Ferinject

Package leaflet: Information for the patient

Ferinject 50 mg iron/mL injectable dispersion/for infusion

ferric carboxymaltose
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, contact your doctor. See section 4.

Contents of this leaflet:

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

1. What Ferinject is and what it is used for

Ferinject 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.
Ferinject is used for the treatment of 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 build up 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 Ferinject

Ferinject must not be administered to you

• 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 non-iron deficiency anaemia.
• 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 Ferinject

• 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

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Ferinject must not be administered to children under 1 year of age.
Incorrect administration of Ferinject may result in loss of the product at the administration site, which can lead to skin irritation and potentially long-lasting brown discoloration at the injection site. Administration must be stopped immediately if this occurs.
Other medicines and Ferinject
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If Ferinject is administered together with oral iron preparations, these oral preparations may be less effective.
Pregnancy
There is limited data on the use of Ferinject 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, you should seek advice from your doctor.
Your doctor will decide whether or not you should be given this medicine.
Breast-feeding
If you are breast-feeding, ask your doctor for advice before being given Ferinject.
It is unlikely that Ferinject poses a risk to the breast-fed infant.
Driving and using machines
It is unlikely that Ferinject affects the ability to drive or operate machinery.
Ferinject contains sodium
This medicine contains up to 5.5 mg of sodium (the main component of table salt) per mL of undiluted dispersion.
Each 2 mL vial contains less than 1 mmol (23 mg) of sodium, i.e. essentially “sodium-free”.
Each 10 mL vial contains up to 55 mg of sodium (the main component of table salt).
This corresponds to 2.8% of the maximum daily dietary intake recommended for an adult.
Each 20 mL vial contains up to 110 mg of sodium (the main component of table salt).
This corresponds to 5.5% of the maximum daily dietary intake recommended for an adult.

3. How Ferinject is administered

Your doctor will decide how much iron to give you, how often, and for how long. 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 Ferinject either undiluted by injection, diluted for infusion, or during dialysis:

• For injection, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once weekly directly into a vein.
• For infusion, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once weekly directly into a vein. Since Ferinject is diluted with sodium chloride solution for infusion, it may have a volume of up to 250 mL and will appear as a brown solution.

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• If you are undergoing dialysis, you may receive Ferinject during a hemodialysis session through the dialysis machine.

Children and adolescents aged between 1 and 13 years
Your doctor or nurse will administer Ferinject either undiluted by injection or diluted for infusion:

• Your child will receive Ferinject directly into a vein. It will appear as a brown solution.
• If your child is undergoing dialysis, Ferinject must not be administered.

Ferinject will be administered in a facility where immediate and appropriate treatment can be provided in case of immunological or allergic reactions. After each administration, your doctor or nurse will observe you for at least 30 minutes.

If you are given more Ferinject than you should

This medicine will be administered by experienced medical personnel, so 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 iron overload.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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., hives), itching, difficulty breathing, wheezing and/or swelling of the lips, tongue, throat or body, and chest pain, which may 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 (known as anaphylactic reactions) and may be associated with heart and circulation 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 sometimes result in 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 Ferinject.
Other side effects that your doctor should be informed about if they worsen:
Common (may affect up to 1 in 10 people): headache, dizziness, feeling of warmth (hot flushes), high blood pressure, nausea, and reaction at the injection/infusion site (see also section 2).
Uncommon (may affect up to 1 in 100 people): numbness, tingling or prickling sensation of the skin, taste disturbances, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching, hives, skin redness, skin rash, muscle pain, 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 a general feeling of being unwell.
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Rare (may affect up to 1 in 1,000 people): inflammation of a vein, anxiety, fainting, feeling faint, wheezing, excessive gas in the stomach or intestines (flatulence), rapid swelling of the face, mouth, tongue or throat which may cause difficulty breathing, pallor, and changes in skin colour in areas 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 and is generally 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 known as 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 can also report side effects directly via the national reporting system at the following website: 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 Ferinject

Keep Ferinject out of the sight and reach of children.
Do not use Ferinject 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. Do not freeze. For storage conditions after dilution or first opening of the medicinal product, see the section “The following information is intended exclusively for healthcare professionals”.
Ferinject is normally stored by the doctor or hospital.

