What Is Imfinzi 500 mg/10 ml Indications and Uses?

Imfinzi 500 mg/10 ml (Durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: 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) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. ... Read more Imfinzi 500 mg/10 ml (Durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: 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) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. 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). in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 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) as determined by an FDA-approved test. in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

Pharmacology (Source, Chemical and Physical Composition) Of Imfinzi 500 mg/10 ml

Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production. Imfinzi 500 mg/10 ml (Durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC). PD-L1 blockade with durvalumab led to increased T-cell activation in vitro and decreased tumor size in co-engrafted human tumor and immune cell xenograft mouse models.

Dosage And Administration of Imfinzi 500 mg/10 ml

Neoadjuvant and Adjuvant Treatment of Resectable NSCLC - Weight ≥30 kg: Neoadjuvant: Imfinzi 500 mg/10 ml (Durvalumab) 1,500 mg in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery. Adjuvant: Durvalumab 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. Weight <30 kg: Neoadjuvant: Durvalumab 20 mg/kg every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery. Adjuvant: 20 mg/kg every 4 weeks as a single agent for up to 12 cycles after surgery. Unresectable Stage III NSCLC, following concurrent platinum-based chemotherapy and radiation therapy- Weight ≥30 kg: Durvalumab 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks. Weight <30 kg: Durvalumab 10 mg/kg every 2 weeks. Metastatic NSCLC : Weight ≥30 kg: Durvalumab 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer Durvalumab 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-actl 75 mg in combination with Durvalumab dose 6 at week 16. Weight <30 kg: Durvalumab 20 mg/kg every 3 weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then administer Durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of tremelimumab-actl 1 mg/kg in combination with Durvalumab dose 6 at week 16. LS-SCLC, following concurrent platinum-based chemotherapy and radiation therapy : Weight ≥30 kg: 1,500 mg every 4 weeks. Weight <30 kg: 20 mg/kg every 4 weeks. ES-SCLC : Weight ≥30 kg: With etoposide and either carboplatin or cisplatin, administer Durvalumab 1,500 mg every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent. Weight <30 kg: With etoposide and either carboplatin or cisplatin, administer Durvalumab 20 mg/kg every 3 weeks in combination with chemotherapy, and then 10 mg/kg every 2 weeks as a single agent. BTC : Weight ≥30 kg: administer Durvalumab 1,500 mg every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent. Weight <30 kg: administer Durvalumab 20 mg/kg every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent. uHCC : Weight ≥30 kg: Durvalumab 1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by Durvalumab as a single agent every 4 weeks. Weight <30 kg: Durvalumab 20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Durvalumab as a single agent every 4 weeks. dMMR endometrial cancer : Weight ≥30 kg: Durvalumab 1,120 mg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by Durvalumab 1,500 mg every 4 weeks as a single agent. Weight <30 kg: Durvalumab 15 mg/kg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by Durvalumab 20 mg/kg every 4 weeks as a single agent. MIBC : Weight ≥30 kg: Neoadjuvant: Durvalumab 1,500 mg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery. Adjuvant: Durvalumab 1,500 mg every 4 weeks as a single agent for up to 8 cyles after surgery. Weight <30 kg: Neoadjuvant: Durvalumab 20 mg/kg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery. Adjuvant: Durvalumab 20 mg/kg every 4 weeks as a single agent for up to 8 cycles after surgery.

Side Effects of Imfinzi 500 mg/10 ml

Imfinzi 500 mg/10 ml (Durvalumab) 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 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 Tremelimumab-actl and Platinum-Based Chemotherapy: Most common adverse reactions (≥ 20%) of patients with metastatic NSCLC) are nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. Imfinzi as a Single Agent: Most common adverse reactions (≥20%) of patients with limited-stage SCLC) are pneumonitis or radiation pneumonitis, and fatigue. 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 Gemcitabine and Cisplatin

Precautions And Warnings for Imfinzi 500 mg/10 ml

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, 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 500 mg/10 ml (Durvalumab) 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.

Use During Pregnancy and Lactation

There are no available data on the use of Imfinzi 500 mg/10 ml (Durvalumab) in pregnant women. There are no data on the presence of durvalumab in human milk, its effects on the breastfed child, or the effects on milk production.

Therapeutic Class

Targeted Cancer Therapy

Storage Conditions of It

Store in a refrigerator at 2°C to 8°C in original carton to protect from light. Do not freeze. Do not shake. Pack Images: Imfinzi 500 mg IV Infusion Thanks for using MedEx! How would you rate your experience so far?