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Abrocitinib Pregnancy and Breastfeeding Warnings

Brand names: Cibinqo

Medically reviewed by Drugs.com. Last updated on Jul 5, 2022.

Abrocitinib Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: Available data from pregnancies reported in clinical trials are not sufficient to establish a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Comments:
-There are limited data on the use of this drug in pregnant women.
-A pregnancy exposure registry is available.
-Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the last dose of this drug.

In animal reproduction studies, oral administration of this drug to pregnant rats and rabbits during organogenesis at exposure 14 or 5 times the maximum recommended human dose (MRHD) respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits. There are no controlled data in human pregnancy.

Based on findings in rats, oral administration of this drug may impair female fertility. Impaired fertility in female rats was reversible 1 month after treatment discontinuation.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Pregnant women exposed to this drug and health care providers are encouraged to call 1¬ 877-311-3770.

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

Abrocitinib Breastfeeding Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-When a drug is present in animal milk, it is likely that it will be present in human milk.
-Due to serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with this drug and for one day after the last dose.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2022) "Product Information. Cibinqo (abrocitinib)." Pfizer U.S. Pharmaceuticals Group

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2022) "Product Information. Cibinqo (abrocitinib)." Pfizer U.S. Pharmaceuticals Group

Further information

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

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