Important Safety Information (cont’d) Other Immune-Mediated Adverse Reactions (cont’d)


– Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic infl ammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection


Infusion-Related Reactions • TECENTRIQ can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue TECENTRIQ based on the severity. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses


• Infusion-related reactions occurred in 1.3% of patients receiving TECENTRIQ alone, including Grade 3 (0.2%) reactions


• The frequency and severity of infusion-related reactions were similar across the recommended dose range


Complications of Allogeneic HSCT After PD-1/PD-L1 Inhibitors • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody


• Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identifi ed infectious cause)


• These complications may occur despite intervening therapy between PD-1/PD-L1 blockage and allogeneic HSCT


• Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefi ts versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT


Embryo-Fetal Toxicity • Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death


• Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose


Use in Specifi c Populations Nursing Mothers • There is no information regarding the presence of TECENTRIQ in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown


• Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose


Learn more at TECENTRIQ.COM/uHCC


Fertility


• Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment


Most Common Adverse Reactions


The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with bevacizumab for HCC were hypertension (30%), fatigue/asthenia (26%), and proteinuria (20%).


You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.


Please see Brief Summary of TECENTRIQ Prescribing Information on the following pages, and full Avastin Prescribing Information for additional Important Safety Information.


References: 1. TECENTRIQ Prescribing Information. Genentech, Inc. 2. Li D, Sedano S, Allen R, Gong J, Cho M, Sharma S. Current treatment landscape for advanced hepatocellular carcinoma: patient outcomes and the impact on quality of life. Cancers (Basel). 2019;11:841. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®


) for Hepatobiliary Cancers V.1.2022. © National


Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 29, 2022. To view the most recent and complete version of the guideline, go online to www.NCCN.org. 4. Finn RS, Qin S, Ikeda M, et al; IMbrave150 Investigators. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020;382:1894-1905.


© 2022 Genentech USA, Inc. All rights reserved. M-US-00014400(v1.0)


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