Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. 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. †Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. 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 US-13205; US-21853; US-26031; US-29294; US-33316; US-37286; US-42398; US-46844 Last Updated 12/20. Call your doctor for instructions if you miss an appointment for your Imfinzi injection. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Durvalumab[4] (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. signs of a hormonal disorder - unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, feeling cold, weight gain, or weight loss. This product information is intended for US Healthcare Professionals only. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. Important immune-mediated adverse reactions listed under Warnings and Precautions may not. IMFINZI is administered as an intravenous infusion over 60 minutes. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 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. 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. 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. Call your doctor for medical advice about side effects. 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. 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%). Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Withhold IMFINZI for Grade 2 colitis or diarrhea; permanently discontinue Prescribing Information has additional information for dosage modification and management specific to adverse reactions. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose. This results in the weakening of the immune system. Administer infusion solution immediately once prepared. IMFINZI can cause immune-mediated hepatitis. Initial Criteria (approved up to 6 months, subject to formulary changes): Brand Name: Imfinzi. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. 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. Imfinzi is available in 120mg and 500mg vials. A healthcare provider will give you this injection. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. See Dosing and Administration for specific details. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Available for Android and iOS devices. 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. Durvalumab (Imfinzi) has been designed to attach to a receptor called PD-1. ©2020 AstraZeneca. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Various grades of visual impairment to include blindness can occur. Uveitis, iritis, and other ocular inflammatory toxicities can occur. The safety and effectiveness of IMFINZI have not been established in pediatric patients. See Dosing and Administration for specific details. Tell your doctor about all your current medicines and any medicine you start or stop using. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Medically reviewed by Judith Stewart, BPharm. 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. Initiate treatment with insulin as clinically indicated. : Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. 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. 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. 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 … Last updated on Feb 25, 2021. 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. This administration takes about 60 minutes per session, and these sessions occur every two to four weeks. : Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. There are no contraindications for IMFINZI® (durvalumab). 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. Among the 1889 patients, 38% were exposed for 6 months or more and 18% were exposed for 12 months or more. In these trials, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks. *Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. 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. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Tell your doctor if you become pregnant. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Copyright 1996-2021 Cerner Multum, Inc. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Do not shake the solution. Initiate treatment with insulin as clinically indicated. Greater than 30 kg: : Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Confirmed objective response rate (ORR) as assessed by blinded independent … [6] IMFINZI can cause severe or life-threatening infusion-related reactions. 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). 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. IMFINZI can cause primary or secondary adrenal insufficiency. Various grades of visual impairment to include blindness can occur. 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 … Imfinzi is administered as an intravenous infusion over 60 minutes. : Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.1)]. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse 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%). Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. 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. cold symptoms such as stuffy nose, sneezing, sore throat; This is not a complete list of side effects and others may occur. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. All rights reserved. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. IMFINZI is a medicine that may treat certain cancers by working with your immune system. ‡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. 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. Imfinzi works by causing your immune system to attack tumor cells. — Administer Imfinzi through an IV line containing a sterile, low-protein binding 0.2 or 0.22 Do not breastfeed while using Imfinzi, and for at least 3 months after your last dose. Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. [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). This medicine must be given slowly and the infusion can take about 1 hour to complete. Written by Cerner Multum. an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. 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. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms. Dosage Modifications for Adverse Reactions No dose reduction for IMFINZI is recommended. These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Usual Adult Dose for Small Cell Lung Cancer: 30 kg or less: 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 Grade 3. : IMFINZI can cause primary or secondary adrenal insufficiency. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Imfinzi is administered via IV in the hospital and does not come in a pill form. Generic Name: durvalumab (dur VAL ue mab) You will most likely receive this treatment in an outpatient clinic or hospital once every 3 or 6 weeks. Institute medical management promptly, including specialty consultation as appropriate. 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). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Please see complete Prescribing Information, including Medication Guide. 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. The recommended dosefor IMFINZI monotherapyandIMFINZI in combination with chemotherapy ispresented in Table 1.IMFINZI is administered as an intravenous infusion over 1 hour. A healthcare provider will give you this injection. Some cases can be associated with retinal detachment. Withhold or permanently discontinue IMFINZI depending on severity. Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. If uveitis occurs in combination with other. Durvalumab is administered intravenously. See Dosing and Administration for specific details. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). 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. †Based on the modeling of pharmacokinetic data and exposure relationships for safety in patients weighing >30 kg with UC or NSCLC. 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 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. 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. Your doctor will determine your exact dosage and schedule. Table 1. 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 Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Institute medical management promptly, including specialty consultation as appropriate. These problems can sometimes become severe … Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. Administer corticosteroids for Grade 2 or greater colitis or diarrhea. *Refer to Prescribing Information for information on dosage modifications. IMFINZI is administered as an intravenous infusion over 60 minutes. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. The data also reflect exposure to For previously treated IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Table 1. The information in this site is for US health care professionals only. 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). This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. 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. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). 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. 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. 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). 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†. Imfinzi may harm an unborn baby. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)]. 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. How Durvalumab Is Given Durvalumab is administered as an IV once every two weeks. You should not use Imfinzi if you are allergic to durvalumab.