Fexabogard

FEXABOGARD, 50 mg iron/mL, injectable/infusion dispersion
Ferric carboxymaltose
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Table of contents

1. What Fexabogard is and what it is used for
2. Important information before using Fexabogard
3. How to use Fexabogard
4. Possible side effects
5. How to store Fexabogard
6. Contents of the package and other information

1. What Fexabogard is and what it is used for

Fexabogard is an iron-containing medicine.
Iron-containing medicines are administered when the patient's body lacks iron. This condition is called
iron deficiency.
Fexabogard is used to treat iron deficiency when:

• oral iron medicines are not sufficiently effective;
• the patient does not tolerate oral iron medicines;
• the doctor has determined that iron must be rapidly supplied to the patient to replenish body stores.

Your doctor will confirm whether you have iron deficiency by ordering a blood test.

2. Important information before using Fexabogard

When not to use Fexabogard

• if the patient is allergic (hypersensitive) to iron carboxymaltose or any of the other ingredients of this medicine (listed in section 6);
• in case of severe allergic reactions (hypersensitivity) to other injectable iron-containing medicines;
• if the patient has anaemia not caused by iron deficiency;
• if the patient has iron overload (excess iron in the body) or disorders of iron metabolism.

Warnings and precautions
Before starting treatment with Fexabogard, discuss the following with your doctor or nurse:

• if the patient has previously experienced allergy to medicines;
• if the patient has systemic lupus erythematosus;
• if the patient has rheumatoid arthritis;
• if the patient has severe asthma, eczema or other allergies;
• if the patient has an infection;
• if the patient has liver disorders; if the patient has or has previously had low blood phosphate levels.

Fexabogard must not be administered to children under 1 year of age.
Improper administration of Fexabogard may cause leakage of the product at the injection site,
which may lead to skin irritation and potentially long-lasting brown skin discoloration
at the injection site. In such a case, administration of the medicine must be stopped immediately.
Fexabogard and other medicines
You must tell your doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take. This also includes medicines available without a prescription.
Concomitant use of Fexabogard and oral iron-containing medicines reduces the effectiveness
of the oral medicines.
Pregnancy
There are only limited data on the use of Fexabogard in pregnant women.
It is important to inform your doctor if the patient is pregnant, suspects she may be pregnant, or
is planning to have a child.
If pregnancy occurs during treatment, medical advice must be sought to determine whether
continuation of treatment with Fexabogard is necessary.
Breast-feeding
If the patient is breast-feeding, medical advice should be sought before administration of Fexabogard.
It is unlikely that Fexabogard poses a risk to breast-fed infants.
Driving and operating machinery
It is unlikely that Fexabogard affects the ability to drive or operate machinery.
Fexabogard contains sodium
Vial containing 2 mL of dispersion: This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e.
the medicine is considered "sodium-free".
Vial containing 10 mL of dispersion: This medicine contains up to 59 mg of sodium (main component of
table salt) in each vial. This corresponds to 2.95% of the maximum recommended daily dietary intake of sodium
in adults.
Vial containing 20 mL of dispersion: This medicine contains up to 118 mg of sodium (main component of
table salt) in each vial. This corresponds to 5.9% of the maximum recommended daily dietary intake of sodium
in adults.

3. How to take Fexabogard

Your doctor will determine the dose of Fexabogard to be given to you, the frequency of administration, and the duration of treatment. To determine the appropriate dose of the medication, your doctor will order a blood test.

Adults and adolescents aged 14 years and older
Fexabogard will be administered by a doctor or nurse either undiluted via intravenous injection, diluted via intravenous infusion, or during dialysis:

• Up to 20 mL of Fexabogard (corresponding to a dose of 1000 mg of iron) is administered by intravenous injection directly into the vein once weekly.
• Patients undergoing hemodialysis may receive Fexabogard administered through the dialysis line.
• For intravenous infusion, up to 20 mL of Fexabogard (corresponding to 1000 mg of iron) is administered directly into the vein once weekly. Prior to administration, Fexabogard must be diluted with sodium chloride solution. The final volume of the prepared solution may be up to 250 mL; the solution is brown in color.

Children and adolescents aged 1 to 13 years
Fexabogard will be administered by a doctor or nurse either undiluted via intravenous injection or diluted via intravenous infusion.

