Dilution Iron Dextran (imferon ®)

Iron Dextran (Imferon ®)

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Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

(Test dose)
[25 mg] [100 ml] [5 min][Prescribed dose] [250 to 1000ml]
(Usually 500 ml NS) Total dose infusion: infuse over 2 to 6 hours.

Stability / Miscellaneous

Parenteral iron treatment should be administered only when iron deficiency is not correctable with oral treatment.

PRECAUTIONS (See package insert for additional precautions / warnings)

General
Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.

INFeD should be used with caution in individuals with histories of significant allergies and/or asthma.

Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administration of subsequent test doses during therapy should be considered. (See DOSAGE AND ADMINISTRATION: Administration.)

Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.)

Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients.

Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD.

Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.

A test dose of 25 mg infused over 5 minutes should be given. Infusion should then be stopped for 1 hour. If there is no reaction after 1 hour continue. Fatal anaphylactic reactions are possible.
May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). Epinephrine should be immediately available.

Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. Reticulocyte count will increase in 3-4 days and peak in 7-10 days.

DOSAGE AND ADMINISTRATION
Oral iron should be discontinued prior to administration of INFeD.

Dosage
I. Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state.

After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count.

Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Factors contributing to the formula are shown below.

mg blood iron		mL blood		g hemoglobin		mg iron
—————	=	—————	x	—————	x	—————
lb body weight		lb body weight		mL blood		g hemoglobin

a. Blood volume . . . . . . . . . . . . . . . .65 mL/kg of body weight

b. Normal hemoglobin (males and females)
over 15 kg (33 lbs) . . . . . . . . . . . .14.8 g/dl
15 kg (33 lbs) or less . . . . . . . . . .12.0 g/dl

c. Iron content of hemoglobin . . . . . . . . . . . . . .0.34%
d. Hemoglobin deficit
e. Weight

Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb).

Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss.

**TOTAL INFeD**® REQUIREMENT FOR HEMOGLOBIN RESTORATION AND IRON STORES REPLACEMENT*
PATIENT		Milliliter Requirement of INFeD Based On Observed
LEAN BODY		Hemoglobin of
WEIGHT
WEIGHT		3	4	5	6	7	8	9	10
kg	lb	(g/dl)	(g/dl)	(g/dl)	(g/dl)	(g/dl)	(g/dl)	(g/dl)	(g/dl)
*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).
5	11	3	3	3	3	2	2	2	2
10	22	7	6	6	5	5	4	4	3
15	33	10	9	9	8	7	7	6	5
20	44	16	15	14	13	12	11	10	9
25	55	20	18	17	16	15	14	13	12
30	66	23	22	21	19	18	17	15	14
35	77	27	26	24	23	21	20	18	17
40	88	31	29	28	26	24	22	21	19
45	99	35	33	31	29	27	25	23	21
50	110	39	37	35	32	30	28	26	24
55	121	43	41	38	36	33	31	28	26
60	132	47	44	42	39	36	34	31	28
65	143	51	48	45	42	39	36	34	31
70	154	55	52	49	45	42	39	36	33
75	165	59	55	52	49	45	42	39	35
80	176	63	59	55	52	48	45	41	38
85	187	66	63	59	55	51	48	44	40
90	198	70	66	62	58	54	50	46	42
95	209	74	70	66	62	57	53	49	45
100	220	78	74	69	65	60	56	52	47
105	231	82	77	73	68	63	59	54	50
110	242	86	81	76	71	67	62	57	52
115	253	90	85	80	75	70	64	59	54
120	264	94	88	83	78	73	67	62	57

*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).

The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows:

Adults and Children over 15 kg (33 lbs): See Dosage Table.
Alternatively the total dose may be calculated:

Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW)

Based on: Desired Hb = the target Hb in g/dl.

Observed Hb = the patient’s current hemoglobin in g/dl.

LBW = Lean body weight in kg. A patient’s lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.

For males: LBW = 50 kg + 2.3 kg for each inch of patient’s height over 5 feet

For females: LBW = 45.5 kg + 2.3 kg for each inch of patient’s height over 5 feet

Children 5 - 15 kg (11 - 33 lbs): See Dosage Table.

INFeD should not normally be given in the first four months of life. (See package insert for PRECAUTIONS: Pediatric Use)

Alternatively the total dose may be calculated:
Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W)

Based on: Desired Hb = the target Hb in g/dl. (Normal Hb for Children 15 kg or less is 12 g/dl)

W = Weight in kg.

II. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis.

Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values.

Quantitative estimates of the individual’s periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose.

The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron:

Replacement iron (in mg) = Blood loss (in mL) x hematocrit

Example: Blood loss of 500 mL with 20% hematocrit

Replacement Iron = 500 x 0.20 = 100 mg

Administration
The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage).

I. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given.

If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Each day’s dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients.

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 deeply, 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.

NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

HOW SUPPLIED
INFeD® (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02).

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Rx Only

REFERENCES
Hatton RC, Portales IT, Finlay A, Ross EA. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Am J Kid Dis. 1995; 26(2):327-330.

Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Nephron. 1972;9:94-98.

Literature revised: March 2006

Product No.: 1001-02

Watson Pharma, Inc.
A subsidiary of Watson Pharmaceuticals, Inc.
Morristown, NJ 07962 USA

Source: [package insert]