IRON INFUSION PROTOCOL

This protocol is for adults with confirmed Iron Deficiency and indications for Intravenous Iron.

• Purpose

This procedure describes the process for the intravenous infusion of iron

2        Scope

This procedure relates to patients requiring iron for the treatment of iron deficiency.

References: WA Health Department – re: iron infusion

Iron Formulation 

1. Ferinject® is the available formulation of iron (ferric) Carboxymaltose
2. Monofer is the available formulation of iron (ferric) Derisomaltose

Precaution:

• Oral iron therapy should preferably not be recommenced until at least one week following an iron infusion.
• This preparation must not be used in the first trimester of pregnancy.

Contraindications:

• Known hypersensitivity
• Use with caution in pts. with elevated liver enzymes or active substance abuse.
• Confirmed previous reaction to intravenous iron to be assessed by Medical Practitioner
• Anaemia not attributed to iron deficiency, e.g. other causes of microcytic anaemia;
• Evidence of iron overload or disturbances in utilisation of iron;
• Pregnancy in the first trimester.

Dosage Calculation for the total body iron deficit:

ADULT: Approximate total body iron deficit & dosage per infusion of Ferric Carboxymaltose (FERRINJECT)

• ^{Maximum dose of Ferric Carboxymaltose (Ferinject®) per infusion is 20mg/kg to maximum of 1000mg.Use ideal body weight in overweight patients.}
• ^{The first dose of Ferric Carboxymaltose (Ferinject®) is given at 20mg/kg to a maximum of 1000mg.}
• ^{A second dose can be given ≥1 week later to replace the remainder of the calculated total body iron deficit (see table below) but not exceeding maximum dose per infusion of 20mg/kg to a maximum of 1000mg.}
• ^{In patients with ongoing blood loss or requiring surgery associated with substantial blood loss, 20mg/kg to a maximum of 1000mg can be given for both doses.}
• #If Hb normal or Hb <70 g/L, or when preferred by the prescriber, calculate total body iron deficit more precisely using the Ganzoni formula.
• *Use ideal body weight in overweight/obese patients (If underweight, use actual body weight).
• A woman’s ideal body weight (medium frame) will be ≥50kg if her height is ≥157 cm or ≥5’2
• A man’s ideal body weight (medium frame) will be ≥50kg if his height is ≥152 cm or ≥5’0

ADULT: Approximate total body iron deficit & dosage per infusion of Ferric Derisomaltose (MONOFER)

• Maximum dose is 20mg/kg body weight.
• Single Infusion >1500mgs not recommended.
• If needed >1500mgs, the dose must be split in two administration with an interval of one week.

Administration

Preparation of the Infusion:

Iron infusions must be delivered via a volumetric infusion device, no test dose is required.Derisomaltose (Monofer), Carboxymaltose (Ferinject)® must only be mixed with 0.9% Sodium Chloride as there is the potential for precipitation and/or interaction with other solutions and therapeutic agents.

Assemble equipment:

• Volumetric infusion pump/IV Stand
• Intravenous administration set
• Required ampoules of iron
• Required volume of Sodium Chloride 0.9%-250ml
• Additive label for the fluid bag
• Syringe 20ml /needles 21g to draw up the iron and add to the fluid bag
• 70% Isopropyl Alcohol swabs
• Tapes/Cotton
• Tourniquet

Add iron to the infusion fluid:

• Perform hand hygiene
• Using aseptic technique, draw up the prescribed iron volume and add it to the infusion bag.
• Add the label, which includes the patient’s name, the name and quantity of the drug, type and quantity of the fluid bag, time and date of preparation. The label is signed by general practitioner and a registered nurse or two (2) nurses, one of whom must be a registered nurse.
• Gently rotate the infusion bag to mix the contents.
• Spike an IV administration set and prime.
• Insert the administration set into the volumetric pump.
• Perform hand hygiene.
• Flush the intravenous cannula with at least 10ml 0.9% Sodium Chloride to ascertain patency of the cannula immediately prior to connecting the iron infusion.