• The child will receive Fexabogard directly into the vein. It will be in the form of a brown solution.
• If the child is undergoing dialysis, Fexabogard must not be administered.

Fexabogard may only be administered in settings where prompt and appropriate medical care is available in case of hypersensitivity reactions. After each administration, the patient will be monitored by a doctor or nurse for at least 30 minutes.

Overdose of Fexabogard
Since this medicine will be administered by trained medical personnel, it is unlikely that the patient will receive an excessive dose.
Overdose may lead to excessive accumulation of iron in the body. To prevent iron overload, your doctor will monitor iron status parameters.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
If the patient experiences any of the following symptoms indicating a severe allergic reaction, inform the doctor immediately:
rash (e.g. hives), itching, difficulty breathing, wheezing and (or) swelling of the lips, tongue, throat or entire body, and chest pain, which may be symptoms of a sometimes severe allergic reaction called Kounis syndrome.
In some patients, the aforementioned allergic reactions (occurring less frequently than in 1 out of 1,000 people) may progress to severe or life-threatening allergic reactions (called anaphylactic reactions), and may be accompanied by heart and circulatory problems and loss of consciousness.
If the patient experiences increased fatigue or muscle or bone pain (pain in arms or legs, joints or back), they should inform the doctor. This may be a sign of decreased phosphate levels in the blood, which may lead to softening of the bones (osteomalacia). This condition may occasionally lead to bone fractures. The doctor may also order blood tests to check phosphate levels, especially if the patient requires repeated iron treatment over a prolonged period.
The doctor supervising the patient is aware of the possibility of the aforementioned adverse reactions and will therefore monitor the patient's condition during and after administration of Fexabogard.
Other adverse reactions that should be reported to the doctor if they become severe:
Common (may affect up to 1 in 10 people):
headache, dizziness, hot flushes, high blood pressure, nausea, and reactions at the site of medicine/infusion administration (see also section 2).
Uncommon (may affect up to 1 in 100 people):
numbness, tingling or pricking sensation of the skin, altered taste sensation, rapid heartbeat, low blood pressure, difficulty breathing, vomiting, indigestion, abdominal pain, constipation, diarrhoea, itchy skin, hives, skin redness, rash, muscle, joint and (or) back pain, pain in arms and legs, muscle cramps, fever, feeling of fatigue, chest pain, swelling of hands and (or) feet, chills and general feeling of discomfort.
Rare (may affect up to 1 in 1,000 people):
vein inflammation, feeling of anxiety, fainting, feeling of impending fainting, wheezing, excessive gas release (bloating), sudden swelling of the face, lips, tongue or throat, which may cause difficulty breathing, paleness and skin discoloration in areas of the body other than the injection site.
Frequency not known (frequency cannot be estimated from the available data):
loss of consciousness and facial swelling.
Flu-like symptoms (which may affect up to 1 in 1,000 people) may occur within a few hours to several days after injection; typical symptoms include high body temperature and muscle and joint pain.
Some blood test results may undergo transient changes. These can be detected by laboratory testing.

• The following blood parameter change commonly occurs: decreased phosphate levels in the blood.
• The following blood parameter changes occur uncommonly: increased activity of certain liver enzymes known as alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase and alkaline phosphatase, and increased activity of an enzyme called lactate dehydrogenase.

If additional information is needed, consult a doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Fexabogard

Keep Fexabogard out of the sight and reach of children.
Do not use Fexabogard after the expiry date stated on the label.
The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze. For storage conditions after dilution or first opening of the container, see section "Information for healthcare professionals only".
Fexabogard is usually stored by a physician or in a hospital.

6. Contents of the packaging and other information

What Fexabogard contains
The active substance is iron (in the form of iron carboxymaltose, an iron carbohydrate complex).
Each mL of dispersion contains 50 mg of iron (as iron carboxymaltose).
The other ingredients are sodium hydroxide (for pH adjustment) (E 524), hydrochloric acid,
concentrated (E 507) (for pH adjustment), and water for injections.

