Apremilast Pregnancy and Breastfeeding Warnings

Brand names: Otezla

Apremilast Pregnancy Warnings

According to some authorities: Use is contraindicated during pregnancy and not recommended in women attempting to become pregnant.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: Based on animal data, this drug may increase the risk of fetal loss. Based on very limited data on use of this drug in pregnant women, a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes has not been established.

Comments:
-Advise pregnant women of the potential risk of fetal loss if this drug is used during pregnancy.
-According to some authorities: Pregnancy should be excluded before initiating treatment.
-Consider pregnancy planning and prevention (with effective methods of contraception) for females of reproductive potential.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryofetal lethality and toxicity. Dose-related increases in abortion and embryofetal death were observed when this drug was administered during organogenesis at doses 2.1 times or greater the maximum recommended human dose (MRHD). Reduced fetal weights and delayed ossification were seen in mice at doses higher than the MRHD. Teratogenicity or adverse effects on fertility were not observed in animal studies. Placental transfer of this drug was evidenced in mice and monkeys. 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. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting https://mothertobaby.org/ongoing-study/otezla/.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Apremilast Breastfeeding Warnings

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

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

Comments:
-There are no data on the presence of this drug or its metabolites in human milk, or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; a risk to the breastfed infant cannot be excluded.
-Consider the use of an alternate drug, especially while nursing a newborn or preterm infant.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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

Medical Disclaimer