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Tocilizumab Pregnancy and Breastfeeding Warnings

Tocilizumab is also known as: Actemra

Tocilizumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: The limited data with this drug in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage. Monoclonal antibodies are actively transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant. Animal studies showed that during organogenesis caused abortion/embryo-fetal death at doses 1.25 times and higher than the maximum recommended human dose by the intravenous route of 8 mg per kg every 2 to 4 weeks. The literature in animals suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition [see Data]. Based on the animal data, there may be a potential risk to the fetus. Comments: -Women of childbearing potential should use effective contraception during and up to 3 months after treatment with this drug.

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. 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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972 or going to http://www.pregnancystudies.org/ongoing-pregnancy-studies/autoimmune-studies/. 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; however, endogenous immunoglobulins of the IgG isotype are excreted into human milk Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -Little information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Until more data become available, caution should be exercised if this drug is used during breastfeeding, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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