durvalumab package insert 2020
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Ó=°Z&¡edþ0? Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Median OS was 47.5 months with IMFINZI (95% CI, 38.4-52.6) vs 29.1 months with placebo (95% CI, 22.1-35.1). NCCN Drugs & Biologics Compendium ®. Accessed November 2020. Durvalumab after chemoradiotherapy in stage III NSCLC: 4-year survival update from the phase 3 PACIFIC trial. All rights reserved. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. 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. Important Safety Information . Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture. Drugdex Drug Evaluations. Faivre-Finn C, Vicente D, Kurata T, et al. NCCN Drugs & Biologics Compendium ® Durvalumab 2019. Institute medical management promptly, including specialty consultation as appropriate. Gray JE, Villegas AE, Daniel DB, et al. IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. The VENTANA PD-L1 (SP263) assay is an FDA-approved complementary diagnostic IHC test PD-L1 status in patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with IMFINZI⢠(durvalumab). 3. Merck & Co., Inc.; 2020. Imfinzi [package insert]. 3. WHO Pharmaceuticals Newsletter No. 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). : IMFINZI can cause primary or secondary adrenal insufficiency. Reduction in risk of progression or death vs placebo was 48% (HR=0.52; 95% CI, 0.42-0.65). 5. Various grades of visual impairment to include blindness can occur. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Faivre-Finn C, Vicente D, Kurata T, et al. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Impact of Baseline Steroids on Efficacy of Programmed Cell Death-1 and Programmed Death-Ligand 1 Blockade in ⦠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. 3. (2020, June). Imfinzi⢠(durvalumab) [package insert]. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. 2018;379(24):2342-2350. 6. 12. Updated November 10, 2020. 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. 1. NSCLC=non-small cell lung cancer; CRT=chemoradiotherapy; OS=overall survival; PFS=progression-free survival; CI=confidence interval; HR=hazard ratio; NR=not reached; RECIST=Response Evaluation Criteria in Solid Tumors; BICR=blinded independent central review. 2. IMFINZI can cause primary or secondary adrenal insufficiency. Imfinzi [package insert]. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Imfinzi [package insert]. 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%). You may report side effects related to AstraZeneca products by clicking here. MICROMEDEX Healthcare Series. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. Dosage and Administration (2) 5/2020 Warnings and Precautions, Venous Thromboembolic Events (5.4) 5/2020 INDICATIONS AND USAGE -----Lynparza is a poly (ADP-ribose) polymerase ⦠Retrieved January 7, 2020 ⦠Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2020. IMFINZI ® (durvalumab) is administered as a 60-minute IV infusion with ⦠Initiate treatment with insulin as clinically indicated. 4. Safety and Efficacy of Durvalumab ⦠Antonia SJ, Villegas A, Daniel D, et al. IMFINZI® (durvalumab) [Prescribing Information]. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. N Engl J Med. Accessed November 20, 2020. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. IMFINZI can cause immune-mediated pneumonitis. 3 full prescribing information warning: esas increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible. Progression-Free Survival. Wilmington, DE; AstraZeneca Pharmaceuticals LP; June 2020. 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. 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%). ©2020, Magellan Rx Management VII. *The post-hoc 4-year OS analysis was conducted at ~4 years after randomization and was not powered to show statistical significance. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of ⦠2. Some cases can be associated with retinal detachment. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. 55. Package Insert. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. 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. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. ... Package Leaflets (PL) for durvalumab ⦠Lancet Oncol. For adult patients with unresectable Stage III non-small cell lung cancer, Median OS†: Not reached vs 28.7 months for placebo (P=0.0025), Median PFS‡: 16.8 vs 5.6 months for placebo (P<0.0001). Grade 3. : Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Dosing exceeds single dose limit of Imfinzi (durvalumab) 10mg/kg or maximum duration of 12 months for NSCLC consolidation therapy. Durvalumab. See Dosing and Administration for specific details. Indications not supported by CMS recognized compendia or acceptable peer reviewed literature. Accessed February 2020. Safety and Efficacy of Durvalumab ⦠Institute medical management promptly, including specialty consultation as appropriate. 5. 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. Withhold or permanently discontinue IMFINZI depending on severity. IV. See Dosing and Administration for specific details. Massard C, Gordon MS, Sharma S, et al. Uveitis, iritis, and other ocular inflammatory toxicities can occur. References 1. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. N Engl J Med. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms. 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. National Comprehensive Cancer Network. Imfinzi [package insert]. 20. 1. : Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. Important immune-mediated adverse reactions listed under Warnings â¦
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§~«èçzA-ix)0gÁ8[ÅZQ87KQ¡oî»°³ëSÌì¦Üá8sÐÅîåÐä°? 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. IMFINZI can cause immune-mediated hepatitis. : Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Package Insert Massard C, Gordon MS, Sharma S, et al. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. ?.`¼mNKQÐ]ÔAÄaº¨³Ô(x$³$Ö¿I çªá¦1Üb¨JrG¥4¶i$d«è:"å±íåק½ÙWXE6ÛOw¸CÓÃãU
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DLFû3¨BcÌÜr9týÐdìîõÆã\ãÀÀå tR*Dóä²"øø^ i+f±¸+ûåÕ¼®½õ¸2@)¼ôHgËÕ&7[¼Yß^ Data on file, US-30714, AstraZeneca Pharmaceuticals LP. 4. References 1. OS rates with IMFINZI vs placebo were: 83% (95% CI, 79.4-86.2) vs 75% (95% CI, 68.5-79.7) at 12 months, 66% (95% CI, 61.8-70.4) vs 55% (95% CI, 48.6-61.4) at 24 months, 57% (95% CI, 52.3-61.4) vs 44% (95% CI, 37.0-49.9) at 36 months, and 50% vs 36% at 48 months.4,5, †The primary 2-year OS analysis was conducted after 299 deaths for 42% maturity (61% of targeted events) with a median follow-up of 25.2 months. 1. Poster presented at: 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Initiate treatment with insulin as clinically indicated. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Antonia SJ, Villegas A, Daniel D, et al. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. 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. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. Safety and Efficacy of Durvalumab ⦠Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with ⦠Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Dr. Holle and Ms. Moran have disclosed that they have no actual or potential conflict of interest in relation to this program. Eckardt JR, von Pawel J, Pujol JL, et al. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. Accessed November 2020. Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI (durvalumab) ⦠See Dosing and Administration for specific details. Advise pregnant women of the potential risk to a fetus. IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. 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. Wilmington, DE; AstraZeneca Pharmaceuticals LP; August 2019. Reduction in the risk of death vs placebo was 32% (95% CI, 0.53-0.87). 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. ©2020, Magellan Rx Management VII. In unresectable Stage III NSCLC following chemoradiotherapy. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. The CISPIAN trial was a randomized, open-label, multi-center, global, Phase III trial in the 1st-line treatment of patients with extensive-stage small-cell lung cancer (SCLC) and compared durvalumab in combination with etoposide and either cisplatin or carboplatin chemotherapy, or durvalumab⦠2. 2017;377(20):1919-1929. ©2020, Magellan Rx Management VI. This product information is intended for US Healthcare Professionals only. (2019). Please see complete Prescribing Information, including Medication Guide. 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. There are no contraindications for IMFINZI® (durvalumab). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. The primary PFS analysis was conducted after 371 events (81% of targeted 458 events) with a median follow-up of 14.5 months. References: 1. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020⦠IMFINZI can cause immune-mediated rash or dermatitis.