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
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.
Data in ID + HF
Demonstrated Efficacy & Safety Profile Data in Chronic Heart Failure Patients (NYHA class II/III) with ID
Ferinject® significantly improved exercise capacity in CHF patients with ID compared to placebo (based on the LS mean change in the 6-MWT from baseline to Week 24: +17.5 m vs. -15.7 m; p=0.002; primary endpoint)1,2
Adapted from the Ferinject® Product Monograph.1
About the 6-minute walk test (6-MWT)
The 6-MWT assesses distance walked (to the nearest metre) in 6 minutes:2
- All tests were performed along a flat, straight corridor with a hard surface, at least 25 m long with turnaround points marked by two chairs at each end of the measured course.
- Patients were instructed to walk the length of the course at their own pace while attempting to cover as much ground as possible.
- They were allowed to rest on the chairs during the test but were encouraged to resume walking as soon as they felt physically able to do so.
- Patients were advised to eat only a light meal and to avoid vigorous exercise within 2 hours prior to the test.
Adverse reactions reported in ≥2% of patients with CHF treated with Ferinject® and more frequently than placebo1
Adapted from the Ferinject® Product Monograph.1
* The group terms Sinus bradycardia, Sudden cardiac death, Vomiting, Flushing, Pain in extremity, and Dyspnea are each composed of several
near synonym terms.
† Group terms that include distinct clinical events are: Chest pain (includes Angina pectoris); Abdominal pain (Abdominal distension); Fatigue
(Malaise, Illness, Discomfort); Injection/infusion site reactions (Extravasation, Hematoma, Post procedural hematoma, Local reaction); Fracture
(Hip fracture, Rib fracture, Spinal compression fracture); Headache (Migraine, Migraine with aura); Dizziness (Vertigo, Balance disorder); Rash
(Exanthema, Urticaria, Pruritus, Boston exanthema); Hypertension (Hypertensive crisis).
Across the heart failure study (CONFIRM-HF), patients in the overall population were aged 35 to 88.1
CONFIRM-HF (cardiology study) design
A phase 4, double-blind, randomized, placebo-controlled trial to determine the effect of Ferinject® on exercise intolerance in CHF patients with ID1
Primary endpoint: The change from baseline in the 6-minute walk test (6-MWT) at 24 weeks.1
- Dosing at Day 1 and Week 6 was based on the simplified dosing table, using screening Hb and body weight.1
- Further dosing at Weeks 12, 24, and 36 was given only if serum ferritin was <100 ng/mL or 100-300 ng/mL with TSAT <20%.1
- Mean age was 68.9 in the Ferinject® group (range: 43-86) and 69.4 in the placebo group (range: 35-88).1
References & footnotes
ID: iron deficiency; HF: heart failure; NYHA: New York Heart Association; CHF: chronic heart failure; LS: least squares; 6-MWT: 6-minute walk test; CI: confidence interval; MedDRA: Medical Dictionary for Regulatory Activities; LVEF: left-ventricular ejection fraction; IV: intravenous; Hb: hemoglobin; TSAT: transferrin saturation.
‡ The study enrolled patients with mild to moderate symptoms despite optimal CHF medication and serum ferritin
<100 ng/mL (or 100 to 300 ng/mL with TSAT <20%). The mean baseline Hb was 12 g/dL. Patients with baseline Hb
≥15 g/dL were excluded.1
§ Stratified by screening Hb values.1
References
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
- Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J. 2015;36:657-668.
Data in IDA
Efficacy and Safety Profiles Were Assessed Across Multiple Therapy Areas1
Explore clinical data in:1
All 5 pivotal clinical trials of Ferinject® in IDA were open-label, randomized, and active-controlled. Refer to the individual page links above for additional information on the trial designs and endpoints, as well as results of each trial.1
References & footnotes
IDA: iron deficiency anemia; IBD: inflammatory bowel disease.
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Dosing & Administration
Ferinject® Dosing Follows a Stepwise Approach1
Ferinject® is for IV use only. It may be administered:1
By infusion, following dilution in sterile 0.9% sodium chloride
By injection, using undiluted dispersion
During a hemodialysis session, undiluted, directly into the venous line of the dialyser
Ferinject® must not be administered by the subcutaneous or intramuscular route.1
- The dosage of Ferinject® is expressed as mg of elemental iron:1
- 1 mL Ferinject® = 50 mg elemental iron
- Vials are available in the following compositions: 100 mg/2 mL, 500 mg/10 mL, and 1000 mg/20 mL.*,1
Find out more about:
References & footnotes
IV: intravenous.
