Ferric carboxymaltose Viatris 50 mg/ml injection and infusion dispersion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ferric carboxymaltose Viatris 50 mg/ml injectable dispersion and solution for infusion

ferric carboxymaltose

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Carboxymaltose ferric Viatris is and what it is used for

2. What you need to know before being given Carboxymaltose ferric Viatris

3. How Carboxymaltose ferric Viatris is given

4. Possible side effects

5. How to store Carboxymaltose ferric Viatris

6. Contents of the pack and other information

1. What Carboximaltosa férrica Viatris is and what it is used for

Carboximaltose iron is a medicine that contains iron.

Medicines containing iron are used when there is not enough iron in the body. This condition is known as iron deficiency.

Carboximaltose iron is used to treat iron deficiency when:

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

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

2. What you need to know before Carboxymaltose Iron is administered to you

Do not use Carboxymaltose Iron

• If you are allergic (hypersensitive) to carboxymaltose iron or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations.
• If you have anaemia not caused by iron deficiency.
• If you have iron overload (too much iron in the body) or disorders in iron utilisation.

Warnings and precautions

Consult your doctor or nurse before starting treatment with carboxymaltose iron:

• If you have a history of drug allergies.
• 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.

Carboxymaltose iron must not be administered to children under 1 year of age.

Incorrect administration of carboxymaltose iron may result in leakage of the product at the administration site, which may lead to skin irritation and brown discolouration at the site that may last for a long time. If this occurs, administration must be stopped immediately.

Other medicines and Carboxymaltose Iron Viatris

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. If carboxymaltose iron is administered together with oral iron preparations, the oral preparations may be less effective.

Pregnancy

There is limited data on the use of Carboxymaltose Iron Viatris in pregnant women. It is important that you speak with your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.

If you become pregnant during treatment, you should consult your doctor so that the doctor can decide whether or not the medicine should be administered.

Breast-feeding

If you are breast-feeding, consult your doctor before receiving carboxymaltose iron. It is unlikely that this medicine poses a risk to breastfed infants. This medicine may be used during breast-feeding.

Driving and using machines

The effect of carboxymaltose iron on the ability to drive and use machines is negligible or none.

Carboxymaltose Iron Viatris contains sodium

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

3. How Carboxymaltose Iron Viatris is administered

Your doctor will decide how much of this medicine you should receive, how often you need it, and for how long. Your doctor will perform a blood test to determine the dose you require.

Adults and adolescents aged 14 years and older

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

• By injection, up to 20 ml of ferric carboxymaltose, corresponding to 1,000 mg of iron, may be administered once weekly directly into a vein.
• By intravenous infusion, up to 20 ml of ferric carboxymaltose, corresponding to 1,000 mg of iron, may be administered once weekly directly into a vein. Since this medicine is diluted with sodium chloride solution for infusion, the volume of the solution may be up to 250 ml and will appear brown.
• If you are undergoing dialysis, you may receive this medicine during a hemodialysis session through the dialyzer.

Children and adolescents aged 1 to 13 years

The doctor or nurse will administer ferric carboxymaltose either undiluted by injection or diluted by intravenous infusion:

• Your child will receive this medicine directly into a vein. It will appear brown.
• If your child is undergoing dialysis, ferric carboxymaltose must not be administered.

Ferric carboxymaltose will be administered in a facility where immunological or allergic reactions can be appropriately and rapidly treated. After each administration, you will remain under observation for at least 30 minutes under the supervision of a doctor or nurse.

If you receive more Carboxymaltose Iron Viatris than you should

Since this medicine will be administered by trained medical personnel, it is unlikely that you will receive too high a dose.

Overdose may lead to iron accumulation in the body. Your doctor will monitor your iron parameters to prevent iron accumulation.

4. Possible adverse effects

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

Serious adverse effects:

Immediately inform your doctor if you experience any of the following signs and symptoms, which 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 serious allergic reaction called Kounis syndrome.

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

You should consult a doctor if you develop worsening fatigue, or bone or muscle pain (pain in the arms or legs, joints, or back). This could be a sign of low blood phosphorus levels, which could cause your bones to soften (osteomalacia). This condition may sometimes lead to bone fractures. Your doctor may also monitor your blood phosphate levels, especially if you require multiple iron treatments over time.

