Ferric carboxymaltose Teva

Package leaflet: Information for the patient

FERRIC CARBOXYMALTOSE TEVA 50 mg iron/mL injectable dispersion/for infusion

iron as ferric carboxymaltose
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you 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 experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What CARBOSSIMALTOSIO FERRICO TEVA is and what it is used for
2. What you need to know before you are given CARBOSSIMALTOSIO FERRICO TEVA
3. How CARBOSSIMALTOSIO FERRICO TEVA is administered
4. Possible side effects
5. How to store CARBOSSIMALTOSIO FERRICO TEVA
6. Contents of the pack and other information

1. What CARBOSSIMALTOSIO FERRICO TEVA is and what it is used for

CARBOSSIMALTOSIO FERRICO TEVA is a medicine containing iron.
Medicines containing iron are used when the body does not have a sufficient amount of iron.
This condition is called iron deficiency.
CARBOSSIMALTOSIO FERRICO TEVA is used to treat iron deficiency when:

• oral iron is not sufficiently effective;
• you cannot tolerate orally administered iron;
• your doctor decides that you need iron very quickly to restore iron stores.

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

2. What you need to know before you are given FERRIC CARBOXYMALTOSE TEVA

TEVA
You must not be given FERRIC CARBOXYMALTOSE TEVA

• 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 previously experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations;
• if you have anemia 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 you are given FERRIC CARBOXYMALTOSE TEVA:

• if you have previously had allergies to medicines;
• if you suffer from systemic lupus erythematosus;
• if you suffer from rheumatoid arthritis;
• if you suffer from severe asthma, eczema, or other allergies;
• if you have an infection;
• if you have liver disorders;
• if you have or have had low levels of phosphate in the blood.

Improper administration of FERRIC CARBOXYMALTOSE TEVA may result in leakage of the product at the administration site, which can cause skin irritation and potentially long-lasting brown discoloration at the injection site. Administration must be stopped immediately if this occurs.
Children
FERRIC CARBOXYMALTOSE TEVA must not be administered to children under 1 year of age.
Other medicines and FERRIC CARBOXYMALTOSE TEVA
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. If FERRIC CARBOXYMALTOSE TEVA is administered together with oral iron preparations, these oral preparations may be less effective.
Pregnancy
Data on the use of ferric carboxymaltose in pregnant women are limited. It is important to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant during treatment, you should consult your doctor. Your doctor will decide whether or not you should be given this medicine.
Breast-feeding
If you are breast-feeding, consult your doctor before being given FERRIC CARBOXYMALTOSE TEVA. It is unlikely that FERRIC CARBOXYMALTOSE TEVA poses a risk to the breast-fed infant.
Driving and using machines
It is unlikely that FERRIC CARBOXYMALTOSE TEVA affects the ability to drive or operate machinery.
FERRIC CARBOXYMALTOSE TEVA contains sodium
2 mL vial of dispersion: this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially "sodium-free".
10 mL vial of dispersion: this medicine contains up to 46 mg of sodium (the main component of table salt) per vial. This corresponds to 2.3% of the maximum daily recommended dietary intake for an adult.
20 mL vial of dispersion: this medicine contains up to 92 mg of sodium (the main component of table salt) per vial. This corresponds to 4.6% of the maximum daily recommended dietary intake for an adult.

3. How CARBOSSIMALTOSIO FERRICO TEVA is administered

Your doctor will decide the amount of CARBOSSIMALTOSIO FERRICO TEVA to be administered,
the frequency, and the duration of treatment.
Your doctor will perform a blood test to determine the required dose.

Adults and adolescents aged 14 years and older
Your doctor or nurse will administer CARBOSSIMALTOSIO FERRICO TEVA undiluted
by injection, diluted by infusion, or during dialysis:

• by injection: up to 20 mL of CARBOSSIMALTOSIO FERRICO TEVA, corresponding to 1,000 mg of iron, may be administered once weekly directly into a vein;
• by infusion: up to 20 mL of CARBOSSIMALTOSIO FERRICO TEVA, corresponding to 1,000 mg of iron, may be administered once weekly directly into a vein. Since for infusion CARBOSSIMALTOSIO FERRICO TEVA is diluted with a sodium chloride solution, the volume may reach up to 250 mL and appear as a brown-colored solution;
• if you are undergoing dialysis, CARBOSSIMALTOSIO FERRICO TEVA may be administered during a hemodialysis session through the dialyzer.

