Dosing & Administration
INFeD OFFERS FLEXIBLE DOSING
INFeD DOSING AND DURATION
The total amount of INFeD required for the treatment of IDA or iron replacement for blood loss is determined from the patient’s body weight, current Hb level, and desired target hemoglobin. The total iron replacement dose of INFeD can be administered in smaller doses.
ADMINISTERING
A TEST DOSE
FOR INTRAVENOUS INJECTION
Prior to the first intravenous INFeD therapeutic dose, administer an intravenous test dose of 0.5 mL. Administer the test dose at a gradual rate over at least 30 seconds. Delay administration of the initial therapeutic INFeD dose until 1 hour or more after the test dose. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of INFeD.
INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.
FOR INTRAMUSCULAR INJECTION
Prior to the first intramuscular INFeD therapeutic dose, administer an intramuscular test dose of 0.5 mL. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Delay administration of the initial therapeutic INFeD dose until 1 hour or more after the test dose. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of INFeD.
If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total required dose has been reached. Each day's dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients.
The maximum daily dose of INFeD should not exceed 2 mL.
INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock – never into the arm or other exposed areas – and should be injected with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.
RECOMMENDED DOSAGE FOR IDA
Calculate the INFeD dose based upon this table and formulas below. Continue INFeD until hemoglobin is within the normal range and iron stores are replete.
*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dL for patients with body weights greater than 15 kg (33 lbs) and a hemoglobin of 12 g/dL for patients with body weights less than or equal to 15 kg (33 lbs).
THE TOTAL DOSE MAY BE CALCULATED USING THE FORMULAS BELOW:
ORAL IRON SHOULD BE DISCONTINUED PRIOR TO ADMINISTRATION OF INFeD
Administration of a test INFeD dose prior to the first therapeutic dose is required (see instructions below). If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose.
- Administer daily doses of no more than 2 mL until the total required dose is administered
- Dose is calculated based on patient weight (see administration table above)
- Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin)
- Iron storage parameters may improve prior to hematologic parameters
- Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis
Note: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.
RECOMMENDED DOSAGE OF IRON REPLACEMENT FOR BLOOD LOSS
Iron therapy in patients who sustain blood losses on an intermittent or repetitive basis should be directed toward replacement of the equivalent amount of iron represented in blood loss.
Calculation of INFeD dose is based upon the approximate amount of blood loss and pretreatment hematocrit.
Note: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.
INFeD DOSE (in mL) = [BLOOD LOSS (in mL) X HEMATOCRIT] ÷ 50 mg/mL
Example: Blood loss of 500 mL
with 20% hematocrit
Replacement Iron = 500 x 0.20 = 100 mg
INFeD dose volume = 100 mg = 2mL
Note: The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron.
