Ferric carboxymaltose Sandoz 50 mg/ml injectable dispersion and infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sandoz Ferric Carboxymaltose 50 mg/ml injectable dispersion and infusion solution EFG

ferric carboxymaltose

Read the entire leaflet carefully before you are given this medicine,

because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you get any side effects, talk to your doctor, including any side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Carboxymaltose Sandoz is and what it is used for
2. What you need to know before being given Carboxymaltose Sandoz
3. How Carboxymaltose Sandoz is given
4. Possible side effects
5. How to store Carboxymaltose Sandoz
6. Contents of the pack and other information

1. What Carboxymaltose Iron Sandoz is and what it is used for

Carboxymaltose Iron Sandoz is a medicine containing iron.

Medicines containing iron are used when there is insufficient iron in the body. This condition is known as iron deficiency.

Carboxymaltose iron is used for the treatment of iron deficiency when:

• Oral iron is not sufficiently effective.
• Oral iron cannot be tolerated.
• Your doctor decides that you need iron rapidly 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 using Carboxymaltose Iron Sandoz

Do not use Carboxymaltose Iron Sandoz

• if you are allergic (hypersensitive) to ferric carboxymaltose 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 (excess iron in the body) or disorders affecting iron utilization.

Warnings and precautions

Talk to your doctor or nurse before starting treatment with ferric carboxymaltose:

• 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 liver problems,
• if you have or have had low levels of phosphate in the blood.

Ferric carboxymaltose must not be administered to children under 1 year of age.

Incorrect administration of ferric carboxymaltose may result in leakage of the product at the injection site, which can cause skin irritation and brown discoloration at the site that may last for a long time. If this occurs, administration must be stopped immediately.

Other medicines and Carboxymaltose Iron Sandoz

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

Pregnancy

There is limited data on the use of ferric carboxymaltose in pregnant women. It is important that you inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. If you become pregnant during treatment, you should consult your doctor. Your doctor will decide whether or not you should receive this medicine.

Breast-feeding

If you are breast-feeding, consult your doctor before receiving ferric carboxymaltose. It is unlikely that ferric carboxymaltose will pose a risk to breastfed infants.

Driving and using machines

Ferric carboxymaltose is unlikely to affect your ability to drive or operate machinery.

Carboxymaltose Iron Sandoz contains sodium

2 ml vial of dispersion: This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.

10 ml vial of dispersion: This medicine contains up to 59 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 2.95% of the maximum daily sodium intake recommended for an adult.

20 ml vial of dispersion: This medicine contains up to 118 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 5.9% of the maximum daily sodium intake recommended for an adult.

3. How Carboxymaltose Ferric Sandoz is administered

Your doctor will decide how much ferric carboxymaltose to give you, 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 diluted by infusion, undiluted by injection, or during dialysis:

• By injection, you may be given up to 20 ml of ferric carboxymaltose, corresponding to 1,000 mg of iron, once weekly, directly into a vein.
• If you are undergoing dialysis, ferric carboxymaltose may be administered during a hemodialysis session through the dialyzer.
• With infusion, you may be given up to 20 ml of ferric carboxymaltose, corresponding to 1,000 mg of iron, once weekly directly into a vein. Since ferric carboxymaltose 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 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 ferric carboxymaltose into a vein. It will have a brown appearance.
• If your child is undergoing dialysis, ferric carboxymaltose must not be administered.

Ferric carboxymaltose will be administered in a facility where immunological 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 Ferric Sandoz 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 experiences 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 circulatory problems and loss of consciousness.

You should consult a doctor if you develop worsening fatigue, or muscle or bone pain (in the arms or legs, joints, or back). This could be a sign of low blood phosphorus levels, which could cause softening of your bones (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 of the skin, altered taste, 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 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):

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 areas of the body other than the injection site.

Not known (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 the injection and is usually characterized by symptoms such as high temperature and muscle and joint pain.

Some blood parameters may be temporarily altered, which could 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 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 Sandoz

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C. Do not freeze. For storage conditions after dilution or first opening of the medicine, see section "This information is intended for healthcare professionals only".

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ferric Carboxymaltose Sandoz

The active substance is iron (as ferric carboxymaltose, an iron carbohydrate complex). One ml of dispersion contains 50 mg of iron (as ferric carboxymaltose).

The other components (excipients) are sodium hydroxide (to adjust pH) (E 524), concentrated hydrochloric acid (E 507) (to adjust pH), and water for injections.

Appearance of the product and contents of the container

Ferric Carboxymaltose Sandoz is a dark brown, non-transparent injectable and infusion dispersion.

Ferric Carboxymaltose Sandoz is supplied in glass vials closed with a grey rubber stopper and an aluminium flip-off cap containing:

• 2 ml of dispersion corresponding to 100 mg of iron. Available in pack sizes of 1, 2 and 5 vials.
• 10 ml of dispersion corresponding to 500 mg of iron. Available in pack sizes of 1, 2 and 5 vials.
• 20 ml of dispersion corresponding to 1,000 mg of iron. Available in pack size of 1 vial.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer Responsible

Lek Pharmaceuticals d.d

Verovskova Ulica, 57

1526 Ljubljana

Slovenia

Date of the most recent review of this leaflet: June 2024.

