Ferinject is an anti anaemic 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 the 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.

You must not receive Ferinject

• if you are allergic (hypersensitive) to ferric carboxymaltose 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 anemia not caused by iron deficiency.
• if you have an iron overload (too much iron in your body) or disturbances in the utilization 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
• if you have or have had low levels of phosphate in the blood

Ferinject should not be given to children under 14 years.

Incorrect administration of Ferinject may cause leakage of the product at the administration site, which may lead to irritation of the skin and potentially long-lasting brown discoloration at the site of administration. 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 a prescription. If Ferinject is given together with oral iron preparations, then these oral preparations could be less efficient.

Pregnancy

There are limited data from the use of Ferinject 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. 

Breastfeeding

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 milliliter of undiluted solution. This has to be taken into account by patients on a sodium controlled diet.

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 hemodialysis session via the dialyzer.
• 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 the accumulation of iron in storage sites. Your doctor will monitor iron parameters such as serum ferritin and transferrin to avoid iron accumulation.

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/anaphylactic 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, feeling hot (flushing), high blood pressure, nausea, and injection/infusion site reactions (see also 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, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, redness of the skin, rash, muscle-, joint -and/or back pain, pain in arms or legs, 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, a general feeling of discomfort, loss of consciousness, anxiety, fainting, feeling faint, wheeze, excessive wind (flatulence), rapid swelling of the face, mouth, tongue or throat which may cause difficulty in breathing, paleness, and swelling of the face.

Flu-like illness (may affect up to 1 in 1,000 people) may occur a few hours to several days after injection and is typically characterized by symptoms such as high temperature, and aches and pains in muscles and joints.

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

The following change in blood parameters is common: decrease in blood phosphorus.

The following changes in blood parameters are uncommon: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, 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:

• by contacting the local representative of the Marketing Authorisation Holder.

Name: ARAC Healthcare

Adress City: Riyadh

Tel: + 966 11 417 1596

e-mail: Drug.safety@arac.sa

• or through safety@viforpharma.com

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.