Ferric carboxymaltose Mylan

Package leaflet: Information for the patient

Ferric Carboxymaltose Mylan 50 mg iron/mL injectable dispersion/for infusion

ferric carboxymaltose
Equivalent medicine
Read all of this 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 or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Carboxymaltose Iron Mylan 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.
Carboxymaltose Iron Mylan 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 replenish iron stores.

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

2. What you should know before being given Carbossimaltosio Ferrico Mylan

You must not be given Carbossimaltosio Ferrico Mylan

• 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 anaemia not caused by iron deficiency.
• If you have iron overload (excess iron in the body) or disorders of iron utilization.

Warnings and precautions
Talk to your doctor or nurse before you are given Carbossimaltosio Ferrico Mylan:

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

Carbossimaltosio Ferrico Mylan must not be administered to children under 1 year of age.
Incorrect administration of Carbossimaltosio Ferrico Mylan may cause leakage of the product at the
administration site, which can lead to skin irritation and potentially permanent brown discoloration at the
administration site. Administration must be stopped immediately if this occurs.
Other medicines and Carbossimaltosio Ferrico Mylan
Tell your doctor if you are using, have recently used, or might use any other medicines, including those
obtained without a prescription. If Carbossimaltosio Ferrico Mylan is administered together with oral iron
preparations, these oral preparations may be less effective.
Pregnancy
There is limited data on the use of Carbossimaltosio Ferrico Mylan in pregnant women. 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, consult your doctor. Your doctor will decide whether you should
be given this medicine.
Breast-feeding
If you are breast-feeding, ask your doctor for advice before being given Carbossimaltosio Ferrico Mylan.
It is unlikely that this medicine poses a risk to the breast-fed infant. This medicine may be used during
breast-feeding.
Driving and using machines
Carbossimaltosio Ferrico Mylan has no effect or negligible effect on the ability to drive and use machines.
Carbossimaltosio Ferrico Mylan contains sodium
This medicine contains up to a maximum of 5.5 mg of sodium (a main component of cooking salt) per mL
of undiluted dispersion. This corresponds to 0.3% of the maximum recommended daily dietary intake for
an adult.

3. How Ferric Carboxymaltose Mylan is administered

Your doctor will decide how much iron you should receive, how often, and for how long the treatment should last.
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 undiluted Ferric Carboxymaltose Mylan as an injection, during dialysis, or diluted as an infusion:

• As an injection, you may receive up to 20 mL of Ferric Carboxymaltose Mylan, corresponding to 1,000 mg of iron, once weekly directly into a vein.
• As an infusion, you may receive up to 20 mL of Ferric Carboxymaltose Mylan, corresponding to 1,000 mg of iron, once weekly directly into a vein. Since this medicine is diluted with sodium chloride solution for infusion, the volume may be up to 250 mL and will appear as a brown solution.
• If you are undergoing dialysis, Ferric Carboxymaltose Mylan may be administered during a hemodialysis session through the dialysis machine.

Children and adolescents aged between 1 and 13 years
Your doctor or nurse will administer undiluted Ferric Carboxymaltose Mylan as an injection or diluted as an infusion:

• The medicine will be administered directly into the child's vein. It will appear as a brown solution.
• If the child is undergoing dialysis, Ferric Carboxymaltose Mylan must not be administered.

Ferric Carboxymaltose Mylan will be administered in a facility where immediate and appropriate treatment for immunological or allergic reactions can be provided. After each administration, your doctor or nurse will monitor you for at least 30 minutes.

