Trospium / xanomeline Pregnancy and Breastfeeding Warnings

Brand names: Cobenfy

Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.

Trospium / xanomeline Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk. Animal studies have revealed evidence of maternal and fetal toxicity.

Comments:
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryofetal and developmental toxicity at maternally toxic doses. Administration of xanomeline alone or in combination with trospium chloride to pregnant animals during the period of organogenesis caused maternal toxicity and/or death at doses at least 3 times greater than the maximum recommended human dose (MRHD). Reported effects of maternally toxic xanomeline doses included decreased fetal/neonatal weights, stillbirths, and/or neonatal deaths. Trospium chloride alone was associated with maternal toxicity and neonatal deaths in some species at doses greater than 3 times the MRHD, based on BSA. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

There is a risk to the pregnant patient from untreated schizophrenia, including an increased risk of relapse, hospitalization, and suicide. Schizophrenia is associated with adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Trospium / xanomeline Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown (trospium, xanomeline)
Excreted into animal milk: Yes (trospium, xanomeline)

Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

See references

Further information

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