imfinzi mechanism of action

Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. IMFINZI is a medicine that may treat certain cancers by working with your immune system. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. In patients who received Imfinzi on clinical trials in which radiation therapy was generally not administered immediately prior to initiation of Imfinzi, the incidence of immune-mediated pneumonitis was 2% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. Select one or more newsletters to continue. Your healthcare provider will check you for these problems during your treatment with Imfinzi. Imfinzi can cause immune-mediated thyroid disorders. The trial used a fixed dose of Imfinzi(1500 mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression as a single medicine. The most common adverse reactions (occurring in ≥ 20% of patients) were nausea, fatigue/asthenia and alopecia. Patients with history of chest radiation therapy; a history of active primary immunodeficiency; autoimmune disorders including paraneoplastic syndrome; active or prior documented autoimmune or inflammatory disorders; use of systemic immunosuppressants within 14 days before the first dose of the treatment except physiological dose of systemic corticosteroids were ineligible. The recommended dose is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Imfinzi can cause immune-mediated colitis that is frequently associated with diarrhea. The steady state AUC, Ctrough, and Cmax in patients administered with 1500 mg every 4 weeks are 6% higher, 19% lower, and 55% higher than those administered with 10 mg/kg every 2 weeks, respectively. The effect of severe renal impairment (CLcr 15 to 29 mL/min) or moderate hepatic impairment (bilirubin > 1.5 to 3x ULN and any AST) or severe hepatic impairment (bilirubin > 3x ULN and any AST) on the pharmacokinetics of durvalumab is unknown. You may report side effects to FDA at 1-800-FDA-1088. It includes drugs overview, Imfinzi mechanism of action, clinical trials, regulatory milestones, … Withhold or discontinue Imfinzi based on the severity [see Dosage and Administration (2.2)]. Each 120 mg vial of Imfinzi contains 120 mg of durvalumab in 2.4 mL solution. Fatal adverse reactions occurred in 4.9% of patients receiving Imfinzi plus chemotherapy. Advise females of reproductive potential to use effective contraception during treatment with Imfinzi and for at least 3 months following the last dose of Imfinzi. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to Imfinzi were similar whether Imfinzi was given as a single agent in patients with various cancers in a pooled data set or in patients with ES-SCLC when given in combination with chemotherapy. Immune-mediated adrenal insufficiency occurred in 0.4% (7/1889) of patients receiving Imfinzi, including Grade 3 (<0.1%) adverse reactions. Withhold or permanently discontinue Imfinzi based on the severity [see Dosage and Administration (2.2)]. … Imfinzi (durvalumab) Injection is a clear to opalescent, colorless to slightly yellow solution supplied in a carton containing one single-dose vial either as: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. ALT or AST increases to more than 3 and up to 8 times the ULN, total bilirubin increases to more than 1.5 and up to 3 times ULN, ALT or AST increases to more than 8 times ULN, total bilirubin increases to more than 3 times the ULN, AST or ALT is more than 1 and up to 3 times ULN at baseline and increases to more than 5 and up to 10 times ULN, AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more than 8 and up to 10 times ULN, AST or ALT increases to more than 10 times ULN, Total bilirubin increases to more than 3 times ULN, Withhold until clinically stable or permanently discontinue depending on severity, ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal. … A total of 475 patients received Imfinzi 10 mg/kg intravenously every 2 weeks. In Patients Who Received Recent Prior Radiation. Selective, high affinity antibody that blocks PD-L1 binding to PD-1 and CD80, allowing T cells to recognize and kill tumor cells. Durvalumab is a programmed cell death ligand 1 (PD-L1) blocking antibody. Animal fertility studies have not been conducted with durvalumab. There are no data on the use of IMFINZI in pregnant women. View Imfinzi description for details of the chemical structure and excipients (inactive components). Imfinzi (durvalumab) Injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution, free from visible particles. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). Events resolved in 43 of the 79 patients and resulted in permanent discontinuation in 24 patients. Events resolved in 3 of the 7 patients and none resulted in permanent discontinuation. The data also reflect exposure to Imfinzi in combination with chemotherapy in 265 patients from the CASPIAN study (a randomized, open-label study in patients with ES-SCLC). If you would like more information about Imfinzi, talk with your healthcare provider. Injection: 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial. When Imfinzi is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information. Detailed clinical and laboratory monitoring guidelines for early detection of adverse reactions of IMFINZI and recommended management are described in the full prescribing information (link below). All patients received Imfinzi 10 mg/kg via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or disease progression. Getting medical treatment right away may help keep these problems from becoming more serious. It releases the inhibition of immune responses, without … Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. Treatment with systemic corticosteroids was administered in this patient. Interrupt, slow the rate of, or permanently discontinue Imfinzi based on the severity [see Dosage and Administration (2.2)]. The safety of Imfinzi in combination with etoposide and either carboplatin or cisplatin in previously untreated ES-SCLC was evaluated in CASPIAN, a randomized, open-label, multicenter, active-controlled trial. These complications can be serious and can lead to death. By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production. Events resolved in 23 of the 31 patients and resulted in permanent discontinuation in 8 patients. Mechanism of action. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) patients who received Imfinzi. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Imfinzi can cause primary or secondary adrenal insufficiency. Subjects in the Imfinzi arm had a 48% lower chance of lung cancer growing or spreading than those receiving placebo. Design, CMS, Hosting & Web Development :: ePublishing, Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges, MAGI's Clinical Research vConference — Spring 2021, Regenerative Medicine: Steps to Accelerate Development, Clinical Trial Agreements: A Guide to Key Words and Phrases, Mid-Study Updates Delay Trials At Least a Month, CSDD Report Finds, Real-Time Data Helped Sponsors Respond to Sites’ Needs During the Pandemic, Increasing Protocol Complexity Requires Adapting Quality Metrics Tools, Ask the Experts: Participant Reimbursement, Compensation and Incentives. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Imfinzi is specifically indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: 1) have disease progression during or following platinum-containing chemotherapy 2) have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Imfinzi is specifically approved for patients with Stage III non-small cell lung cancer who… MIMS Class . M. tuberculosis-infected PD-1 knockout mice exhibit markedly decreased survival compared with wild-type controls, which correlated with increased bacterial proliferation and inflammatory responses in these animals. Results also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm (68% versus 58% for SoC alone). Withhold or permanently discontinue Imfinzi based on the severity [see Dosage and Administration (2.2)]. There are no data on the use of Imfinzi in pregnant women. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 blocking antibodies. In Patients Who did Not Receive Recent Prior Radiation. Table 4 summarizes the laboratory abnormalities that occurred in at least 20% of patients treated with Imfinzi. L01XC28 - durvalumab ; Belongs to the class of … Cardiac/vascular: Myocarditis, pericarditis, vasculitis. You can ask your healthcare provider for information about Imfinzi that is written for health professionals. The investigator-assessed confirmed ORR was 68% (95% CI: 62%, 73%) in the Imfinzi plus chemotherapy arm and 58% (95% CI: 52%, 63%) in the chemotherapy alone arm. Imfinzi was tested against placebo. In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery resulted in an increase in premature delivery, fetal loss, and premature neonatal death (see Data). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in < 2% of patients and were similar across arms.

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