* Vials should be visually inspected for sediment and damage before use. Use only those containing sediment-free, homogeneous dispersion.1
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Dosing & Administration
Recommended Dosing in Adult Patients
Determine the individual adult iron need1
Determine the total iron needed using the table below, taking into account your patient’s body weight and current hemoglobin (Hb) level.1
Adapted from the Ferinject® Product Monograph.1
Calculate and administer the maximum individual iron dose(s)1
Based on the total iron need determined in Step 1, administer the appropriate dose(s) of Ferinject®. Keep in mind that a single Ferinject® administration in adult patients should not exceed:1
15 mg
iron/kg
body weight
1000 mg
of iron
(20 mL Ferinject®)
Maximum recommended cumulative dose: 1000 mg of iron (20 mL Ferinject®) per week. If the total iron need is higher, each additional dose should be administered a minimum of 7 days from the last.1
HDD-CKD PATIENTS
A single maximum daily dose of 200 mg iron should not be exceeded in hemodialysis-dependent chronic kidney disease patients.1
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. The maximum cumulative dose is restricted to 1000 mg if Hb >90 g/L and 1500 mg if Hb ≤90 g/L. Do not administer more than 1000 mg iron per week.1
Reassess post-iron repletion1
Reassessment should be performed by the clinician based on the individual patient’s condition.1
Reassess hemoglobin (Hb) level no earlier than 4 weeks after the final administration of Ferinject® to allow adequate time for erythropoiesis and iron utilization. If further iron repletion is required, return to Step 1.1
References & footnotes
HDD-CKD: hemodialysis-dependent chronic kidney disease.
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
About Ferinject®
An IV Iron with Worldwide Experience*,1,2
OVER
17
years in the
global market2
OVER
30
million patient-years
of experience2
Available in
87
countries2
Manufactured by
VIFOR
(International) AG2
Assessed across VARIOUS THERAPY AREAS, including in:1
The FIRST AND ONLY IV iron in Canada indicated
in all of the following:†,1,2
Adult heart failure patients (NYHA class II/III) with ID
+
Adult patients with IDA
+
Pediatric patients (ages 1+) with IDA
Mechanism of Action*
A colloidal dispersion of ferric carboxymaltose*,1
Ferinject® contains an iron complex consisting of a polynuclear iron-hydroxide core with a carbohydrate ligand.1
Designed to provide utilizable iron for both transport and storage*,1
Transferrin
Ferritin
Different IV iron complexes are not clinically interchangeable, as they differ in their structures, which affects their pharmacokinetic profiles.1
References & footnotes
IV: intravenous; NYHA: New York Heart Association; ID: iron deficiency; IDA: iron deficiency anemia.
* Clinical significance unknown.
† Comparative clinical significance has not been established.
References
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
- CSL Vifor Canada DoF_Attestation Letter-A_First and Only Claim_9April2025 and CSL Vifor Canada_DoF_Attestation Letter-B_Worldwide Experience Claim_2025.
Postpartum Women Data
Demonstrated Efficacy Data in Women with Postpartum IDA
Significantly more postpartum women achieved Hb >120 g/L with Ferinject® vs. oral iron between baseline and Day 42 (91.4% vs. 66.7%; p<0.0001; primary endpoint)*,1,2
Adapted from Seid MH, et al.2
1VIT06011 (women’s health study) design
A phase 3, open-label, randomized, active-controlled trial of Ferinject® vs. oral iron1
Primary endpoint: The proportion of patients achieving Hb >120 g/L any time between baseline and the end of study (Day 42).1
Patients were randomized and stratified by:1
- Baseline Hb levels
- Screening ferritin
- Requirement for a C-section
References & footnotes
IDA: iron deficiency anemia; Hb: hemoglobin.
* The mean baseline Hb was 8.9 g/L.1
† Ferinject® dosage was based on the calculated iron deficit according to the simplified table using pre-pregnancy weight.1
References
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
- Seid MH, Derman RJ, Baker JB, et al. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol. 2008;199:435.e1-7.