What Fexabogard looks like and contents of the pack
Fexabogard is a dark brown, opaque dispersion for injection/infusion.
Fexabogard is available in glass vials sealed with a grey rubber stopper and an aluminium flip-off cap, packed in a cardboard box containing:

• 2 mL dispersion corresponding to 100 mg iron. Available in packs of 1, 2 and 5 vials.
• 10 mL dispersion corresponding to 500 mg iron. Available in packs of 1, 2 and 5 vials.
• 20 mL dispersion corresponding to 1000 mg iron. Available in a pack containing 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. 22 209 70 00
{Logo of the Marketing Authorisation Holder}

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands IJzer(III)carboxymaltose Sandoz 50 mg/ml, oplossing voor injectie of infusie
Austria Eisencarboxymaltose Sandoz 50mg/ml -Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung
Belgium Ferric carboxymaltose Sandoz 50 mg iron/ml solution for injection/infusion
Bulgaria XABOGARD, КСАБОГАРД
Germany FerApplic 50 mg/ml Injektions/Infusionslösung
Spain Hierro carboximaltosa Sandoz 50 mg/ml solución inyectable y para perfusión EFG
Finland Xabogard 50 mg Fe/ml injektio/infuusioneste, liuos
Croatia XABOGARD 50 mg/ml otopina za injekciju ili infuziju
Ireland Ferric carboxymaltose 50 mg iron/ml solution for injection/infusion
Italy Carbossimaltosio ferrico Sandoz
Malta Ferric carboxymaltose 50 mg iron/ml solution for injection/infusion
Portugal Carboximaltose férrica Sandoz
Romania XABOGARD 50 mg fer/ml solutie injectabila/perfuzabila
Sweden Xabogard 50 mg Fe/ml injektions/infusionsvätska, lösning
Slovenia XABOGARD 50 mg/ml raztopina za injiciranje/infundiranje
Slovakia Ferric carboxymaltose Sandoz 50 mg železa/ml injekčný/infúzny roztok
Denmark Xabogard
France CARBOXYMALTOSE FERRIQUE SANDOZ 50 mg/ml, dispersion injectable / pour perfusion
Hungary Vas-karboximaltóz Sandoz 50 mg/ml oldatos injekció vagy infúzió
Norway Xabogard
Greece Ferric carboxymaltose/Sandoz
Poland Fexabogard

Information intended exclusively for professional medical personnel:

Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions, both objective and subjective, during and after each administration of Fexabogard.
Fexabogard must be administered only when trained personnel capable of assessing and managing anaphylactic reactions are immediately available, and in a setting fully equipped with resuscitation equipment. Patients should be observed for at least 30 minutes after each administration of Fexabogard to detect any adverse reactions.

Step 1: Determining iron requirement
The individual iron requirement for correcting iron deficiency with Fexabogard is based on the patient's body weight and hemoglobin (Hb) concentration. To determine the total iron requirement, refer to Table 1. Two doses may be required to meet the total iron requirement; see Step 2 for maximum single iron doses.

Table 1: Determining total iron requirement

Step 2: Calculating and administering the individual maximum iron dose(s)
Based on the established total iron requirement, an appropriate dose (or doses) of Fexabogard should be administered, taking into account the following:

Adults and adolescents aged 14 years and older
A single administration of Fexabogard should not exceed:

• 15 mg of iron per kg of body weight (intravenous injection) or 20 mg of iron per kg of body weight (intravenous infusion)
• 1000 mg of iron (20 mL of Fexabogard product).

The maximum recommended cumulative dose of Fexabogard is 1000 mg of iron (20 mL of Fexabogard product) per week. If the total iron requirement is higher, additional dosing should be administered no sooner than 7 days after the first dose.

Children and adolescents aged 1 to 13 years
A single administration of Fexabogard should not exceed:

• 15 mg of iron per kg of body weight
• 750 mg of iron (15 mL of Fexabogard product)

The maximum recommended cumulative dose of Fexabogard is 750 mg of iron (15 mL of Fexabogard product) per week. If the total iron requirement is higher, additional dosing should be administered no sooner than 7 days after the first dose.

Children under 1 year of age
Fexabogard is not recommended for use in children under 1 year of age.

