2043IMFINZI is a registered trademark of AstraZeneca group of companies.©AstraZeneca 2018, MEDICATION GUIDEIMFINZI®(im-FIN-zee)(durvalumab)InjectionWhat is the most important information I should know about IMFINZI?IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract or a type of lung cancer by working with your immune system.IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. At the data cutoff for the ORR analysis, median response duration was not reached (range: 0.9+ to 19.9+ months). The most common adverse reactions in at least 15% of patients were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection. It was a much narrower label than what they had initially sought, but the approval marked the best news the Boston biotech has put out in years. 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. Hypothyroidism was preceded by thyroiditis or hyperthyroidism in 25% of patients. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.1)]. •Lactation: Advise female patients not to breastfeed while taking IMFINZI and for at least 3 months after the last dose [see Warnings and Precautions (5.10) and Use in Specific Populations (8.2)].Manufactured for:AstraZeneca Pharmaceuticals LPWilmington, DE 19850By: AstraZeneca UK Limited1 Francis Crick Ave.Cambridge, England CB2 0AAUS License No. 13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility. Data presented at ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation for IMFINZI in locally-advanced, unresectable lung cancer. Administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth) and increase in neonatal deaths. 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. Adrenal Insufficiency: Monitor patients for clinical signs and symptoms of adrenal insufficiency. Toggle navigation. IMFINZI improves progression-free survival (PFS) by more than 11 months compared to standard of care following chemoradiation therapy (CRT) and is the first medicine to show superior PFS in this setting . No overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. 1.3 Small Cell Lung Cancer . Imfinzi with NDC 0310-4500 is a a human prescription drug product labeled by Astrazeneca Pharmaceuticals Lp. The median time to onset was 2 months (range: 1 day to 14.2 months). Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated. Medicinal product information search platform (AIPS) with information for authorised human medicines. 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. Monitor patients for signs and symptoms of pneumonitis. 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. Diarrhea or colitis resolved in 78% of the patients. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). 2.3. The pre-specified interim PFS analysis based on 371 events (81% of total planned events) demonstrated a statistically significant improvement in PFS in patients randomized to IMFINZI compared to placebo. Issued: 02/2018. Sixty-six percent (66%) of patients had visceral metastasis (bone, liver, or lung), including 34% with liver metastasis. 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. Human IgG1 is excreted in human milk. It is not known if IMFINZI passes into your breast milk. No dose reductions are recommended. •Infusion-Related Reactions [see Warnings and Precautions (5.9)]. The effects of durvalumab on prenatal and postnatal development were evaluated in reproduction studies in cynomolgus monkeys. 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. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in < 2% of patients and were similar across arms. Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. Systemic corticosteroids were required in 0.4% of patients, including 0.1% of patients who required high-dose corticosteroids. IMFINZI was discontinued for adverse reactions in 3.3% of patients. FDA approved this application approximately 6 weeks ahead of the goal date. Imfinzi. Ask your healthcare provider or pharmacist for more information.Call your healthcare provider for medical advice about side effects. Compare monoclonal antibodies. brand. Interrupt IMFINZI based on the severity [see Dosage and Administration (2.3)].Hypopituitarism leading to adrenal insufficiency and diabetes insipidus occurred in < 0.1% of 1889 patients who received IMFINZI in clinical studies. •Dermatological Reactions: Advise patients to contact their healthcare provider immediately signs or symptoms of severe dermatological reactions [see Warnings and Precautions (5.6)]. Systemic corticosteroids were required in 21% of patients, with 12% requiring high-dose corticosteroids and 0.1% requiring infliximab. The contents of the National Drug Codes List website are provided for educational purposes only and are not intended in any way as medical advice, medical diagnosis or treatment. Recommended Dosage Modifications for Adverse ReactionsAdverse ReactionSeverityNational Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Randomization was stratified by sex, age (< 65 years vs. ≥ 65 years) and smoking history (smoker vs. non-smoker). Discard the vial if the solution is cloudy, discolored, or visible particles are observed. IMFINZI can cause immune-mediated rash or dermatitis. IMFINZI can cause serious side effects (see above): The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. IMFINZI can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus and hypophysitis/hypopituitarism.Thyroid Disorders: Monitor thyroid function prior to and periodically during treatment with IMFINZI. Fatal cases have been reported. 