Data in IDA
Demonstrated Efficacy Data in Patients with IDA & Non-Dialysis-Dependent CKD
High-dose Ferinject® significantly delayed the primary endpoint vs. oral iron in NDD-CKD patients (HR: 0.65; 95% CI: 0.44, 0.95; p=0.026)1,2
The primary endpoint = time to initiation of additional or alternative anemia management or two consecutive Hb values <10 g/L (without an Hb increase of ≥5 g/L between the values).1
Adapted from Macdougall IC, et al.2
FIND-CKD (nephrology study) design
A phase 3b, open-label, randomized, dose-ranging, active-controlled trial of Ferinject® vs. oral iron1
Primary endpoint: The time to either the initiation of additional or alternative anemia management or two consecutive Hb values <10 g/L (without an Hb increase of ≥5 g/L between the values).1
- Mean age (range) was:1
- 69.5 (23-92) for high-dose Ferinject®
- 68.1 (29-88) for low-dose Ferinject®
- 69.3 (18-96) for oral iron
- The comparison between the two Ferinject® groups was not powered to reach statistical significance.1
Demonstrated Efficacy Data in Hemodialysis Patients with IDA Associated with CKD
Data for proportion of patients reaching an Hb increase of ≥10 g/L at 4 weeks after baseline for Ferinject® vs. IV iron sucrose in HDD-CKD patients (46.4% vs. 37.2%; p=0.2101; primary endpoint)†,1
Adapted from the Ferinject® Product Monograph.1
Note: Data for descriptive comparative purposes only, as no formal statistical analyses were planned to directly compare Ferinject® and iron sucrose in this study.1
VIT-IV-CL-015 (nephrology study) design
A phase 3, open-label, randomized, active-controlled trial of Ferinject® vs. IV iron sucrose1
Primary endpoint: The percentage of patients in the per-protocol population reaching an Hb increase of ≥10 g/L at 4 weeks after baseline.1
- Treatment in both groups continued until the individually calculated cumulative iron dose§ was reached.1
- Mean cumulative dose of iron as Ferinject®: 1700 mg.1
- Mean age was 52.6 in the Ferinject® group (range: 22-80) and 51.0 in the IV iron sucrose group (range: 22-79).1
Note: Data for descriptive comparative purposes only, as no formal statistical analyses were planned to directly compare Ferinject® and iron sucrose in this study.1
References & footnotes
IDA: iron deficiency anemia; CKD: chronic kidney disease; NDD-CKD: non-dialysis-dependent chronic kidney disease; Hb: hemoglobin; HR: hazard ratio; CI: confidence interval; eGFR: estimated glomerular filtration rate; TSAT: transferrin saturation; IV: intravenous; HDD-CKD: hemodialysis-dependent chronic kidney disease.
* The study enrolled patients with Hb 90-110 g/L and serum ferritin <100 ng/mL or <200 ng/mL with TSAT <20%,
without erythropoiesis-stimulating agent therapy.1
† The mean baseline Hb was 93.6 g/L.1
‡ Patients had Hb ≤115 g/L and TSAT <20% or serum ferritin <200 ng/mL, with or without erythropoietin therapy.1
§ Total cumulative iron requirement was calculated using the Ganzoni formula.1
References
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
- Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014;29:2075-2084.
Data in IDA
Demonstrated Efficacy Data in Patients with IDA & Chronic IBD: Results vs. IV Iron Sucrose
Significantly more patients with chronic IBD responded to Ferinject® vs. IV iron sucrose by Week 12 (65.8% vs. 53.6%; p=0.004; primary endpoint)*,1
Adapted from the Ferinject® Product Monograph.1
FERGIcor (gastroenterology study) design
A phase 3, open-label, randomized, active-controlled trial of a simplified dosing schedule of Ferinject® vs. individually calculated doses of IV iron sucrose1
Primary endpoint: The number of responders, defined as Hb increase ≥20 g/L by Week 12.1
- 35.2% of Ferinject® patients had Crohn’s disease (vs. 31.0% in the IV iron sucrose group).1
- 64.8% of Ferinject® patients had ulcerative colitis (vs. 69.0% in the IV iron sucrose group).1
- Mean age was 39.7 in the Ferinject® group (range: 18-81) and 39.6 in the IV iron sucrose group (range: 18-78).1
Demonstrated Efficacy Data in Patients with IDA & Chronic IBD: Results vs. Oral Iron
Ferinject® was shown to be noninferior to oral iron in IBD patients based on mean change in Hb from baseline to Week 12 (38.3 g/L vs. 37.5 g/L; p=0.8016; primary endpoint)‡,§,1
Adapted from the Ferinject® Product Monograph.1
VIT-IV-CL-008 (gastroenterology study) design
A phase 3, open-label, randomized, active-controlled, non-inferiority trial of Ferinject® vs. oral iron1
Primary endpoint: The change in Hb from baseline to Week 12.1
- 27.9% of Ferinject® patients had Crohn’s disease (vs. 26.5% in the oral iron group).1
- 72.1% of Ferinject® patients had ulcerative colitis (vs. 73.5% in the oral iron group).1
- Mean age was 40.7 in the Ferinject® group (range: 19-78) and 45.2 in the oral iron group (range: 20-78).1
References & footnotes
IDA: iron deficiency anemia; IBD: inflammatory bowel disease; IV: intravenous; Hb: hemoglobin; CI: confidence interval; LS: least squares; TSAT: transferrin saturation.
