Package Insert: Information for the Patient

Carboxymaltose Iron Sandoz 50 mg/ml Injectable Suspension and for Infusion EFG

carboxymaltose iron

Read this package insert carefully before this medicine is administered to you,

because it contains important information for you.

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

Carboximaltosa ferrica Sandoz 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.

Carboximaltosa ferrica 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 reserves.

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

Do not use Carboximaltosa ferrica Sandoz

• if you are allergic (hypersensitive) to carboximaltosa ferrica or to any of the other components of this medication (listed in section 6),
• if you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations,
• if you have anemia not caused 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 carboximaltosa ferrica:

• 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.

Carboximaltosa ferrica should not be administered to children under 1 year of age.

Incorrect administration of carboximaltosa ferrica 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.

Other medications and Carboximaltosa ferrica Sandoz

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 carboximaltosa ferrica is administered with oral iron preparations, the oral preparations may be less effective.

Pregnancy

There are few data on the use of carboximaltosa ferrica in pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant during treatment, consult your doctor. Your doctor will decide whether you should receive the medication or not.

Breastfeeding

If you are breastfeeding, consult your doctor before receiving carboximaltosa ferrica. It is unlikely that carboximaltosa ferrica will pose a risk to the infant.

Driving and operating machinery

It is unlikely that carboximaltosa ferrica will affect your ability to drive and operate machinery.

Carboximaltosa ferrica Sandoz contains sodium

Vial with 2 ml of dispersion: This medication contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

Vial with 10 ml of dispersion: This medication contains a maximum of 59 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.95% of the maximum daily sodium intake recommended for an adult.

Vial with 20 ml of dispersion: This medication contains a maximum of 118 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 5.9% of the maximum daily sodium intake recommended for an adult.

Your doctor will decide how much carboximaltosa ferrica 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 carboximaltosa ferrica diluted by infusion, undiluted by injection, or during dialysis:

• By injection, you may be given up to 20 ml of carboximaltosa ferrica, which corresponds to 1,000 mg of iron, once a week, directly into a vein.
• If you receive dialysis, you may be given carboximaltosa ferrica during a hemodialysis session through the dialyzer.
• By infusion, you may be given up to 20 ml of carboximaltosa ferrica, which corresponds to 1,000 mg of iron, once a week directly into a vein. As carboximaltosa ferrica 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.

Children and adolescents 1 to 13 years old

Your doctor or nurse will administer carboximaltosa ferrica undiluted by injection or diluted by intravenous infusion:

• Your child will receive carboximaltosa ferrica into the vein. It will have a brown appearance.
• If your child undergoes dialysis, carboximaltosa ferrica should not be administered.

Carboximaltosa ferrica 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 30 minutes under the supervision of your doctor or nurse.

If you receive more Carboximaltosa Ferrica Sandoz than you should

As this medication will be administered by a qualified medical professional, it is unlikely that you will receive an excessive dose. Overdose may cause iron accumulation in the body. Your doctor will monitor your iron parameters to prevent iron accumulation.

Like all medicines, this medicine may 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 (for example, urticaria), 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 (affecting fewer than 1 in 1,000 people) may 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 ferric carboxymaltose.

Other side effects that you should inform your doctor if they become severe:

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

headache, dizziness, feeling of heat (flushing), hypertension, nausea, and reactions at the injection/infusion site (see also section 2).

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

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, urticaria, 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 feeling of discomfort.

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

inflammation of a vein, anxiety, fainting, feeling of weakness, wheezing, excessive flatulence, sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, paleness, and change in skin color in other areas of the body different from the administration site.

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

Psuedogripal 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 could be detected in laboratory tests.

• It is common for the following blood parameter changes to occur: decrease in blood phosphate levels.
• The following blood parameter changes are infrequent: 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 the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86 °F (30 °C). Do not freeze. For storage conditions after dilution or first opening of the medication, see section “This information is intended solely for healthcare professionals”.

Ferric Carboxymaltose Sandoz will normally be stored by your doctor or the hospital.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. This will help protect the environment.

Composition of Carboximaltosa Ferrica Sandoz

The active ingredient is iron (as carboximaltosa ferrica, a carbohydrate iron compound). One ml of dispersion contains 50 mg of iron (as carboximaltosa ferrica).

The other components (excipients) are sodium hydroxide (for pH adjustment) (E 524), concentrated hydrochloric acid (E 507) (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Carboximaltosa Ferrica Sandoz is a brownish dark, non-transparent injectable and perfusion dispersion.

Carboximaltosa Ferrica Sandoz is supplied in closed glass vials with a grey rubber stopper and an aluminum cap that contain:

• 2 ml of dispersion corresponding to 100 mg of iron. Available in formats of 1, 2 and 5 vials.
• 10 ml of dispersion corresponding to 500 mg of iron. Available in formats of 1, 2 and 5 vials.
• 20 ml of dispersion corresponding to 1,000 mg of iron. Available in a format of 1 vial.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for Manufacturing

Lek Pharmaceuticals d.d

Verovskova Ulica, 57

1526 Ljubljana

Slovenia

Last review date of this leaflet:June 2024.