Children and adolescents aged between 1 and 13 years
Your doctor or nurse will administer CARBOSSIMALTOSIO FERRICO TEVA undiluted
by injection or diluted by infusion:

• your child will be given CARBOSSIMALTOSIO FERRICO TEVA directly into a vein. The medicine will appear as a brown-colored solution;
• if your child is undergoing dialysis, CARBOSSIMALTOSIO FERRICO TEVA must not be administered.

CARBOSSIMALTOSIO FERRICO TEVA will be administered in a healthcare facility where
immune-allergic reactions can be treated promptly and appropriately. After each administration,
your doctor or nurse will monitor you for at least 30 minutes.

If you are given more CARBOSSIMALTOSIO FERRICO TEVA than you should
Since this medicine will be administered by qualified medical personnel, it is unlikely that
you will receive an excessive amount.
Overdose may cause iron accumulation in the body. Your doctor will monitor iron parameters to prevent such accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects:
Inform your doctor immediately if you experience any of the following signs and symptoms, which may indicate a severe allergic reaction: skin rash (e.g. urticaria), itching, difficulty breathing, wheezing and/or swelling of the lips, tongue, throat or body, and chest pain, which could be signs of a potentially serious allergic reaction called Kounis syndrome.
In some patients, these allergic reactions (occurring in fewer than 1 in 1,000 people) may become severe or life-threatening (anaphylactic reactions) and may be associated with heart and circulation problems and loss of consciousness.
Inform your doctor if you experience worsening fatigue or muscle or bone pain (pain in arms or legs, joints, or back). This could be a sign of low blood phosphorus levels, which may lead to softening of the bones (osteomalacia). This condition may sometimes cause bone fractures. Your doctor may also monitor your blood phosphate levels, especially if you require repeated iron treatments over time.
Your doctor is aware of these possible side effects and will monitor you during and after administration of FERRIC CARBOXYMALTOSE TEVA.
Other side effects that should be reported to your doctor if they become severe:
Common (may affect up to 1 in 10 people):
headache, dizziness, feeling of warmth (flushing), 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 on the skin, altered taste sensation, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching, hives, skin redness, 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 malaise.
Rare (may affect up to 1 in 1,000 people):
inflammation of a vein, anxiety, fainting, feeling faint, wheezing, excessive intestinal gas (flatulence), rapid swelling of the face, mouth, tongue or throat that may cause breathing difficulties, pallor, and skin colour changes in areas of the body other than the administration site.
Not known (frequency cannot be estimated from the available data):
loss of consciousness and facial swelling.
An influenza-like illness (may affect up to 1 in 1,000 people) may occur several hours to several days after injection, usually characterized by symptoms such as high temperature and muscle and joint pain.
Some blood test parameters may be temporarily altered, as detectable in laboratory tests.
The following blood parameter change is common: decreased blood phosphorus levels.
The following blood parameter changes are uncommon: increased levels of certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, and alkaline phosphatase, and increased levels of an enzyme called lactate dehydrogenase.
For further information, consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CARBOSSIMALTOSIO FERRICO TEVA

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 that month.
Do not store above 30°C. For storage conditions after dilution or first opening of the medicine, see
the section “The following information is intended exclusively for healthcare professionals”.
Normally, CARBOSSIMALTOSIO FERRICO TEVA is stored by your doctor or hospital.

