Ranofer Dosage/Direction for Use

Calculation of dosage: The total cumulative dose of Ranofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose of Ranofer must be individually determined for each patient according to the total iron deficit calculated with the following formula: See formula.

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See Table 1.

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Calculation of dosage for iron replacement secondary to blood loss and to support autologous blood donation: The required Ranofer dose to compensate the iron deficit is calculated according to the following formulas: If quantity of blood lost is known: The administration of 200 mg i.v. iron (=10 ml Ranofer) results in an increase in haemoglobin 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 Ranofer needed [ml] = number of blood units lost x 10.
If the Hb level is reduced: Use the following 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.
≈ 150 mg iron to be replaced.
→ 7.5 ml Ranofer needed.
Normal posology: Adults and the elderly: 5 - 10 mL Ranofer (100 - 200 mg iron) one to three times a week depending on the haemoglobin 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 Ranofer (3 mg iron) per kg body weight one to three time per week depending on the haemoglobin level.
Maximum Tolerated Dose: As injection, maximum tolerated dose per day given not more than three times per week: 200 mg iron (10 ml Ranofer) injected over at least 10 minutes.
As infusion, maximum tolerated single dose per day given not more than once per week: Patients above 70 kg: 500 mg iron (25 ml Ranofer) in at least 3.5 hours.
Patients of 70 kg and below: 7 mg iron/kg body weight in at least 3.5 hours.
The maximum tolerated single dose is 7 mg iron per kg body weight given once per week, but not exceeding 500 mg iron. Administration time and dilution ratio, please refer to Route of Administration as follows. The infusion times given under Route of Administration must be strictly adhered to, even if the patient does not receive maximum tolerated single dose.
Route of Administration: Ranofer must only be administered by intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.
Intravenous drip infusion: Ranofer must be diluted only in 0.9% m/V sodium chloride solution. Dilution must take place immediately prior to infusion and the solution should be administered as follows: See Table 2.

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For stability reasons, dilutions to lower Ranofer concentrations are not permissible.
Intravenous injection: Ranofer can be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minutes and not exceeding 10 ml Ranofer (200 mg iron) per injection.
Injection into dialyser: Ranofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.