Package leaflet: Information for the patient Ferinject 50 mg iron/mL solution for injection/infusion

Ferric carboxymaltose

This medicine is subject to additional moni-” toring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 further questions, ask your doctor.

-    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Ferinject is and what it is used for

2.    What you need to know before you receive Fer-inject

3.    How Ferinject is given

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 an antianaemic preparation, a medicine that is used to treat anaemia. It contains iron in the form of an iron carbohydrate. Iron is an essential element required for the oxygen-carrying capacity of haemoglobin in red blood cells and of myoglobin in muscle tissue. Moreover, iron is involved in many other functions necessary for maintenance of life in the human body.

Ferinject is used for the treatment of patients with iron deficiency, when oral iron preparations are ineffective or cannot be used. The aim of the therapy is to replenish body iron stores and to remedy anaemia, a lack of red blood cells due to iron deficiency.

Before administration, your doctor will perform a blood test to determine the dose of Ferinject you require.

2.    What you need to know before you receive Ferinject

You must not receive Ferinject

-    if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).

-    if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.

-    if you have anaemia not caused by iron deficiency.

-    if you have an iron overload (too much iron in your body) or disturbances in the utilisation of iron.

Warnings and Precautions

Talk to your doctor or nurse before receiving Ferinject:

-    if you have a history of medicine allergy

-    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 disorders

-    Ferinject should not be given to children under 14 years.

-    Incorrect administration of Ferinject may cause leakage of the product at the injection site, which may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. The administration must be stopped immediately when this occurs.

How Ferinject is given

Your doctor or nurse will administer Ferinject undiluted by injection, during dialysis, or diluted by infusion. Ferinject will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.

You will be observed for at least 30 minutes by your doctor or nurse after each administration.

Other medicines and Ferinject

Tell your doctor if you are using, have recently used or might use any other medicines, including medicines obtained without prescription. If Ferinject is given together with oral iron preparations, then these oral preparations could be less efficient.

Pregnancy

Ferinject has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you become pregnant during treatment, you must ask your doctor for advice. 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 you are given Ferinject. It is unlikely that Ferinject represents a risk to the nursing child.

Driving and using machines

Ferinject is unlikely to impair the ability to drive or operate machines.

Important information about some of the ingredients of Ferinject

This medicinal product contains 0.24 mmol (or 5.5 mg) sodium per millilitre of undiluted solution. This has to be taken into account by patients on a sodium-controlled diet.

3.    How Ferinject is administered

Your doctor can administer Ferinject by three possible routes: undiluted by injection, during dialysis, or diluted by infusion.

-    By injection, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a week directly into the vein.

-    If you are on dialysis, you may receive Ferinject during a haemodialysis session via the dialyser.

-    By infusion, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a week directly into the vein. Because Ferinject is diluted with sodium chloride solution for the infusion, it may have a volume of up to 250 mL and appear as a brown solution.

If you receive more Ferinject than you should

Your doctor will take responsibility for determining the appropriate dose and choosing the route, frequency and duration of your treatment.

Overdose can cause accumulation of iron in storage sites. Your doctor will monitor iron parameters such as serum ferritin and transferrin to avoid iron accumulation.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: Rash (e.g. hives), itching, difficulty breathing, wheezing and/or swelling of the lips, tongue, throat or body.

In some patients these allergic reactions (affecting less than 1 in 1,000 people) may become severe or life-threatening (known as anaphylactoid reactions) and can be associated with heart and circulation problems and loss of consciousness.

Your doctor is aware of these possible side effects and will monitor you during and after the administration of Ferinject.

Other side effects that you should tell your doctor about if they become serious:

Common side effects (may affect up to 1 in 10 people): headache, dizziness, high blood pressure, nausea and injection site reactions (also see section 2).

Uncommon side effects (may affect up to 1 in 100 people): numbness, tingling or prickling sensation on the skin, a change in your taste sensation, high heart rate, low blood pressure, redness in the face, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diahorrea, itching, hives, redness of the skin, rash, muscle-, joint -and/or back pain, muscle spasms, fever, tiredness, chest pain, swelling of the hands and/or the feet, and chills.

Rare side effects (may affect up to 1 in 1,000 people): inflammation of a vein, shivering and a general feeling of discomfort, loss of consciousness, anxiety, fainting, feeling faint, wheeze, excessive wind (flatulence), rapid swelling of the deep layers of the skin, paleness and swelling of the face, and flu-like symptoms like fever, headache and/or feeling ill (influenza-like illness).

Some blood parameters may change temporarily, which could be detected in laboratory tests.

The following changes in blood parameters are common: decrease in blood phosphorus and increase of a certain liver enzyme called alanine aminotransferase.

The following changes in blood parameters are uncommon: increase in certain liver enzymes called aspartate aminotransferase, gamma-gluta-myltransferase and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.

Ask your doctor for more information.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

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 which is stated on the label. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light. Do not store above 30 °C. Do not freeze. Once the Ferinject vials have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately.

Ferinject will normally be stored for you by your doctor or the hospital.

6.    Contents of the pack and other information

What Ferinject contains

The active substance is iron (as ferric carboxy-maltose, an iron carbohydrate compound). The concentration of iron present in the product is 50 mg per millilitre. The other ingredients are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection.

What Ferinject looks like and contents of the pack

Ferinject is a dark brown, non-transparent solution for injection/infusion.

Ferinject is supplied in glass vials containing:

-    2 mL solution corresponding to 100 mg iron. Available in pack sizes of 1, 2 and 5 vials.

-    10 mL solution corresponding to 500 mg iron. Available in pack sizes of 1, 2 and 5 vials.

-    20 mL solution corresponding to 1,000 mg iron. Available in a pack size of 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vifor France SA 7-13, Bd Paul Emile Victor 92200 Neuilly-sur-Seine France

Tel.+33 (0)1 41 06 58 90 Fax+33 (0)1 41 06 58 99 e-mail: contact-fr@viforpharma.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom: Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.

This leaflet was last revised in April 2015.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Vifor Pharma UK Limited

The Old Stables, Bagshot Park ■ Bagshot Surrey GU19 5PJ UK

Intravenous infusion

Ferinject may administered by intravenous infusion, in which case it must be diluted. The maximum single dose is 20 mg iron/kg body weight but should not exceed 1,000 mg iron. Ferinject must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferinject should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxy-maltose solution).

Monitoring measures

Post-iron repletion, regular assessments should be performed to ensure that iron levels are corrected and maintained. Studies have shown that a suitable time point for reassessing iron need is at least 4 weeks post final Ferinject administration. In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.

Incompatibilities

The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last injection of Ferinject.

Overdose

Administration of Ferinject in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosi-derosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e. g. consider the use of an iron chelator.