Your doctor is aware of these possible adverse effects and will monitor you during and after administration of Ferric Carboxymaltose.

Other adverse effects you should report to your doctor if they become severe:

Common (may affect up to 1 in 10 people):

headache, dizziness, sensation of warmth (hot flushes), hypertension, nausea, and injection/perfusion site reactions (see also section 2).

Uncommon (may affect up to 1 in 100 people):

numbness, tingling or prickling sensation in the skin, altered taste sensation, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, skin redness, skin rash, muscle, 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 general malaise.

Rare (may affect up to 1 in 1,000 people):

vein inflammation, anxiety, fainting, feeling of weakness, wheezing, excessive flatulence, sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, pallor, and skin color changes in body areas other than the injection site.

Unknown (frequency cannot be estimated from 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 several days after injection and is typically characterized by symptoms such as high temperature and muscle and joint pain.

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

The following change in blood parameters is common: decreased blood phosphorus levels.

The following changes in blood parameters are uncommon: increased levels of certain liver enzymes known as alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, and alkaline phosphatase, and increased levels of an enzyme called lactate dehydrogenase.

Ask your doctor for more information.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ferric Carboxymaltose Viatris

Keep this medicine out of the 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 indicated.

Store in the original packaging to protect from light. Do not store above 30 °C. Do not freeze. Once the vials of Ferric Carboxymaltose Viatris have been opened, they must be used immediately. After dilution with a sodium chloride solution, the diluted dispersion should be used immediately.

Ferric Carboxymaltose Viatris is normally stored by the doctor or hospital.

6. Contents of the pack and other information

Composition of Ferric Carboxymaltose Viatris

The active substance is ferric carboxymaltose, an iron carbohydrate complex. The concentration of iron present in the product is 50 mg per millilitre. The other components (excipients) are hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH) and water for injections.

Appearance of the medicinal product and contents of the pack

Ferric Carboxymaltose Viatris 50 mg/ml for injection and infusion is a dark brown, non-transparent aqueous solution supplied in glass vials with a rubber stopper and aluminium cap.

100 mg/2 ml available in pack sizes of 1, 2 or 5 vials.

500 mg/10 ml available in pack sizes of 1, 2 or 5 vials.

1,000 mg/20 ml available in a pack size of 1 vial.

Some pack sizes may not be marketed.

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

KYMOS S.L.
Ronda de Can Fatjó, 7B
Parc Tecnològic del Vallès
Cerdanyola del Vallès
08290 Barcelona
Spain

Or

Viatris Santé
1 rue de Turin
69007 Lyon
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: Eisencarboxymaltose Viatris 50 mg/ml Dispersion zur Injektion/Infusion
Belgium: Ferric carboxymaltose Viatris
Croatia: Correctiron
Denmark: Ferricarboxymaltose Viatris
Slovenia: Železo Viatris 50 mg/ml disperzija za injiciranje/infundiranje
Spain: Carboximaltosa férrica Viatris 50 mg/ml dispersión inyectable y para perfusión
Finland: Fercarbos
France: Carboxymaltose Ferrique Viatris 50 mg/mL, dispersion injectable/pour perfusion
Hungary: Correctiron 50 mg/ml disperzija za injekciju/infuziju
Italy: Carbossimaltosio Ferrico Mylan
Luxembourg: Correctiron 50 mg/ml dispersion injectable/pour perfusion
Norway: Jernkarboksymaltose Viatris
Netherlands: IJzer(III)carboxymaltose Viatris 50 mg/ml, dispersie voor injectie/infusie
Portugal: Carboximaltose férrica Mylan
Romania: Carboximaltoza ferica Viatris 50 mg/ml dispersie injectabila/perfuzabila
Sweden: Fercarbos

Date of the most recent revision of this leaflet: December 2024

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

This information is intended for healthcare professionals only:

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of Ferric Carboxymaltose Viatris. This treatment should only be administered when trained personnel and full resuscitation equipment are immediately available to evaluate and manage anaphylactic reactions. Patients should be observed for at least 30 minutes after each administration of Ferric Carboxymaltose Viatris for the occurrence of adverse reactions.

