Ferinject Infusion (438)

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Ferinject® Infusion (Ferric carboxymaltose)
Injection, iron (as ferric carboxymaltose) 50mg/ml
Available as 2ml, 10ml or 20ml vials

Ferinject is indicated for the treatment of iron deficiency in women with a serum ferritin of <30ug/l when:

oral iron preparations are ineffective
oral iron preparations cannot be used
there is a clinical need to deliver iron rapidly

The diagnosis of iron deficiency must be based on laboratory tests.

All care providers should discuss the option to use Ferinject® with a Senior Obstetrician.

Patients that meet the criteria for Ferinject® infusion should read the patient information leaflet and have any questions answered before proceeding with treatment (See appendix 1 – Patient information Leaflet)

IMPORTANT NOTES

Ferinject® may cause anaphylactoid reactions, which can be immediate, severe and potentially life-threatening. Resuscitative medication and trained personnel should be available whenever Ferinject® is administered. The risk of anaphylaxis is enhanced for patients with known (medical) allergies. Fetal bradycardia may occur following administration of Ferinject®. This bradycardia is usually transient and as a consequence of a hypersensitivity reaction in the mother. Fetal monitoring should be carried out in any patients who experience a hypersensitivity reaction. CTG if ≥28 weeks fetal auscultation if <28 weeks.
There is a risk of extravasation that can result in long-term brown discolouration of the surrounding skin. Appendix 2 – Extravasation monitoring and management - outlines the symptoms of extravasation and its management should this occur.
Patients should be observed carefully during and for at least 30 minutes after administration of Ferinject®

Total Dose Infusion

Ferinject® should be administered during a planned daytime admission, to a locally agreed area, from Monday to Friday only.
Administration can only be undertaken in a clinical area where emergency equipment is available as there is a risk of anaphylaxis and should be controlled via an infusion pump.
Please contact pharmacy to check total dose if required.
If, at any time, during the IV administration of Ferinject®, any signs of a hypersensitivity reaction, intolerance or extravasation are detected, administration must be stopped immediately.
The cumulative dose for repletion of iron using Ferinject® is based on the patient’s body weight and haemoglobin (Hb) level and must NOTbe exceeded.

The amount of Ferinject® required should be determined from the dosage table below.

Table 1: Determination of the cumulative iron dose

Hb	Patient body weight
g/L	Below 35 kg	35 kg to <70 kg	70kg and over
<100	500 mg	1,500 mg	2,000 mg
100 to 140	500 mg	1,000 mg	1,500 mg
For doses greater than 1000mg see maximum tolerated single dose below

Maximum tolerated single dose

A single dose of Ferinject should not exceed 1,000 mg of iron per day.

Do NOT administer 1,000 mg of iron more than once a week

If the total dose is >1000 mg of iron, then the total dose should be divided and administered each week over a total of two weeks.

Post-iron repletion assessments

Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks following completion of the first treatment cycle to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.

IV Infusion

Ferinject® is administered by intravenous infusion, via an infusion pump, up to a maximum single dose of 1,000mg of iron (up to maximum of 20mg/kg body weight). Ferinject® must be diluted only in sterile 0.9% sodium chloride infusion as shown in Table 2 below. See appendix 3 - checklist for prescribing and administration.

Table 2: Dilution plan of Ferinject® for intravenous infusion

Ferinject®	Iron	Volume of 0.9% sodium chloride infusion	Minimum administration time
10ml	500mg	100ml	6 minutes
20ml	1,000mg	250ml	15 minutes

Contraindications: It is important to read the current SPC for this product.

Extra Precautions for Use

Oral iron should be stopped at least 24 hours before infusion of Ferinject® and should not be started for at least 5 days following the last infusion of Ferinject®.

Extravasation of ferric carboxymaltose at the infusion site may lead to brown discolouration and irritation of the skin. In the case of extravasation, the administration of Ferinject® must be stopped immediately. See Appendix 2.

Licensed Status

Not licensed for use during the first trimester of pregnancy but can be used during the second and third trimester and during lactation if oral iron is ineffective or impracticable.

Appendix 1: Iron infusions - patient/relative information leaflet

Iron infusions - patient/relative information leaflet (pdf)

Appendix 2: Extravasation monitoring and management

Extravasation monitoring

Caution should be exercised to avoid paravenous leakage when administering IV iron. Paravenous leakage at the infusion site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of infusion. It should be suspected if one or more of the following is observed:

The infusion is not flowing freely or has stopped.
Swelling, discomfort, burning or pain occurs at the infusion site.

There is no published evidence to suggest that extravasation correlates with the use of positive pressure devices. It is widely thought that gravity devices minimise the risk of extravasation. Yet it is difficult to find the evidence in the literature to support this view and recent studies suggest there is no such link. The most effective safeguard against extravasation is to visually inspect the infusion site regularly. Patients should be informed about the possibility of discolouration and advised to report any signs of irritation or pain at the infusion site.

Extravasation reactions

Data supporting the management of extravasation reactions for non-cytotoxic agents are limited, and management is often extrapolated from other drugs with variable results. The guidance below is extrapolated from the West of Scotland Cancer Network guideline for the management of extravasation reactions with systemic anti-cancer therapy. For further information please refer to the guideline available here.

In case of suspected paravenous leakage, treatment requires prompt attention:

Stop the infusion immediately and disconnect the drip, do not remove
the cannula.
Inform medical staff immediately.
Aspirate the extravasated drug by connecting a clean syringe to the cannula and drawing back.
Mark the extravasation area with a pen and remove the cannula.
Elevate the limb (if possible).
Cool the area for 24-48 hours and closely monitor the skin and underlying tissues for changes.
Consider referral to plastic surgery team.
Clearly document the management plan in the patient’s medical records.
Complete a clinical incident form (Datix).

Appendix 3: Checklist for prescribing and administration of Ferinject® (ferric carboxymaltose)

Checklist for prescribing and administration of Ferinject® (ferric carboxymaltose) (pdf)

Last reviewed: 16/03/2021

Next review date: 01/03/2024

Author(s): Susan Kafka.

Version: 3

Approved By: Maternity Clinical Governance Group

Document Id: 438

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