Tecentriq IV Injection

Tecentriq IV Injection is used for: Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma, Small Cell Lung Cancer (SCLC), Hepatocellular Carcinoma (HCC), Melanoma

Intravenous Injection: 840 mg/14 mL (60 mg/mL) and 1200 mg/20 mL (60 mg/mL) solution in a single-dose vial. Administer Atezolizumab intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. Urothelial Carcinoma Administer Atezolizumab as a single agent as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Non-Small Cell Lung Cancer (NSCLC) In the adjuvant setting, administer Atezolizumab following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks for up to 1 year. In the metastatic setting, administer Atezolizumab as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. When administering with chemotherapy with or without bevacizumab, administer Atezolizumab prior to chemotherapy and bevacizumab when given on the same day. Small Cell Lung Cancer Administer Atezolizumab as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. When administering with carboplatin and etoposide, administer Atezolizumab prior to chemotherapy when given on the same day. Hepatocellular Carcinoma Administer Atezolizumab as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer Atezolizumab prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks. Melanoma Following completion of a 28 day cycle of cobimetinib and vemurafenib, administer Atezolizumab 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.

Alveolar Soft Part Sarcoma Indicated as a single agent, for unresectable or metastatic alveolar soft part sarcoma (ASPS) in adults and pediatric patients aged >2 years 15 mg/kg (not to exceed 1,200 mg) IV q3Weeks Continue until disease progression or unacceptable toxicity

Renal impairment Mild or moderate (eGFR 30-89 mL/min/1.73 m2): No dose adjustment is recommended Severe (eGFR <20 mL/min/1.73 m2): Not studied

IV Preparation Dilution Withdraw required amount from vial Dilute into a 250-mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% NaCl Dilute with 0.9% NaCl only Gently invert diluted solution; do not shake Discard partially used or empty vial IV Administration For IV infusion only; do not give as IV bolus or IV push Administer through an IV line with or without a sterile, nonpyrogenic, low-protein binding in-line filter (pore size of 0.2-0.22 micron) First IV infusion: Infuse over 60 min Subsequent IV infusions: If first infusion is tolerated, may administer subsequent doses over 30 min When administering in combination with chemotherapy, administer atezolizumab before chemotherapy when given on the same day Do not co-administer with other drugs through the same IV line

Atezolizumabis contraindicated in patients with a known hypersensitivity to atezolizumab or any of the 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. Withhold or permanently discontinue based on severity and type of reaction. Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions. Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. Monitoring Parameters Monitor for signs and symptoms of infusion- and immune-related reactions. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.

Pregnancy Based on its mechanism of action, can cause fetal harm when administered during pregnancy No available data on use in pregnant women Animal data 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 Contraception Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose Infertility Based on animal studies, atezolizumab may impair fertility in females of reproductive potential while receiving treatment Lactation Unknown if distributed in human breast milk As human IgG is excreted in human milk, potential for absorption and harm to the infant is unknown Advise lactating woman not to breastfeed during treatment and for at least 5 months after the last dose

Side effects of Atezolizumab : >10% (Urothelial carcinoma) Fatigue (52%) Decreased appetite (24-26%) Nausea (22-25%) Diarrhea (18-24%) Urinary tract infection (17-22%) Constipation (15-21%) Pyrexia (14-21%) Back/neck pain (15-18%) Pruritus (13-18%) Peripheral edema (17-18%) Rash (15-17%) Vomiting (16-17%) Abdominal pain (15-17%) Dyspnea (12-16%) Cough (14%) Hyponatremia, Grade 3 or 4 (15%) Arthralgia (13-14%) Hematuria (14%) >10% (NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin) Anemia (67-83%) Hyperglycemia (61%) Neuropathy (56%) Increased BUN (52%) Neutropenia (52%) Fatigue/asthenia (44-50%) Lymphocytopenia (49%) Alopecia (48%) Lymphopenia (48%) Hypoalbuminemia (40-48%) Hyponatremia (38-42%) Myalgia/pain (42%) Hypomagnesemia (26-42%) Increased AST (31-40%) Nausea (18-39%) Increased alkaline phosphatase (39%) Increased ALT (27-37%) Diarrhea (16-33%) Neutropenia, Grade 3 or 4 (31%) Increased TSH (30%) Constipation (18-30%) Decreased appetite (23-29%) Hyperkalemia (28%) Increased creatinine (23-28%) Hypocalcemia (26%) Arthralgia (26%) Cough (20-26%) Hypertension (25%) Hyperphosphatemia (25%) Hypophosphatemia (25%) Hypokalemia (23%) Rash (12-23%) Dyspnea (22%) Pyrexia (18-19%) Vomiting (19%) Epistaxis (17%) Lymphopenia, Grade 3 or 4 (17%) Proteinuria (16%) Headache (16%) Arthralgia (1-12%) >10% (TNBC) Alopecia (56%) Fatigue (47%) Peripheral neuropathies (47%) Nausea (46%) Diarrhea (33%) Anemia (28%) Constipation (25%) Headache (23%) Neutropenia (21%) Vomiting (20%) Decreased appetite (20%) Pyrexia (19%) Arthralgia (18%) Rash (17%) Peripheral edema (15%) Back pain (15%) Myalgia (14%) Pruritus (14%) Dizziness (14%) Dysgeusia (14%) Hypothyroidism (14%) Decreased neutrophils (13%) Urinary tract infection (12%) Asthenia (12%) Pain in extremity (11%) Upper respiratory infection (11%) Nasopharangitis (11%) >10% (SCLC) Anemia (94%) Neutropenia (73%) Hyperglycemia (67%) Thrombocytopenia (58%) Lymphopenia (46%) Neutropenia, Grade 3-4 (45%) Increased alkaline phosphatase (38%) Fatigue/asthenia (39%) Nausea (38%) Alopecia (37%) Hyponatremia (34%) Hypoalbuminemia (32%) Hypomagnesemia (31%) Decreased TSH (28%) Decreased appetite (27%) Constipation (26%) Hypocalcemia (26%) Increased ALT (26%) Increased AST (22%) Increased blood creatinine (22%) Neutropenia (22%) Hyperphosphatemia (21%) Increased TSH (21%) Thrombocytopenia, Grade 3-4 (20%) Vomiting (20%) Anemia, Grade 3-4 (17%) Hyponatremia, Grade 3-4 (15%) Lymphopenia, Grade 3-4 (14%) Hyperglycemia, Grade 3-4 (10%)

Monoclonal antibody to programmed cell death ligand-1 protein (PDL1); binding PDL1 blocks the interaction between PDL-1 and its ligands (including B7.1 receptors) PDL-1 PDL1 is expressed on the surface of activated T cells under normal conditions; binding PDL1 inhibits immune activation and reduces T-cell cytotoxic activity when bound This negative feedback loop is essential for maintaining normal immune responses and limits T-cell activity to protect normal cells during chronic inflammation Tumor cells may circumvent T-cell–mediated cytotoxicity by expressing PDL1 on the tumor itself or on tumor-infiltrating immune cells, resulting in the inhibition of immune-mediated killing of tumor cells

Tecentriq 1200mg/20 ml IV Injection manufactured by Roche Bangladesh Limited. Its generic name is Atezolizumab. Tecentriq is availble in Bangladesh. Farmaco BD drug index information on Tecentriq IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.