IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Dosage Modifications for Adverse Reactions No dose reduction for IMFINZI is recommended. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids. To make sure Imfinzi is safe for you, tell your doctor if you have have an active infection, or if you have ever had: an organ transplant or a stem cell transplant (recent or planned); radiation treatment of your chest area; or. Do not breastfeed while using Imfinzi, and for at least 3 months after your last dose. Grade 3. By attaching to the receptor, durvalumab (Imfinzi) prevents cancer cells from switching T-cells and B-cells off, thereby increasing the ability of the immune system to kill cancer cells. an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Locally Advanced, Unresectable Non-Small Cell Lung Cancer, In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms. Your doctor will determine your exact dosage and schedule. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Table 1. Durvalumab is known as a checkpoint inhibitor drug. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms, In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every two weeks until disease progression, unacceptable toxicity, or … IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. Version: 5.01. IMFINZI ® (durvalumab) is administered as a 60-minute IV infusion with no premedication required Patients with a body weight <30 kg must receive weight-based dosing, equivalent to … How Durvalumab Is Given Durvalumab is administered as an IV once every two weeks. severe and fatal immune-mediated reactions. Across all studies, IMFINZI was administered at a dose of 10 mg/kg intravenously 1 [6] Durvalumab[4] (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Among the 1889 patients, 38% were exposed for 6 months or more and 18% were exposed for 12 months or more. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. The data also reflect exposure to There are no data on the use of IMFINZI in pregnant women. IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Tell your doctor about all your current medicines and any medicine you start or stop using. Imfinzi is administered via IV in the hospital and does not come in a pill form. Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving IMFINZI. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. (36°F to 46°F), 8 hours at room temperature up to 25°C (77°F), Administer infusion solution intravenously over 1 hour through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter, Do not co-administer other drugs through the same infusion line, 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, Help your patients monitor their treatment experience, including immune-mediated adverse events, by calling 1-855-LHOUSE1 (1-855-546-8731), Learn how to order IMFINZI® (durvalumab) with the Access & Reimbursement Guide. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. Imfinzi is administered as an intravenous infusion over 60 minutes. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. The information in this site is for US health care professionals only. Grade 3. : Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy. Dosing, Wastage, and Coding Guide for IMFINZI® (durvalumab) 1 INDICATIONS IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed Important immune-mediated adverse reactions listed under Warnings and Precautions may not. IMFINZI can cause immune-mediated rash or dermatitis. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Advise pregnant women of the potential risk to a fetus. — Administer Imfinzi through an IV line containing a sterile, low-protein binding 0.2 or 0.22 Last updated on Feb 25, 2021. If uveitis occurs in combination with other. Imfinzi is available in 120mg and 500mg vials. If uveitis occurs in combination with other. Initiate treatment with insulin as clinically indicated. For previously treated Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. 2.1 If an eligible dose is not rounded down, clinical rationale is required. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. • The recommended dose of Imfinzi is 10 mg/kg administered as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Imfinzi is also used to treat small cell lung cancer in combination with the chemotherapy medicines etoposide and carboplatin or cisplatin when the cancer has spread within your lungs or to other parts of the body. You may report side effects related to AstraZeneca products by clicking here. In these trials, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks. Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Generic Name: durvalumab (dur VAL ue mab) IMFINZI is administered as a 1-hour IV infusion with no premedication required IMFINZI 10 mg/kg 1-hour IV infusion once every 2 weeks Individual weight-based dosing • For unresectable Stage III NSCLC, IMFINZI may beor a Initial Criteria (approved up to 6 months, subject to formulary changes): These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Usual Adult Dose for Non-Small Cell Lung Cancer: 10 mg/kg IV over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. According to AZ, if the new regimen is approved, Imfinzi (durvalumab) could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)]. Greater than 30 kg: Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 blocking antibodies. IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids. References: 1. Monitor for signs and symptoms of infusion-related reactions. : Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. The safety and effectiveness of IMFINZI have not been established in pediatric patients. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Initiate treatment with insulin as clinically indicated. IMFINZI contains durvalumab as the active substance and is administered as an intravenous infusion. The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%), In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Your health care provider will give you this medicine. Follow patients closely for evidence of transplant-related complications and intervene promptly. We comply with the HONcode standard for trustworthy health information -, Drug class: anti-PD-1 monoclonal antibodies, Voluntary Withdrawal of Imfinzi Indication in Advanced Bladder Cancer in the US. : Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. : Uveitis, iritis, and other ocular inflammatory toxicities can occur. Get emergency medical help if you have signs of an allergic reaction to Imfinzi: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI can cause immune-mediated hepatitis. NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information. Call your doctor for instructions if you miss an appointment for your Imfinzi injection. Call your doctor at once if you have new or unusual symptoms, such as: tiredness, mood changes, headaches, vision problems, muscle weakness, stomach problems, weight changes, skin rash, hair loss, bleeding or bruising, yellowing of your skin or eyes, increased or decreased urination, dark urine, bloody or tarry stools, worsening cough, chest pain, or trouble breathing. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. A healthcare provider will give you this injection. Administer corticosteroids for Grade 2 or greater colitis or diarrhea. Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. †Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. IMFINZI® (durvalumab) [Prescribing Information]. Mix diluted solution by gentle inversion. There are no contraindications for IMFINZI® (durvalumab). Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. IMFINZI can cause immune-mediated pneumonitis. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. Confirmed objective response rate (ORR) as assessed by blinded independent … Durvalumab is administered intravenously. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. IMFINZI is administered as an intravenous infusion over 60 minutes . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Use: For patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. This results in the weakening of the immune system. A healthcare provider will give you this injection. You should not use Imfinzi if you are allergic to durvalumab. Brand Name: Imfinzi. