Tocilizumab Pregnancy and Breastfeeding Warnings

Brand names: Actemra, Tofidence, Tyenne

Medically reviewed by Drugs.com. Last updated on Jan 3, 2023.

Tocilizumab Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data, there may be a potential risk to the fetus. Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-Monoclonal antibodies (such as this drug) are actively transported across the placenta during the third trimester and may affect immune response in infants exposed in utero.
-According to some authorities: Effective contraception is required for patients of childbearing potential during therapy and for several months (e.g., up to 3 months) after the last dose; local protocol should be consulted regarding contraception timing.

Animal studies have failed to reveal evidence of teratogenic/dysmorphogenic effect at any dose but revealed evidence of an increased incidence of abortion/embryofetal death at high doses. IV administration to pregnant Cynomolgus monkeys during organogenesis caused abortion/embryofetal death at doses 1.25 times and higher than the maximum recommended human dose (8 mg/kg IV every 2 to 4 weeks). Animal data suggests that inhibition of interleukin 6 (IL-6) signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition. 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 are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered before administering live or live-attenuated vaccines to infants exposed to this drug in utero.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Tocilizumab Breastfeeding Warnings

If this drug is required by the mother, it is not a reason to discontinue nursing. Caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Little information is available on the clinical use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Maternal immunoglobulin G (IgG) is excreted into human milk.

Only small amounts of this drug were detected in breast milk after IV doses in several mothers. The infant's gastrointestinal tract is likely to partially destroy this drug; absorption by the infant is probably minimal. A few mothers have breastfed their infants with undetectable infant serum levels and no reported adverse effects.

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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