hurries up [0.1:<0.001 Objective Response Rate Objective Response Rate 65% 29% (95% CI) # (59%, 70%) (21%, 37%) Complete response 1% 1% Partial response 63% 27% P-value> <0.001 Duration of Response (DoR) Median Duration of Response in months (95% CI) 11.0 (8.6, 12.6) 4.2 (3.0, 5.9) Figure 1. Kaplan-Meier Curves of PFS by Investigator Assessment in AURA3 In a sensitivity analysis of PFS according to blinded independent central review, median PFS was 11 months in the Tagrisso arm compared to 4.2 months in the chemotherapy arm (HR 0.28; 95% CI: 0.20, 0.38). CNS Metastases Efficacy Data in AURA3 A BICR assessment of CNS efficacy by RECIST 1.1 in the subgroup of 46/419 (11%) patients identified to have measurable CNS lesions on a baseline brain scan are summarized in Table 5. Table 5. CNS Efficacy by BICR in Patients with Measurable CNS Lesions at Baseline Brain Scan in AURA3 * According to RECIST v1.1. Based on confirmed response. Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event. Efficacy Parameter Tagrisso N=30 Chemotherapy N=16 CNS Objective Response Rate * CNS Objective Response Rate 57% 25% (95% CI) (37%, 75%) (7%, 52%) Complete response 7% 0% Partial response 50% 25% CNS Duration of Response Median Duration of Response, Months (Range) NR (1.4, 12.5) 5.7 (1.4, 5.7) NR Not Reached Pretreated T790M Positive NSCLC Patients AURA Extension and AURA2 The efficacy of Tagrisso was demonstrated in two multicenter, single-arm, open-label clinical trials, AURA Extension and AURA2, in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI. All patients were required to have EGFR T790M mutation-positive NSCLC as detected by the cobas EGFR mutation test and received Tagrisso 80 mg once daily. The major efficacy outcome measure of both trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR). Duration of response (DOR) and Progression-Free Survival (PFS) were additional outcome measures. AURA Extension and AURA2 population characteristics were: median age 63 years (range 35 to 89), female (68%), White (36%), Asian (60%), never smoker (72%), World Health Organization (WHO) performance status 0 (37%) or 1 (63%), adenocarcinoma histology (96%), 1 prior line of therapy [EGFR-TKI treatment only, second line, chemotherapy-naïve] (31%), 2 or more prior lines of therapy (69%). Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases. 47% of patients had metastatic bone disease. Somatic EGFR mutations in addition to T790M were exon 19 deletion (68%), L858R (29%), G719X (2%), and S768I (2%). Efficacy results by BICR from AURA Extension and AURA2 are summarized in Table 6. The majority (96%) of patients with confirmed objective responses had ongoing responses ranging from 1.1 to 5.6 months after a median duration of follow-up of 4.2 months for AURA Extension and 4.0 months for AURA2. Table 6. Efficacy Results by BICR in AURA Extension and AURA2 * Pooled analysis of AURA Extension and AURA2 Objective response rate according to RECIST v1.1. Efficacy Parameter Study 1 (N=201) Study 2 (N=210) Overall * (N=411) Objective Response Rate (95% CI) 57% (50, 64) 61% (54, 68) 59% (54, 64) Complete Response 0 1% 0.5% Partial Response 57% 60% 59% In a separate dose finding part of AURA Extension, 63 patients with centrally confirmed T790M-positive NSCLC progressed on prior systemic therapy, including an EGFR TKI were administered Tagrisso 80 mg. In these patients, the BICR-confirmed objective response rate was 51% (32/63) and the median duration of response was 12.4 months from the time of first documented response. How Supplied/Storage and Handling 80 mg tablets: beige, oval and biconvex tablet marked with AZ 80 on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1350-30). 40 mg tablets: beige, round and biconvex tablet marked with AZ 40 on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1349-30). Store Tagrisso bottles at 25 C (77 F). Excursions permitted to 15-30 C (59-86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease/Pneumonitis Inform patients of the risks of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.1) ] . QTc Interval Prolongation Inform patients of symptoms that may be indicative of significant QTc prolongation including dizziness, lightheadedness, and syncope. Advise patients to report these symptoms and to inform their physician about the use of any heart or blood pressure medications [see Warnings and Precautions (5.2) ] . Tagrisso can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3) ] . Keratitis Advise patients to contact their healthcare provider immediately if they develop eye symptoms (eye inflammation, lacrimation, light sensitivity, eye pain, red eye or changes in vision) [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Tagrisso can cause fetal harm if taken during pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females to inform their healthcare provider if they become pregnant or if pregnancy is suspected, while taking Tagrisso [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ] . Females and Males of Reproductive Potential Advise females of reproductive potential to use effective contraception during treatment with Tagrisso and for 6 weeks after the final dose [see Use in Specific Populations (8.3) ] . Advise males to use effective contraception during treatment and for 4 months after the final dose of Tagrisso [see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with Tagrisso and for 2 weeks after the final dose [see Use in Specific Populations (8.2) ] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Tagrisso is a registered trademark of the AstraZeneca group of companies. AstraZeneca 2017 Patient Information Tagrisso ( tuh-GRISS-oh ) (osimertinib) tablets What is the most important information I should know about Tagrisso? Tagrisso may cause serious side effects, including: lung problems. Tagrisso may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever. heart problems, including heart failure. Tagrisso may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking Tagrisso and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded. eye problems. Tagrisso may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with Tagrisso. See What are the possible side effects of Tagrisso? for more information about side effects. What is Tagrisso? Tagrisso is a prescription medicine used to treat non-small cell lung cancer (NSCLC). Tagrisso may be used when your non-small cell lung cancer has spread to other parts of the body and: has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, called T790M, and you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working. Your doctor will perform