Package Insert: Information for the User

Ferinject 50 mg/ml Injectable and Infusion Solution

Iron Carboxymaltose

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

1.What is Ferinject and what is it used for

2.What you need to know before starting to use Ferinject

3.How to administer Ferinject

4.Possible adverse effects

5.Storage of Ferinject

6.Contents of the package and additional information

Ferinject is a medication that contains iron.

Iron-containing medications are used when there is not enough iron in the body. This condition is called iron deficiency.

Ferinject is used to treat iron deficiency when:

• Oral iron is not sufficiently effective.You cannot tolerate oral iron.
• Your doctor decides that you need iron very quickly to replenish your iron stores.

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

Do not useFerinject

• If you are allergic (hypersensitive) to iron carboxymaltose or to any of the other components of this medication (listed in section 6).
• If you have experienced severe allergic reactions to other injectable iron preparations.
• If you have anemianotcaused by iron deficiency.
• If you have iron overload (too much iron in the body) or problems with iron utilization.

Warnings and precautions

Consult your doctor or nurse before starting to receive Ferinject:

• If you have a history of allergies to medications.
• 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 levels of phosphate in the blood.

Do not administer Ferinject to children under 1 year of age.

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

Use of Ferinject with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication, including medications obtained without a prescription. If Ferinject is administered with oral iron preparations, the oral preparations may be less effective.

Pregnancy

There are few data on the use of Ferinjectin pregnant women. If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

If you become pregnant during treatment, ask your doctor for advice; the doctor will be able to decide whether to administer the medication or not.

Breastfeeding

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

Driving and operating machines

It is unlikely that Ferinject will affect the ability to drive and operate machines.

Ferinject contains sodium

This medication contains up to 5.5mg of sodium (main component of table salt/for cooking) per milliliter of undiluted dispersion, equivalent to 0.3% of the maximum daily sodium intake recommended for an adult.

Your doctor will decide how much Ferinject to administer, 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 or older

Your doctor or nurse will administer Ferinject undiluted by injection, diluted by intravenous infusion, or during dialysis:

• Ferinject can be administered by injection, up to 20ml, which corresponds to 1,000mg of iron, once a week, directly into a vein.
• Ferinject can be administered by intravenous infusion, up to 20ml, which corresponds to 1,000mg 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 can be up to 250ml and will have a brown appearance.If you undergo dialysis, you can receive Ferinject during a hemodialysis session through the dialyzer.

Children and adolescents 1 to 13 years

• Your doctor or nurse will administer 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 undergoes dialysis, Ferinject should not be administered.

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

If you receive more Ferinject than you should

Since this medication will be administered by a qualified medical professional, it is unlikely that you will receive an excessive dose.

An overdose may cause iron accumulation in the body. Your doctor will monitor your iron parameters to prevent iron accumulation.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects:

Inform 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., and chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

You should consult a doctor if you experience worsening fatigue, muscle or bone pain (pain in the arms or legs, joints, or back). This may be a sign of a decrease in phosphate levels in the blood that could cause your bones to soften (osteomalacia). This condition can sometimes cause fractures in the bones. The doctor may also monitor phosphate levels in the blood, especially if you need multiple treatments with iron 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 you should inform your doctor if they become severe:

Frequent(may affect up to 1 in 10people): headache, dizziness, sensation of heat (flushing), hypertension, nausea, and reactions at the injection/infusion site (see also section 2).

Occasional(may affect up to 1 in 100people): numbness, tingling, or prickling sensation in the skin, change in sense of taste, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, skin redness, skin rash, muscle pain, joint pain, 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 general discomfort.

Rare(may affect up to 1 in 1,000people): vein inflammation, anxiety, fainting, feeling weak, wheezing, excessive flatulence, sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, palenessand change in skin color in other areas of the body different from thesite of administration.

Unknown(frequency cannot be estimated with available data): loss of consciousness and facial swelling.

