evaluate Atezolizumab Pregnancy and Breastfeeding Warnings Atezolizumab is also known as: Tecentriq Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Atezolizumab Pregnancy Warnings This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: Not assigned. Risk Summary: -Based on animal studies, this drug impairs fertility in females of reproductive potential. -Based on its mechanism of action, this drug can cause harm to a developing fetus. Animal reproduction studies have not been conducted to evaluate the effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown to disrupt tolerance to a fetus and to result in an increase in fetal loss. 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. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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 Atezolizumab Breastfeeding Warnings Because this drug is a large protein molecule with a molecular weight of 145,000, the amount in breastmilk is likely to be very low and absorption is unlikely as it is probably destroyed in the infant GI tract. Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Lactating women should not breastfeed during treatment and for at least 5 months after the last dose. See references References for pregnancy information "Product Information. Tecentriq (atezolizumab)." Genentech, South San Francisco, CA. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 References for breastfeeding information Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 "Product Information. Tecentriq (atezolizumab)." Genentech, South San Francisco, CA. Print this page See Also... atezolizumab Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Atezolizumab Rating 1 User Review 1 User Review Not Rated - Be the first! Drug Class Anti-PD-1 monoclonal antibodies Help and Support Looking for answers? Ask a question or go join the atezolizumab support group to connect with others who have similar interests. is very important
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