Defiron™

Iron Sucrose

Haematinics (Haematinics)

Indication:
DefironTM is indicated for the treatment of Iron deficiency in the following indications:
* Where there is a clinical need for a rapid Iron supply
* In patients who cannot tolerate oral Iron therapy or who are non-compliant
* In active inflammatory bowel disease where oral Iron preparations are ineffective
* Non-dialysis dependent-chronic kidney disease (NDD-CKD)patients receiving an erythropoietin
* Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
* Hemodialysis dependent-chronic kidney disease (HDD-CKD)patients receiving an erythropoietin
* Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.

Dosage & Administration:

Administration: DefironTM is exclusively to be administered intravenously by drip infusion, by slow injection or directly into the venous limb of the dialyser and is not suitable for intramuscular use and for total dose infusion (TDI), where the full dose of Iron required, representing the patient's total Iron deficit is administered in one complete infusion. Before administration of the first therapeutic dose, a test dose should be given. If any allergic reactions or intolerance occurs during administration, the therapy must be stopped immediately.
Intravenous injection: DefironTM can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Defiron® (20 mg Iron) per minute [5 ml Defiron® (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml DefironTM (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Defiron® (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.
Infusion: DefironTM should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Defiron® (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
Injection into dialyser: DefironTM may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): DefironTM may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): DefironTM is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
Calculation of Dosage:
The dosage has to be individually adapted according to the total Iron deficit calculated with the following formula:

Total Iron deficit [mg] = body weight [kg] x (target Hb - actual Hb) [g/L] x 0.24* + depot Iron [mg]

Up to 35 kg body weight: target Hb = 130 g/L resp. depot Iron = 15 mg/kg body weight.

Above 35 kg body weight: target Hb = 150 g/L resp. depot Iron = 500 mg.

*Factor 0.24=0.0034 x 0.07 x 1,000 (Iron content of hemoglobin = 0.34%/Blood volume = 7% of body weight/Factor 1000 = conversion from gm to mg)

Total amount of Defiron® to be administered (in ml) =

Total iron deficit [mg]
20 mg/ml

Calculation of no. of ampoules required for different body weight and different haemoglobin level
If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be splitted. If no response of the hematological parameters is observed after 1 to 2 weeks the original diagnosis should be reconsidered.
Calculation of dosage for Iron replacement secondary to blood loss and to support autologous blood donation:
The required Defiron® dose to compensate the Iron deficit is calculated according the following formulas: If the quantity of blood lost is known: The administration of 200 mg IV Iron (=10 ml Defiron®) results in an increase in hemoglobin which is equivalent to 1 unit blood (= 400 ml with 150 g/L Hb content). Iron to be replaced [mg] = number of blood units lost x 200 or Amount of Defiron® needed (ml) = number of blood units lost x 10.
If the Hb level is reduced: Use the previous formula considering that the depot Iron does not need to be restored.
Iron to be replaced [mg] = body weight [kg] x 0.24 x (target Hb - actual Hb) [g/L]
e.g.: body weight 60 kg, Hb deficit = 10 [g/L] => Iron to be replaced 150 mg => 7.5 ml Defiron® needed.
Normal Dosage
Adults and Elderly: 5-10 ml Defiron® (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Defiron® (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Preparation:
DefironTM Injection: Each pack contains one ampoule of Iron Sucrose Injection USP (5 ml), 100 ml 0.9% Sodium Chloride (Solo™), one infusion set with butterfly needle, one sterile disposable syringe (5 ml), one alcohol prep. pad and one band aid.