If you are given more Ferric Carboxymaltose Mylan than you should
Since this medicine is administered by qualified medical personnel, it is unlikely that you will receive an excessive amount.
Overdose may lead to iron accumulation in the body. Your doctor will monitor iron parameters to prevent iron overload.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences 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 sensation, 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 known as Kounis syndrome.
In some patients, these allergic reactions (affecting fewer than 1 in 1,000 people) may become severe or life-threatening (anaphylactic reactions) and may be associated with heart and circulatory problems and loss of consciousness.
Inform your doctor if you develop worsening fatigue, 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 occasionally cause 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 administration of Ferric Carboxymaltose Mylan.
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, sensation of warmth (flushing), high blood pressure, nausea, and injection/infusion site reactions (see also section 2).
Uncommon (may affect up to 1 in 100 people):
numbness, tingling or pins and needles sensation on the skin, altered taste sensation, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching sensation, hives, skin redness, skin rash, muscle pain, joint pain and/or back pain, pain in arms or legs, muscle spasms, fever, fatigue, chest pain, swelling of the hands and/or feet, chills, and a general feeling of being unwell.
Rare (may affect up to 1 in 1,000 people):
inflammation of a vein, anxiety, fainting, feeling faint, wheezing, excess gas in the intestine (flatulence), rapid swelling of the face, mouth, tongue or throat that may cause breathing difficulties, pallor, and changes in skin colour 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 from several hours to several days after injection and is usually characterised by symptoms such as high temperature and muscle and joint pain.
Some blood parameters may be temporarily altered, as detectable in laboratory tests.
The following blood parameter change is common: reduction in blood phosphorus levels.
The following blood parameter changes are uncommon: increase in certain liver enzymes known as alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase and alkaline phosphatase, and increase in 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, consult 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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ferric Carboxymaltose Mylan

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.
Store in the original packaging to protect the medicine from light. Do not store above 30°C. Do not freeze. After opening the vials of Ferric Carboxymaltose Mylan, they must be used immediately. After dilution with sodium chloride solution, the diluted dispersion must be used immediately.
Ferric Carboxymaltose Mylan will normally be stored for you by your doctor or the hospital.

6. Package contents and other information

What Carboxymaltose Iron Mylan contains
The active substance is ferric carboxymaltose, an iron carbohydrate complex. The concentration of
iron in the product is 50 mg per millilitre. The other components are hydrochloric acid (for pH
adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Description of the appearance of Carboxymaltose Iron Mylan and package contents
Carboxymaltose Iron Mylan 50 mg iron/mL injectable dispersion/for infusion is a non-transparent aqueous dispersion, dark brown in colour, contained in a glass vial with a rubber stopper and aluminium seal.
100 mg/2 mL available in packs of 1, 2 or 5 vials.
500 mg/10 mL available in packs of 1, 2 or 5 vials.
1,000 mg/20 mL available in packs of 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
KYMOS S.L.
Ronda de Can Fatjó, 7B
Parc Tecnologic Del Vallès
Cerdanyola Del Vallès
08290 Barcelona
Spain
Viatris Santé
1 rue de Turin
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Eisencarboxymaltose Viatris 50 mg/ml Dispersion zur Injektion/Infusion
Belgium Ferric Carboxymaltose Viatris 50 mg iron/ml dispersion for injection/infusion
Ferric Carboxymaltose Viatris 50 mg de fer/ml dispersion injectable/pour perfusion
Ferric Carboxymaltose Viatris 50 mg Eisen/ml Dispersion zur Injektion/Infusion
Croatia Correctiron 50 mg/ml disperzija za injekciju/infuziju
Denmark Ferricarboxymaltose Viatris
Finland Fercarbos
France Carboxymaltose Ferrique Viatris 50 mg/mL, dispersion injectable/pour perfusion
Italy Carboxymaltose Iron Mylan
Luxembourg Correctiron 50 mg/ml dispersion injectable/pour perfusion
Norway Jernkarboksymaltose Viatris
Netherlands IJzer(III)carboxymaltose Viatris 50 mg/ml, dispersie voor injectie/infusie
Portugal Carboximaltose férrica Mylan
Romania Carboximaltoză ferică Viatris 50 mg/ml dispersie injectabilă/perfuzabilă
Slovenia Železo Viatris 50 mg/ml disperzija za injiciranje/infundiranje
Spain Carboximaltosa Ferrica Viatris 50 mg/ml dispersión inyectable y para perfusión
Sweden Fercarbos

The following information is intended for healthcare professionals only:

Carefully monitor patients for signs and symptoms of hypersensitivity reactions during and after each
administration of Ferric Carboxymaltose Mylan. This treatment should be administered only when
qualified personnel are immediately available to evaluate and manage anaphylactic reactions, in a
healthcare setting where full resuscitation equipment is available. The patient must be kept under
observation to monitor for adverse reactions for at least 30 minutes after each administration of
Ferric Carboxymaltose Mylan.

