Reporting adverse events

Reporting Adverse Events in Canada

Adverse events should be reported. You can report any suspected side effects associated with the use of health products to Health Canada by: 

Adverse events should also be reported to CSL Behring Canada
(AdverseReporting@cslbehring.com).
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The FIRST AND ONLY IV iron in Canada indicated in both adult and pediatric patients with IDA, as well as adult HF patients (NYHA class II/III) with ID*,1,2

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CHOOSE FERINJECT

®

(ferric carboxymaltose)

Ferinject® (ferric carboxymaltose) is indicated:1

  • For the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older when oral iron preparations are not tolerated or are ineffective. 
  • For the treatment of iron deficiency (ID) in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity. 

The diagnosis of iron deficiency must be based on laboratory tests.1

IV: intravenous; IDA: iron deficiency anemia; HF: heart failure; NYHA: New York Heart Association; ID: iron deficiency.
* Comparative clinical significance has not been established.
References: 1. Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024. 2. CSL Vifor Canada DoF_Attestation Letter-A_First and Only Claim_9April2025.

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Adverse events should be reported. You can report any suspected side effects associated with the use of health products to Health Canada by:

Adverse events should also be reported to CSL Behring Canada (AdverseReporting@cslbehring.com).

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Indications and clinical use:

Ferinject® (ferric carboxymaltose) is indicated:

  • for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older when oral iron preparations are not tolerated or are ineffective.
  • for the treatment of iron deficiency (ID) in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity.

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

Contraindications:

Ferinject® is contraindicated in patients:

  • with known serious hypersensitivity to other parenteral iron products.
  • with anemia not attributed to iron deficiency (e.g., other microcytic anemia).
  • with evidence of iron overload or disturbances in utilization of iron (e.g., hemochromatosis, hemosiderosis).

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

Serious warnings and precautions:

Hypersensitivity reactions: Ferinject® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

  • Serious hypersensitivity reactions, including life-threatening and fatal anaphylaxis/anaphylactoid reactions, have been reported in patients receiving intravenous (IV) iron products including Ferinject®.
  • Patients should be observed for signs and symptoms of hypersensitivity reactions, including monitoring of blood pressure and pulse, during and for at least 30 minutes following each administration of Ferinject®. 
  • Ferinject® should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Other relevant warnings and precautions:

  • Accumulation of iron in storage sites and possible hemosiderosis from excessive therapy with parenteral iron; monitoring of hematologic response and iron parameters, such as serum ferritin and transferrin saturation (TSAT), is recommended
  • Hypophosphatemia and hypophosphatemic osteomalacia; monitoring serum phosphate levels in patients with risk factors, including prior to a repeat course is recommended; monitoring is also recommended in any patient who receives a second course within three months
  • Risk in patients with liver dysfunction and in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular porphyria cutanea tarda (PCT)
  • Hypersensitivity reactions; monitoring for signs and symptoms of a reaction during and for at least 30 minutes after administration is recommended
  • Infection
  • Paravenous leakage
  • Limited clinical data in pregnant women; treatment should be confined to gestation week 16 and beyond if the benefit is judged to outweigh the potential risk to both the mother and fetus
  • Fetal bradycardia (usually transient); monitoring of the unborn baby is recommended during administration to pregnant women
  • Potential for adverse events among breastfed children of breastfeeding women treated with Ferinject®; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferinject® in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece. 

The Product Monograph is also available by emailing medinfo.canada@viforpharma.com or by calling 1-866-773-7721 during business hours or 514-219-7560 for urgent or after-hours service.

Reference

  1. Ferinject® Product Monograph. Vifor (International) Inc. June 27, 
 2024.
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