What are the considerations for using sugammadex (Bridion) in pregnant patients?

Sugammadex Use in Pregnant Patients

Sugammadex can be used in pregnant patients when the benefits outweigh the risks, as there is no evidence of teratogenicity in animal studies, though limited human data exists. 1

Safety Profile in Pregnancy

• The FDA label indicates there are no data on sugammadex use in pregnant women to inform any drug-associated risks 1
• Animal reproduction studies showed no evidence of teratogenicity following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times the maximum recommended human dose 1
• Some animal studies showed incomplete ossification of sternebra and reduced fetal body weights in rabbits at 8 times the maximum recommended human dose, but this was at a dose level where maternal toxicity was also observed 1
• In pre- and postnatal development studies, sugammadex treatment resulted in increased early postnatal loss in animal studies at exposures equivalent to the maximum recommended human dose 1

Pharmacological Considerations

• Sugammadex is a large, highly polar molecule, which theoretically limits placental transfer to the fetus 2
• When used for reversal of neuromuscular blockade, sugammadex (16 mg/kg) can fully reverse rocuronium within 3 minutes compared with 9 minutes for spontaneous offset of suxamethonium 2
• High-dose rocuronium (1.0-1.2 mg/kg) with sugammadex backup is a suitable alternative to suxamethonium for rapid sequence induction in obstetric anesthesia 2
• The dose of sugammadex should be pre-calculated and immediately available for an assistant to draw up and administer 2

Special Considerations

• Caution is required in pregnant women on high-dose magnesium sulfate with nifedipine, which may cause prolongation of neuromuscular blockade and insufficient reversal with sugammadex 3
• Sugammadex binds to progestogen, potentially decreasing progestogen exposure, which has implications for hormonal contraceptives 1
• Women taking oral hormonal contraceptives must follow "missed pill rules" and use additional non-hormonal contraceptive methods for 7 days after sugammadex administration 1

Clinical Experience

• Limited case reports suggest sugammadex may be a safe option for both mother and baby in pregnant women undergoing non-obstetric surgery, but more evidence is needed 4
• Sugammadex has been used successfully in pregnant patients undergoing electroconvulsive therapy, with no reported anesthesia-related maternal complications 5
• Evidence regarding sugammadex rescue reversal shortly after high-dose rocuronium in cases of cannot intubate/cannot ventilate situations during pregnancy is accumulating 6

Lactation Considerations

• No data are available regarding the presence of sugammadex in human milk or its effects on breastfed infants 1
• Animal studies show that sugammadex is present in rat milk 1
• The Association of Anaesthetists guideline states that sugammadex is acceptable to use during breastfeeding, as it is a large, highly polar molecule with likely very low levels in milk and unlikely oral absorption by the infant 2

Practical Approach

• When considering sugammadex in pregnant patients, weigh the benefits of rapid reversal of neuromuscular blockade against the limited safety data 6, 7
• For emergency situations like failed intubation in obstetric anesthesia, the benefits of sugammadex may outweigh theoretical risks 2
• Document discussions about potential risks and benefits when using sugammadex in pregnant patients 7
• Consider alternative reversal agents like neostigmine when the urgency of reversal is not critical 6