Revofer™
Ferric Carboxymaltose
Hematinic (Hematinic)
Indication:
For the treatment of IDA in adult patients who have
• Intolerance to oral iron or have had unsatisfactory response to oral iron or
• Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Dosage & Administration:
For patients weighing 50 kg (110 lb) or more: Revofer™ should be given in two doses separated by at least 7 days. Each dose should be given as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg (110 lb): Revofer™ should be given in two doses separated by at least 7 days. Each dose should be given as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
Method of Administration:
Revofer™ must be administered only by the intravenous route: by bolus injection or by infusion. It must be diluted only in sterile 0.9% Sodium Chloride solution as shown in the below table:
Dilution plan of Revofer™ for Intravenous Infusion:
Volume of Revofer™ | Equivalent Iron Dose | Maximum amount of Sterile 0.9% Sodium Chloride solution | Minimum Administration Time |
10 ml | 500 mg | 100 ml | 6 minutes |
15 ml | 750 mg | 250 ml | 15 minutes |
Preparation:
Revofer™ 500 IV Injection: Each box contains one vial of 10 ml Ferric Carboxymaltose solution with one 100 ml 0.9% Sodium Chloride solution, Infusion Set, First Aid Band, Alcohol Pad & 10 ml sterile Disposable Syringe.
Revofer™ 750 IV Injection: Each box contains one vial of 15 ml Ferric Carboxymaltose solution with one 250 ml 0.9% Sodium Chloride solution, Infusion Set, First Aid Band, Alcohol Pad & 10 ml sterile Disposable Syringe.