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FERINJECT is a brand name for Iron, supplied as a dispersion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment). 3 CLINICAL PHARMACOLOGY, Pharmacokinetics). The efficacy and safety of FERINJECT has not been investigated in children below 1 year of age. FERINJECT is therefore not recommended for use in children in this age group.
4 Geriatrics). 2 CONTRAINDICATIONS 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. For a complete listing, see
3 CLINICAL PHARMACOLOGY, Pharmacokinetics). The efficacy and safety of FERINJECT has not been investigated in children below 1 year of age. FERINJECT is therefore not recommended for use in children in this age group. 4 Geriatrics). 2 CONTRAINDICATIONS 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.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • with known serious hypersensitivity to other parenteral iron products. , other microcytic anemia). , hemochromatosis, hemosiderosis).
Product Monograph Master Template Template Date:
September 2020 FERINJECT (ferric carboxymaltose) Page 5 of 36 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions 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.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Serious hypersensitivity reactions, including life threatening and fatal anaphylaxis/anaphylactoid reactions, have been reported in patients receiving intravenous (IV) iron products including FERINJECT (see 7 WARNINGS AND PRECAUTIONS, Immune).
• 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 (see 7 WARNINGS AND PRECAUTIONS, Immune).
• FERINJECT should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions (see 7 WARNINGS AND PRECAUTIONS, Immune). 1 Dosing Considerations • The dosage of FERINJECT (ferric carboxymaltose) is expressed as mg of elemental iron, with each mL containing 50 mg of elemental iron.
4 Geriatrics). 2 CONTRAINDICATIONS 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. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• with known serious hypersensitivity to other parenteral iron products. , other microcytic anemia). , hemochromatosis, hemosiderosis).
Product Monograph Master Template Template Date:
September 2020 FERINJECT (ferric carboxymaltose) Page 5 of 36 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions 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.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Serious hypersensitivity reactions, including life threatening and fatal anaphylaxis/anaphylactoid reactions, have been reported in patients receiving intravenous (IV) iron products including FERINJECT (see 7 WARNINGS AND PRECAUTIONS, Immune).
• 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 (see 7 WARNINGS AND PRECAUTIONS, Immune).
• FERINJECT should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions (see 7 WARNINGS AND PRECAUTIONS, Immune). 1 Dosing Considerations • The dosage of FERINJECT (ferric carboxymaltose) is expressed as mg of elemental iron, with each mL containing 50 mg of elemental iron.
2 Recommended Dose and Dosage Adjustment The recommended dosing of FERINJECT follows a stepwise approach: 1) determination of the individual iron need, 2) calculation and administration of the iron dose(s), and 3) post iron repletion assessments.
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. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• with known serious hypersensitivity to other parenteral iron products. , other microcytic anemia). , hemochromatosis, hemosiderosis).
Product Monograph Master Template Template Date:
September 2020 FERINJECT (ferric carboxymaltose) Page 5 of 36
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Iron in Canada.
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2 Recommended Dose and Dosage Adjustment The recommended dosing of FERINJECT follows a stepwise approach: 1) determination of the individual iron need, 2) calculation and administration of the iron dose(s), and 3) post iron repletion assessments.
These steps are outlined below:
Adults Step 1: Determination of the iron need The individual iron need for repletion using FERINJECT is determined based on the patient’s body weight and hemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need.
See Step 2 for the maximum individual iron doses. 7 500 mg 500 mg 500 mg Iron deficiency must be confirmed by laboratory tests (see 1 INDICATIONS).
Product Monograph Master Template Template Date:
September 2020 FERINJECT (ferric carboxymaltose) Page 6 of 36 Step 2: Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined using Table 1 above, the appropriate dose(s) of FERINJECT should be administered taking into consideration the following: A single FERINJECT administration should not exceed: • 15 mg iron/kg body weight • 1000 mg of iron (20 mL FERINJECT) The maximum recommended cumulative dose of FERINJECT is 1000 mg of iron (20 mL FERINJECT) per week.
If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose.
Step 3:
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 post final FERINJECT administration to allow adequate time for erythropoiesis and iron utilization.
In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.
Pediatrics (1 to 17 years of age) Step 1:
Determination of the iron need The individual iron need for repletion using FERINJECT is determined based on the patient’s body weight and Hb level. The individual total iron need must be calculated for each patient either with the following Ganzoni formula or according to Table 2.
It is recommended that the cumulative dose (total iron need as calculated by the Ganzoni formula or using Table 2) does not exceed those shown in Table 2. See Step 2 for the maximum individual iron doses. 4 + storage iron [mg] Below 35 kg body weight: Target Hb = 13 g/dL and storage iron = 15 mg/kg body weight 35 kg body weight and above: Target Hb = 15 g/dL and storage iron = 500 mg The calculated iron need is to be rounded to the nearest 50 mg.
See Table 2 for examples of iron need for various body weights and Hb levels. 3 150 mg 300 mg 450 mg 500 mg 500 mg 500 mg Product Monograph Master Template Template Date: September 2020 FERINJECT (ferric carboxymaltose) Page 7 of 36 Iron deficiency must be confirmed by laboratory tests (see 1 INDICATIONS).
Step 2:
Calculation and […]
These steps are outlined below:
Adults Step 1: Determination of the iron need The individual iron need for repletion using FERINJECT is determined based on the patient’s body weight and hemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need.
See Step 2 for the maximum individual iron doses. 7 500 mg 500 mg 500 mg Iron deficiency must be confirmed by laboratory tests (see 1 INDICATIONS).
Product Monograph Master Template Template Date:
September 2020 FERINJECT (ferric carboxymaltose) Page 6 of 36 Step 2: Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined using Table 1 above, the appropriate dose(s) of FERINJECT should be administered taking into consideration the following: A single FERINJECT administration should not exceed: • 15 mg iron/kg body weight • 1000 mg of iron (20 mL FERINJECT) The maximum recommended cumulative dose of FERINJECT is 1000 mg of iron (20 mL FERINJECT) per week.
If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose.
Step 3:
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 post final FERINJECT administration to allow adequate time for erythropoiesis and iron utilization.
In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.
Pediatrics (1 to 17 years of age) Step 1:
Determination of the iron need The individual iron need for repletion using FERINJECT is determined based on the patient’s body weight and Hb level. The individual total iron need must be calculated for each patient either with the following Ganzoni formula or according to Table 2.
It is recommended that the cumulative dose (total iron need as calculated by the Ganzoni formula or using Table 2) does not exceed those shown in Table 2. See Step 2 for the maximum individual iron doses. 4 + storage iron [mg] Below 35 kg body weight: Target Hb = 13 g/dL and storage iron = 15 mg/kg body weight 35 kg body weight and above: Target Hb = 15 g/dL and storage iron = 500 mg The calculated iron need is to be rounded to the nearest 50 mg.
See Table 2 for examples of iron need for various body weights and Hb levels. 3 150 mg 300 mg 450 mg 500 mg 500 mg 500 mg Product Monograph Master Template Template Date: September 2020 FERINJECT (ferric carboxymaltose) Page 7 of 36 Iron deficiency must be confirmed by laboratory tests (see 1 INDICATIONS).
Step 2:
Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined above, the appropriate dose(s) of FERINJECT should be administered taking into consideration the following: A single FERINJECT administration should not exceed: • 15 mg iron/kg body weight • 750 mg of iron (15 mL FERINJECT) The maximum recommended cumulative dose of FERINJECT is 750 mg of iron (15 mL FERINJECT) per week.
If the total iron need is higher, then the administration of an additional dose […]