Product Precaution

HPS Pharmacies wish to advise that a cluster of adverse reactions has recently been reported for Ferinject® vials as follows:

Ferinject® Vials
Ferric carboxymaltose 500mg/10mL
ARTG 162641

Ferinject® Vials
Ferric carboxymaltose 100mg/2mL
ARTG 162636

The reactions reported include pruritus, rash, tachypnoea, cough, throat itch, numbness and tingling of the lips, confusion, and abdominal pain. Management included transfer to the emergency department and administration of adrenaline, antihistamines, salbutamol, and IV hydrocortisone. All patients recovered without sequelae.

While parenterally administered iron preparations are known to cause hypersensitivity reactions, these reactions are expected to be uncommon (occurring in <1/100 and ≥1/1000). In the 12 months to January 2018, a total of 47 hypersensitivity reactions were reported to the Therapeutic Goods Administration involving Ferinjec® as a single agent. The risk of these reactions is increased in patients who have allergies, autoimmune diseases, or inflammatory conditions. However, reactions can occur in patients without any risk factors who have previously tolerated parenteral iron therapy.

It is recommended that the parenteral administration of iron only occur in units where facilities for cardiopulmonary resuscitation are available. All patients should be closely observed for adverse effects during administration and for at least 30 minutes after each injection or infusion.1 The infusion must be stopped if allergic reactions or signs of intolerance occur. Supportive care should then initiated according to the hospital’s treatment protocols. Additional caution should be exercised in patients with acute or chronic infection, asthma, eczema or atopic allergies.

Retain this notice in a prominent position, including in other related business units for all staff to review. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Vifor Pharma on (03) 9686 0111.

References:

  1. Ferinject® (ferric carboxymaltose) Australian approved product information. Melbourne: Vifor Pharma. Approved July 2016.

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