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. IMFINZI may be used when your urothelial carcinoma: •has spread or cannot be removed by surgery and, •you have tried chemotherapy that contains platinum, and it did not work or is no longer working. 5 WARNINGS AND PRECAUTIONS 5.1 Immune-Mediated Adverse Reactions - IMFINZI is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1)... 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?This is the date when the listing record will expire if not updated or certified by the product labeler. IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids.Monitor patients for signs and symptoms of diarrhea or colitis. Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O. •Discard partially used or empty vials of IMFINZI.Storage of Infusion Solution •IMFINZI does not contain a preservative. Injection: 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial. If you think you may have a medical emergency, please call your doctor or 911 immediately. Patients received IMFINZI 10 mg/kg intravenously every 2 weeks [see Clinical Studies (14.1)]. The median time to onset was 1.8 months (range: 1 day to 13.9 months) and the median time to resolution was 4.9 months (range: 0 days to 13.7 months). Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 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)], 26% of patients developed rash or dermatitis and 0.4% of the patients developed vitiligo. Twenty percent (20%) of patients had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy as their only prior line of therapy. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months following the last dose of IMFINZI. PD-L1 and PD-1 knockout mice have also shown decreased survival following infection with lymphocytic choriomeningitis virus. Grade 3-4 adverse events were seen in 43% of patients. Administer corticosteroids, prednisone 1 to 2 mg per kg per day or equivalent for moderate (Grade 2) pneumonitis or prednisone 1 to 4 mg per kg per day or equivalent for more severe (Grade 3-4) pneumonitis, followed by taper. The efficacy of IMFINZI was evaluated in the PACIFIC study (NCT02125461), a multicenter, randomized, double-blind, placebo-controlled study in patients with unresectable Stage III NSCLC who completed at least 2 cycles of concurrent platinum-based chemotherapy and definitive radiation within 42 days prior to initiation of the study drug and had a WHO performance status of 0 or 1. The incidence of pneumonitis (including radiation pneumonitis) was higher in patients in the PACIFIC study who completed treatment with definitive chemoradiation within 42 days prior to initiation of IMFINZI (34%) compared to patients in other clinical studies (2.3%) in which radiation therapy was generally not administered immediately prior to initiation of IMFINZI.In the PACIFIC study, the incidence of Grade 3 pneumonitis was 3.4% and of Grade 5 pneumonitis was 1.1% in the IMFINZI arm. ORR was also analyzed by PD-L1 expression status as measured by VENTANA PD-L1 (SP263) Assay. Evaluate patients with suspected pneumonitis with radiographic imaging. "The most common side effects of IMFINZI in people with urothelial carcinoma include: •feeling tired •muscle or bone pain •constipation •decreased appetite •nausea •swelling of your arms and legs •urinary tract infectionThe most common side effects of IMFINZI in people with NSCLC include: •cough •feeling tired •inflammation in the lungs (pneumonitis) •upper respiratory tract infections •shortness of breat •rashTell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of IMFINZI. Rash resolved in 62% of patients. FDA-Approved Indications. Dosage Modifications for Adverse Reactions . •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)]. This medication belongs to a class of drugs known as monoclonal antibodies. 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. The PACIFIC study did not include sufficient numbers of patients aged 75 years and over to determine whether they respond differently from younger patients. 