Building Relationships: When your patient enrolls in Lighthouse, he or she is matched with their own Nurse Advocate. Imfinzi is used specifically when the tumour produces a protein known as PD-L1. The goal of Lighthouse is to ensure that they are coming to you and telling you what you need to know at the first sign of an issue. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Access 360™ provides: To learn more about the AstraZeneca Access 360™ program, please call 1-844-ASK-A360 (1-844-275-2360) Monday to Friday, 8 AM-8 PM ET, or visit www.MyAccess360.com. The clinical response rate of evaluable patients will be reported along with a 95% confidence interval. The AstraZeneca Access 360™ program provides personal support to connect patients to affordability programs and streamline access and reimbursement for IMFINZI. Advise pregnant women of the potential risk to a fetus. Health Plan Dependent Enrollment Form 2020. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in, In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (=20%) were nausea, fatigue/asthenia, and alopecia. IMFINZI (durvalumab) Imfinzi FEP Clinical Criteria 2. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective in NSCLC with activating mutation in the EGFR. 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. If a patient mentions something that sounds like an immune-mediated adverse event (imAE), the Advocate will take note, follow up, and if necessary, direct the patient to either you or the emergency room so that appropriate action can be taken. ECOG performance status less than or equal to 2. white blood cell (WBC) count greater than or equal to 3 (SqrRoot) 10^9/L. Researchers also tracked the time it took for a patient to die after chemo and radiation. Adults age 18 and older who had EGFR-mutated non-small-cell lung carcinoma (NSCLC) that was treated and now transformed to SCLC or another neuroendocrine tumor. an ALT level less than or equal to 2.5 (SqrRoot) ULN, (less than or equal to 5X ULN if liver metastasis). Lowell Student Scholarship Information Packet . 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. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. However, patients with long-standing (>5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/microliters) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions. For your convenience, there are 3 ways to complete a Prior Authorization request: ), or patients with congenital long QT syndrome. ClinicalTrials.gov Identifier: NCT04538378, Interventional Several phase III trials showed durable response with poly (ADP-ribose) polymerase (PARP) inhibitors in the breast and ovarian cancer with BRCA mutation, a tumor suppressor gene involving homologous recombination repair (HRR) pathway, and several PARP inhibitors are now FDA approved for these cancers. Then they will be contacted every 6 months for the rest of their life.... -To assess the efficacy of a combination of durvalumab and olaparib with respect to best overall response (BOR) according to Response Evaluation Criteria (RECIST 1.1) in patients with EGFR-mutated non-small-cell lung carcinoma (NSCLC) that transform to SCLC and other neuroendocrine carcinomas. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Subjects should have received platinum-based chemotherapy with or without immunotherapy for small cell/neuroendocrine transformation or refused such therapy. Note: local surgery of isolated lesions for palliative intent is acceptable. 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. Subjects must be able to understand and willing to sign a written informed consent document, Patients who are receiving any other investigational agents. Participants will take the study drugs until their disease gets worse or they have unacceptable 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. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Participants will be screened under a separate protocol. EST or visit www.MyAccess360.com. Uveitis, iritis, and other ocular inflammatory toxicities can occur. The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%). Treatment will continue until disease progression or unacceptable toxicity. Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4. To see if the combination of durvalumab and olaparib will cause tumors to shrink. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Palliative radiation within 24 hours prior to enrollment. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. NO disease progression or unacceptable toxicities Prior - Approval Renewal Limits Duration 12 months NO renewal for Non-small cell lung cancer (NSCLC) The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). You have reached the maximum number of saved studies (100). At its core, Lighthouse is all about creating a supportive relationship between a patient and their Advocate, so it’s important for the two of them to be in contact on a regular basis. A type of white blood cell called T-cellsthat play an important role in the normal function of the immune system are activated and can attack and destroy cancer cells. Imfinzi (durvalumab) is a medication used for the treatment of locally advanced or metastatic urothelial carcinoma (bladder cancer) and unresectable, stage III non-small cell lung cancer (NSCLC). 