Abbreviated Prescribing Information
Imfinzi

Presentation: 500 mg/10mL and 120mg/2.4mL intravenous infusion. Indications: 1) Treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. 2) In combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 3) In combination with tremelimumab and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 4) In combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements. 5) In combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). 6) In combination with tremelimumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 7) In combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Dosage and administration: Administer IMFINZI as an intravenous infusion over 60 minutes after dilution. Unresectable stage III NSCLC: Patients weighing 30 kg and more: 10mg/kg every 2 weeks or 1500mg every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. Patients weighing less than 30 kg: 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. ES-SCLC: Patients weighing 30 kg and more: 1500mg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1500mg every 4 weeks as a single agent until disease progression or unacceptable toxicity. Patients weighing less than 30kg: 20mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20mg/kg every 4 weeks as a single agent until disease progression or unacceptable toxicity. Metastatic NSCLC: Patients weighing 30 kg and more: 1,500 mg every 3 weeks in combination with tremelimumab 75 mg and platinum-based chemotherapy for 4 cycles, and then administer IMFINZI 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab 75 mg in combination with IMFINZI dose 6 at week 16. Patients weighing less than 30kg: 20 mg/kg every 3 weeks in combination with tremelimumab 1 mg/kg and platinum-based chemotherapy, and then administer IMFINZI 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of tremelimumab 1 mg/kg in combination with IMFINZI dose 6 at week. Neoadjuvant and Adjuvant Treatment of Resectable NSCLC: Patients weighing 30 kg and more: Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery. Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. Patients weighing less than 30 kg: Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery. Adjuvant: IMFINZI 20 mg/kg every 4 weeks as a single agent for up to 12 cycles after surgery. BTC: Patients weighing 30 kg and more: administer IMFINZI 1,500 mg every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent. Patients weighing less than 30kg: administer IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent. uHCC: Patients weighing 30 kg and more: IMFINZI 1,500 mg in combination with tremelimumab 300 mg as a single dose at Cycle 1/Day 1, followed by IMFINZI as a single agent every 4 weeks. Patients weighing less than 30kg: IMFINZI 20 mg/kg in combination with tremelimumab 4 mg/kg as a single dose at Cycle 1/Day 1, followed by IMFINZI as a single agent every 4 weeks. dMMR endometrial cancer: Patients weighing 30 kg and more: IMFINZI 1,120 mg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by 1,500 mg every 4 weeks as a single agent. Patients weighing less than 30 kg: IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by 20 mg/kg every 4 weeks as a single agent. Contraindications: None. Precautions: Immune-mediated Adverse Reactions: May be severe or fatal, can occur in any organ system or tissue, including 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, and immune-mediated pancreatitis. 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: Interrupt, slow the rate of infusion, or permanently discontinue IMFINZI based on the severity of the reaction. 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. Undesirable effects: IMFINZI as a Single Agent: Most common adverse reactions (≥20% of patients with unresectable, Stage III NSCLC) are cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. IMFINZI in Combination with Platinum-Based Chemotherapy: Most common adverse reactions (≥20% of patients with extensive-stage SCLC) are nausea, fatigue/asthenia, and alopecia. IMFINZI in Combination with Tremelimumab and Platinum-Based Chemotherapy: Most common adverse reactions (≥ 20% of patients with metastatic NSCLC) were nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. IMFINZI in combination with chemotherapy: Most common adverse reactions (≥ 20% of patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. IMFINZI in Combination with gemcitabine and cisplatin: Most common adverse reactions (≥ 20% of patients with BTC) are fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia. IMFINZI in Combination with Tremelimumab: Most common adverse reactions (≥ 20% of patients with uHCC) are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. IMFINZI in Combination with Carboplatin and Paclitaxel, followed by IMFINZI as a single agent: Most common adverse reactions (≥ 20% of patients with endometrial cancer) were peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, decreased magnesium, increased ALT, increased AST, diarrhea, vomiting, cough, decreased potassium, dyspnea, headache, increased alkaline phosphatase, and decreased appetite.  Full local prescribing information is available upon request. API.HK.IMF.0824​​

HK-10404 12/06/2024