CARBOXIMALTOSA FERRICA VIATRIS 50 mg/ml Injectable Dispersion and Perfusion Solution

2. What you need to know before you are given Carboxymaltose Iron Viatris

Do not use Carboxymaltose Iron Viatris

• If you are allergic (hypersensitive) to carboxymaltose iron 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 that is not caused 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 carboxymaltose iron:

• 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 had low phosphate levels in your blood.

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

Incorrect administration of carboxymaltose iron 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.

Other medicines and Carboxymaltose Iron Viatris

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

Pregnancy

There are limited data on the use of carboxymaltose iron viatris in pregnant women. It is important that you talk to your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.

If you become pregnant during treatment, you should talk to your doctor; this way, your doctor can decide whether you should be given the medicine or not.

Breast-feeding

If you are breast-feeding, talk to your doctor before you are given carboxymaltose iron. It is unlikely that this medicine will pose a risk to breast-fed infants. This medicine can be used during breast-feeding.

Driving and using machines

Carboxymaltose iron has no or negligible influence on the ability to drive and use machines.

Carboxymaltose Iron Viatris contains sodium

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

3. How Carboxymaltose Iron Viatris is given

Your doctor will decide how much of this medicine 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 of age and older

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

• By injection, you may be given up to 20 ml of carboxymaltose iron, 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 carboxymaltose iron, which corresponds to 1,000 mg of iron, once a week, 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 have a brown appearance.
• If you are on dialysis, you may receive this medicine during a hemodialysis session through the dialyzer.

Children and adolescents 1 to 13 years of age

The doctor or nurse will give carboxymaltose iron undiluted by injection or diluted by intravenous infusion:

• Your child will receive this medicine directly into the vein. It will have a brown appearance.
• If your child is on dialysis, carboxymaltose iron should not be given.

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

If you are given more Carboxymaltose Iron Viatris 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 circulation 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 may 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 the administration of Carboxymaltose Iron.

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), 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 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 may make breathing difficult, paleness, and change in skin color of 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.

Flu-like illness (may affect up to 1 in 1,000 people) may occur a few hours or several days after the 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.

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 they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboxymaltose Iron Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date is the last day of the month stated.

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

Carboxymaltose Iron Viatris will usually be stored by your doctor or hospital.

6. Contents of the pack and additional information

Composition of Carboxymaltose Iron Viatris

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

Appearance of the product and pack contents

Carboxymaltose Iron Viatris 50 mg/ml injectable dispersion and for infusion is a dark brown, non-transparent aqueous solution presented in glass vials with a rubber stopper and an aluminum closure 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.

Not all pack sizes may 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 Tecnologic Del Vallès

Cerdanyola Del Vallès

08290 Barcelona

Spain

Or

Viatris Santé

1 rue de Turin

69007 Lyon

France

For further information, 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: Carboxymaltose Iron Viatris 50 mg/ml injectable dispersion and for infusion

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: Carboxymaltose Iron Mylan

Romania: Carboximaltoza ferica Viatris 50 mg/ml dispersie injectabila/perfuzabila

Sweden: Fercarbos

Date of last revision of this leaflet:December 2024

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

This information is intended only for healthcare professionals:

Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of Carboxymaltose Iron Viatris. This treatment should only be administered when immediate availability of personnel trained 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 Carboxymaltose Iron Viatris in case of adverse effects.

Step 1: Determination of iron needed

The individual iron needs for replenishment with this medicinal product are determined based on the patient's body weight and hemoglobin (Hb) level. Consult Table 1 for the determination of the total iron needed. Two doses may be necessary to replenish all the needed iron; consult 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 Carboxymaltose Iron Viatris should be administered, taking into account the following:

Adults and adolescents 14 years or older

A single administration of Carboxymaltose Iron Viatris 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 Carboxymaltose Iron Viatris)

The maximum recommended accumulated dose per week of Carboxymaltose Iron Viatris is 1,000 mg of iron (20 ml of Carboxymaltose Iron Viatris). 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 Carboxymaltose Iron Viatris should not exceed:

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

The maximum recommended accumulated dose per week of Carboxymaltose Iron Viatris is 750 mg of iron (15 ml of carboxymaltose iron). 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 carboxymaltose iron 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 is not recommended in children 1 to 13 years with chronic kidney disease requiring hemodialysis.

Method of administration

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

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

Intravenous injection

Carboxymaltose Iron Viatris 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 Carboxymaltose Iron Viatris

Intravenous infusion

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

Table 3: Dilution guideline for Carboxymaltose Iron Viatris for intravenous infusion

Monitoring measures

The doctor should carry out a new assessment based on the patient's particular clinical picture. The Hb level should be re-evaluated at least 4 weeks after the last administration of carboxymaltose iron, to allow sufficient time for erythropoiesis and iron utilization. If the patient needs further iron replenishment, 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 carboxymaltose iron.

Overdose

Administration of carboxymaltose iron in amounts exceeding the amount needed to correct iron deficiency at the time of administration may lead to iron accumulation in deposits, which in the long term will produce hemosiderosis. 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., consider the use of an iron chelator.

Stability during use

Validity period after opening the package:

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

Validity period after dilution with sterile 0.9% m/V sodium chloride solution:

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, in general, should not exceed 24 hours between 2°C and 8°C, unless the dilution is performed in controlled and validated aseptic conditions.

The chemical and physical stability of the diluted product has been demonstrated for 72 hours at 25°C.