* Response defined as achieving Hb ≥20 g/L by Week 12. The mean baseline Hb was 10.2 g/L.1
† Patients included in the study had Hb 70-120 g/L (women) or 70-130 g/L (men) and serum ferritin <100 ng/mL. The
iron amount required was calculated according to the Ganzoni formula.1
‡ The mean baseline Hb was 86.2 g/L.1
§ The lower limit of the 95% CI for difference of Hb changes between the treatments was -5.0 g/L; hence, non-inferiority was concluded.1
¶ Patients included in the study had baseline Hb ≤110 g/L and TSAT <20% or serum ferritin <100 ng/mL, with a
calculated iron requirement of at least 1000 mg based on the Ganzoni formula.1
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Data in IDA
Demonstrated Safety Profile in IDA
Results of the pooled safety population of 2196 adults from multiple therapy areas1
- TEAEs (all-causality): 42.4% (932 patients)
- Most commonly reported (≥2%): headache, edema, hypertension, injection/infusion site reactions, rash, arthralgia, urinary tract infections, dizziness, nausea, nasopharyngitis, and diarrhea.
- SAEs (all-causality): 6.0% (131 patients)
- No SAEs were reported in >1% of patients treated with Ferinject®.
- Pyrexia, headache, and pulmonary embolism, reported in 1 patient each, were the only treatment-related SAEs reported for Ferinject® patients.
- Discontinuation due to TEAEs: 0.3% (6 TEAEs)
- There were 0.5% TEAEs leading to death, none of which was considered related to Ferinject®.
Adverse reactions reported in ≥1% of adult patients treated with Ferinject®1
Adapted from the Ferinject® Product Monograph.1
MedDRA: Medical Dictionary for Regulatory Activities; IV: intravenous.
* The group terms Vomiting, Pyrexia, and Dyspnea are each composed of several near synonym terms.
† Group terms that include distinct clinical events are: Chest pain (includes Angina pectoris); Abdominal pain (Abdominal distension); Edema (Peripheral
swelling); Injection/infusion site reactions (Extravasation, Hematoma, Post procedural hematoma, Local reaction); Fatigue (Malaise, Illness, Discomfort);
Upper respiratory tract infection (Rhinitis, Sinusitis); Lower respiratory tract infection (Bronchitis, Pneumonia); Influenza (Influenza-like illness); Arthralgia
(Joint stiffness, Joint swelling); Muscle spasms (Musculoskeletal stiffness); Headache (Migraine, Migraine with aura); Dizziness (Vertigo, Balance disorder);
Rash (Exanthema, Urticaria, Pruritus, Boston exanthema); Hypertension (Hypertensive crisis); Hypotension (Blood pressure abnormal, Dialysis hypotension).
Comparable frequency of TEAEs in pediatric patients (aged 1-17 years) as in the overall study population‡,1
- TEAEs (all causality): 35%
- Most commonly reported (≥5%): hypophosphatemia, rash, injection/infusion site reaction, headache, and vomiting.
- No SAEs among pediatric patients
- 1 TEAE leading to discontinuation (injection site pain)
- No new or unexpected TEAEs were observed in the pediatric population compared to those reported in the adult population.
Adverse reactions reported in ≥1% of pediatric patients treated with Ferinject®1
Adapted from the Ferinject® Product Monograph.1
IDA: iron deficiency anemia; MedDRA: Medical Dictionary for Regulatory Activities.
§ The group terms Vomiting and Flushing are each composed of several near synonym terms.
¶ Group terms that include distinct clinical events are: Injection/infusion site reactions (includes Extravasation,
Hematoma, Post procedural hematoma, Local reaction); Headache (Migraine, Migraine with aura); Rash
(Exanthema, Urticaria, Pruritus, Boston exanthema).
