Atezolizumab / hyaluronidase Pregnancy and Breastfeeding Warnings

Brand names: Tecentriq Hybreza

Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.

Atezolizumab / hyaluronidase Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Verify the pregnancy status of females of reproductive potential before starting treatment.
-Counsel women of childbearing potential to use effective contraception during therapy and for 5 months after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Female fertility may be compromised by this drug.

Atezolizumab: Animal reproduction studies have not been conducted. Based on this drug's mechanism of action and evidence from animal studies reported in the literature, inhibition of the programmed death-ligand 1 (PD-L1)/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death. Malformations related to PD-L1/PD-1 blockade were not reported; however, there may be an increased risk of immune-mediated disorders or altered immune response associated with fetal exposure to PD-L1/PD-1 inhibitors, including this drug.

Hyaluronidase: Animal studies have failed to reveal evidence of teratogenicity. Administration of hyaluronidase to pregnant animals during the period of organogenesis at doses up to 2400 times higher than the human dose demonstrated reduced fetal weights and increased fetal resorptions. Teratogenic, reproductive, or learning/memory effects were not reported in animal studies.

There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

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

Atezolizumab / hyaluronidase Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 5 months after the last dose.

Excreted into human milk: Unknown (atezolizumab, hyaluronidase)
Excreted into animal milk: Data not available (atezolizumab, hyaluronidase)

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-According to some experts: If this drug is used while breastfeeding, waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the nursing infant.
-Atezolizumab is a human immunoglobulin G (IgG) antibody; maternal IgG antibodies are present in milk.
-Because atezolizumab is a large protein molecule, the amount in milk is expected to be very low and absorption probably minimal due to destruction within the infant's gastrointestinal tract.

See references

Further information

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