Step 1: Determination of total iron requirement
The individual iron requirement for repletion with this medicinal product is determined based on the
patient's body weight and hemoglobin (Hb) level. For determination of the total iron requirement, refer
to Table 1. Two doses may be necessary to achieve complete iron repletion; see Step 2 for maximum
individual iron doses.

Table 1: Determination of total iron requirement

Step 2: Calculation and administration of the individual maximum dose(s) of iron
Based on the total iron requirement determined, the appropriate dose(s) of Ferric Carboxymaltose Mylan should be administered taking into account the following:
Adults and adolescents aged 14 years and older
A single administration of Ferric Carboxymaltose Mylan must not exceed:

• 15 mg of iron/kg body weight (intravenous injection) or 20 mg of iron/kg body weight (intravenous infusion)
• 1,000 mg of iron (20 mL of Ferric Carboxymaltose Mylan).

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

• 15 mg of iron/kg body weight
• 750 mg of iron (15 mL of Ferric Carboxymaltose Mylan).

The recommended maximum cumulative dose of Ferric Carboxymaltose Mylan is 750 mg of iron (15 mL of Ferric Carboxymaltose Mylan) per week. If the total iron requirement is higher, administration of an additional dose should occur at least 7 days after the first dose.
Children under 1 year of age
The use of Ferric Carboxymaltose Mylan is not recommended in children under 1 year of age.
Patients with chronic kidney disease dependent on haemodialysis
In adults and adolescents aged 14 years and older, a maximum single daily dose of 200 mg of iron must not be exceeded in patients with chronic kidney disease dependent on haemodialysis.
Its use is not recommended in children aged between 1 and 13 years affected by chronic kidney disease requiring haemodialysis.
Method of administration
Ferric Carboxymaltose Mylan must be administered exclusively via the intravenous route: by injection, by infusion, or during a haemodialysis session directly into the venous access of the dialyser without dilution. Ferric Carboxymaltose Mylan must not be administered subcutaneously or intramuscularly.
Caution must be exercised during administration of Ferric Carboxymaltose Mylan to avoid paravenous extravasation. Paravenous extravasation of Ferric Carboxymaltose Mylan at the administration site may cause skin irritation and potentially long-lasting brown discoloration of the administration site. In case of paravenous extravasation, administration of Ferric Carboxymaltose Mylan must be immediately discontinued.
Intravenous injection
Ferric Carboxymaltose Mylan can be administered by intravenous injection using the undiluted solution. 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 for Ferric Carboxymaltose Mylan for intravenous injection
intravenous

Intravenous infusion
Ferric Carboxymaltose Mylan 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 Mylan must be diluted exclusively in a sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferric Carboxymaltose Mylan must not be diluted to concentrations lower than 2 mg of iron/mL (excluding the volume of the ferric carboxymaltose dispersion).
Table 3: Dilution schedule for Ferric Carboxymaltose Mylan for intravenous infusion

Monitoring measures
The physician should perform a reassessment based on the individual patient's condition. The Hb level
should be re-evaluated at least 4 weeks after the last administration of Ferric Carboxymaltose Mylan to ensure adequate time for erythropoiesis and iron utilization. If the patient requires further iron repletion, the iron requirement must be recalculated using Table 1 above.

Incompatibilities
Oral iron absorption is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be initiated earlier than 5 days after the last administration of Ferric Carboxymaltose Mylan.

Overdose
Administration of Ferric Carboxymaltose Mylan in amounts exceeding the iron deficiency present at the time of administration may lead to iron accumulation in storage sites, resulting in hemosiderosis. Monitoring of iron parameters, such as serum ferritin and transferrin saturation, may be useful in detecting iron accumulation. If iron accumulation occurs, manage according to standard medical practice, for example, consider using 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, the product should be used immediately.

Shelf life after dilution with 0.9% m/V sterile sodium chloride solution:
From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless dilution occurs under controlled and validated aseptic conditions.
Chemical and physical stability of the diluted product in use has been demonstrated for 72 hours at 25°C.