses.

Table 1: Determining total iron requirement

Step 2: Calculating and administering the individual maximum dose (or doses) of iron

Based on the determined total iron requirement, the corresponding dose (or doses) of Ferinject should be administered, taking into account the following:
Adults and adolescents aged 14 and over
A single dose 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, administration of an additional dose should be done at an interval of at least 7 days from the first dose.
Children and adolescents aged 1 to 13
A single dose 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, administration of an additional dose should be done at an interval of at least 7 days from 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 and over: in patients with chronic kidney disease requiring hemodialysis, the single maximum daily dose should not exceed 200 mg of iron.
In children aged 1 to 13 with chronic kidney disease requiring hemodialysis, Ferinject is not recommended for use.
Administration method
Ferinject is intended for intravenous use only: by injection, infusion, or during hemodialysis in an undiluted form directly into the venous line leading to the dialyzer. Ferinject should not be administered subcutaneously or intramuscularly.
When administering Ferinject, caution should be exercised to avoid extravasation of the medicinal product into the perivenous space. Extravasation of Ferinject into the perivenous space may lead to skin irritation and potentially long-lasting brown discoloration of the skin at the injection site. If extravasation occurs, administration of Ferinject should be stopped immediately.

Step 1: Intravenous injection

Ferinject can be administered by intravenous injection in an undiluted form. In adults and adolescents aged 14 and over, the maximum single dose is 15 mg of iron per kg of body weight, but should not exceed 1,000 mg of iron. In children aged 1 to 13, the maximum single dose is 15 mg of iron per kg of body weight, but should not exceed 750 mg of iron. The rate of administration is presented in Table 2:

Table 2: Rate of administration of Ferinject by intravenous injection

Step 2: Intravenous infusion
Ferinject can be administered by intravenous infusion. In this case, it must be diluted.
In adults and adolescents aged 14 and over, the maximum single dose is 20 mg of iron per kg of body weight, but should not exceed 1,000 mg of iron. In children aged 1 to 13, the maximum single dose is 15 mg of iron per kg of body weight, but should not exceed 750 mg of iron.
Ferinject should be diluted only with sterile 0.9% m/V sodium chloride solution, as presented in Table 3. Note: due to the stability of the solution, Ferinject should not be diluted to concentrations below 2 mg of iron per ml (without considering the volume of the carboxymaltose iron dispersion).

Table 3: Scheme for diluting Ferinject for intravenous infusion

Monitoring measures
The doctor should reassess based on the individual patient's condition. Reassessment of hemoglobin levels should be performed no 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 supplementation, the iron requirement should be recalculated using Table 1 above.
Incompatibilities
Intravenously administered iron products reduce the absorption of iron given orally at the same time. Therefore, if oral iron therapy is necessary, it should not be started earlier than 5 days after the last administration of Ferinject.
Overdose
Administration of Ferinject in amounts exceeding the dose required to replenish iron deficiency at the time of administration may lead to iron accumulation in the storage pool and, consequently, to hemosiderosis. In the diagnosis of iron overload, monitoring of iron metabolism parameters, such as serum ferritin and transferrin saturation, may be helpful. In case of iron accumulation, standard treatment for this condition should be initiated, such as the use of iron-chelating agents.
Shelf life after first opening of the pack:
For microbiological reasons, the product for intravenous use should be used immediately after preparation.
If not used immediately, the user is responsible for ensuring the storage conditions and shelf life. The product must be administered in controlled and checked aseptic conditions. Chemical and physical stability ensuring the product's suitability for use has been demonstrated during storage for 7 days at 30°C.
Stability in polyethylene and polypropylene containers after dilution in sterile 0.9% m/V sodium chloride solution:
For microbiological reasons, the product for intravenous use should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.
If not used immediately, the user is responsible for ensuring the storage conditions and shelf life, which usually means storage for up to 24 hours at a temperature between 2°C and 8°C.
Chemical and physical stability ensuring the product's suitability for use has been demonstrated during storage for 72 hours at 30°C at concentrations of 2 mg/ml and 5 mg/ml.
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Stability in a polypropylene syringe (undiluted):
For microbiological reasons, the product should be used immediately after preparation.
If not used immediately, the user is responsible for ensuring the storage conditions and shelf life, which usually means storage for up to 24 hours at a temperature between 2°C and 8°C.
Chemical and physical stability ensuring the product's suitability for use has been demonstrated during storage for 72 hours at 30°C.
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