A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ferrlecit Warnings, Precautions, Pregnancy, Nursing, Abuse - Sodium ferric gluconate
Ferrlecit Warnings, Precautions, Pregnancy, Nursing, Abuse - Sodium ferric gluconate
WARNINGS
HYPERSENSITIVITY REACTIONS: POTENTIALLY FATAL HYPERSENSITIVITY
REACTIONS CHARACTERIZED BY CARDIOVASCULAR COLLAPSE, CARDIAC ARREST, BRONCHOSPASM,
ORAL OR PHARYNGEAL EDEMA, DYSPNEA, ANGIOEDEMA, URTICARIA, OR PRURITUS SOMETIMES
ASSOCIATED WITH PAIN AND MUSCLE SPASM OF THE CHEST OR BACK WHICH COULD RESULT
IN DEATH HAVE BEEN REPORTED RARELY IN PATIENTS RECEIVING FERRLECIT®. FATAL
IMMEDIATE HYPERSENSITIVITY REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING
THERAPY WITH MANY IRON CARBOHYDRATE COMPLEXES. SERIOUS ANAPHYLACTOID REACTIONS
REQUIRE APPROPRIATE RESUSCITATIVE MEASURES. ALTHOUGH FATAL REACTIONS HAVE NOT
BEEN OBSERVED IN FERRLECIT® CLINICAL STUDIES, INSUFFICIENT NUMBERS OF PATIENTS
MAY HAVE BEEN ENROLLED TO OBSERVE THIS EVENT. See ADVERSE REACTIONS
FLUSHING AND HYPOTENSION: HYPOTENSION ASSOCIATED WITH FLUSHING,
LIGHTHEADEDNESS, MALAISE, FATIGUE, WEAKNESS OR SEVERE PAIN IN THE CHEST, BACK,
FLANKS, OR GROIN HAS BEEN ASSOCIATED WITH RAPID ADMINISTRATION OF INTRAVENOUS
IRON. THESE HYPOTENSIVE REACTIONS ARE NOT ASSOCIATED WITH SIGNS OF HYPERSENSITIVITY
AND HAVE USUALLY RESOLVED WITHIN ONE OR TWO HOURS. SUCCESSFUL TREATMENT MAY
CONSIST OF OBSERVATION OR, IF THE HYPOTENSION CAUSES SYMPTOMS, VOLUME EXPANSION.
IN NORTH AMERICAN TRIALS, FERRLECIT® DOSES OF 62.5MG OF ELEMENTAL IRON WERE
ADMINISTERED OVER 30 MINUTES, AND DOSES OF 125MG OF ELEMENTAL IRON WERE ADMINISTERED
OVER ONE HOUR. THIS RATE OF ADMINISTRATION (2.1 MG/MIN) SHOULD NOT BE EXCEEDED.
See ADVERSE REACTIONS
PRECAUTIONS
General: Iron is not easily eliminated from the body and accumulation
can be toxic. Unnecessary therapy with parenteral iron will cause excess storage
of iron with consequent possibility of iatrogenic hemosiderosis. Iron overload
is particularly apt to occur in patients with hemoglobinopathies and other refractory
anemias. Ferrlecit® should not be administered to patients with iron overload.
See OVERDOSAGE
Carcinogenesis, mutagenesis, impairment of fertility: Long
term carcinogenicity studies in animals were not performed. Studies to assess
the effects of Ferrlecit® on fertility were not conducted, Ferrlecit®
was not mutagenic in the Ames test and the rat micronucleus test. It produced
a clastogenic effect in an in vitro chromosomal aberration assay in Chinese
hamster ovary cells.
Pregnancy Category B: Ferrlecit® was not teratogenic at
doses of elemental iron up to 100 mg/kg/day (300 mg/m2/day) in mice and 20 mg/kg/day
(120 mg/m2/day) in rats. On a body surface area basis, these doses were 1.3
and 3.24 times the recommended human dose (125 mg/day or 92.5 mg/m2/day) for
a person of 50 kg body weight, average height and body surface area of 1.46
m2. There were no adequate and well-controlled studies in pregnant women. Ferrlecit®
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk, caution should
be exercised when Ferrlecit® is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of Ferrlecit® in
pediatric patients has not been established. Ferrlecit® contains benzyl
alcohol and therefore should not be used in neonates.
Geriatric Use: Clinical studies of Ferrlecit® did not include
sufficient numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients.
In particular, 51/159 hemodialysis patients in North American clinical studies
were aged 65 years of older. Among these patients, no differences in safety
or efficacy as a result of age were identified. In general, dose selection for
an elderly patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function , and of concomitant disease or other drug therapy.
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