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. •have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.This indication is approved under accelerated approval based on tumor response rate and duration of response. Serious adverse reactions occurred in 46% of patients. 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. 2. •If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.What are the possible side effects of IMFINZI?IMFINZI can cause serious side effects, including:See "What is the most important information I should know about IMFINZI? Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI. Interrupt IMFINZI based on the severity [see Dosage and Administration (2.3)]. •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. Programmed Death Ligand-1 Antagonists - [MoA] (Mechanism of Action), Programmed Death Ligand-1-directed Antibody Interactions - [MoA] (Mechanism of Action), Programmed Death Ligand-1 Blocker - [EPC] (Established Pharmacologic Class). Laboratory Abnormalities Worsening from Baseline Occurring in ≥ 20% of Patients in the PACIFIC StudyIMFINZIPlaceboLaboratory AbnormalityAll GradesGraded according to NCI CTCAE version 4.0(%)Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: IMFINZI (range: 464 to 470) and placebo (range: 224 to 228)Grade 3 or 4(%)All Grades(%)Grade 3 or 4(%)ChemistryHyperglycemia528518Hypocalcemia460.2410Increased ALT392.3220.4Increased AST362.8210.4Hyponatremia333.6303.1Hyperkalemia321.1291.8Increased GGT243.4221.7HematologyLymphopenia43 17 39 18. 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. If you would like more information about IMFINZI, talk with your healthcare provider. Signs and symptoms that your hormone glands are not working properly may include: •headaches that will not go away or unusual headaches •extreme tiredness •weight gain or weight loss •dizziness or fainting •feeling more hungry or thirsty than usual •hair loss •changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness •feeling cold •constipation •your voice gets deeper •urinating more often than usual •nausea or vomiting •stomach area (abdomen) painKidney problems, including nephritis and kidney failure. Steady state was achieved at approximately 16 weeks.DistributionThe geometric mean (% coefficient of variation [CV%]) steady state volume of distribution was 5.6 (18%) L.EliminationDurvalumab clearance decreases over time, with a mean maximal reduction (CV%) from baseline values of approximately 23% (57%) resulting in a geometric mean (CV%) steady state clearance (CLss) of 8.2 mL/h (39%) at day 365; the decrease in CLss is not considered clinically relevant. Efficacy Results for the PACIFIC Study Endpoint IMFINZI (N=476)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 Placebo (N=237) Progression-Free Survival (PFS)Blinded Independent Central Review Number (%) of patients with event 214 (45%) 157 (66%) Median in months (95% CI) 16.8 (13, 18.1) 5.6 (4.6, 7.8) Hazard Ratio (95% CI)Stratified by sex, age, and smoking history Pike estimator 0.52 (0.42, 0.65) p-value (log-rank)Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O’Brien Fleming boundary) for interim analysis. Signs and symptoms of severe infusion reactions may include: •chills or shaking •itching or rash •flushing •shortness of breath or wheezing •dizziness •fever •feel like passing out •back or neck pain •facial swellingGetting medical treatment right away may help keep these problems from becoming more serious.Your healthcare provider will check you for these problems during your treatment with IMFINZI. Signs and symptoms may include: •fever •cough •frequent urination •pain when urinating •flu-like symptomsSevere infusion reactions. Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold or discontinue IMFINZI to manage adverse reactions as described in Table 1.Table 1. QUALITATIVE AND QUANTITATIVE … IMFINZI is a drug for the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. There are no data on the use of IMFINZI in pregnant women.In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery resulted in an increase in premature delivery, fetal loss and premature neonatal death (see Data). •IMFINZI is usually given every 2 weeks. The absence of a warning or notice for a given drug or drug combination is not indication that the drug or drug combination are safe, appropriate or effective for any given patient. AstraZeneca Canada Inc. May 2018. Tell your doctor if you have any side effect that bothers you or that does not go away. A total of 475 patients received IMFINZI 10 mg/kg intravenously every 2 weeks. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. IMFINZI can cause immune-mediated rash; bullous dermatitis, Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN) have occurred with other products in this class [see Warnings and Precautions (5.7)].Monitor for signs and symptoms of rash.
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