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. Meningococcal Vaccination Information and Waiver. (Clinical Trial), Phase II Trial of Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors, 18 Years and older (Adult, Older Adult), National Institutes of Health Clinical Center, Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937. IMFINZI® (durvalumab) can be ordered from authorized specialty pharmacy providers (SPPs) who also provide support to help patients with their prescribed IMFINZI® (durvalumab) treatment, View additional video resources on Student Change of Address Form. IMFINZI 1500 mg, and investigator’s choice of carboplatin (AUC 5 or 6 mg/mL/min) or cisplatin (75-80 mg/m2) on Day 1 and etoposide (80-100 mg/m2) intravenously on Days 1, 2, and 3 of each 21-day cycle for 4 cycles, followed by IMFINZI 1500 mg every 4 weeks until … Imfinzi Prices. After winning Priority Review from the US regulator in December 2019, Imfinzi (durvalumab) has now been… AstraZeneca Biotechnology Focus On Imfinzi Immuno-oncology Regulation Roche Switzerland Tecentriq UK US FDA They will take olaparib by mouth twice every day. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Encourage your patients to receive support through Lighthouse. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Hgb greater than or equal to 9 g/ dL if no blood transfusion within 4 weeks prior to enrollment OR >10 g/dL if no blood transfusion within 2 weeks prior to enrollment. You are about to enter the IMFINZI.com site for healthcare professionals. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions. c Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc. ... and up to savings percentages are based on all discounted prescriptions that were run through the WellRx program in 2020. 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. Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Choosing to participate in a study is an important personal decision. Although most patients achieve robust responses to EGFR TKIs with tumor shrinkage and symptomatic relief, drug resistance eventually develops in the majority of patients. Please see complete Prescribing Information, including Medication Guide. They may have a tumor biopsy. Systemic anti-cancer treatment or major surgery within 2 weeks prior to enrollment. Patients can contact their Advocates for emotional support, help with setting goals and reminders, or to simply talk about how they are feeling. For questions or . The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The active substance of Imfinzi is durvalumab, an antineoplastic monoclonal antibody (ATC code: L01XC28) that potentiates T-cell response, including anti-tumour response, through blockade of PD -L1 binding to PD-1. Estimated Enrollment : 14 participants: Allocation: N/A: Intervention Model: Single Group Assignment: Masking: None (Open Label) Primary Purpose: Treatment: Official Title: Phase II Trial of Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. This product information is intended for US Healthcare Professionals only. 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. Standalone PHS Inclusion Enrollment Report forms are no longer used. 3 Stratified by sex, age, and smoking history. 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. Patients with symptomatic brain metastases will be excluded from trial secondary to poor prognosis. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab and olaparib, breastfeeding should be discontinued if the mother is treated with study drugs. Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. am – 8 . Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. 2020/2021 Patient Enrollment Form *Required *SELECT ONE: Enrollment Update Information Only Please read the full Prescribing Information and Medication Guide for STELARA®, and discuss any questions you have with your doctor. Individual Income Tax Return 2020 12/10/2020 Form 1040 (PR) Federal Self-Employment Contribution Statement for Residents of Puerto Rico 2020 02/09/2021 Form 1040 (PR) (Schedule H) Household Employment Tax (Puerto Rico Version) 2020 01/15/2021 These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Find the best IMFINZI prices near you now with our cost comparison tool and start saving today. ... form goes here. Small cell lung cancer (SCLC) transformation has been reported as one of the mechanisms of acquired resistance to EGFR TKIs. IMFINZI can cause immune-mediated rash or dermatitis. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Lighthouse support for your patients includes: To better understand how Lighthouse can help support your patients, download the 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. Best overall response [ Time Frame: Disease progression ], Progression-free survival (PFS) [ Time Frame: Disease progression ], Safety and tolerability of a combination [ Time Frame: Treatment phase ], Overall survival (OS) [ Time Frame: Death ]. EGFR-mutated transformed SCLC is an aggressive cancer whose clinical course is similar to that of SCLC. Subjects with initial diagnosis of EGFR-mutated non-small-cell lung carcinoma (NSCLC) and histologically or cytologically confirmed transformation to small cell/neuroendocrine tumors following treatment with EGFR tyrosine kinase inhibitor. Uncontrolled intercurrent illness or medical condition including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring medications ((except chronic atrial fibrillation/flutter with