Other sources of information

Detailed 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 for healthcare professionals only

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of ferric carboxymaltose. Ferric Carboxymaltose Sandoz must only be administered when trained personnel capable of evaluating and managing anaphylactic reactions are immediately available, and in a setting where full resuscitation equipment is accessible. Patients must be observed for at least 30 minutes after each administration of ferric carboxymaltose for the occurrence of adverse effects.

Step 1: Determination of required iron

Individual iron requirements for repletion with ferric carboxymaltose are determined based on body weight and patient hemoglobin (Hb) level. Refer to Table 1 for determination of total iron required. Two doses may be required to replenish the total required iron; see Step 2 for maximum individual iron doses.

Table 1: Determination of total iron required

Hb	Patients body weight
g/dl	mmol/l	Less than 35 kg	35 kg to <70 kg	70 kg or more
< 10	< 6.2	30 mg/kg body weight	1,500 mg	2,000 mg
10 to < 14	6.2 to < 8.7	15 mg/kg body weight	1,000 mg	1,500 mg
≥ 14	≥ 8.7	15 mg/kg body weight	500 mg	500 mg

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

Based on the previously determined iron requirement, the appropriate dose of ferric carboxymaltose should be administered, taking into account the following:

Adults and adolescents aged 14 years or older

A single administration of ferric carboxymaltose 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 Carboximaltose ferric Sandoz).

The recommended maximum cumulative weekly dose of ferric carboxymaltose is 1,000 mg of iron (20 mL of Carboximaltose ferric Sandoz). If the total required iron is higher, administration of an additional dose must not occur until at least 7 days after the first dose.

Children and adolescents aged 1 to 13 years

A single administration of ferric carboxymaltose 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 is 750 mg of iron (15 mL of ferric carboxymaltose). If the total required iron is higher, administration of an additional dose must not occur until at least 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 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 on hemodialysis.

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

Method of administration

Visually inspect vials for particulate matter and damage prior to use. Use only vials containing a homogeneous dispersion free of particulates.

Ferric carboxymaltose must only be administered intravenously: by injection, by infusion, or during a hemodialysis session, undiluted 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

Carboximaltose ferric Sandoz may be administered by 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 must not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg of iron/kg body weight, but must not exceed 750 mg of iron. Administration regimens are shown in Table 2:

Table 2: Administration schedule for intravenous injection of Carboximaltose ferric Sandoz

Volume of Ferric Carboxymaltose Sandoz required	Equivalent iron dose	Administration regimen/ Minimum administration time
2	to	4 ml	100	to	200 mg	No prescribed minimum time
> 4	to	10 ml	> 200	to	500 mg	100 mg of iron/min
> 10	to	20 ml	> 500	to	1,000 mg	15 minutes

Intravenous infusion

Ferric carboxymaltose Sandoz may be administered by intravenous infusion, in which case it must be diluted. In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg of iron/kg body weight, but should not exceed 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 should not exceed 750 mg of iron.

For infusion, ferric carboxymaltose Sandoz must only be diluted in a sterile 0.9% m/v sodium chloride solution as shown in Table 3. Note: For stability reasons, ferric carboxymaltose Sandoz 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 Sandoz for intravenous infusion

Volume of Ferric Carboxymaltose Sandoz required	Equivalent iron dose	Maximum amount of sterile 0.9% m/v sodium chloride solution	Minimum administration time
2	to	4 ml	100	to	200 mg	50 ml	No prescribed minimum time
> 4	to	10 ml	> 200	to	500 mg	100 ml	6 minutes
> 10	to	20 ml	> 500	to	1,000 mg	250 ml	15 minutes

Monitoring Measures

The physician should perform a new assessment based on the individual clinical picture of the patient. Hemoglobin (Hb) levels 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 quantity required to correct the existing iron deficit at the time of administration may lead to iron accumulation in storage sites, potentially resulting in hemosiderosis. Monitoring iron parameters such as serum ferritin and transferrin saturation may help identify iron accumulation. If iron accumulation occurs, manage according to standard medical practice, for example, consider the use of an iron chelator.

In-use Stability

Shelf life after first opening of the vial:

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

Chemical and physical in-use stability has been demonstrated for 7 days at room temperature (20–25 °C).

Shelf life after dilution in polyethylene bottles (after dilution with 0.9% m/v sterile sodium chloride solution):

From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage prior to use are the responsibility of the user, and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution was performed under controlled and validated aseptic conditions.

Chemical and physical in-use 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.

Shelf life in polypropylene syringe (undiluted):

From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage prior to 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 was carried out under controlled and validated aseptic conditions.

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