6. Package contents and other information

What CARBOSSIMALTOSIO FERRICO TEVA contains
The active substance is ferric carboxymaltose, an iron-carbohydrate complex.
The concentration of iron in the product is 50 mg per millilitre.
Each 2 mL vial contains 100 mg of iron (as ferric carboxymaltose).
Each 10 mL vial contains 500 mg of iron (as ferric carboxymaltose).
Each 20 mL vial contains 1,000 mg of iron (as ferric carboxymaltose).
The other components are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Description of the appearance of CARBOSSIMALTOSIO FERRICO TEVA and contents of the pack
CARBOSSIMALTOSIO FERRICO TEVA is a non-transparent injectable/infusion dispersion, dark brown in colour.
CARBOSSIMALTOSIO FERRICO TEVA is supplied in glass vials containing:

• 2 mL of dispersion. Available in packs of 1, 2 and 5 vials.
• 10 mL of dispersion. Available in packs of 1, 2 and 5 vials.
• 20 mL of dispersion. Available in packs of 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

and Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Eisen-Carboxymaltose TEVA 50 mg Eisen/ml Dispersion zur Injektion/Infusion
Bulgaria: Максифер 50 mg/ml инжекционна/инфузионна дисперсия; Maxifer 50 mg/ml dispersion for injection/infusion
Czech Republic: Ferric carboxymaltose Teva
Germany: Eisen(III)-Carboxymaltose AbZ
Denmark: Feriliva
Greece: Ferric carboxymaltose/Teva
Spain: CARBOXIMALTOSA FERRICA TEVA 50 MG/ML DISPERSION INYECTABLE Y PARA PERFUSIÓN EFG
France: CARBOXYMALTOSE FERRIQUE TEVA 50 mg/mL, dispersion injectable/pour perfusion
Croatia: Friona 50 mg/ml disperzija za injekciju/infuziju
Hungary: Vas (III)-karboximaltóz Teva 50 mg/ml diszperziós injekció vagy infúzió
Ireland: Ferric carboxymaltose Teva 50 mg iron/ml dispersion for injection/infusion
Italy: CARBOSSIMALTOSIO FERRICO TEVA
The Netherlands: IJzer(III)carboxymaltose Teva 50 mg/ml, dispersie voor injectie/infusie
Norway: Feriliva
Portugal: Carboximaltose férrica Teva
Romania: Carboximaltoză ferică Teva 50 mg/ml dispersie injectabilă/perfuzabilă
Sweden: Feriliva
Slovenia: Friona 50 mg/ml disperzija za injiciranje/infundiranje
Slovakia: Ferric carboxymaltose Teva 50 mg/ml

The following information is intended exclusively for healthcare professionals:

Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of FERRIC CARBOXYMALTOSE TEVA.
FERRIC CARBOXYMALTOSE TEVA must be administered only if qualified personnel are immediately available to evaluate and manage anaphylactic reactions, and in a facility where full resuscitation equipment is available. The patient must remain under observation for at least 30 minutes after each administration of FERRIC CARBOXYMALTOSE TEVA to monitor for adverse reactions.
The dosing regimen for FERRIC CARBOXYMALTOSE TEVA follows a stepwise approach:
Step 1: Determination of iron requirement
The individual iron requirement to be replenished with FERRIC CARBOXYMALTOSE TEVA is determined based on body weight and haemoglobin (Hb) level of the patient. For determination of total iron requirement, refer to Table 1. Two doses may be required to achieve complete iron repletion; see Step 2 for individual maximum iron doses.
Iron deficiency should be confirmed by laboratory tests.
Table 1: Determination of total iron requirement

Phase 2: Calculation and administration of individual maximum dose(s) of iron
Based on the determined total iron requirement, the appropriate dose(s) of
FERRIC CARBOXYMALTOSE TEVA must be administered taking into account the
following:
Adults and adolescents aged 14 years and older
A single administration of FERRIC CARBOXYMALTOSE TEVA 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 TEVA).

The recommended maximum cumulative dose of FERRIC CARBOXYMALTOSE TEVA is 1,000 mg
of iron (20 mL of FERRIC CARBOXYMALTOSE TEVA) per week. If the total iron requirement is
greater, administration of an additional dose must occur at least 7 days after the first dose.
Children and adolescents aged between 1 and 13 years
A single administration of FERRIC CARBOXYMALTOSE TEVA must not exceed:

• 15 mg of iron/kg body weight;
• 750 mg of iron (15 mL of FERRIC CARBOXYMALTOSE TEVA).

