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Tocilizumab Pregnancy and Breastfeeding Warnings

Tocilizumab is also known as: Actemra

Medically reviewed by Drugs.com. Last updated on Jul 9, 2021.

Tocilizumab Pregnancy Warnings

Use is not recommended unless clearly needed.

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

Comments:
-A pregnancy exposure registry is available.
-Monoclonal antibodies are actively transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant.
-Based on animal data, there may be a potential risk to the fetus.
-Women of childbearing potential should use effective contraception during and up to 3 months after treatment.

Animal studies have shown no evidence for a teratogenic/dysmorphogenic effect at any dose, but there is an increased risk of spontaneous abortion/embryofetal death at high dose. Animal data suggests that inhibition of 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. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 calling 1-877-311-8972.

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

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: Unknown
Excreted into animal milk: Yes

Comments:
-It is known that endogenous immunoglobulins of the IgG isotype are excreted into human milk.
-Little information is available on the clinical use of this drug during breastfeeding, and its effect on the nursing infant are unknown.
-Transfer of a murine analog of the drug into the milk of lactating mice has been observed.
-This drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Actemra (tocilizumab)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Actemra (tocilizumab)." Genentech, South San Francisco, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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