Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
Risk Summary
… There are risks to the mother and fetus
associated with untreated IDA in pregnancy as well as risks to the fetus
associated with maternal severe hypersensitivity reactions (see Clinical Considerations) …
Clinical Considerations
Newly
added information:
Fetal/Neonatal
adverse reactions
Severe adverse reactions including
circulatory failure (severe hypotension, shock including in the context of
anaphylactic reaction) may occur in pregnant women with parenteral iron
products (such as Venofer) which may cause fetal bradycardia, especially during
the second and third trimester.
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy
and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
Published
studies on intravenous iron sucrose treatment after the first trimester of
pregnancy have not shown adverse maternal or fetal outcomes. Available reports
of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. Iron deficiency anemia
during pregnancy should be treated because there are risks to the mother and
fetus associated with untreated iron deficiency anemia (IDA) in pregnancy. Animal
reproduction studies of iron sucrose
administered to rats and rabbits
during the period of
organogenesis at elemental iron doses equivalent to the maximum recommended
human dose based on body surface area revealed no evidence of harm to the fetus. The estimated background risk of major
birth defects and miscarriage for the indicated populations is unknown. Adverse
outcomes in pregnancy occur regardless of the health of the mother or the use
of medications. In the U.S. general population, the estimated background risk
of major birth defects and miscarriage in clinically-recognized pregnancies is
2-4% and 15-20%, respectively.
Clinical
Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Iron
deficiency anemia during pregnancy should be treated. Untreated IDA in
pregnancy is associated with adverse maternal outcomes such as post-partum
anemia. Adverse pregnancy outcomes associated with IDA include increased risk
for preterm delivery and low birth weight.
Data
Human Data
Published data
from randomized controlled studies and prospective observational studies on the
use of Venofer in pregnant women have not reported an association of Venofer
and adverse developmental outcomes. However, these studies did not include
women exposed during the first
trimester of pregnancy and were not designed
to assess the risk of major birth defects. Maternal
adverse events reported
in these studies are similar
to those reported during clinical trials in adult males and non-pregnant
females.
Animal Data
Iron sucrose was administered intravenously to rats and rabbits during
the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25
times or equivalent to the maximum recommended human dose based on body
surface area, respectively) and revealed no evidence of harm to the fetus.
8.2 Lactation
(Pregnancy
and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
Iron sucrose is present in human milk, and available published
reports following exposure to 100-300 mg intravenous iron sucrose have not
reported adverse reactions in breastfed infants.
There are no data on the effects on milk production.
The developmental and health benefits of breastfeeding should be considered,
along with the mother’s clinical need for Venofer and any potential
adverse effects on the breastfed child from Venofer or from the underlying
maternal condition.
Data
A published study showed no difference in iron concentration in the
colostrum of 10 iron deficient breastfeeding women who were 2 to 3 days
postpartum and received a single dose of 100 mg of intravenous iron
sucrose compared to 5 breastfeeding women who received no iron. These results
may underestimate the amount of iron in breastmilk following the standard dose
of Venofer.
A published report of 78 breastfeeding women who received 300 mg of
intravenous iron sucrose over 3 days (infant age not reported) did not report
on the safety of iron sucrose in breastfed infants; however adverse reactions
in breastfed infants were not reported.
Clinical Considerations
Monitor breastfed infants for gastrointestinal toxicity
(constipation, diarrhea).
Approved Drug Label (PDF)
6
Adverse Reactions
(Additions and/or revisions are underlined)
The following
serious adverse reactions are described elsewhere in the labeling:
6.2 Adverse Reactions from Post-Marketing Experience
(Additions and/or revisions are underlined)
The following
adverse reactions have been identified during post-approval use of Venofer…
Immune system disorders: anaphylactic-type reactions, angioedema
Psychiatric disorders: confusion
Nervous system disorders: convulsions, collapse, light-headedness,
loss-of-consciousness
Cardiac disorders: bradycardia
Vascular disorders: shock
Respiratory, thoracic and mediastinal
disorders: bronchospasm,
dyspnea
Musculoskeletal and connective tissue
disorders: back pain, swelling
of the joints
Renal and urinary disorders: chromaturia
General disorders and administration site
conditions: hyperhidrosis
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Prior History of
Reactions to Parenteral Iron Products
Question patients
regarding any prior history of reactions to parenteral iron products.
Serious
Hypersensitivity Reactions
Advise patients to
report any symptoms of hypersensitivity that may develop during and following
Venofer administration, such as rash, itching, dizziness, light-headedness,
swelling, and breathing problems.
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