Ferric carboxymaltose Teva 50 mg/ml dispersion for injection and infusion

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ferric carboxymaltose teva 50 mg/ml injectable dispersion and for infusion

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Package leaflet contents

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

1. What Carboximaltosa férrica Teva is and what it is used for

Carboximaltosa férrica Teva 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.

Carboximaltosa férrica is used to treat iron deficiency when:

• oral iron is not sufficiently effective.
• oral iron cannot be tolerated.
• your doctor decides you need iron very quickly 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 starting to use Ferric Carboxymaltose Teva

Do not receive Carboxymaltose Iron Teva

• if you are allergic (hypersensitive) to ferric carboxymaltose or to any of the other components of this medicine (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 (excess iron in the body) or disorders in iron utilization.

Warnings and precautions

Consult your doctor or nurse before starting treatment with ferric carboxymaltose:

• 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.

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

Pediatric population

Carboxymaltose iron should 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 need to take any other medicines, including medicines 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. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

If you become pregnant during treatment, you should consult your doctor, who will decide whether or not you should continue receiving the medicine.

Breastfeeding

If you are breastfeeding, consult your doctor before being administered ferric carboxymaltose. It is unlikely that ferric carboxymaltose will pose a risk to breastfed infants.

Driving and operating machinery

It is unlikely that ferric carboxymaltose will affect the ability to drive and use machines.

Ferric carboxymaltose Teva contains sodium

2 ml vial of dispersion: This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".

10 ml vial of dispersion: This medicine contains up to 46 mg of sodium (main component of table/cooking salt) in each vial. This corresponds to 2.3% of the maximum daily recommended sodium intake for an adult.

20 ml vial of dispersion: This medicine contains up to 92 mg of sodium (main component of table/cooking salt) in each vial. This corresponds to 4.6% of the maximum daily recommended sodium intake for an adult.

3. How Carboxymaltose Iron Teva is administered

Your doctor will decide how much carboxymaltose iron 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 this medicine undiluted by injection, diluted by intravenous infusion, or during dialysis:

• By injection, you may be given up to 20 ml of carboxymaltose iron, corresponding to 1,000 mg of iron, once weekly, directly into a vein.
• By infusion, you may be given up to 20 ml of carboxymaltose iron, corresponding to 1,000 mg of iron, once weekly, directly into a vein. Since carboxymaltose iron is diluted with sodium chloride solution for intravenous infusion, the volume of the solution may be up to 250 ml and will have a brown appearance.
• If you are undergoing dialysis, you may receive carboxymaltose iron during a hemodialysis session through the dialyzer.

Children and adolescents aged 1 to 13 years

Your doctor or nurse will administer this medicine undiluted by injection or diluted by intravenous infusion:

• Your child will receive carboxymaltose iron directly into the vein. It will have a brown appearance.
• If your child is undergoing dialysis, carboxymaltose iron must not be administered.

Carboxymaltose iron will be administered in a facility where immunological or allergic reactions can be properly 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 Iron Teva 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 side effects, although not everyone will experience them.

Serious side 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.

Consult your doctor if you develop worsening fatigue, or muscle or bone pain (in the arms or legs, joints, or back). These may be signs of low blood phosphate levels, which could cause your bones to soften (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 side effects and will monitor you during and after the administration of ferric carboxymaltose.

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

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

Headache, dizziness, feeling 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 in 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 pain, joint 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 malaise.

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

Vein inflammation, anxiety, fainting, feeling of weakness, 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.

Pseudo-flu illness (may affect up to 1 in 1,000 people) may occur several hours or several days after 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 phosphate 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 reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ferric Carboxymaltose Teva

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

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

Do not store above 25 °C.

For information on storage conditions after dilution or after first opening of the medicine, see section “This information is intended for healthcare professionals only”.

This medicine is usually stored by your doctor or hospital.

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

6. Contents of the container and additional information

Composition of Ferric Carboxymaltose Teva

The active substance is ferric carboxymaltose, an iron carbohydrate complex.

