FERINJECT 50 mg/ml DISPERSION FOR INJECTION AND INFUSION

2. What you need to know before you use Ferinject

Do not useFerinject

• If you are allergic (hypersensitive) to iron carboxymaltose or any of the other ingredients of this medicine (listed in section 6).
• If you have had severe allergic reactions (hypersensitivity) to other injectable iron preparations.
• If you have anemia notcaused by iron deficiency.
• If you have iron overload (too much iron in the body) or problems with iron use.

Warnings and precautions

Talk to your doctor or nurse before you start receiving Ferinject:

• If you have a history of 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 any infection.
• If you have any liver disorder.
• If you have or have had low phosphate levels in the blood.

Ferinject should not be given to children under 1 year of age.

Incorrect administration of Ferinject can cause product loss at the administration site, which can lead to skin irritation and a brown discoloration of the administration site that can last for a long time. If this happens, administration should be stopped immediately.

Using Ferinject with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines, including medicines obtained without a prescription. If Ferinject is given with oral iron preparations, the oral preparations may be less effective.

Pregnancy

There are limited data on the use of Ferinject in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before using this medicine.

If you become pregnant during treatment, you should ask your doctor for advice; your doctor will decide whether you should be given the medicine or not.

Breastfeeding

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

Driving and using machines

Ferinject is unlikely to affect your ability to drive or use machines.

Ferinject contains sodium

This medicine contains up to 5.5 mg of sodium (a major component of table/cooking salt) per milliliter of undiluted dispersion.

Each 2 ml vial contains less than 1 mmol of sodium (23 mg); this is essentially "sodium-free".

Each 10 ml vial contains up to 55 mg of sodium (a major component of table/cooking salt). This is equivalent to 2.8% of the maximum recommended daily sodium intake for an adult.

Each 20 ml vial contains up to 110 mg of sodium (a major component of table/cooking salt). This is equivalent to 5.5% of the maximum recommended daily sodium intake for an adult.

3. How to use Ferinject

Your doctor will decide how much Ferinject to give you, how often you need it, and for how long. Your doctor will do a blood test to determine the dose you need.

Adults and adolescents 14 years and older

The doctor or nurse will give you Ferinject undiluted by injection, diluted by intravenous infusion, or during dialysis:

• By injection, you may be given up to 20 ml of Ferinject, which corresponds to 1,000 mg of iron, once a week, directly into a vein.
• With intravenous infusion, you may be given up to 20 ml of Ferinject, which corresponds to 1,000 mg of iron, once a week directly into a vein. Since Ferinject is diluted with sodium chloride solution for intravenous infusion, the volume of the solution may be up to 250 ml and will have a brown appearance.
• If you are on dialysis, you may receive Ferinject during a hemodialysis session through the dialyzer.

Children and adolescents 1 to 13 years

• The doctor or nurse will give Ferinject undiluted by injection or diluted by intravenous infusion: Your child will receive Ferinject directly into the vein. It will have a brown appearance.
• If your child is on dialysis, Ferinject should not be given.

Ferinject will be given in a facility where immune allergic reactions can be treated adequately and promptly. After each administration, you will be monitored for at least 30 minutes under the supervision of the doctor or nurse.

If you receive more Ferinject than you should

Since this medicine will be given to you by trained medical staff, it is unlikely that you will be given too high a dose.

Overdose may cause iron accumulation in the body. Your doctor will monitor your iron parameters 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 severe allergic reaction: skin rash (e.g., hives), 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 severe allergic reaction called Kounis syndrome.

In some patients, these allergic reactions (which affect less than 1 in 1,000 people) can be severe or potentially life-threatening (known as anaphylactic reactions) and may be associated with heart or circulatory problems and loss of consciousness.

You should talk to a doctor if you get worse tiredness, muscle or bone pain (pain in the arms or legs, joints, or back). This may be a sign of low phosphate levels in the blood, which could cause your bones to soften (osteomalacia). This condition can sometimes cause bone fractures. Your doctor may also check your phosphate levels in the blood, especially if you need several iron treatments over time.