The recommended maximum cumulative dose of FERRIC CARBOXYMALTOSE TEVA is 750 mg
of iron (15 mL of FERRIC CARBOXYMALTOSE TEVA) per week. If the total iron requirement is
greater, administration of an additional dose must occur at least 7 days after the first dose.
Phase 3: Evaluation after iron repletion
The physician must perform a reassessment based on the individual patient's condition. Haemoglobin
(Hb) levels should be re-evaluated no sooner than 4 weeks after the last administration of
FERRIC CARBOXYMALTOSE TEVA, to ensure adequate time for erythropoiesis and iron utilization.
If the patient requires further iron repletion, the iron requirement must be recalculated (see Phase 1).
Children under 1 year of age
FERRIC CARBOXYMALTOSE TEVA is not recommended in children under 1 year of age.
Patients with chronic kidney disease dependent on haemodialysis
For adults and adolescents aged 14 years and older, a single maximum daily dose of 200 mg of iron
must not be exceeded in patients with chronic kidney disease dependent on haemodialysis.
FERRIC CARBOXYMALTOSE TEVA is not recommended in children aged between 1 and
13 years with chronic kidney disease requiring haemodialysis.
Method of administration
Before use, visually inspect the vials to exclude damage and sedimentation. Use only vials containing
a homogeneous dispersion free of particulates. Each vial of FERRIC CARBOXYMALTOSE TEVA is
for single use only.
FERRIC CARBOXYMALTOSE TEVA must be administered exclusively by intravenous route:

• by injection, or
• by infusion, or
• during a haemodialysis session, undiluted directly into the venous access of the dialyser.

FERRIC CARBOXYMALTOSE TEVA must not be administered by subcutaneous or intramuscular
route.
During administration of FERRIC CARBOXYMALTOSE TEVA, caution must be exercised to avoid
paravenous extravasation. Paravenous extravasation of FERRIC CARBOXYMALTOSE TEVA at the
administration site may cause skin irritation and potentially long-lasting brown discoloration at the
administration site. In case of paravenous extravasation, administration of FERRIC CARBOXYMALTOSE
TEVA must be immediately discontinued.
Intravenous injection
FERRIC CARBOXYMALTOSE TEVA may be administered by intravenous injection using an undiluted
dispersion. In adults and adolescents aged 14 years and 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 between 1 and 13 years,
the maximum single dose is 15 mg of iron/kg body weight, but must not exceed 750 mg of iron.
Administration rates are shown in Table 2:
Table 2: Administration rates of FERRIC CARBOXYMALTOSE TEVA for
intravenous injection

Intravenous infusion
FERRIC CARBOXYMALTOSE TEVA may be administered by intravenous infusion.
In this 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 must not exceed 1,000 mg of iron.
In children aged between 1 and 13 years, the maximum single dose is 15 mg of iron/kg body
weight, but must not exceed 750 mg of iron.
For infusion, FERRIC CARBOXYMALTOSE TEVA must be diluted only in a sterile 0.9% m/V
sodium chloride solution, as shown in Table 3. Note: for stability reasons, FERRIC CARBOXYMALTOSE TEVA 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 TEVA for intravenous
infusion

Incompatibilities
Oral iron absorption is reduced when administered concomitantly with parenteral iron preparations. Therefore, if necessary, oral iron therapy must not be initiated earlier than 5 days after the last administration of FERRIC CARBOXYMALTOSE TEVA.

Overdose
Administration of FERRIC CARBOXYMALTOSE TEVA in amounts exceeding those required to correct the existing iron deficiency 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 be useful in identifying iron accumulation. If iron accumulation occurs, manage according to standard medical practice, for example, by considering the use of an iron chelator.

In-use stability
Shelf-life after first opening of the container:
From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage times and conditions prior to use.

Shelf-life after dilution with 0.9% m/V sterile sodium chloride solution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 15–25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage times and conditions prior to use, which should normally not exceed 24 hours at 15–25°C, unless the dilution was carried out under controlled and validated aseptic conditions.