Dosage Modifications for Adverse Reactions . Do not shake the solution. The product's dosage form is injection, solution and is administered via intravenous form. 1. While immune-mediated reactions usually manifest during treatment with IMFINZI, immune-mediated adverse reactions can also manifest after discontinuation of IMFINZI.For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. Durvalumab is used to treat a certain type of bladder and urinary tract cancer. The study population characteristics were: median age of 64 years (range: 23 to 90); 70% male; 69% White and 27% Asian; 16% current smokers, 75% former smokers and 9% never smokers; 51% WHO performance status of 1; 53% with Stage IIIA and 45% were Stage IIIB; 46% with squamous and 54% with non-squamous histology. Date of License: May-01-2017 . If you think you may have a medical emergency, please call your doctor or 911 immediately. •Embryo-Fetal Toxicity: Advise females of reproductive potential that IMFINZI can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1, 8.3)].Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of IMFINZI [see Use in Specific Populations (8.3)]. The information in this website is intended for healthcare providers and consumers in the United States. Imfinzi® (durvalumab) (Intravenous) -E- Document Number: IC-0490 Last Review Date: 01/ 05/2021 Date of Origin: 08/05/2019 Dates Reviewed: 08/2019, 10/2019, 01/2020, 04/2020, 07/2020, 10/2020, 01/2021 I. 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. IMFINZI was discontinued in 0.3% of the 1889 patients. Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. •a type of lung cancer called non-small cell lung cancer (NSCLC). 5.7 Other Immune-Mediated Adverse Reactions. IMFINZI® (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer Details Category: Antibodies Published on Tuesday, 23 July 2019 09:52 Hits: 1144 IMFINZI is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy. The efficacy of IMFINZI was evaluated in the urothelial carcinoma cohort of Study 1108 (NCT01693562), a multicenter, multi-cohort, open-label clinical trial. Imfinzi (durvalumab) BL 761069. 2.3. OS data were not mature at the time of the interim PFS analysis. QUALITATIVE AND QUANTITATIVE … The major efficacy outcome measures were progression-free survival (PFS) as assessed by a BICR RECIST 1.1 and overall survival (OS). Adverse Reactions in ≥ 10% of Patients in Study 1108 Urothelial Carcinoma CohortIMFINZIN=182Adverse ReactionAll Grades(%)Grades 3 – 4(%)Gastrointestinal DisordersConstipation211Nausea162Abdominal painIncludes abdominal pain upper, abdominal pain lower and flank pain143Diarrhea/Colitis131General Disorders and AdministrationFatigueIncludes asthenia, lethargy, and malaise396Peripheral edemaIncludes edema, localized edema, edema peripheral, lymphedema, peripheral swelling, scrotal edema, and scrotal swelling152Pyrexia/Tumor associated fever141InfectionsUrinary tract infectionIncludes cystitis, candiduria and urosepsis154Metabolism and Nutrition DisordersDecreased appetite/Hypophagia191Musculoskeletal and Connective Tissue DisordersMusculoskeletal painIncludes back pain, musculoskeletal chest pain, musculoskeletal pain and discomfort, myalgia, and neck pain244Respiratory, Thoracic, and Mediastinal DisordersDyspnea/Exertional Dyspnea132Cough/Productive Cough100Skin and Subcutaneous Tissue DisordersRashIncludes dermatitis, dermatitis acneiform, dermatitis psoriasiform, psoriasis, rash maculo-papular, rash pruritic, rash papular, rash pustular, skin toxicity, eczema, erythema, erythema multiforme, rash erythematous, acne, and lichen planus111Table 3. The generic name of Imfinzi is durvalumab. Tumor assessments were performed at Weeks 6, 12 and 16, then every 8 weeks for the first year and every 12 weeks thereafter. In clinical studies enrolling 1889 patients who received IMFINZI, type 1 diabetes mellitus occurred in < 0.1 % of patients. Systemic corticosteroids were required in 21% of patients, with 12% requiring high-dose corticosteroids and 0.1% requiring infliximab. •Infection: Advise patients to contact their healthcare provider immediately for infection [see Warnings and Precautions (5.8)]. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Interrupt or permanently discontinue IMFINZI, based on the severity of the reaction [see Dosage and Administration (2.3)]. It is also used to treat lung cancer. Risk SummaryThere is no information regarding the presence of durvalumab in human milk, the effects on the breastfed infant, or the effects on milk production. The carcinogenic and genotoxic potential of durvalumab have not been evaluated.Animal fertility studies have not been conducted with durvalumab. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Non-Proprietary Name: Durvalumab What is the Non-Proprietary Name?The non-proprietary name is sometimes called the generic name. Interrupt or permanently discontinue IMFINZI based on the severity [see Dosage and Administration (2.3)].In clinical studies enrolling 1889 patients with various cancers who received IMFINZI [see Adverse Reactions (6.1)], hepatitis occurred in 12% of patients, including Grade 3 (4.4%), Grade 4 (0.4%) and Grade 5 (0.2%) immune-mediated hepatitis. This medicinal product is subject to additional monitoring. The overall incidence of infections in IMFINZI-treated patients (56%) in the PACIFIC study was higher compared to patients in other studies (38%) in which radiation therapy was generally not administered immediately prior to initiation of IMFINZI. Sixty-six percent (66%) of patients had ECOG score of 1 and 41% of patients had a baseline creatinine clearance < 60 mL/min. In the urothelial carcinoma cohort in Study 1108 the most common Grade 3 or higher infection was urinary tract infections, which occurred in 4% of patients. Signs and symptoms of hepatitis may include: •yellowing of your skin