Flu-like illness (may affect up to 1 in 1,000 people) may occur several hours or days after injection and is usually characterized by symptoms such as elevated temperature and muscle and joint pain.

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

It is common for the following changes in blood parameters to occur: decrease in blood phosphate levels.

The following changes in blood parameters are occasional: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.

Consult your doctor for more information.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep Ferinjectout of sight and reach of children.

Do not useFerinjectafter the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C. Do notfreeze.

To know the storage conditions after dilution or after the first opening of the medication, see section “This information is intended solely for healthcare professionals”.

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

Composition of Ferinject

The active ingredient iscarboxymaltose iron, a carbon hydrate iron compound. The iron concentration present in the product is 50mg per milliliter. Each 2ml vial contains carboxymaltose iron equivalent to 100mg of iron. Each 10ml vial contains carboxymaltose iron equivalent to 500mg of iron. Each 20ml vial contains carboxymaltose iron equivalent to 1,000mg of iron.The other components (excipients) aresodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH), and water for injectable preparations.

Appearance of the product and contents of the package

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

Ferinject is presented in glass vials containing:

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible 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 medicinal product is authorized in the Member States of the European Economic Area (EEA) and in the United Kingdom (Northern Ireland)with 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®.

Last review date of this leaflet:September 2024.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Local Representative:

Vifor Pharma España S.L.

Av. Diagonal 611, 10th floor

08028 Barcelona

Spain

Phone: 902 12 11 11

Fax: 932 202 340

Email: [email protected]

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of Ferinject.

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

Step 1: Determination of the iron needed

The individual iron needs for replacement with Ferinjectare determined based on the patient's body weight and hemoglobin (Hb) level. See Table1 for the determination of the total iron needed. Two doses may be necessary to replace all the iron needed, see Step2 for the maximum individual iron doses.

Table1:Determination of the total iron needed

Step 2: Calculation and administration of the maximum individual iron dose(s)

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

Adults and adolescents 14years or older

A single administration of Ferinject should not exceed:

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

The maximum recommended cumulative 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 7days after the first dose.

Children and adolescents 1to 13years

A single administration of Ferinject should not exceed:

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

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

Children under 1year

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

Patients with chronic kidney disease who depend on hemodialysis

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

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

Administration form

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

Care should be taken to avoid paravenous leakage when administering Ferinject. Paravenous leakage of Ferinject at the injection site may cause skin irritation and possible long-term brown discoloration. In case of paravenous leakage, administration of Ferinject should be immediately discontinued.

Intravenous injection

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

Table2: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 maximum single dose is 20mg of iron/kg of body weight, but should not exceed 1,000mg of iron. In children 1 to 13 years, the maximum individual dose is 15mg of iron/kg of body weight, but should not exceed 750mg of iron.

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

Table3:Dilution guidelines for Ferinject for intravenous infusion

Monitoring

The doctor should perform a new evaluation based on the patient's individual clinical picture. The patient's hemoglobin level should be reevaluated at least 4 weeks after the last administration of Ferinject, allowing 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

The oral absorption of iron 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

The administration of Ferinject in amounts exceeding the amount necessary to correct iron deficiency may lead to iron accumulation in deposits, which will eventually cause hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may help identify a situation of iron accumulation. If iron accumulation occurs, treatment should be in accordance with standard medical practice, i.e., consider the use of an iron chelator.

Stability during use

Validity period once the package is opened:

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

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

The product should be administered in controlled and validated aseptic conditions. Chemical and physical stability has been demonstrated during use for 7days at 30°C.

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

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

If not used immediately, the times and conditions of use before use are the responsibility of the user, and generally should not exceed 24hours between2°Cand8°C.

Chemical and physical stability has been demonstrated during use for 72hours at 30°C at concentrations of 2mg/ml and 5mg/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 use before use are the responsibility of the user, and generally should not exceed 24hours between2°Cand8°C.

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