The concentration of iron present in the product is 50 mg per milliliter.

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 (excipients) are sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.

Nature of the product and contents of the container

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

Ferric Carboxymaltose Teva is supplied in glass vials containing:

• 2 ml of dispersion. Pack sizes available: 1, 2, and 5 vials.
• 10 ml of dispersion. Pack sizes available: 1, 2, and 5 vials.
• 20 ml of dispersion. Pack size available: 1 vial.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturing Responsible Person

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturing Responsible Person:

PLIVA Croatia Ltd.,

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the most recent revision of this leaflet: February 2024

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89432/P_89432.html

QR code + URL

---

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 Teva.

Ferric carboxymaltose must only be administered when trained personnel are immediately available to evaluate and treat anaphylactic reactions, and in a setting where full resuscitation equipment is readily accessible. Patients must be observed for at least 30 minutes after each administration of ferric carboxymaltose for the occurrence of adverse reactions.

The dosage of ferric carboxymaltose should follow the stepwise guidelines below:

Step 1: Determination of iron requirement

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

Iron deficiency should be confirmed by laboratory testing.

Table 1: Determination of total iron requirement

Hb	Patient 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 determined total 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 ferric carboxymaltose)

The recommended maximum cumulative weekly dose of ferric carboxymaltose is 1,000 mg of iron (20 mL of ferric carboxymaltose). If the total iron required is higher, administration of an additional dose should be performed 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 iron required is higher, administration of an additional dose should be performed at least 7 days after the first dose.

Step 3: Assessments following iron repletion

The physician must perform a new evaluation based on the patient's individual clinical condition. 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 repletion, iron requirements should be recalculated (see Step 1).

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 dependent 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 dependent 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

Prior to use, vials should be visually inspected for particulate matter or defects. Only use vials in which the dispersion is homogeneous and free of sediment.

Each vial of ferric carboxymaltose is for single use only.

Ferric carboxymaltose must be administered only by intravenous route:

• by injection, or
• by infusion, or
• during a hemodialysis session, undiluted, directly into the venous limb of the dialyzer.

Ferric carboxymaltose must not be administered by subcutaneous or intramuscular route.

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

Ferric carboxymaltose may be administered by intravenous injection using the undiluted dispersion. 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 individual 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 regimen for intravenous injection of ferric carboxymaltose

Volume of ferric carboxymaltose 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 iron/min
>10 to 20 mL	>500 to 1,000 mg	15 minutes

Intravenous infusion

Ferric carboxymaltose may be administered by intravenous infusion, in which case it must be diluted. In adults and adolescents aged 14 years or 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 1 to 13 years, the maximum individual dose is 15 mg of iron/kg body weight, but must not exceed 750 mg of iron.

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

Table 3: Dilution regimen for ferric carboxymaltose for intravenous infusion

Volume of ferric carboxymaltose 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

Incompatibilities

The absorption of oral iron is reduced when administered simultaneously with parenteral iron preparations. Therefore, if necessary, oral iron therapy should not be initiated until at least 5 days have elapsed since the last administration of ferric carboxymaltose.

Overdose

Administration of ferric carboxymaltose in amounts exceeding the quantity required to correct iron deficiency at the time of administration may lead to iron accumulation in body stores, which over time may result in hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation (TSAT) can help identify iron accumulation. If iron accumulation occurs, treat according to standard medical practice, i.e., consider the use of an iron chelator.

In-use stability

Shelf life after first opening of the container:

From a microbiological standpoint, unless the method of opening excludes the risk of microbial contamination, parenteral preparations should be used immediately.

If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.

Shelf life after dilution with sterile 0.9 % m/V sodium chloride solution:

Chemical and physical in-use stability has been demonstrated for 24 hours between 15 °C and 25 °C.

From a microbiological standpoint, parenteral preparations 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 15 °C and 25 °C, unless the dilution is carried out under controlled and validated aseptic conditions.