IMFINZI is administered as an intravenous infusion over 60 minutes. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. A healthcare provider will give you this injection. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. 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. severe and fatal immune-mediated reactions. This medicine must be given slowly and the infusion can take about 1 hour to complete. Institute medical management promptly, including specialty consultation as appropriate. This results in the weakening of the immune system. Important immune-mediated adverse reactions listed under Warnings and Precautions may not. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)]. IMFINZI can cause immune-mediated hepatitis. IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. IMFINZI is administered as an intravenous infusion over 60 minutes. IMFINZI can cause severe or life-threatening infusion-related reactions. 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. Usual Adult Dose for Small Cell Lung Cancer: 30 kg or less: 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. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks. IMFINZI can cause primary or secondary adrenal insufficiency. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. — Administer Imfinzi through an IV line containing a sterile, low-protein binding 0.2 or 0.22 Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. 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. IMFINZI can cause immune-mediated rash or dermatitis. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. IMFINZI is administered as an intravenous infusion over 60 minutes. 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. Recommended Dosages of IMFINZI IMFINZI contains durvalumab as the active substance and is administered as an intravenous infusion. Written by Cerner Multum. Imfinzi may harm an unborn baby. You should not use Imfinzi if you are allergic to durvalumab. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Do not shake the solution. Prescribing Information has additional information for dosage modification and management specific to adverse reactions. 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 This product information is intended for US Healthcare Professionals only. 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. IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. : Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some side effects may occur during the injection. 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. Tell your doctor about all your current medicines and any medicine you start or stop using. The information in this site is for US health care professionals only. 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. 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. [6] 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. Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. 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). ©2020 AstraZeneca. : Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. 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. Various grades of visual impairment to include blindness can occur. US-13205; US-21853; US-26031; US-29294; US-33316; US-37286; US-42398; US-46844 Last Updated 12/20. and an additional open-label, single-arm trial that enrolled 444 patients with metastatic NSCLC, an indication for which IMFINZI is not approved. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. 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%). If uveitis occurs in combination with other. †Based on the modeling of pharmacokinetic data and exposure relationships for safety in patients weighing >30 kg with UC or NSCLC. 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. : Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. 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 Table 1. *Refer to Prescribing Information for information on dosage modifications. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. 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. Imfinzi is administered as an intravenous infusion over 60 minutes. Call your doctor for instructions if you miss an appointment for your Imfinzi injection. The data also reflect exposure to Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. 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 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. 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 could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Withhold or permanently discontinue IMFINZI depending on severity. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Tell your doctor if you become pregnant. You may report side effects related to AstraZeneca products by clicking here. 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. 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. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. How Durvalumab Is Given Durvalumab is administered as an IV once every two weeks. 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. References: 1. Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Durvalumab is known as a checkpoint inhibitor drug. Brand Name: Imfinzi. 2.1 If an eligible dose is not rounded down, clinical rationale is required. Administer infusion solution immediately once prepared. • The recommended dose of Imfinzi is 10 mg/kg administered as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). You may report side effects to FDA at 1-800-FDA-1088. In these trials, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. 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. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. 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. A healthcare provider will give you this injection. 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†.