Venofer

Package Leaflet: Information for the User

VENOFER

20 mg iron(III)/ml, solution for injection and infusion

(Ferri hydroxidum saccharum)

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Venofer is and what it is used for
• 2. Important information before you are given Venofer
• 3. How Venofer is given
• 4. Possible side effects
• 5. How to store Venofer
• 6. Contents of the pack and other information

1. What Venofer is and what it is used for

Venofer is an iron replacement therapy given by injection into a vein to treat iron deficiency when oral iron supplements are not effective or cannot be used. Iron is used in the bone marrow to produce hemoglobin (Hb). Venofer is used to treat iron deficiency in cases where it is necessary to replenish the body's iron stores quickly.

• when there is a clinical need for rapid replenishment of the body's iron stores,
• in patients who do not tolerate oral iron supplements or in whom such treatment is not possible,
• when oral iron supplements are ineffective (e.g., in cases of active inflammatory bowel disease).

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2. Important information before you are given Venofer

When not to use Venofer:

if you have anemia that is not caused by iron deficiency; if your body has too much iron or does not use iron properly; if you are allergic (hypersensitive) to Venofer or any of the other ingredients of this medicine; if you have had a serious allergic reaction (hypersensitivity) to other injectable iron products.

Warnings and precautions:

Before receiving Venofer, tell your doctor or nurse if you have ever had an allergy to any medicine; if you have systemic lupus erythematosus; if you have rheumatoid arthritis; if you have severe asthma, eczema, or other atopic allergies; if you have any infections; if you have liver problems.

Venofer and other medicines:

As with all intravenous iron products, Venofer should not be given at the same time as oral iron supplements, as this may reduce the absorption of oral iron supplements.

Pregnancy and breastfeeding:

Venofer has not been studied in pregnant women during the first three months of pregnancy. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant during treatment, consult your doctor. Your doctor will decide whether you should receive Venofer. If you are breastfeeding, consult your doctor before receiving Venofer.

Driving and using machines:

After receiving Venofer, you may experience dizziness, disorientation, or fainting. In this case, do not drive or operate machinery until these symptoms have resolved. If in doubt, consult your doctor.

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Venofer contains sodium:

Venofer contains up to 7 mg of sodium (the main component of common salt) per ml. This corresponds to 0.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Venofer is given

Your doctor will decide the dose of Venofer you should receive and how often and for how long you should receive it. To adjust the dose, your doctor will perform blood tests. Your doctor or nurse will administer Venofer in one of the following ways:

• slow intravenous injection - 1 to 3 times a week;
• as an intravenous infusion - 1 to 3 times a week;
• during dialysis - the medicine will be given into the venous line of the dialysis machine. Venofer should only be given in facilities where immediate medical attention is available in case of an allergic reaction. After each administration of Venofer, the patient should be monitored by a doctor or nurse for at least 30 minutes to detect any adverse reactions.

4. Possible side effects

Like all medicines, Venofer can cause side effects, although not everybody gets them. The most commonly reported side effects in clinical trials were changes in taste, such as metallic taste, low or high blood pressure, reaction at the injection/infusion site, nausea.

• Low blood pressure (dizziness, fainting).
• Swelling of the face.
• Difficulty breathing.
• Chest pain, which can be a sign of a severe allergic reaction called Kounis syndrome. If you think you have had an allergic reaction, tell your doctor or nurse immediately.

Other side effects:

Frequent(may affect up to 1 in 10 people)

• Changes in taste, such as metallic taste. This usually does not last for a long time.
• Low or high blood pressure.
• Nausea.
• Reactions at the injection/infusion site, such as pain, irritation, itching, bruising, or skin discoloration.

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Uncommon(may affect up to 1 in 100 people)

• Headache or dizziness.
• Abdominal pain or diarrhea.
• Vomiting.
• Wheezing, difficulty breathing.
• Itching, rash.
• Muscle cramps, spasms, or pain.
• Numbness or tingling.
• Decreased sensation.
• Phlebitis.
• Flushing, feeling of heat.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, fatigue.
• Swelling of hands and feet.
• Pain.
• Increased liver enzyme activity (AlAT, AspAT, GGT) in blood.
• Increased ferritin levels in serum.

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

• Fainting.
• Somnolence or lethargy.
• Palpitations.
• Change in urine color.
• Chest pain.
• Excessive sweating.
• Fever.
• Increased lactate dehydrogenase activity in blood.

