imfinzi enrollment form 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. 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%). 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. Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI. The Advocates support patients with regular check-ins as often as the patient would like and additional resources, ultimately encouraging them to take an active role in their treatment journey. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. absolute neutrophil count (ANC) greater than or equal to 1.0 (SqrRoot) 10^9/L, platelet count greater than or equal to 75 (SqrRoot) 10^9/L, and. 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. Immune checkpoint inhibitors alone are not effective for EGFR-mutated transformed SCLC. ECOG performance status less than or equal to 2. white blood cell (WBC) count greater than or equal to 3 (SqrRoot) 10^9/L. Treatment Support: Advocates partner with your patients to get a firm understanding of their personal health and concerns. For Grade, Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients. IMFINZI™ (durvalumab, ... Urothelial bladder cancers arise from the epithelium of the bladder and are the sixth most common form of cancer in the US. Transcript Request. greater than or equal to 51 mL/min/1.73 m2 for participant with creatinine levels, greater than or equal to 1.5 X institutional ULN. The most frequent serious adverse reactions (=2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Choosing to participate in a study is an important personal decision. 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 There are no standard treatments for it. Male patients must use a condom from the time of screening throughout the total duration of the protocol treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Lung cancers with EGFR mutations may develop resistance to therapies targeting this protein by evolving/being transformed into small cell or neuroendocrine cancers. Please remove one or more studies before adding more. It is given through a small plastic tube that is put in an arm vein. us fda approves imfinzi® (durvalumab) for unresectable stage iii non-small cell lung cancer The most common Grade 3 or 4 adverse reaction (=3%) was fatigue/asthenia (3.4%). Listing a study does not mean it has been evaluated by the U.S. Federal Government. By submitting this form, I am requesting to be enrolled in Janssen CarePath Savings Program for STELARA® (the 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. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. 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). How to enroll your patients in Access 360™. Subjects should have received platinum-based chemotherapy with or without immunotherapy for small cell/neuroendocrine transformation or refused such therapy. The AstraZeneca Access 360™ program provides personal support to connect patients to affordability programs and streamline access and reimbursement for IMFINZI. Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard. They will take olaparib by mouth twice every day. The clinical response rate of evaluable patients will be reported along with a 95% confidence interval. 1. History of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency. IMFINZI can cause immune-mediated hepatitis. 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 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). Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . Clinical Services Fax: 1-877-378-4727 Message: Attached is a Prior Authorization request form. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. With the support of the Lighthouse Advocates and our patient resources, your patients will feel empowered to take ownership of their IMFINZI treatment experience. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. The cost for Imfinzi intravenous solution (50 mg/mL) is around $942 for a supply of … The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%). 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. Imfinzi contains the active substance durvalumab. Researchers also tracked the time it took for a patient to die after chemo and radiation. 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). Immune checkpoint blockade appears to be most effective against hypermutated tumors, suggesting that clinical responses correlate with an increased propensity to produce neoantigens. 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. Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection. IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed. Durvalumab (Imfinzi®) is designed to enhance your immune system’s ability to target and specifically kill cancer cells in a lung cancer patient. You may report side effects related to AstraZeneca products by clicking here. 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. All rights reserved. Lighthouse HCP Brochure. Uveitis, iritis, and other ocular inflammatory toxicities can occur. Advise pregnant women of the potential risk to a fetus. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. NO disease progression or unacceptable toxicities Prior - Approval Renewal Limits Duration 12 months NO renewal for Non-small cell lung cancer (NSCLC) Researchers want to see if a new combination of drugs can help. Standalone PHS Inclusion Enrollment Report forms are no longer used. 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. Request for a Letter of Enrollment. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The PAF can be completed either by completing the Enrollment Form or online with the 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. Download IMFINZI Enrollment Forms and Resources Ensure your patients are enrolled to receive assistance and find IMFINZI coding and reimbursement materials GET STARTED The Pillars of Lighthouse. 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. Sometimes, cancer cells can escape discovery from specific cancer-fighting cells known as T-cells . This announcement contains inside information . PFS and OS will be estimated by the Kaplan-Meier method. 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. Some cases can be associated with retinal detachment. 