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MONOFERRIC is a brand name for Iron, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 01/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2025 7 WARNINGS AND PRECAUTIONS, Skin 01/2025 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 01/2025 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 01/2025 TABLE OF CONTENTS Sections or subsections that are not…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...................................................................................................
2 Recommended Dose and Dosage Adjustment .............................................................. 4 Administration............................................................................................................... 7 5 OVERDOSAGE ..................................................................................................................
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1 Adverse Reaction Overview In phase II and III clinical trials, 3922 patients were treated with MONOFERRIC. 1638 (42 %) patients reported a total of 3622 adverse events (AEs). The most common treatment-emergent adverse events (TEAEs) (all causality) reported in more than 2 % of patients by preferred term were constipation (63 (2 %)), diarrhoea (71 (2 %)), dizziness (59 (2 %)) headache (92 (2 %)), nasopharyngitis (80 (2 %)) and nausea (97 (2%)).
Of the 3622 AEs, 346 serious adverse events (SAEs) were reported in 273 patients (7 %). No treatment- emergent SAEs were reported in > 1 % in patients treated with MONOFERRIC. The most common SAE was pneumonia (11 patients) and congestive heart failure (10 patients).
In the 3922 patients treated with MONOFERRIC, a total of 17 SARs reported in 16 patients (< 1 %) were considered as probably or possibly related to MONOFERRIC (all whom recovered). These were anaphylactic reaction, staphylococcal sepsis, angina unstable, generalized tonic-clonic seizure, dyspnea, rash pruritic, syncope, and eight cases of hypersensitivity, acute myocardial infarction, and infusion related reaction.
MONOFERRIC® (Ferric Derisomaltose for Injection) Product Monograph Page 13 of 41 Of the 3922 patients treated with MONOFERRIC in clinical trials, 65 (2 %) patients experienced TEAEs leading to withdrawal from study. 7 %) patients reported a serious or severe hypersensitivity reaction, in which 8 of these cases occurred within one day of dosing with MONOFERRIC.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Across five randomized clinical trials a total of 2799 patients received MONOFERRIC.
3 Pediatrics 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...................................................................................................
2 Recommended Dose and Dosage Adjustment .............................................................. 4 Administration............................................................................................................... 7 5 OVERDOSAGE ..................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 8 7 WARNINGS AND PRECAUTIONS ....................................................................................... 1 Special Populations .....................................................................................................
MONOFERRIC is contraindicated in the following situations: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. g. g. hemochromatosis, hemosiderosis) • Decompensated liver cirrhosis or active hepatitis MONOFERRIC® (Ferric Derisomaltose for Injection) Product Monograph Page 5 of 41
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 %) received a cumulative dose of 2000 mg. 1 %) patients were listed as receiving ‘other’ cumulative dose. MONOFERRIC was administered either as an IV infusion of 1000 mg over approximately 15 minutes or as an IV injection of 500 mg over 2 minutes per week, for an individual dose up to a maximum cumulative dose of 2000 mg.
A total of 168 patients received 200 mg of IV iron sucrose by infusion up to twice weekly up to a cumulative dose of 2000 mg. In Study IDA-03, a total of 989 patients with IDA of various causes (gynecological, gastroenterological, oncological and unknown or unspecified IDA) other than CKD were exposed to MONOFERRIC, which was administered as an IV infusion of a single fixed 1000 mg dose over 20 minutes.
A total of 494 patients received iron sucrose administered as 200 mg IV injections repeated up to five times for a cumulative dose of 1000 mg. 2% in the MONOFERRIC and iron sucrose groups, respectively. Non-Dialysis-Dependent Chronic Kidney (NDD-CKD) Disease A total of 228 non-dialysis dependent patients with CKD (NDD-CKD) were exposed to MONOFERRIC in Study CKD-02.
MONOFERRIC was administered either as IV infusions or IV bolus injections. The infusion was given in weekly doses for up to 2 weeks, to a maximum of 1000 mg iron each week until full replacement dose was achieved. 9 % sodium chloride and given over approximately 15-20 minutes.
Bolus injections of 500 mg were administered undiluted over approximately 2 minutes, once per week until full replacement dose was achieved. Oral iron was administered as 200 mg iron sulphate daily for 8 weeks. The mean cumulative dose of MONOFERRIC administered to the patients in the infusion and bolus subgroups were 907 ± 170 mg (range: 750:1500 mg) and 926 ± 241 mg (range: 500:2000 mg), respectively.
The mean cumulative dose of MONOFERRIC was 916 ± 208 mg (range: 500:2000 mg). In Study CKD-04, a total of 1019 non-dialysis dependent CKD (NDD-CKD) patients were exposed to MONOFERRIC, which was administered as an IV infusion of a single fixed 1000 mg dose over 20 minutes.
A total of 506 patients received iron sucrose administered as 200 mg IV injections repeated up to five times for a cumulative dose of 1000 mg. 9% in the MONOFERRIC and iron sucrose groups, respectively. Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Studies In Study CKD-03, a total of 230 hemodialysis-dependent CKD (DD-CKD) patients were exposed to MONOFERRIC, of which 114 (50 %) received a dose of 500 mg by IV single bolus injection and 116 (50 %) received a total dose of 500 mg as fractionated (100 mg + 200 mg + 200 mg) IV bolus injections.
A total of 117 patients received 500 mg of IV iron sucrose administered as 500 mg fractioned (100 mg + 200 mg + 200 mg) IV bolus injections. MONOFERRIC® (Ferric Derisomaltose for Injection) Product Monograph Page 15 of 41 Table 2: Clinical Trial TEAEs Reported in ≥ 2% of Patients by Study (IDA-01, IDA-03, in patients with IDA* and CKD-02, CKD-03, and CKD-04 in patients with CKD) Iron Deficiency Anemia IDA-01+IDA-03 Chronic Kidney Disease CKD-02 Chronic Kidney Disease CKD-03 Chronic Kidney Disease CKD-04 ferric derisomaltose iron sucrose ferric derisomaltose oral iron ferric derisomaltose iron sucrose ferric derisomaltose iron sucrose N [%] N [%] N [%] N [%] N [%] N [%] N [%] N […]
1 Pregnant Women ...................................................................................................... 2 Breast-feeding ...........................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics ...................................................................................................................
12 8 ADVERSE REACTIONS ..................................................................................................... 1 Adverse Reaction Overview.........................................................................................
2 Clinical Trial Adverse Reactions ................................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ....................................................................................................................
5 Post-Market Adverse Reactions .................................................................................. 16 9 DRUG INTERACTIONS .....................................................................................................
2 Drug Interactions Overview ......................................................................................... 3 Drug-Behavioural Interactions ....................................................................................
4 Drug-Drug Interactions ................................................................................................ 5 Drug-Food Interactions ...............................................................................................
6 Drug-Herb Interactions................................................................................................ 7 Drug-Laboratory Test Interactions ..............................................................................
17 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics ........................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 20 PART II: SCIENTIFIC INFORMATION ........................................................................................
21 13 PHARMACEUTICAL INFORMATION ............................................................................. 21 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .......................................................................................... 22 Iron Deficiency Anemia (IDA) of different etiologies ...............................................................
22 Iron Deficiency Anemia in Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) Patients ................................................................................................................................... 27 Iron Deficiency Anemia in Hemodialysis-dependent […]