Patients with chronic kidney disease requiring hemodialysis
Adults and adolescents aged 14 years and older: in patients with chronic kidney disease requiring hemodialysis, a single maximum daily dose of 200 mg of iron should not be exceeded.
Fexabogard is not recommended for use in children aged 1 to 13 years with chronic kidney disease requiring hemodialysis.

Administration method
Before use, visually inspect vials for precipitates and damage. Use only vials containing a clear, homogeneous dispersion free of particulates.
Fexabogard is intended exclusively for intravenous administration: as an injection, infusion, or during hemodialysis as an undiluted solution directly through the venous line leading to the dialyzer. Fexabogard must not be administered subcutaneously or intramuscularly.
Extreme caution must be exercised during administration of Fexabogard to avoid extravasation. Extravasation of Fexabogard into perivenous tissue may cause skin irritation and long-lasting brown skin discoloration at the injection site. If extravasation occurs, administration of Fexabogard must be stopped immediately.

Intravenous injection
Fexabogard may be administered as an undiluted dispersion via intravenous injection. In adults and adolescents aged 14 years and older, the maximum single dose is 15 mg of iron per kg of body weight, but must not exceed 1000 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. The recommended administration rate is shown in Table 2:

Table 2: Administration rate of Fexabogard for intravenous injection

Intravenous infusion
The medicinal product Fexabogard may be administered by intravenous infusion. In such cases, 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 must not exceed 1000 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.
For infusion, Fexabogard must be diluted only with sterile 0.9% m/V sodium chloride solution, according to the instructions given in Table 3. Note: Due to the stability of the solution, the medicinal product Fexabogard must not be diluted to concentrations below 2 mg iron/mL (excluding the volume of iron carboxymaltose dispersion).
Table 3: Dilution scheme for Fexabogard medicinal product for intravenous infusion

Monitoring procedures
The physician should perform a reassessment based on the individual patient's condition. Reassessment
of Hb concentration should be carried out no earlier than 4 weeks after the last administration of Fexabogard,
to ensure sufficient time for erythropoiesis and iron utilization in the body.
If the patient requires further iron deficiency correction, iron requirements should be recalculated using
Table 1 above.
Pharmaceutical incompatibilities
Parenterally administered iron-containing products reduce the absorption of iron administered orally at the
same time. Therefore, if oral iron therapy is necessary, it should not be initiated earlier than 5 days after the
last administration of Fexabogard.
Overdose
Administration of Fexabogard in amounts exceeding the dose required to correct iron deficiency at the time
of administration may lead to iron accumulation in the storage pool and, consequently, to hemosiderosis.
In diagnosing iron overload, monitoring of iron metabolism parameters, such as serum ferritin concentration
and transferrin saturation, may be useful. In case of confirmed iron accumulation, standard treatment
approaches for such cases should be initiated, e.g., consideration of iron-chelating agents.
Stability ensuring suitability for use
Shelf-life after first opening of the vial:
From a microbiological standpoint, the parenteral preparation should be used immediately after preparation.
If not used immediately, the user is responsible for observing storage duration and conditions ensuring
suitability for use. The product must be administered under controlled and verified aseptic conditions.
Chemical and physical stability ensuring suitability for use has been demonstrated for up to 7 days when
stored at room temperature (20°C – 25°C).
Stability in polyethylene containers after dilution with sterile 0.9% sodium chloride solution:
From a microbiological standpoint, the parenteral preparation should be used immediately after dilution
with sterile 0.9% sodium chloride solution.
If not used immediately, the user is responsible for observing storage duration and conditions ensuring
suitability for use, which typically means storage for a maximum of 24 hours at 2°C to 8°C, unless dilution
was performed under controlled and validated aseptic conditions.
Chemical and physical stability ensuring suitability for use has been demonstrated for 24 hours at room
temperature (20°C – 25°C) for concentrations of 2 mg/mL, 4 mg/mL, and 5 mg/mL.
Stability in polypropylene syringe (undiluted):
From a microbiological standpoint, the product should be used immediately after preparation. If not used
immediately, the user is responsible for observing storage duration and conditions ensuring suitability for use,
which typically means storage for a maximum of 24 hours at 2°C to 8°C, unless preparation was performed under
controlled and validated aseptic conditions.
Chemical and physical stability ensuring suitability for use has been demonstrated for 24 hours at room
temperature (20°C – 25°C).