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. There are no contraindications for IMFINZI® (durvalumab). For your convenience, there are 3 ways to complete a Prior Authorization request: 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. Box 52080 MC 139 Phoenix, AZ 85072-2080 Attn. Meningococcal Vaccination Information and Waiver. 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. Pregnant women are excluded from this study because olaparib is a PARP inhibitor agent with the potential for teratogenic or abortifacient effects. Systemic anti-cancer treatment or major surgery within 2 weeks prior to enrollment. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Patients will be evaluated for toxicity every 4 weeks by CTCAE v5.0, and for response every 8 (+/-1) weeks by RECIST 1.1. IMFINZI is clear to opalescent, colourless to slightly yellow solution. This product information is intended for US Healthcare Professionals only. Patients must have measurable disease per RECIST 1.1. 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. Adequate hematological function within 28 days prior to enrollment as defined below: Adequate hepatic function within 28 days prior to enrollment as defined by: Adequate renal function within 28 days prior to enrollment as defined by: Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl), ---< 1.5x institution upper limit of normal OR. • Visually inspect the medicinal product for particulate matter and discolouration. For questions or . The trial compared the use of Imfinzi with active surveillance of the disease, whose acronym is NSCLC. Patient Last Name Imfinzi binds to the PD-L… 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. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Health Plan Dependent Enrollment Form 2020. Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Make-up Final Exam Appeal Form. Participants will be screened under a separate protocol. 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 … Serious adverse reactions occurred in 29% of patients receiving IMFINZI. For general information, Learn About Clinical Studies. Various grades of visual impairment to include blindness can occur. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Various grades of visual impairment to include blindness can occur. To learn more about how patients will experience the Lighthouse program, Helping patients access the care they need. Note: local surgery of isolated lesions for palliative intent is acceptable. Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment. Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. pm. 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. Instead, data collection for up to 20 Inclusion Enrollment Reports has been folded into each Study Record. Lighthouse support for your patients includes: To better understand how Lighthouse can help support your patients, download the Imfinzi Prices. Empowering Patients: Patients don’t always know how or when to bring up concerns. IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. EST or visit www.MyAccess360.com. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Participants will get durvalumab on Day 1 of each 28-day cycle. 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 ]. 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 d Administer IMFINZI prior to chemotherapy on the same day. 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. Please complete form, sign, and fax all pages. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Inclusion Enrollment Report. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. 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. History of allogenic organ transplantation, bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 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. IMFINZI can cause primary or secondary adrenal insufficiency. 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 (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 is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer). am – 8 . 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. US-26009; US-33656; US-39735; US-42895; US-49806 Last Updated 2/21. But they add that there is also potential for further upside. 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. Imfinzi ® (durvalumab) Injectable Aetna Precertification Notification Phone: 1-866-752-7021 Medication Precertification Request FAX: 1-888-267-3277 Page 2 of 2 For Medicare Advantage Part B: (All fields must be completed and legible for Precertification Review) Phone: 1-866-503-0857 FAX: 1-844-268-7263 Patient First Name . They will keep a medicine diary. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. IMFINZI can cause immune-mediated pneumonitis. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of enrollment and confirmed prior to treatment on day 1. IMFINZI can cause severe or life-threatening infusion-related reactions. 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. 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. Patients can contact their Advocates for emotional support, help with setting goals and reminders, or to simply talk about how they are feeling. 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. Length of Authorization 1,10 • Bladder Cancer/Urothelial … Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (, Monitor patients for hyperglycemia or other signs and symptoms of diabetes. There are no standard treatments for this disease and prospective studies have not been conducted to date. Small cell lung cancer (SCLC) transformation has been reported as one of the mechanisms of acquired resistance to EGFR TKIs. Olaparib tablet will be administered at a total daily dose of 600 mg orally in two divided doses, approximately 12 hours apart. Electronic Patient Authorization Form (ePAF). 2020 ENROLLMENT FORM PLEASE CHECK ALL BOXES THAT APPLY AND COMPLETE THE APPROPRIATE SECTION(S) OF THE FORM TO GET STARTED, COMPLETE THE ENROLLMENT FORM AND SUBMIT ONLINE, OR PRINT AND FAX THE COMPLETED DOWNLOADABLE FORM TO 855-755-0518. Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

Don Carlos Essen, Glendower Pro Shop, Handball Wm 1984, Philipp Brenninkmeyer Wohnort, Wienerbrød Rezept Dänemark, Wetter See Kappl, Steven Spielberg Frau,