Other sources of information

The detailed information of this medicine is available on 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

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of carboximaltosa ferrica. Carboximaltosa ferrica Sandoz 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 30 minutes after each administration of carboximaltosa ferrica for potential adverse effects.

Step 1: Determination of the iron needed

The individual iron needs for replacement with carboximaltosa ferrica 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 required to replace 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 iron dose

Based on the previously determined iron need, the appropriate dose of carboximaltosa ferrica should be administered, taking into account the following:

Adults and adolescents 14 years of age or older

A single administration of carboximaltosa ferrica should not exceed:

• 15 mg of iron/kg body weight (for intravenous injection) or 20 mg of iron/kg body weight (for intravenous perfusion).
• 1,000 mg of iron (20 ml of Carboximaltosa Ferrica Sandoz).

The recommended maximum cumulative dose of carboximaltosa ferrica per week is 1,000 mg of iron (20 ml of Carboximaltosa Ferrica Sandoz). 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 of age

A single administration of carboximaltosa ferrica should not exceed:

• 15 mg of iron/kg body weight

• 750 mg of iron (15 ml of carboximaltosa ferrica)

The recommended maximum cumulative dose of carboximaltosa ferrica per week is 750 mg of iron (15 ml of carboximaltosa ferrica). 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 of age

The use of carboximaltosa ferrica is not recommended in children under 1 year of age.

Patients with chronic nephropathy who depend on hemodialysis

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

The use of carboximaltosa ferrica is not recommended in children 1 to 13 years of age with chronic nephropathy who require hemodialysis.

Administration form

Visually inspect the vials for sediment and damage before use. Only those that contain a homogeneous dispersion free of sediment should be used.

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

Care should be taken to avoid paravenous spillage when administering carboximaltosa ferrica. Paravenous spillage of carboximaltosa ferrica at the administration site may cause skin irritation and possible long-lasting brown discoloration. In case of paravenous spillage, administration of carboximaltosa ferrica should be stopped immediately.

Intravenous injection

Carboximaltosa ferrica Sandoz can be administered by intravenous injection without dilution. In adults and adolescents 14 years of age or older, the maximum single dose is 15 mg of iron/kg body weight, but not exceeding 1,000 mg of iron. In children 1 to 13 years of age, the maximum single dose is 15 mg of iron/kg body weight, but not exceeding 750 mg of iron. Administration guidelines are shown in Table 2:

Table 2: Administration guidelines for intravenous injection of Carboximaltosa Ferrica Sandoz

Intravenous perfusion

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

For perfusion, carboximaltosa ferrica Sandoz can only be diluted in a sterile 0.9% w/v sodium chloride solution as shown in Table 3. Note: for stability reasons, carboximaltosa ferrica Sandoz should not be diluted to concentrations below 2 mg of iron/ml (excluding the volume of the carboximaltosa ferrica dispersion).

Table 3: Dilution guidelines for Carboximaltosa Ferrica Sandoz for intravenous perfusion

Monitoring measures

The doctor should perform a new evaluation based on the patient's particular clinical condition. The hemoglobin level should be reevaluated at least 4 weeks after the last administration of carboximaltosa ferrica, allowing sufficient time for erythropoiesis and iron utilization. If the patient needs further iron replacement, the iron needs should be recalculated using the previous Table 1.

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 carboximaltosa ferrica.

Overdose

The administration of carboximaltosa ferrica in amounts exceeding the amount needed to correct the iron deficiency at the time of administration may lead to the accumulation of iron in deposits, which may 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 carried out according to standard medical practice, for example, considering the use of an iron chelator.

Stability in use

Validity period after the first opening of the vial:

From a microbiological point of view, parenteral preparations should be used immediately. If not used immediately, the times and conditions of use in storage are the responsibility of the user. Administration of the product should be carried out in controlled and validated aseptic conditions.

Chemical and physical stability has been demonstrated for 7 days at room temperature

(20 - 25 °C).

Validity period after dilution in polyethylene flasks (after dilution with sterile 0.9% w/v sodium chloride solution):

From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of use, before use, are the responsibility of the user, and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the preparation has taken place in controlled and validated aseptic conditions.

Chemical and physical stability has been demonstrated for 24 hours at room temperature (20-25 °C) at concentrations of: 2 mg/ml, 4 mg/ml and 5 mg/ml.

Validity period in polypropylene syringe (undiluted):

From a microbiological point of view, the product should be used immediately. If not usedimmediately, the times and conditions of use, before use, are the responsibility of the user, and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the preparation has taken place in controlled and validated aseptic conditions.

Chemical and physical stability has been demonstrated for 24 hours at room temperature (20 - 25 °C).