For stability reasons, dilutions to concentrations less than 2 mg iron/mL are not allowed.

    Procedure:

• A medical order must be obtained for the iron infusion. Check the prescription for dose, volume of fluid and rate of infusion.
• Previous reactions, sensitivities or allergic reactions to iron must be determined prior to the infusion for the doctor to assess if clinically significant.
• Weigh the patient.
• Obtain a set of baseline observations: temperature, pulse, respirations and blood pressure, and oxygen saturation (finger oximetry).
• Get consent form signed from the patient & Inform the patient to notify staff, if any symptoms of:

o    Itchy Rash

o    Chest tightness

o    Shortness of breath

o    Racing heart

o    Nausea

o    Pain at the cannula site

• Emergency trolley, including Adrenaline 1:1000mg x 3 amps
• Ensure a Medical Practitioner will be in the vicinity and easily contactable for the duration of the iron infusion and for 30 minutes post infusion
• Insert an intravenous cannula – sited in the distal area of upper extremity, avoiding the dorsal metacarpal veins. Flush the cannula with saline 0.9% to ensure patency, before commencing iron infusion. Ensure pt. is comfortable and has no burning or pain at site when flushed.
• Document site and gauge of cannula inserted in medical chart

Observations (document):

• Temperature, pulse, respirations and blood pressure as per normal observations at baseline and at initial 5 minutes, and at the end of the infusion and at 30 minutes post infusion.
• Patients may be discharged 30 minutes post infusion if observations are satisfactory.
• Remove the intravenous cannula prior to discharge.

Adverse Effects/Management:

• If there are any adverse effects, cease the infusion immediately, and contact the medical practitioner on site.
• If the patient complains of pain cease the infusion immediately, do not disconnect line from pt. contact the medical practitioner on site for assessment and treatment.
• Hypotension is often dose related and the decision may be made to administer the infusion over a longer period of time.
• For mild reactions; give promethazine (Phenergan), hydrocortisone and paracetamol as ordered by medical practitioner.
• If anaphylaxis occurs, give IM 0.5ml of 1:1000 Adrenaline immediately and also it is recommended that affected patients are not exposed to further infusions of that Iron brand.

Tissue infiltration (extravasation) with iron:

Caution should be exercised to avoid Para venous leakage when administering iron. Para venous leakage of iron at the injection site may lead to irritation of the skin and potentially long lasting brown discoloration at the site of injection. In case of Para venous leakage, the administration of iron must be stopped immediately.

The important indicator of the severity of the extravasation is PAIN. (No necrosis of the skin has ever been reported).

In the event of the iron infusion infiltrating tissue surrounding the intravenous cannula insertion site:

• Immediate cease the infusion DO NOT DISCONNECT THE LINE.
• Contact the medical practitioner on site for assessment and treatment
• Apply a cold compress. DO NOT COVER THE SITE WITH BANDAGES

• Audit Strategy

Appendix 1:  Ganzoni Equation:

The standard method for calculating the total iron deficit is the Ganzoni Equation.  This formula gives the total iron deficit and dose in mg for restoration of haemoglobin (Hb) & repletion of body iron stores.

 Round the calculated dose to the nearest 100mg. Note: vial sizes are 100mg and 500mg.

Total body iron deficit in mg =   Iron depot   +    [weight in kg x 0.24 x (target Hb in g/L – actual Hb in g/L)]

• Use ideal body weight if overweight/obese
• Iron depot (store): >34kg weight =500mg; ≤34kg weight =15mg/kg weight to a maximum of 500mg
• Target Hb: >34kg weight=150g/L; ≤34kg weight=130g/L

Ideal body weight is calculated from the following formula (Australian Medicines Handbook):

 www.amh.net.au/online/misc/idealweightcalculator.html

• Females: 5 kg + 0.9 kg/cm for each cm >152 cm. Males: 50 kg + 0.9 kg/cm for each cm >152 cm.
• Add 10% for a heavy frame; subtract 10% for a light frame.