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 |
|
|
|
|
|
|
|
|
| 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]
|
