Atezolizumab and Hyaluronidase (human recombinant)

TECENTRIQ HYBREZA is a combination of atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, and hyaluronidase, an endoglycosidase indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC…

PD-L1 may be expressed on tumor cells and/or tumor infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.

TECENTRIQ HYBREZA has different recommended dosage and administration than intravenous atezolizumab products. TECENTRIQ HYBREZA is for subcutaneous use in the thigh only. Do not administer TECENTRIQ HYBREZA intravenously. The recommended dosage for adult patients and pediatric patients (12 years and older who weigh 40 kg or greater) is: TECENTRIQ HYBREZA 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks. TECENTRIQ HYBREZA must be administered by a healthcare professional. NSCLC Dosage In the adjuvant setting, administer TECENTRIQ HYBREZA following resection and up to 4 cycles of platinum-based chemotherapy every 3 weeks for up to 1 year. In the metastatic setting, administer TECENTRIQ HYBREZA every 3 weeks.

TECENTRIQ HYBREZA is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. TECENTRIQ HYBREZA is contraindicated in patients with known hypersensitivity to hyaluronidase or any of its excipients.

Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-Related Reactions: Pause or slow the rate of injection, or permanently discontinue based on severity of the reaction.

The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and Fatal Immune-Mediated Adverse Reactions Infusion-Related Reactions Complications of Allogeneic HSCT after PD-1/PD-L1 Inhibitors Most common adverse reactions (AR) (≥ 10%) with TECENTRIQ HYBREZA as monotherapy in patients with NSCLC were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. Safety of TECENTRIQ HYBREZA for the approved NSCLC, ES-SCLC, HCC, melanoma, ASPS, MIBC, and colon cancer indications is based on safety of intravenous atezolizumab in these populations. Most common AR with intravenous atezolizumab are presented below by indication and regimen: Most common AR (≥ 20%) as monotherapy were: First-line NSCLC: fatigue/asthenia. Metastatic NSCLC: fatigue/asthenia, cough, decreased appetite, dyspnea, and myalgia/pain.

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.