Imalgene 500 Pregnancy
Imalgene 500 crosses the placenta (Ellingson 1977; Little 1972).
Imalgene 500 produces dose dependent increases in uterine contractions; effects may vary by trimester. The plasma clearance of Imalgene 500 is reduced during pregnancy. Dose related neonatal depression and decreased Apgar scores have been reported with large doses administered at delivery (Little 1972; Neuman 2013; White 1982).
Based on animal data, repeated or prolonged use of general anesthetic and sedation medications that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity may affect brain development. Evaluate benefits and potential risks of fetal exposure to Imalgene 500 when duration of surgery is expected to be >3 hours (Olutoye 2018).
Although obstetric use is not recommended by the manufacturer, Imalgene 500 has been evaluated for use during cesarean and vaginal delivery (ACOG 209 2019; Akamatsu 1974; Galbert 1973). Imalgene 500 may be considered as an alternative induction agent in females requiring general anesthesia for cesarean delivery who are hemodynamically unstable (Devroe 2015). Use of Imalgene 500 as an adjunctive analgesic in cesarean section has also been evaluated; however, use for this purpose may require additional studies (Carvalho 2017; Heesen 2015). When sedation and analgesia is needed for other procedures during pregnancy, low doses of Imalgene 500 may be used, but other agents are preferred (Neuman 2013; Schwenk 2018). Use of Imalgene 500 infusion for the treatment of refractory status epilepticus in a pregnant patient has been noted in a case report (Talahma 2018).
The ACOG recommends that pregnant women should not be denied medically necessary surgery, regardless of trimester. If the procedure is elective, it should be delayed until after delivery (ACOG 775 2019).
Use is not recommended. Excreted into human milk: Likely Excreted into animal milk: Yes
Breastmilk levels of this drug have not been measured after administration to humans. Minimal data indicate that use in nursing mothers may not affect the breastfed infant or lactation. This drug should only be used with careful monitoring during breastfeeding.
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Information checked by Dr. Sachin Kumar, MD Pharmacology