Your doctor is aware of these possible side effects and will monitor you during and after Ferinject administration.

Other side effects that you should tell your doctor about if they become serious:

Common(may affect up to 1 in 10 people): headache, dizziness, feeling of heat (flushes), hypertension, nausea, and injection/infusion site reactions (see also section 2).

Uncommon(may affect up to 1 in 100 people): numbness, tingling, or prickling sensation in the skin, change in taste, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, redness of the skin, skin rash, muscle pain, joint pain, and/or back pain, pain in the arms or legs, muscle spasms, fever, tiredness, chest pain, swelling of the hands and/or feet, chills, and general malaise.

Rare(may affect up to 1 in 1,000 people): vein inflammation, anxiety, fainting, feeling of weakness, wheezing, excessive gas, sudden swelling of the face, mouth, tongue, or throat that can make breathing difficult, paleness, and change in skin color in areas of the body other than the injection site.

Unknown(frequency cannot be estimated from the available data): loss of consciousness and swelling of the face.

Pseudo-flu syndrome (may affect up to 1 in 1,000 people) may occur a few hours or several days after injection and is usually characterized by symptoms such as elevated temperature and pain in the muscles and joints.

Some blood parameters may be temporarily altered, which can be detected in laboratory tests.

The following change in blood parameters is common: decrease in blood phosphate levels.

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 experience any side effects, talk to your doctor or nurse, even if you think they are not related to this medicine. You can also report side effects directly to the Spanish Medicines Agency at www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ferinject

Keep Ferinject out of the sight and reach of children.

Do not use Ferinject after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C. Do not freeze.

To know the storage conditions after dilution or after the first opening of the medicine, see the section "This information is intended only for healthcare professionals".

Normally, it will be the doctor or hospital that stores Ferinject.

6. Package Contents and Additional Information

Ferinject Composition

The active ingredient is carboxymaltose iron, an iron carbohydrate compound. The iron concentration present in the product is 50 mg per milliliter. 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 components (excipients) are sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injectable preparations.

Product Appearance and Package Contents

Ferinject is a dark brown, non-transparent injectable and infusion dispersion.

Ferinject is presented in glass vials containing:

• 2 ml of dispersion. Package sizes: 1, 2, or 5 vials.
• 10 ml of dispersion. Package sizes: 1, 2, or 5 vials.
• 20 ml of dispersion. Package size: 1 vial of 20 ml.

Only some package 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

Tel. +33 (0)1 41 06 58 90

Fax +33 (0)1 41 06 58 99

e-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area (EEA)and in the United Kingdom (Northern Ireland)under the following names:

Germany, Austria, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Spain, Estonia, Finland, France, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden: Ferinject®. Belgium, Luxembourg: Injectafer®. Slovenia: Iroprem®.

Date of the last revision of this leaflet:May 2025.

Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder.

Local Representative:

Vifor Pharma España S.L.

Av. Diagonal 611, Planta 10

08028 Barcelona

Spain

Telephone: 902 12 11 11

Fax: 932 202 340

E-mail: [email protected]

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Patients should be closely monitored for signs and symptoms of hypersensitivity reactions during and after each administration of Ferinject.

Ferinject should only be administered when immediate availability of trained personnel and equipment to evaluate and treat anaphylactic reactions is present, in an environment where a complete resuscitation device can be guaranteed. The patient should be observed for at least 30 minutes after each administration of Ferinject for potential adverse effects.

Step 1: Determination of Iron Needed

Individual iron needs for replacement with Ferinject are determined based on the patient's body weight and hemoglobin (Hb) level. Refer to Table 1 for the determination of the total iron needed. Two doses may be necessary to replace all the necessary iron; refer to Step 2 for the maximum individual iron doses.

Table 1:Determination of Total Iron Needed

Step 2: Calculation and Administration of the Maximum Individual Dose(s) of Iron

Based on the determined total iron need, the appropriate dose of Ferinject should be administered, taking into account the following:

Adults and adolescents 14 years or older

A single administration of Ferinject should not exceed:

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

The maximum recommended accumulated dose of Ferinject per week is 1,000 mg of iron (20 ml of Ferinject). If the total iron needed is higher, the administration of an additional dose should be at least 7 days after the first dose.