6. Package contents and other information

What Ferinject 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
ferric carboxymaltose equivalent to 100 mg of iron. Each 10 mL vial contains
ferric carboxymaltose equivalent to 500 mg of iron. Each 20 mL vial contains
ferric carboxymaltose equivalent to 1,000 mg of iron. The other components are sodium hydroxide
(for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.
Description of the appearance of Ferinject and package contents
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Ferinject is an injectable/infusion dispersion, non-transparent, dark brown in colour.
Ferinject is supplied in glass vials containing:

• 2 mL of dispersion. Pack sizes of 1, 2 or 5 vials.
• 10 mL of dispersion. Pack sizes of 1, 2 or 5 vials.
• 20 mL of dispersion. Pack size of 1 vial.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tel. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
e-mail: [email protected]
Marketing Authorisation Holder in Italy:
Vifor Pharma Italia Srl
Via Paolo di Dono 73
00142 Roma
Italy
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland):
Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.
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The following information is intended for healthcare professionals only:
Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of Ferinject. Ferinject must be administered only if qualified personnel able to evaluate and manage anaphylactic reactions are immediately available, and in a facility where resuscitation equipment is accessible. The patient must be observed for adverse reactions for at least 30 minutes after each administration of Ferinject.
Step 1: Determination of iron requirement
The individual iron requirement for repletion using Ferinject is determined based on the patient's body weight and haemoglobin (Hb) level. Refer to Table 1 to determine the total iron requirement. Two doses may be needed to replenish the total iron requirement; see Step 2 for individual maximum 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 determined total iron requirement, the appropriate dose(s) of Ferinject must be administered taking into account the following:

Adults and adolescents aged 14 years and older
A single administration of Ferinject must not exceed:

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

The recommended maximum cumulative dose of Ferinject is 1,000 mg iron (20 mL of Ferinject) per week. If the total iron requirement is higher, administration of an additional dose must occur no sooner than 7 days after the first dose.

Children and adolescents aged between 1 and 13 years
A single administration of Ferinject must not exceed:

• 15 mg iron/kg body weight
• 750 mg iron (15 mL of Ferinject)

The recommended maximum cumulative dose of Ferinject is 750 mg iron (15 mL of Ferinject) per week. If the total iron requirement is higher, administration of an additional dose must occur no sooner than 7 days after the first dose.

Children under 1 year of age
The use of Ferinject is not recommended in children under 1 year of age.

Patients with dialysis-dependent chronic kidney disease
In adult and adolescent patients aged 14 years and older with dialysis-dependent chronic kidney disease, a maximum single daily dose of 200 mg iron must not be exceeded.

The use of Ferinject in children aged between 1 and 13 years with dialysis-dependent chronic kidney disease is not recommended.

Method of administration
Ferinject must be administered exclusively by intravenous route: as an injection, infusion, or during a haemodialysis session, undiluted directly into the venous access of the dialyser.
Ferinject must not be administered subcutaneously or intramuscularly.
During administration of Ferinject, care must be taken to avoid extravasation. Paravenous extravasation of Ferinject at the administration site may cause skin irritation and potentially long-lasting skin discoloration at the injection site. In case of paravenous extravasation, administration of Ferinject must be stopped immediately.

Intravenous injection
Ferinject may 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 iron/kg body weight, but must not exceed 1,000 mg iron. In children aged between 1 and 13 years, the maximum single dose is 15 mg iron/kg body weight, but must not exceed 750 mg iron. The recommended administration rates are shown in Table 2:

Table 2: Administration rates of Ferinject for intravenous injection

Intravenous infusion
Ferinject 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 of
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 iron/kg of body weight, but must not exceed 750 mg of iron.
For infusion, Ferinject must be diluted only in a sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferinject must not be diluted to concentrations below 2 mg iron/mL (excluding the volume of the ferric carboxymaltose dispersion).
Table 3: Dilution schedule for Ferinject for intravenous infusion

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Monitoring measures
The physician must perform reassessment according to the individual patient's condition. Hb levels should be re-evaluated no sooner than 4 weeks after the last administration of Ferinject, allowing sufficient time for erythropoiesis and iron utilization. If the patient requires further iron replenishment, the iron requirement must be recalculated using Table 1 above.

Incompatibilities
Oral iron absorption is reduced when oral iron preparations are administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be initiated until at least 5 days after the last administration of Ferinject.

Overdose
Administration of Ferinject in amounts exceeding those required to correct iron deficiency at the time of administration may lead to iron accumulation in storage sites, eventually resulting in hemosiderosis. Monitoring iron parameters such as serum ferritin and transferrin saturation may assist 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, parenteral preparations should be used immediately.
If not used immediately, the storage times and conditions prior to use are the responsibility of the user. The product must be administered under controlled, validated aseptic conditions.
Chemical and physical stability in use has been demonstrated for 7 days at 30°C.

Shelf-life in polyethylene and polypropylene containers after dilution with 0.9% m/V sterile sodium chloride solution:
From a microbiological standpoint, parenteral preparations should be used immediately after dilution with 0.9% m/V sterile sodium chloride solution.
If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally do not exceed 24 hours between 2 and 8°C.
In-use chemical and physical stability of the product has been demonstrated for 72 hours at 30°C at concentrations of 2 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 storage times and conditions prior to use are the responsibility of the user and normally do not exceed 24 hours between 2 and 8°C.
Chemical and physical stability of the product in use has been demonstrated for 72 hours at 30°C.
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