Step 1: Determination of iron requirement

Individual iron requirements for replacement with this medicinal product are determined based on body weight and haemoglobin (Hb) level of the patient. Refer to Table 1 for the determination of total iron required. Two doses may be necessary to replace the total required iron. See Step 2 for individual maximum iron doses.

Table 1: Determination of total iron required

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

Based on the determined total iron requirement, the appropriate dose of Ferric Carboxymaltose Viatris should be administered, taking into account the following:

Adults and adolescents aged 14 years or older

A single administration of Ferric Carboxymaltose Viatris must not exceed:

• 15 mg of iron/kg body weight (for administration by intravenous injection) or 20 mg of iron/kg body weight (for administration by intravenous infusion).
• 1,000 mg of iron (20 mL of Ferric Carboxymaltose Viatris)

The recommended maximum cumulative weekly dose of Ferric Carboxymaltose Viatris is 1,000 mg of iron (20 mL of Ferric Carboxymaltose Viatris). If the total iron required is higher, administration of an additional dose should occur no sooner than 7 days after the first dose.

Children and adolescents aged 1 to 13 years

A single administration of Ferric Carboxymaltose Viatris must not exceed:

• 15 mg of iron/kg body weight
• 750 mg of iron (15 mL of ferric carboxymaltose)

The recommended maximum cumulative weekly dose of Ferric Carboxymaltose Viatris is 750 mg of iron (15 mL of ferric carboxymaltose). If the total iron required is higher, administration of an additional dose should occur no sooner than 7 days after the first dose.

Children under 1 year of age

The use of ferric carboxymaltose is not recommended in children under 1 year of age.

Patients with chronic kidney disease dependent on hemodialysis

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

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

Method of administration

Ferric Carboxymaltose Viatris must be administered intravenously only: by injection, by infusion, or during a hemodialysis session, without dilution, directly into the venous limb of the dialyzer. Ferric carboxymaltose must not be administered subcutaneously or intramuscularly.

Care must be taken to avoid paravenous leakage when administering ferric carboxymaltose. Paravenous leakage of ferric carboxymaltose at the administration site may cause skin irritation and possible long-lasting brown discoloration. In case of paravenous leakage, administration of ferric carboxymaltose must be immediately discontinued.

Intravenous injection

Ferric Carboxymaltose Viatris may be administered as an undiluted intravenous injection. In adults and adolescents aged 14 years or older, the maximum single dose is 15 mg of iron/kg body weight, but not exceeding 1,000 mg of iron. In children aged 1 to 13 years, the maximum individual dose is 15 mg of iron/kg body weight, but must not exceed 750 mg of iron. Administration guidelines are shown in Table 2:

Table 2: Administration guidelines for intravenous injection of Ferric Carboxymaltose Viatris

Intravenous infusion

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

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

Table 3: Dilution schedule for ferric carboxymaltose Viatris for intravenous infusion

Monitoring measures

The physician must carry out a new assessment based on the individual clinical condition of the patient. The Hb level should be re-evaluated at least 4 weeks after the last administration of ferric carboxymaltose, to allow sufficient time for erythropoiesis and iron utilization. If the patient requires further iron replacement, iron requirements 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 initiated until at least 5 days after the last administration of ferric carboxymaltose.

Overdose

Administration of ferric carboxymaltose in amounts exceeding the amount required to correct iron deficiency at the time of administration may lead to iron accumulation in storage sites, which over time may result in hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may help identify iron accumulation. If iron accumulation occurs, manage according to standard medical practice, i.e., consider the use of an iron chelator.

Stability during use

Shelf life after first opening of the container:

From a microbiological standpoint, unless the opening method eliminates the risk of microbiological contamination, the medicinal product should be used immediately.

Shelf life after dilution with sterile 0.9% m/V sodium chloride solution:

From a microbiological standpoint, this product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and generally should not exceed 24 hours between 2°C and 8°C, unless the dilution is carried out under controlled and validated aseptic conditions.

Chemical and physical in-use stability has been demonstrated for the diluted product for 72 hours at 25°C.