Antidote
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of glucarpidase in human or animal pregnancy have been located, but such reports are unlikely because of the drug’s indication. The use of methotrexate in pregnancy is contraindicated (see Methotrexate). However, if the drug was used because a pregnant woman inadvertently received methotrexate, the benefit–risk ratio might favor glucarpidase.
FETAL RISK SUMMARY
Glucarpidase is a carboxypeptidase produced by recombinant DNA technology. The enzyme is a homodimer protein that converts methotrexate to its inactive metabolites. It is indicated for the treatment of toxic plasma methotrexate concentrations (>1 µmol/L) in patients with delayed methotrexate clearance due to impaired renal function. The metabolism and plasma protein binding data were not specified, but the elimination half-life is 9 hours (1).
Reproduction studies in animals have not been conducted. Neither have studies been conducted for carcinogenic and mutagenic potential, and studies for impairment of fertility.
It is not known if glucarpidase crosses the human placenta. The molecular weight (83,000) suggests that the protein will not cross to the embryo–fetus, at least early in gestation.
BREASTFEEDING SUMMARY
No reports describing the use of glucarpidase during human lactation have been located. The molecular weight (83,000) suggests that the protein will not be excreted into mature milk, but might be excreted during the colostral phase. However, reports of its use during breastfeeding are unlikely because of its indication. Methotrexate is contraindicated during breastfeeding (see Methotrexate).
Reference
1.Product information. Voraxaze. BTG International, 2012.