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Durvalumab may cause your immune system to attack healthy organs and tissues in your body. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. This medicine must be given slowly and the infusion can take about 1 hour to complete. Prescribing Information has additional information for dosage modification and management specific to adverse reactions. Select one or more newsletters to continue. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Copyright 1996-2021 Cerner Multum, Inc. Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:This indication is approved under accelerated approval based on tumor response rate and duration of response. IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. IMFINZI can cause primary or secondary adrenal insufficiency. Uveitis, iritis, and other ocular inflammatory toxicities can occur. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. : Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. Use: This drug in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). : Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Written by Cerner Multum. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. IMFINZI can cause immune-mediated nephritis. Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Please see complete Prescribing Information, including Medication Guide. A healthcare provider will give you this injection. IMFINZI can result in severe and life-threatening immune-mediated adverse reactions, including pneumonitis, hepatitis, colitis, and endocrinopathies. IMFINZI is administered as an intravenous infusion over 60 minutes. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.1)]. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. Various grades of visual impairment to include blindness can occur. *Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.0% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. All rights reserved. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. The approved recommended dose of IMFINZI is 10 mg/kg, administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. See Dosing and Administration for specific details. This product information is intended for US Healthcare Professionals only. Some cases can be associated with retinal detachment. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. See Dosing and Administration for specific details. IMFINZI is a medicine that may treat certain cancers by working with your immune system. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. cold symptoms such as stuffy nose, sneezing, sore throat; This is not a complete list of side effects and others may occur. Table 1. †Based on the modeling of pharmacokinetic data and exposure relationships for safety in patients weighing >30 kg with UC or NSCLC. NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. : Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. [5] It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279). No dose reductions of IMFINZI are recommended. ©2020 AstraZeneca. IMFINZI is administered as an IV infusion with no premedication required 1 For UC or Unresectable Stage III NSCLC: Weight-based dose (10 mg/kg) The recommended dose of IMFINZI (durvalumab) is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks as long as clinical benefit is observed or until unacceptable toxicity. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. IMFINZI can cause severe or life-threatening infusion-related reactions. You may report side effects to FDA at 1-800-FDA-1088. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions. Administer infusion solution immediately once prepared. Withhold or permanently discontinue IMFINZI depending on severity. US-13205; US-21853; US-26031; US-29294; US-33316; US-37286; US-42398; US-46844 Last Updated 12/20. Recommended Dosages of IMFINZI Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Imfinzi only for the indication prescribed. NSCLC=non-small cell lung cancer; Q2W=once every 2 weeks; Q4W=once every 4 weeks; IV=intravenous; UC=urothelial carcinoma; AUC=area under the curve. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Some side effects may occur during the injection. Institute medical management promptly, including specialty consultation as appropriate. 1500 mg IV every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Alecensa, methotrexate, Keytruda, Avastin, pembrolizumab, cisplatin, nivolumab, Opdivo, Tagrisso, etoposide. Medically reviewed by Judith Stewart, BPharm. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible. This medicine must be given slowly and the infusion can take about 1 hour to complete. Call your doctor for medical advice about side effects. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. For adult patients with unresectable Stage III non-small cell lung cancer, IMFINZI® (durvalumab) is administered as a 60-minute IV infusion with no premedication required, There are no anticipated clinically meaningful differences in efficacy and safety between Q2W and Q4W dosing with IMFINZI® (durvalumab)1†. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Table 1. Available for Android and iOS devices. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL, Discard partially used or empty vials of IMFINZI. Withhold IMFINZI for Grade 2 colitis or diarrhea; permanently discontinue This administration takes about 60 minutes per session, and these sessions occur every two to four weeks. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling). chest pain, new or worsening cough, feeling short of breath; severe stomach pain, diarrhea, bloody or tarry stools; new or worsening skin rash, itching, or blistering; problems in other organs - mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems; liver problems - loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); kidney problems - little or no urination, red or pink urine, swelling in your feet or ankles; transplant rejection - rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; or. The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%), In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands. The recommended dosefor IMFINZI monotherapyandIMFINZI in combination with chemotherapy ispresented in Table 1.IMFINZI is administered as an intravenous infusion over 1 hour. Some cases can be associated with retinal detachment. These problems can sometimes become severe … 20 mg/kg IV every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a single agent until weight increases to greater than 30 kg If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed: 24 hours in a refrigerator at 2°C to 8°C Imfinzi may harm an unborn baby. Discard the vial if the solution is cloudy, discolored, or visible particles are observed, Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Withhold or permanently discontinue IMFINZI depending on severity. Durvalumab (Imfinzi) has been designed to attach to a receptor called PD-1. Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. The amount of durvalumab that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies. c When IMFINZI is administered in combination with chemotherapy, refer also to the Product Information for etoposide, and carboplatin or cisplatin, and to Section 5.1 … The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies ]. and an additional open-label, single-arm trial that enrolled 444 patients with metastatic NSCLC, an indication for which IMFINZI is not approved. Exposure to durvalumab increases more than dose-proportionally at doses less than 3 mg/kg (0.3 times the approved dosage), but increases in a dose-proportional manner at doses Various grades of visual impairment to include blindness can occur. Imfinzi is used to treat non-small cell lung cancer in patients whose tumors cannot be removed by surgery, and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; SJS=Stevens Johnson Syndrome; TEN=toxic epidermal necrolysis; DRESS=Drug Rash with Eosinophilia and Systemic Symptoms; N/A=not applicable. See Dosing and Administration for specific details. You will most likely receive this treatment in an outpatient clinic or hospital once every 3 or 6 weeks. ‡If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.