or the whites of your eyes •severe nausea or vomiting •pain on the right side of your stomach area (abdomen) •drowsiness •dark urine (tea colored) •bleeding or bruising more easily than normal •feeling less hungry than usualIntestinal problems (colitis). The drug is approved in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide) for the indication. Interrupt or permanently discontinue IMFINZI based on the severity [see Dosage and Administration (2.3)].In clinical studies enrolling 1889 patients with various cancers who received IMFINZI [see Adverse Reactions (6.1)], nephritis (reported as any of the following increased creatinine or urea, acute kidney injury, renal failure, decreased glomerular filtration rate, tubulointerstitial nephritis, decreased creatinine clearance, glomerulonephritis, and nephritis) occurred in 6.3% of patients including Grade 3 (1.1%), Grade 4 (0.2%) and Grade 5 (0.1%) immune-mediated nephritis. The generic name usually includes the active ingredient(s) of the product. 2017 Sep 14;3(9):e172411. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described in the Warnings and Precautions section reflect exposure to IMFINZI in 1889 patients from the PACIFIC study (a randomized, placebo-controlled study that enrolled 475 patients with Stage III NSCLC), Study 1108 (an open-label, single-arm, multicohort study that enrolled 191 patients with urothelial carcinoma and 779 patients with various other solid tumors), and an additional open-label, single-arm trial that enrolled 444 patients with metastatic lung cancer, an indication for which durvalumab is not approved. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. O departamento de Informações Médicas da AstraZeneca pode enviar publicações de estudos clínicos pivotais na íntegra. The overall response rate in patients 65 years or older was 15% (17/112) and was 12% (4/34) in patients 75 years or older. Fatal cases have occurred. A total of 475 patients received IMFINZI 10 mg/kg intravenously every 2 weeks. Each mL contains durvalumab, 50 mg, L-histidine (2 mg), L-histidine hydrochloride monohydrate (2.7 mg), α,α-trehalose dihydrate (104 mg), Polysorbate 80 (0.2 mg), and Water for Injection, USP. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). •Discard partially used or empty vials of IMFINZI.Storage of Infusion Solution •IMFINZI does not contain a preservative. Of the 182 patients treated with IMFINZI in patients with urothelial carcinoma, 112 patients were 65 years or older and 34 patients were 75 years or older. •Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Withhold or discontinue IMFINZI to manage adverse reactions as The major efficacy outcome measures were confirmed Overall Response Rate (ORR) according to RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), and duration of response (DoR).The median age was 67 years (range: 34 to 88), 72% were male, 64% were White. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Powles T, O'Donnell PH, Massard C, et al. These problems can sometimes become serious or life-threatening and can lead to death.Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:Lung problems (pneumonitis). •Administer infusion solution immediately once prepared. IMFINZI was discontinued for adverse reactions in 3.3% of patients. On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or … Discard unused portion.Store at 2° to 8°C (36° to 46°F).Do not freeze or shake.Keep vial in original carton to protect from light.Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.Do not use if vial seal is broken or missing.Must dilute before use.See prescribing information.AstraZeneca. Based on its mechanism of action, fetal exposure to durvalumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in PD-1 knockout mice. You can ask your healthcare provider for information about IMFINZI that is written for health professionals.What are the ingredients in IMFINZI?Active ingredient: durvalumabInactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection, USP.Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850By: AstraZeneca UK Limited1 Francis Crick Ave.Cambridge, England CB2 0AAUS License No. •Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis [see Warnings and Precautions (5.4)]. Pneumonitis resolved in 47% of patients experiencing pneumonitis. Preparation •Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Start Marketing Date: 05-01-2017 What is the Start Marketing Date?This is the date that the labeler indicates was the start of its marketing of the drug product. Data presented at ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation for IMFINZI in locally-advanced, unresectable lung cancer. 5.6 Immune-Mediated Dermatologic Reactions. Urothelial CarcinomaThe safety data described in Table 2 reflect exposure to IMFINZI in 182 patients with locally advanced or metastatic urothelial carcinoma in the urothelial carcinoma cohort of Study 1108 whose disease has progressed during or after one standard platinum-based regimen. 2 vials. By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production.Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Durvalumab was detected in infant serum on postpartum Day 1, indicating the presence of placental transfer of durvalumab. If uveitis occurs in combination with other immune-mediated adverse reactions, evaluate for Vogt-Koyanagi-Harada syndrome, which has been observed with other products in this class and may require treatment with systemic steroids to reduce the risk of permanent vision loss.The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in 1889 patients who received IMFINZI: aseptic meningitis, hemolytic anemia, immune thrombocytopenic purpura, myocarditis, myositis, and ocular inflammatory toxicity, including uveitis and keratitis [see Adverse Reactions (6.1)].
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