Aprocitentan Pregnancy and Breastfeeding Warnings

Brand names: Tryvio

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

Aprocitentan Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal reproduction studies with other endothelin receptor antagonists (ERAs), this drug can cause embryofetal toxicity and teratogenicity. Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Negative pregnancy status should be verified in patients of childbearing potential, before the start of treatment, monthly during treatment, and 1 month after the last dose.
-This drug has the potential to cause fetal harm, including birth defects and fetal death.
-Immediately notify the physician if the onset of menses is delayed or pregnancy is suspected.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-This drug may impair fertility in males of reproductive potential; it is not known if effects on fertility would be reversible.
-Patients of reproductive potential should use acceptable method of contraception before the start of treatment, during treatment, and for 1 month after the last dose; acceptable forms of contraception include, but are not limited to, intrauterine devices, contraceptive implants, tubal sterilization, or a combination of methods (either 1 hormone method with a barrier method or 2 barrier methods). Alternatively, if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. In embryofetal developmental toxicity studies, cardiovascular and mandibular arch fusion malformations were observed at all doses. In pre- and postnatal development studies, this drug showed reduced pup survival and impairment of the male fertility of the offspring at all doses. Other ERAs have shown an adverse effect on spermatogenesis in humans and/or animals. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers should report any prenatal exposure to this drug by calling 1-866-429-8964.

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

Aprocitentan Breastfeeding Warnings

Because no information is available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-When a drug is present in animal milk, it is likely that the drug will also be present in human milk.
-Because this drug is more than 99% bound to plasma proteins, the amount in milk is likely to be low; however, it has a 41-hour half-life and may accumulate in the infant.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in breastfed infants.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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