Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. A healthcare provider will give you this injection. Initiate treatment with insulin as clinically indicated. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Greater than 30 kg: Last updated on Feb 25, 2021. Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. : Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. IMFINZI can cause immune-mediated pneumonitis. Table 1. [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). IMFINZI can cause immune-mediated rash or dermatitis. 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. 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. Initiate treatment with insulin as clinically indicated. References: 1. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Do not shake the solution. IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 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. 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 safety and effectiveness of IMFINZI have not been established in pediatric patients. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Follow your doctor's instructions about any restrictions on food, beverages, or activity. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms. Advise pregnant women of the potential risk to a fetus. Various grades of visual impairment to include blindness can occur. 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. IMFINZI can cause immune-mediated nephritis. Tell your doctor about all your current medicines and any medicine you start or stop using. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. 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). Monitor patients for hyperglycemia or other signs and symptoms of diabetes. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)]. If uveitis occurs in combination with other. Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. This administration takes about 60 minutes per session, and these sessions occur every two to four weeks. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Grade 3. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. 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. Mix diluted solution by gentle inversion. 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. For previously treated Administer infusion solution immediately once prepared. The data also reflect exposure to Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. 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. 2.1 If an eligible dose is not rounded down, clinical rationale is required. Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving IMFINZI. IMFINZI is a medicine that may treat certain cancers by working with your immune system. How Durvalumab Is Given Durvalumab is administered as an IV once every two weeks. This results in the weakening of the immune system. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. IMFINZI can cause immune-mediated hepatitis. 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. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Confirmed objective response rate (ORR) as assessed by blinded independent … Imfinzi is available in 120mg and 500mg vials. Call your doctor for medical advice about side effects. *Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. ‡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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.1)]. Administer corticosteroids for Grade 2 or greater colitis or diarrhea. There are no data on the use of IMFINZI in pregnant women. ©2020 AstraZeneca. severe and fatal immune-mediated reactions. 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%). 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. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. 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). 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). Table 1. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. IMFINZI is administered as an intravenous infusion over 60 minutes . Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The steady state AUC is 6% higher, the Ctrough is 19% lower, and Cmax is 55% higher in those who received 1500 mg Q4W compared to those who received 10 mg/kg Q2W.1. 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. You are about to enter the IMFINZI.com site for healthcare professionals. IMFINZI contains durvalumab as the active substance and is administered as an intravenous infusion. 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. Available for Android and iOS devices. Your health care provider will give you this medicine. The information in this site is for US health care professionals only. 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). 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. 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 This product information is intended for US Healthcare Professionals only. Imfinzi (durvalumab) is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body. All rights reserved. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies ]. IMFINZI is administered as an intravenous infusion over 60 minutes. Monitor for signs and symptoms of infusion-related reactions. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Please see complete Prescribing Information, including Medication Guide. IMFINZI® (durvalumab) [Prescribing Information]. You will most likely receive this treatment in an outpatient clinic or hospital once every 3 or 6 weeks. 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 Usual Adult Dose for Small Cell Lung Cancer: 30 kg or less: Durvalumab[4] (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Alecensa, methotrexate, Keytruda, Avastin, pembrolizumab, cisplatin, nivolumab, Opdivo, Tagrisso, etoposide. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. (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. See Dosing and Administration for specific details. 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) 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 †Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. 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. Important immune-mediated adverse reactions listed under Warnings and Precautions may not. Grade 3. : Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. 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. Among the 1889 patients, 38% were exposed for 6 months or more and 18% were exposed for 12 months or more. 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%). Call your doctor for instructions if you miss an appointment for your Imfinzi injection. Durvalumab (Imfinzi) has been designed to attach to a receptor called PD-1. Version: 5.01. You may report side effects related to AstraZeneca products by clicking here. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. 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. IMFINZI is administered as an intravenous infusion over 60 minutes. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. 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. Generic Name: durvalumab (dur VAL ue mab) Imfinzi is administered via IV in the hospital and does not come in a pill form. 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. This medicine must be given slowly and the infusion can take about 1 hour to complete. †Based on the modeling of pharmacokinetic data and exposure relationships for safety in patients weighing >30 kg with UC or NSCLC. 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 … 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. Uveitis, iritis, and other ocular inflammatory toxicities can occur. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Medically reviewed by Judith Stewart, BPharm. You may report side effects to FDA at 1-800-FDA-1088. 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 … 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. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. IMFINZI can cause severe or life-threatening infusion-related reactions. Some cases can be associated with retinal detachment. 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. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. A healthcare provider will give you this injection. 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. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). 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. Brand Name: Imfinzi. cold symptoms such as stuffy nose, sneezing, sore throat; This is not a complete list of side effects and others may occur. 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 IMFINZI can cause primary or secondary adrenal insufficiency. : Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. 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. Imfinzi works by causing your immune system to attack tumor cells. Durvalumab is known as a checkpoint inhibitor drug. 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. Pembrolizumab (brand name: Keytruda) is a cancer medicine administered by a slow intravenous (IV) infusion into your vein, usually over a period of at least 30 minutes. Withhold or permanently discontinue IMFINZI depending on severity. 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 There are no contraindications for IMFINZI® (durvalumab). A healthcare provider will give you this injection. Across all studies, IMFINZI was administered at a dose of 10 mg/kg intravenously 1 Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The recommended dosefor IMFINZI monotherapyandIMFINZI in combination with chemotherapy ispresented in Table 1.IMFINZI is administered as an intravenous infusion over 1 hour. Initial Criteria (approved up to 6 months, subject to formulary changes): No dose reductions of IMFINZI are recommended. Durvalumab may cause your immune system to attack healthy organs and tissues in your body. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. [6] See Dosing and Administration for specific details. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Various grades of visual impairment to include blindness can occur. Copyright 1996-2021 Cerner Multum, Inc. 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. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. 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. Written by Cerner Multum. Durvalumab is administered intravenously. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions. These problems can sometimes become severe … 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. 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. : Uveitis, iritis, and other ocular inflammatory toxicities can occur. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. Institute medical management promptly, including specialty consultation as appropriate. 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. IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. 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†. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks. Do not breastfeed while using Imfinzi, and for at least 3 months after your last dose. See Dosing and Administration for specific details. This medicine must be given slowly and the infusion can take about 1 hour to complete. • The recommended dose of Imfinzi is 10 mg/kg administered as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity. : Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 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 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. Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Your doctor will determine your exact dosage and schedule. 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. Withhold or permanently discontinue IMFINZI depending on severity. Prescribing Information has additional information for dosage modification and management specific to adverse reactions. Some cases can be associated with retinal detachment. IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. and an additional open-label, single-arm trial that enrolled 444 patients with metastatic NSCLC, an indication for which IMFINZI is not approved.
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