Vyleesi Pregnancy & Lactation Safety: What You Need to Know Before Using Bremelanotide

Is Vyleesi contraindicated in pregnancy?

No. The label's contraindications section names two conditions only: uncontrolled hypertension and known cardiovascular disease [1]. Pregnancy is not on that list.

Instead, pregnancy is covered in Section 8.1, which says that based on animal findings, use of Vyleesi in pregnant women may be associated with the potential for fetal harm, and instructs patients to discontinue Vyleesi if pregnancy is suspected [1]. A separate line tells women of reproductive potential to use effective contraception while taking the drug [1].

The label's own risk summary says the few pregnancies reported in clinical trials are insufficient to determine whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes [1]. It adds that the lowest bremelanotide dose associated with fetal harm has not been identified in either animal species tested [1].

The pregnancy and breastfeeding text above is from Vyleesi's November 13, 2025 label. FDA approved an update to Section 8 on October 22, 2026; that wording was not yet in the DailyMed label as of October 28, 2026 [2].

What the animal studies found

The developmental program used a dog embryofetal study and a mouse pre- and postnatal study. According to the label, those were the only two species that could be successfully dosed subcutaneously during gestation [1].

Dogs. Eight dogs per dose received 2, 8, or 20 mg/kg subcutaneously from gestation day 18 to 35, the window from implantation to late embryogenesis in the dog. Embryofetal toxicity, measured as post-implantation loss, was elevated roughly 3- to 8-fold compared with controls across all treated groups, and was not dose-dependent. No developmental no-observed-effect level was set. At the low dose of 2 mg/kg/day, exposure was about 16 times the human exposure based on AUC [1].

Mice. Thirty mice per dose received 0, 30, 75, or 150 mg/kg/day subcutaneously from gestation day 6 through lactation day 2. Developmental effects appeared in the offspring at 125 times the human AUC or more, so again no developmental no-observed-effect level was set. There were no significant effects on the growth and development of the second-generation pups [1].

The label reports that the lowest dose associated with fetal harm has not been identified in either species [1].

What the human pregnancy data show

The label reports 7 pregnancies among more than 1,057 patients treated with Vyleesi for up to 12 months. No major congenital anomalies were reported. There was one spontaneous abortion (miscarriage), five full-term live births, and one outcome that was unknown because the patient was lost to follow-up [1].

The label says the few pregnancies in clinical trials are insufficient to determine whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes [1].

A pregnancy exposure registry is described in the label, which encourages pregnant women exposed to Vyleesi, and their healthcare providers, to call (800) 922-1038 [1]. Suspected adverse reactions can be reported to Cosette Pharmaceuticals at 1-800-922-1038 or to FDA at 1-800-FDA-1088 [1].

Vyleesi and breastfeeding

Section 8.2 states that there is no information on the presence of bremelanotide or its metabolites in human milk, on the effects on the breastfed infant, or on the effects on milk production [1]. It says the developmental and health benefits of breastfeeding should be considered alongside the mother's clinical need for Vyleesi and any potential adverse effects on the breastfed child [1].

Contraception and suspected pregnancy

The label advises women of reproductive potential to use effective contraception while taking Vyleesi, and patients to discontinue the drug if pregnancy is suspected [1]. It gives these instructions alongside the statement that the lowest dose causing fetal harm in animals has not been identified [1].

Vyleesi is taken as needed rather than daily: 1.75 mg subcutaneously into the abdomen or thigh at least 45 minutes before anticipated sexual activity, no more than one dose in 24 hours, and more than 8 doses per month is not recommended [1]. It is not indicated for postmenopausal women or for men, and it is not indicated to enhance sexual performance [1].

What about compounded PT-141?

All of the pregnancy and lactation information above comes from the Vyleesi label, which covers the FDA-approved 1.75 mg autoinjector [1]. Products sold as compounded or research-use PT-141 are not Vyleesi and are not FDA-approved drugs, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before they are marketed [3][1]. The label statements about pregnancy, miscarriage risk and human milk do not describe those products.