a test to make sure that Tagrisso is right for you. It is not known if Tagrisso is safe and effective in children. Before taking Tagrisso, tell your doctor about all of your medical conditions, including if you: have lung or breathing problems. have heart problems, including a condition called long QTc syndrome. have problems with your electrolytes, such as sodium, potassium, calcium or magnesium. have a history of eye problems. are pregnant or plan to become pregnant. Tagrisso can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with Tagrisso or think you may be pregnant. Females who are able to become pregnant should use effective birth control during treatment with Tagrisso and for 6 weeks after the final dose of Tagrisso. Males who have female partners that are able to become pregnant should use effective birth control during treatment with Tagrisso and for 4 months after the final dose of Tagrisso. are breastfeeding or plan to breastfeed. It is not known if Tagrisso passes into your breast milk. Do not breastfeed during treatment with Tagrisso and for 2 weeks after your final dose of Tagrisso. Talk to your doctor about the best way to feed your baby during this time. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine. How should I take Tagrisso? Take Tagrisso exactly as your doctor tells you to take it. Your doctor may change your dose, temporarily stop, or permanently stop treatment with Tagrisso if you have side effects. Take Tagrisso 1 time each day. You can take Tagrisso with or without food. If you miss a dose of Tagrisso, do not make up for the missed dose. Take your next dose at your regular time. If you cannot swallow Tagrisso tablets whole: place your dose of Tagrisso in a container that contains 60 mL (2 ounces) of water. Do not use carbonated water or any other liquids. stir the Tagrisso tablet and water until the Tagrisso tablet is in small pieces (the tablet will not completely dissolve). Do not crush, heat, or use ultrasound to prepare the mixture. drink the Tagrisso and water mixture right away. add 120 mL to 240 mL (4 to 8 ounces) of water into the container and drink to make sure that you take your full dose of Tagrisso. What are the possible side effects of Tagrisso? Tagrisso may cause serious side effects, including: See What is the most important information I should know about Tagrisso? The most common side effects of Tagrisso are: diarrhea rash dry skin changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails tiredness Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tagrisso. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Tagrisso? Store Tagrisso at room temperature between 68 F to 77 F (20 C to 25 C). Safely throw away medicine that is out of date or that you no longer need. Keep Tagrisso and all medicines out of the reach of children. General information about the safe and effective use of Tagrisso. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tagrisso for a condition for which it was not prescribed. Do not give Tagrisso to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about Tagrisso that is written for a healthcare professional. What are the ingredients in Tagrisso? Active ingredient: osimertinib Inactive ingredients: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and sodium stearyl fumarate. Tablet coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black. For more information, go to www.Tagrisso.com or call 1-800-236-9933. Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 AstraZeneca 2017 This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 2017 Tagrisso osimertinib 40 mg NDC 0310- 1349 -30 30 Tablets Each tablet contains 40 mg osimertinib. USUAL ADULT DOSAGE: See Prescribing Information. WARNING: As with all medications, keep out of the reach of children. Store at room temperature between 68 F to 77 F (20 C to 25 C). Rx only AstraZeneca Tagrisso osimertinib 80 mg NDC 0310- 1350 -30 30 Tablets Each tablet contains 80 mg osimertinib. USUAL ADULT DOSAGE: See Prescribing Information. WARNING: As with all medications, keep out of the reach of children. Store at room temperature between 68 F to 77 F (20 C to 25 C). Rx only AstraZeneca Tagrisso osimertinib tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0310-1349 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 40 Inactive Ingredients Ingredient Name Strength MANNITOL CELLULOSE, MICROCRYSTALLINE SODIUM STEARYL FUMARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3350 TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED Product Characteristics Color BROWN (beige) Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code AZ;40 Contains Packaging # Item Code Package Description 1 NDC:0310-1349-30 30 TABLET, FILM COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208065 11/13/2015 Tagrisso osimertinib tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0310-1350 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 80 Inactive Ingredients Ingredient Name Strength MANNITOL CELLULOSE, MICROCRYSTALLINE SODIUM STEARYL FUMARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3350 TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED Product Characteristics Color BROWN (beige) Score no score Shape OVAL (biconvex) Size 15mm Flavor Imprint Code AZ;80 Contains Packaging # Item Code Package Description 1 NDC:0310-1350-30 30 TABLET, FILM COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208065 11/13/2015 Labeler - AstraZeneca Pharmaceuticals LP (054743190) Registrant - AstraZeneca PLC (230790719) Revised: 10/2017 AstraZeneca Pharmaceuticals LP Next Interactions Print this page Add to My Med List More about Tagrisso (osimertinib) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: EGFR inhibitors Consumer resources Tagrisso Tagrisso (Advanced Reading) Professional resources Tagrisso (AHFS Monograph) Related treatment guides Non-Small Cell Lung Cancer> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug 2 years Approval History FDA approved 2015 Manufacturer AstraZeneca Drug Class EGFR inhibitors Related Drugs EGFR inhibitors Tarceva , Erbitux , erlotinib , cetuximab , Vectibix , gefitinib Non-Small Cell Lung Cancer Avastin , methotrexate , Taxol , Opdivo , cisplatin , Taxotere , Tarceva , Keytruda , paclitaxel , nivolumab , gemcitabine , Gemzar , Abraxane , docetaxel , Alimta , bevacizumab , pembrolizumab , pemetrexed , erlotinib , Trexall , Tecentriq , crizotinib , Cyramza , atezolizumab , More... Tagrisso Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Tagrisso Images Tagrisso 40 mg (AZ 40 ) View larger images} } looking ahead to
fall asleep Tagrisso transport
EmoticonEmoticon