controlled vascular rate), or psychiatric illness/social situations that may impair the patient s tolerance of study treatments and, in the judgment of the investigator, would make the patient inappropriate for the study. Supporting and empowering patients to take ownership of their treatment with IMFINZI® (durvalumab). There are no contraindications for IMFINZI® (durvalumab). Please remove one or more studies before adding more. Initiate treatment with insulin as clinically indicated. The cost for Imfinzi intravenous solution (50 mg/mL) is around $942 for a supply of … Given what is known so far from PACIFIC, analysts estimate that Imfinzi has probably produced a PFS benefit of at least six months, which Deutsche Bank analysts reckon should translate into an initial commercial opportunity of >$1.75bn. Pregnant women are excluded from this study because olaparib is a PARP inhibitor agent with the potential for teratogenic or abortifacient effects. When it binds to its receptors (called PD-1) found on T-cells, the normal function of T-cells is altered, and they fail to kill cancer cells. IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed. For this product the estimated delivery time is usually between 12 and 20 working days. IF REQUESTING A REFERRAL TO THE MERCK PATIENT ASSISTANCE PROGRAM, PLEASE INCLUDE A … 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. Postmenopausal is defined as: amenorrheic for 1 year or more following cessation of exogenous hormonal treatments; luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post- menopausal range for women under 50, radiation-induced oophorectomy with last menses >1 year ago; chemotherapy-induced menopause with more than one-year interval since last menses; surgical sterilization (bilateral oophorectomy or hysterectomy). IMFINZI (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: Have disease progression during or following platinum-containing chemotherapy Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Patients must have measurable disease per RECIST 1.1. 2 Among the ITT population, 7% in the IMFINZI arm and 10% in the placebo arm had non-measurable disease as assessed by BICR according to RECIST v1.1. About 30 days after they stop taking the study drugs, participants will have a follow-up visit. Detailed summary reports of your patients’ experiences are kept by the Advocate and can be provided to you at your patients’ request. Imfinzi improves overall survival at interim analysis in the Phase III CASPIAN trial in 1st-line extensive-stage small cell lung cancer. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Targeted therapies designed for specific genetic alterations, known as cancer driver mutations, have changed the treatment paradigm in advanced non-small cell lung carcinoma (NSCLC). But they add that there is also potential for further upside. assistance, please call Access 360, Monday through Friday, 8 . Imfinzi contains the active substance durvalumab. There are no standard treatments for this disease and prospective studies have not been conducted to date. Patients will be assessed for toxicity by reporting the grades of toxicity and the type of toxicity observed for all patients. They support your patients by tracking any changes that may occur during treatment and after treatment ends, so that patients can focus more on the things they enjoy. IMFINZI™ (durvalumab, ... Urothelial bladder cancers arise from the epithelium of the bladder and are the sixth most common form of cancer in the US. Inclusion Enrollment Report. See Dosing and Administration for specific details. The trial compared the use of Imfinzi with active surveillance of the disease, whose acronym is NSCLC. However, patients who have had treatment for their brain metastasis and whose brain disease is stable without steroid therapy for 2 weeks may be enrolled. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Instead, data collection for up to 20 Inclusion Enrollment Reports has been folded into each Study Record. 5 Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O’Brien Fleming boundary) for interim analysis Monitor for signs and symptoms of infusion-related reactions. Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. Talk with your doctor and family members or friends about deciding to join a study. The safety and effectiveness of IMFINZI have not been established in pediatric patients. Participants will get durvalumab on Day 1 of each 28-day cycle. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Pillars of Lighthouse. The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of screening throughout the total duration of the protocol treatment and for at least three months after the last dose of the study drug (s). Olaparib tablet will be administered at a total daily dose of 600 mg orally in two divided doses, approximately 12 hours apart. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication based on primary investigator decision. Lung cancers with EGFR mutations may develop resistance to therapies targeting this protein by evolving/being transformed into small cell or neuroendocrine cancers. Form 1040: U.S. Subjects with initial diagnosis of EGFR-mutated non-small-cell lung carcinoma (NSCLC) and histologically or cytologically confirmed transformation to small cell or neuroendocrine tumor following treatment with EGFR tyrosine kinase inhibitor. Electronic Patient Authorization Form (ePAF). Participants will have a physical exam. To get your patients started, choose the most convenient method of enrollment: For Access 360™ to best support your patient, a Patient Authorization Form (PAF) is required. Length of Authorization 1,10 • Bladder Cancer/Urothelial … Institute medical management promptly, including specialty consultation as appropriate. