Ferinject Injection 50mg/ml, 10ML X 5 vials (iron infusion)

Instructions:

Professional Use Instructions

Ferinject must only be administered by the intravenous route. It must not be administered by the subcutaneous or intramuscular route.

Treatment should be based on an individual assessment of the patient’s iron requirement, body weight, haemoglobin level, clinical condition, and relevant laboratory results. The patient’s iron deficiency must be confirmed by laboratory testing before administration.

Method of Administration

Ferinject may be administered by:

Intravenous injection
Intravenous infusion
Administration during haemodialysis, undiluted directly into the venous limb of the dialyser

For intravenous infusion, Ferinject must only be diluted with sterile 0.9% sodium chloride solution. No other intravenous dilution solutions or therapeutic agents should be used.

Administration Requirements

Ferinject should only be administered when:

Staff trained to evaluate and manage anaphylactic reactions are immediately available
Full resuscitation facilities are available
The patient can be appropriately monitored during and after administration
The treatment area is suitable for intravenous medicine administration

Each patient should be observed for adverse effects for at least 30 minutes after each administration.

Dose and Monitoring

The dose must be calculated by the prescriber or administering clinician according to the patient’s individual iron requirement.

For adults and adolescents aged 14 years and above, a single administration should not exceed:

15mg iron/kg body weight for intravenous injection
20mg iron/kg body weight for intravenous infusion
1,000mg iron per administration

The maximum recommended cumulative dose is 1,000mg iron per week. If additional iron is required, the next dose should be administered at least 7 days after the first dose.

Haemoglobin should be reassessed no earlier than 4 weeks after the final Ferinject administration to allow time for erythropoiesis and iron utilisation.

Before Use

Before administration:

Confirm the product is clinically appropriate for the patient.
Confirm iron deficiency using appropriate laboratory tests.
Check the patient’s medical history, allergies, current medicines, and contraindications.
Inspect the vial visually for sediment or damage.
Use only vials containing a sediment-free, homogeneous dispersion.
Do not use if the vial is damaged, expired, or the product appears abnormal.
Ensure emergency equipment and trained staff are available before administration.
Contraindications

Ferinject must not be used in patients with:

Hypersensitivity to ferric carboxymaltose, Ferinject, or any listed excipients
Known serious hypersensitivity to other parenteral iron products
Anaemia not caused by iron deficiency
Evidence of iron overload
Disturbances in the utilisation of iron
Important Warnings and Precautions

Parenteral iron products can cause hypersensitivity reactions, including serious and potentially fatal anaphylactic reactions. Treatment must be stopped immediately if hypersensitivity reactions or signs of intolerance occur.

Caution is required in patients with:

Known allergies, including drug allergies
Severe asthma, eczema, or atopic allergy
Immune or inflammatory conditions
Acute or chronic infection
Hepatic impairment
Risk factors for hypophosphataemia
Long-term or repeated high-dose ferric carboxymaltose treatment

Serum phosphate should be monitored in patients receiving multiple high-dose administrations, long-term treatment, or those with risk factors for hypophosphataemia.

Possible Side Effects

Possible side effects include:

Nausea
Injection or infusion site reactions
Hypophosphataemia
Headache
Flushing
Dizziness
Hypertension
Abdominal pain
Vomiting
Constipation
Diarrhoea
Rash, itching, or urticaria
Muscle aches or joint pain
Fatigue, chills, or fever

Rare but serious reactions may include anaphylactic reactions. Patients should be advised to seek medical attention if they experience symptoms such as breathing difficulty, swelling, chest pain, collapse, severe dizziness, worsening fatigue with muscle pain, or bone pain.

Extravasation Warning

Care should be taken to avoid paravenous leakage during administration. Leakage of Ferinject at the administration site may cause skin irritation and potentially long-lasting brown discolouration. If leakage occurs, administration must be stopped immediately.

Storage Instructions
Do not store above 30°C
Do not freeze
Store in the original packaging
Keep out of the sight and reach of children
Do not use after the expiry date shown on the packaging

After first opening or dilution, the product should be used immediately from a microbiological point of view. Any unused product or waste material should be disposed of in accordance with local requirements.

Disposal

Each vial is intended for single use only. Any unused medicine, needles, syringes, infusion materials, or clinical waste should be disposed of safely in accordance with local clinical waste and sharps disposal procedures.

Disclaimer

This information is intended for healthcare professionals and does not replace the Summary of Product Characteristics, Patient Information Leaflet, local clinical protocols, or professional judgement. Always refer to the official manufacturer’s product information before prescribing, dispensing, or administering Ferinject.