Suzetrigine Pregnancy and Breastfeeding Warnings

Brand names: Journavx

Medically reviewed by Drugs.com. Last updated on Feb 18, 2025.

Suzetrigine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Advise patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone to use an additional nonhormonal contraceptive or to use alternative contraceptives during treatment with this drug and for 28 days after discontinuing.
-This drug may reversibly impact likelihood of females of reproductive potential to become pregnant while on treatment.
-Patients using contraceptives should continue to use contraceptives.

Animal studies in pregnant rats and rabbits have revealed evidence of increased post-implantation loss, decreased live fetuses, decreased fetal body weight and maternal toxicity at oral doses up to 2.2 times the maximum recommended human dose (MRHD), and 5.9 times the MRHD, respectively. Placental transfer has been observed in pregnant rats. There are no controlled data in human pregnancy.

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

Suzetrigine Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-When a drug is present in animal milk, it is likely that the drug will be present in human milk.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-Potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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