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), 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. Follow patients closely for evidence of transplant-related complications and intervene promptly. This announcement contains inside information . Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. at . 8 AM-8 PM However, some tumors can evade destruction by the immune system by using a strategy called the “PD-1/PD-L1 pathway.” PD-L1 is a protein frequently found on the surface of cancer cells. 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. Patients will be treated with durvalumab (1,500 mg), IV, every 28 days and olaparib (300 mg BID for total daily dose of 600 mg) in a 28-day cycles. 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 primary or secondary adrenal insufficiency. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Lighthouse empowers patients to take an active role in their treatment journey by facilitating relationships with Nurse Advocates who: Building Relationships: When your patient enrolls in Lighthouse, he or she is matched with their own Nurse Advocate. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In the case of short-term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to enrollment is 7 days. Course Registration Forms . History of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency. 1-844-ASK-A360 In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Why Should I Register and Submit Results? Uveitis, iritis, and other ocular inflammatory toxicities can occur. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Extensive-stage small cell lung cancer (SCLC) AND the following: a. How to enroll your patients in Access 360™. Persistent toxicities (greater than or equal to CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy. Some cases can be associated with retinal detachment. Patients will be evaluated for toxicity every 4 weeks by CTCAE v5.0, and for response every 8 (+/-1) weeks by RECIST 1.1. Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ): EGFR-Mutated Non-Small-Cell Lung Carcinoma. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Sometimes, cancer cells can escape discovery from specific cancer-fighting cells known as T-cells . Analyses of EGFR transformed SCLC tumors suggest that these tumors are HRR deficient. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Some cases can be associated with retinal detachment. 1-844-275-2360. Withhold or permanently discontinue IMFINZI depending on severity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.1)]. us fda approves imfinzi® (durvalumab) for unresectable stage iii non-small cell lung cancer Durvalumab (Imfinzi®) is designed to enhance your immune system’s ability to target and specifically kill cancer cells in a lung cancer patient. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. With the support of the Lighthouse Advocates and our patient resources, your patients will feel empowered to take ownership of their IMFINZI treatment experience. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) and patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HBV or HCV RNA.. HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs. Lighthouse HCP Brochure. Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Note: dihydropyridine calcium - channel blockers are permitted for management of underling disease. Various grades of visual impairment to include blindness can occur. Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving IMFINZI. They will have blood tests. They will have an electrocardiogram to evaluate their heart. Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment. Imfinzi improves overall survival at interim Thu, Jun 27, 2019 08:00 CET. IMFINZI Enrollment Form A multi-page enrollment form to capture necessary patient, provider, and prescription information to start a new request for support. Imfinzi binds to the PD-L… If uveitis occurs in combination with other, Electronic Patient Authorization Form (ePAF), Provide 24/7 personalized attention to your patients and their caregivers, Encourage your patients to keep you updated on their treatment experience so you can make better decisions for their care, Partner with your patients to help them better understand what they can expect during and after treatment with IMFINZI, Enable you and your practice to remain informed about your patients' treatment experience, Assistance with understanding patient insurance coverage and pharmacy options, Deliver disease-state education to nurses and other healthcare staff at your facility, Provide education on the early recognition and management of adverse events associated with AstraZeneca therapies, Deliver educational tools and resources designed for nurses, patients, and caregivers, 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%). Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. 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).
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