References & footnotes
IDA: iron deficiency anemia; TEAE(s): treatment-emergent adverse event(s); SAEs: serious TEAEs.
‡ The safety of Ferinject® in pediatric patients with IDA was evaluated in a randomized, active-controlled study of
78 patients aged 1 to 17 years (median 14.5 years). Forty patients received Ferinject® 15 mg/kg to a maximum single
dose of 750 mg on Days 0 and 7 for a maximum total dose of 1500 mg, while 38 patients received oral ferrous sulfate
for 28 days.1
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Dosing & Administration
Instructions for Intravenous (IV) Administration
Recommendations for administration by IV infusion1
When administering Ferinject® by IV infusion, it must be diluted in sterile 0.9% sodium chloride solution and administered following the recommendations below:1
Adapted from the Ferinject® Product Monograph.1
- Ferinject® must only be mixed with sterile 0.9% sodium chloride solution. No other IV dilution solutions or therapeutic agents should be used, as there is the potential for precipitation and/or incompatibility.1
- Diluted Ferinject® for IV infusion should be used within 24 hours of dilution when stored at 2 to 8°C.1
Ferinject® should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the Ferinject® dispersion).1
Recommendations for administration by IV injection1
When administering Ferinject® by IV injection using undiluted dispersion, follow the recommended rates of administration in the table below:1
Adapted from the Ferinject® Product Monograph.1
Undiluted Ferinject® for IV injection should be used immediately after opening.1
Ferinject® should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Patients should be observed for signs and symptoms of hypersensitivity reactions, including monitoring of blood pressure and pulse, during and for ≥30 minutes following each administration of Ferinject®.1
For complete dosing and administration information, please refer to the Ferinject® Product Monograph.
References & footnotes
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Dosing & Administration
Recommended Dosing in Pediatric Patients
Determine the individual pediatric iron need1
After confirming iron deficiency by laboratory tests, determine the individual iron need based on the patient’s body weight and hemoglobin (Hb) level. The individual total iron need must be calculated for each patient either with the Ganzoni formula or according to the table below.1
Ganzoni formula
Calculate the iron need, rounded to the nearest 50 mg, using the Ganzoni formula:1
Total iron deficit [mg] =
body weight [kg] x (target Hb-actual Hb) [g/dL] x 2.4 + storage iron [mg]
- For patients weighing <35 kg: calculate using 13 g/dL for the target Hb and 15 mg/kg for the storage iron.1
- For patients weighing ≥35 kg: calculate using 15 g/dL for the target Hb and 500 mg for the storage iron.1
Table for determining the total iron need
Adapted from the Ferinject® Product Monograph.1
Regardless of the option used to calculate the total iron needed, it must be rounded to the nearest 50 mg. The cumulative dose should not exceed those calculated by the Ganzoni formula or shown in the table above.1
Calculate and administer the maximum individual iron dose(s)1
Based on the total iron need determined in Step 1, administer the appropriate dose(s) of Ferinject®. Keep in mind that a single Ferinject® administration in pediatric patients should not exceed:1
15 mg
iron/kg
body weight
750 mg
of iron
(15 mL Ferinject®)
Maximum recommended cumulative dose: 750 mg of iron (15 mL Ferinject®) per week. If the total iron need is higher, each additional dose should be administered a minimum of 7 days from the last.1
HDD-CKD PATIENTS
The efficacy and safety of Ferinject® have not been investigated in children and adolescents with chronic kidney disease requiring hemodialysis. Ferinject® is therefore not recommended for use in this population.1
Reassess post-iron repletion1
Reassessment should be performed by the clinician based on the individual patient’s condition.1
Reassess hemoglobin (Hb) level no earlier than 4 weeks after the final administration of Ferinject® to allow adequate time for erythropoiesis and iron utilization. If further iron repletion is required, the iron need should be recalculated using the Ganzoni formula in Step 1.1
References & footnotes
HDD-CKD: hemodialysis-dependent chronic kidney disease.
Reference
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Support & Resources
Helpful Downloads for You & Your Patients
Important Safety Information
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).
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.
References & footnotes
References
- Ferinject® Product Monograph. Vifor (International) Inc. June 27, 2024.
Adverse events should be reported. You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
Adverse events should also be reported to CSL Behring Canada (AdverseReporting@cslbehring.com).