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Class ⬇

Chelating Agent

PREGNANCY RECOMMENDATION:Limited Human Data—Animal Data Suggest Potential Risk

BREASTFEEDING RECOMMENDATION:Potential Toxicity

Pregnancy Summary ⬆ ⬇

Four case studies describing the use of deferasirox in human pregnancy were located. A total of 12 pregnancies were reported with inadvertent exposure at conception. Deferasirox was discontinued with pregnancy confirmation ranging from 6 to 22 weeks’ gestation. All 12 pregnancies delivered healthy newborns at or near term with no reported anomalies or complications. In one other study, 15 women with beta-thalassemia were reported to have 19 pregnancies with first- trimester exposure to iron-chelating agents. Of these 15 women, 12 were on single-agent therapy and 3 were on double-agent therapy (thus, 4 were using deferasirox, 9 deferoxamine, and 5 deferiprone). The spontaneous loss rate was 21%, but of the remaining deliveries, no fetal anomalies were reported. However, information regarding specific pregnancy outcomes based on each individual drug was not supplied. The drug will probably cross the placenta, so some fetal exposure will likely occur. However, this limited human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal studies found some embryofetal toxicity in one species at doses less than 10 times the RHD. Using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure.

Breastfeeding Summary ⬆ ⬇

One abstract was located that described the use of deferasirox during human lactation. A patient with beta-thalassemia was started on the drug shortly after birth. The breast milk drug level was undetectable (<0.1 ng/mL) when analyzed 2 hours after a treatment dose. This would suggest that transfer into breast milk is very limited; however, a single case with one sample evaluated cannot confirm that the drug will not be found in breast milk. Further study is indicated. However, due to the concern for potential serious adverse effects that might be seen in a breastfed infant, the manufacturer recommends that women not breastfeed while being treated with this drug. Nevertheless, breastfeeding while using this drug should be based on the mother’s clinical need for treatment. If used, the infant should be monitored for the most common reported adult side effects of nausea and abdominal pain (both leading to irritability), vomiting, diarrhea, rash, and elevated serum creatinine levels.

Reference ⬆

  1. Prescribing Information. Exjade . Novartis Pharmaceutical; 2021.
  2. ViniD, ServosP, DrosouM. Normal pregnancy in a patient with Beta-thalassemia major receiving iron chelation therapy with deferasirox (Exjade). Eur J Haematol . 2011;86:274-275.
  3. AnastasiS, LisiR, AbbateG, et al. Absence of teratogenicity of deferasirox treatment during pregnancy in a thalassemic patient. Pediatr Endocrinol Rev . 2011; 8(suppl 2):345-347.
  4. RicchiP, CostantiniS, SpasianoA, et al. A case of well-tolerated and safe deferasirox administration during the first trimester of a spontaneous pregnancy in an advanced maternal age thalassemic patient. Acta Haematol . 2011;125:222-224.
  5. DiamantidisMD, NeokleousN, AgapidouA, et al. Iron chelation therapy of transfusion-dependent Beta-thalassemia during pregnancy in the era of novel drugs: is deferasirox toxic? Int J Hematol . 2016;103:537-544.
  6. FozzaC, AsaraMA, VaccaN, et al. Pregnancy outcome among women with Beta-Thalassemia Major in North Sardinia. Acta Haematol . 2017;138: 166-167.
  7. GiampretiA, MattioliF, FaraoniL, et al. Lactation in beta thalassemia major: is deferasirox compatible? The first case with clinical data and breastmilk concentrations. Clin Toxicol (Abstract) . 2018;56:539.