Vetidumor

Patient Information Leaflet

Vetidumor 50 mg iron/mL injectable dispersion/for infusion

iron as ferric carboxymaltose
Equivalent medicine
Please read all of 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 Vetidumor is and what it is used for
2. What you need to know before Vetidumor is administered to you
3. How Vetidumor is administered
4. Possible side effects
5. How to store Vetidumor
6. Contents of the pack and other information

1. What Vetidumor is and what it is used for

Vetidumor 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.
Vetidumor 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 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 Vetidumor

Do not receive Vetidumor

• 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 utilisation.

Warnings and precautions
Talk to your doctor or nurse before you are given Vetidumor:

• 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 suffer from liver disorders
• if you have or have had low levels of phosphate in the blood.

Incorrect administration of Vetidumor may result in product leakage at the injection 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.
Children
Vetidumor must not be administered to children under 1 year of age.
Other medicines and Vetidumor
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If Vetidumor 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 seek advice from your doctor. Your doctor will decide whether or not you should be given this medicine.
Breastfeeding
If you are breastfeeding, ask your doctor for advice before being given Vetidumor. It is unlikely that Vetidumor poses a risk to the breastfed infant.
Driving and using machines
It is unlikely that Vetidumor will affect your ability to drive or operate machinery.
Vetidumor 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 is equivalent to 2.3% of the maximum daily recommended dietary intake for an adult.

3. How Vetidumor is administered

Your doctor will decide the amount of Vetidumor to be administered, 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 undiluted Vetidumor by injection, diluted Vetidumor by infusion, or during dialysis:

• By injection, you may be given up to 20 mL of Vetidumor, corresponding to 1,000 mg of iron, once weekly directly into a vein.
• By infusion, you may be given up to 20 mL of Vetidumor, corresponding to 1,000 mg of iron, once weekly directly into a vein. Since Vetidumor is diluted with a sodium chloride solution for infusion, it may have a volume of up to 250 mL and appear as a brown solution.
• If you are undergoing dialysis, Vetidumor may be administered during a haemodialysis session through the dialyser.

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

• Your child will be given Vetidumor directly into a vein. The medicine will appear as a brown solution.
• If your child is undergoing dialysis, Vetidumor must not be administered.

Vetidumor will be administered in a facility where immunological or 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 Vetidumor 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 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 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 the arms or legs, joints, or back). This could be a sign of low phosphate levels in the blood, which could lead to softening of the bones (osteomalacia). This condition may sometimes cause bone fractures. Your doctor may 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 Vetidumor.
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 reaction at the injection/infusion site (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, rapid 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 the arms or legs, muscle spasms, fever, fatigue, chest pain, swelling of the hands and/or feet, chills, and general feeling of being unwell.
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 which may cause breathing difficulties, pallor, and skin colour changes in body areas other than the administration site.
Not known (frequency cannot be estimated from 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 parameters may be temporarily altered, as detectable in laboratory tests.
The following blood parameter change is common: decreased phosphate levels in the blood.
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, please consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or nurse. You may 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 Vetidumor

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, see the section "The following information is intended exclusively for healthcare professionals".
Normally, Vetidumor is stored by your doctor or hospital.

6. Package contents and other information

What Vetidumor 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).
The other components are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Day Zero ehf.
Reykjavíkurvegur 62
220 Hafnarfjörður
Iceland

Manufacturer
PLIVA Croatia Ltd.
Prilaz baruna Filipovića 25
Zagreb 10000
Croatia

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
AT: Vetidumor 50 mg Eisen/ml Dispersion zur Injektion/Infusion
IT: Vetidumor

The following information is intended exclusively for physicians or healthcare professionals:
Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of Vetidumor.
Vetidumor must be administered only if qualified personnel are immediately available to evaluate and manage anaphylactic reactions, in a facility where full resuscitation equipment is available. The patient must remain under observation for at least 30 minutes after each administration of Vetidumor to monitor for adverse reactions.

The dosage regimen for Vetidumor follows a stepwise approach:
Step 1: Determination of iron requirement
The individual iron deficit to be replenished with Vetidumor is determined based on body weight and haemoglobin (Hb) level. For determination of iron requirement, refer to Table 1. Two doses may be required to replenish the total iron deficit; see Step 2 for maximum individual iron doses.
Iron deficiency must be confirmed by laboratory tests.

Table 1: Determination of iron requirement

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

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

The recommended maximum cumulative dose of Vetidumor is 1,000 mg of iron (20 mL of Vetidumor) per
week. If the total iron requirement is higher, 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 Vetidumor must not exceed:

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

The recommended maximum cumulative dose of Vetidumor is 750 mg of iron (15 mL of Vetidumor) per
week. If the total iron requirement is higher, 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 reassessed no sooner than 4 weeks after the last administration of Vetidumor 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
Vetidumor 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 maximum single daily dose of 200 mg of iron must not be exceeded in patients with chronic kidney disease dependent on haemodialysis.
Vetidumor is not recommended in children aged between 1 and 13 years with chronic kidney disease requiring haemodialysis.
Method of administration
Before use, inspect vials visually for damage and sedimentation. Use only vials containing a homogeneous dispersion free of sediment. Each vial of
Vetidumor is for single use only.
Vetidumor must be administered exclusively by intravenous route:

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

Vetidumor must not be administered by subcutaneous or intramuscular route.
During administration of Vetidumor, caution must be exercised to avoid paravenous extravasation. Paravenous extravasation of Vetidumor at the administration site may cause skin irritation and potentially long-lasting brown discoloration at the site of administration. In case of paravenous extravasation, administration of Vetidumor must be immediately discontinued.
Intravenous injection
Vetidumor 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 Vetidumor for intravenous injection

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

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

Overdose
Administration of Vetidumor 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 of 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, consider 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 duration and conditions of in-use storage are the responsibility of the user.

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