Other side effects with unknown frequency include feeling of decreased concentration, feeling of disorientation; loss of consciousness; anxiety; tremors or shakiness; swelling of the face, lips, tongue, or throat, which may cause difficulty breathing; slow heart rate; fast heart rate; circulatory collapse; phlebitis causing blood clots; acute bronchospasm; itching, hives, rash, or skin redness; cold sweat; general feeling of being unwell; pallor; anaphylactic shock (a severe, life-threatening allergic reaction). Flu-like symptoms may occur within a few hours to a few days after injection; typical symptoms are high fever and muscle and joint pain.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. How to store Venofer

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Store the ampoules or vials in the outer carton.

6. Contents of the pack and other information

What Venofer contains

1 ml of solution contains 20 mg of iron as iron(III) hydroxide sucrose complex. 1 ampoule (5 ml) contains 100 mg of iron. The other ingredients are sodium hydroxide (to adjust pH), water for injections.

What Venofer looks like and contents of the pack

Venofer is a dark brown, non-transparent, aqueous solution for intravenous use only, in the form of injections or intravenous infusions (after dilution), containing iron(III) hydroxide sucrose complex. The solution also contains sodium hydroxide and water for injections. Venofer is available in 5 ml glass ampoules, each containing 100 mg of iron. The ampoules are packed in cardboard boxes; each box contains 5 ampoules.

Marketing Authorisation Holder and Manufacturer

Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Administration

Patients should be carefully monitored for signs of hypersensitivity reactions during and after administration of Venofer. Venofer should only be administered under the supervision of a healthcare professional experienced in the management of hypersensitivity reactions and with appropriate medical support to manage anaphylaxis.

The dose of Venofer must be calculated for each patient and should not be exceeded. The calculation of the dose is based on the hemoglobin concentration and body weight.

Dose calculation:

Total iron deficiency [mg] = body weight [kg] x (target hemoglobin concentration – actual hemoglobin concentration) [g/dl] x 2.4* + tissue iron stores [mg]

* Factor 2.4 = 0.0034 (iron content in hemoglobin = 0.34%) x 0.07 (blood volume = 7% of body weight) x 1000 (conversion factor [g] to [mg]) x 10

Total iron deficiency [mg]
Total dose of Venofer (in ml) =
20 mg iron/ml
Total amount of Venofer (ml) to be administered, depending on the patient's body weight, actual Hb level, and target Hb level*.

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To convert hemoglobin concentration from mmol/l to g/dl, multiply the first value by 1.6. If the total required dose exceeds the maximum allowed single dose, it should be divided over time. If there is no improvement in hematological parameters after 1-2 weeks, the accuracy of the original diagnosis should be reconsidered.

Calculation of iron dose in case of iron deficiency due to blood loss and as a support for autologous transfusion

The dose of Venofer required to replenish iron deficiency can be calculated according to the following formulas:

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Intravenous infusion

Venofer must be diluted in a sterile 0.9% w/v sodium chloride solution (NaCl). The product should be diluted immediately before infusion and prepared according to the following instructions:

Intravenous injection

Venofer can be administered by slow intravenous injection at a rate of 1 ml of undiluted solution per minute, not exceeding 10 ml (200 mg iron) per injection.

Injection into the venous line of a dialysis machine

Venofer can be administered during hemodialysis directly into the venous line of the dialysis machine, according to the instructions for intravenous injection.

Incompatibilities:

Do not mix Venofer with other medicinal products, except for sterile 0.9% w/v sodium chloride solution for dilution. There is a risk of precipitation and/or interaction when mixed with other solutions or medicinal products. The compatibility of the preparation with containers other than glass, polyethylene, or PCV is not known.

Special precautions for handling and disposal:

Before use, visually inspect the ampoules for particulate matter and damage. Use only ampoules containing a clear, homogeneous solution.

Shelf life and storage:

Shelf life after first opening of the container: from a microbiological point of view, the product should be used immediately. Shelf life after dilution in 0.9% w/v sodium chloride solution (NaCl): chemical and physical stability of the solution after preparation is maintained for 12 hours at room temperature. From a microbiological point of view, the product should be used immediately after dilution in 0.9% sodium chloride solution. Unless the solution is used immediately, the person who decided to use it later is responsible for assigning a shelf life and storage conditions. This period should not exceed 3 hours at room temperature, unless the dilution was performed under controlled aseptic conditions.

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