Children and adolescents 1 to 13 years

A single administration of Ferinject should not exceed:

• 15 mg of iron/kg body weight
• 750 mg of iron (15 ml of Ferinject)

The maximum recommended accumulated dose of Ferinject is 750 mg of iron (15 ml of Ferinject) per week. If the total iron needed is higher, the administration of an additional dose should be at least 7 days after the first dose.

Children under 1 year

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

Patients with Chronic Kidney Disease on Hemodialysis

In adults and adolescents 14 years or older, a single maximum daily dose of 200 mg of iron should not be exceeded in patients with chronic kidney disease on hemodialysis.

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

Method of Administration

Ferinject should only be administered intravenously: by injection, by infusion, or during a hemodialysis session without dilution directly into the venous line of the dialyzer. Ferinject should not be administered subcutaneously or intramuscularly.

Caution should be exercised to avoid paravenous spillage when administering Ferinject. Paravenous spillage of Ferinject at the administration site may cause skin irritation and possible long-lasting brown discoloration. In case of paravenous spillage, the administration of Ferinject should be immediately interrupted.

Intravenous Injection

Ferinject can be administered by intravenous injection with an undiluted dispersion. In adults and adolescents 14 years or older, the single maximum dose is 15 mg of iron/kg body weight, but not exceeding 1,000 mg of iron. In children 1 to 13 years, the individual maximum dose is 15 mg/kg body weight, but not exceeding 750 mg of iron. The administration guidelines are shown in Table 2:

Table 2:Administration Guidelines for Intravenous Injection of Ferinject

Intravenous Infusion

Ferinject can be administered by intravenous infusion, in which case it should be diluted. In adults and adolescents 14 years or older, the single maximum dose is 20 mg of iron/kg body weight, but not exceeding 1,000 mg of iron. In children 1 to 13 years, the individual maximum dose is 15 mg of iron/kg body weight, but not exceeding 750 mg of iron.

For infusion, Ferinject can only be diluted in a sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: For stability reasons, Ferinject should not be diluted to concentrations below 2 mg of iron/ml (excluding the volume of the carboxymaltose iron dispersion).

Table 3:Dilution Guidelines for Intravenous Infusion of Ferinject

Monitoring Measures

The physician should perform a new assessment based on the patient's particular clinical picture. The Hb level should be reevaluated at least 4 weeks after the last administration of Ferinject, to allow sufficient time for erythropoiesis and iron utilization. If the patient needs further iron replacement, the iron needs should be recalculated using Table 1 above.

Incompatibilities

Oral iron absorption is reduced when administered simultaneously with parenteral iron preparations. Therefore, if necessary, oral iron therapy should not be started until at least 5 days have passed since the last administration of Ferinject.

Overdose

Administration of Ferinject in amounts exceeding the amount necessary to correct iron deficiency may lead to iron accumulation in deposits, which can cause hemosiderosis in the long term. Monitoring of iron parameters such as serum ferritin and transferrin saturation may help identify an iron accumulation situation. If iron accumulation occurs, treatment should be according to usual medical practice, i.e., considering the use of an iron chelator.

Stability During Use

Validity period after opening the package:

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

If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Administration of the product should be carried out under controlled and validated aseptic conditions. Chemical and physical stability during use has been demonstrated for 7 days at 30 °C.

Validity period in polyethylene and polypropylene containers after dilution with sterile 0.9% m/V sodium chloride solution:

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

If not used immediately, the times and conditions of storage prior to use are the responsibility of the user and should not generally exceed 24 hours between 2 °C and 8 °C.

Chemical and physical stability during use has been demonstrated for 72 hours at 30 °C at concentrations of 2 mg/ml and 5 mg/ml.

Validity period in polypropylene syringe (undiluted):

From a microbiological point of view, this product should be used immediately.

If not used immediately, the times and conditions of storage prior to use are the responsibility of the user and should not generally exceed 24 hours between 2 °C and 8 °C.

Chemical and physical stability during use has been demonstrated for 72 hours at 30 °C.