forty six [1%:<15 mL/min/1.73 m 2 ), including subjects on hemodialysis, who were treatment-naïve or who had failed prior therapy with IFN or PegIFN RBV therapy. Subjects were randomized in a 1:1 ratio to one of the following treatment groups: EBR 50 mg once daily + GZR 100 mg once daily for 12 weeks (immediate treatment group) or placebo for 12 weeks followed by open-label treatment with EBR + GZR for 12 weeks (deferred treatment group). In addition, 11 subjects received open-label EBR + GZR for 12 weeks (intensive pharmacokinetic [PK] group). Subjects randomized to the immediate treatment group and intensive PK group had a median age of 58 years (range: 31 to 76); 75% of the subjects were male; 50% were White; 45% were Black or African American; 11% were Hispanic or Latino; 57% had baseline HCV RNA levels greater than 800,000 IU/mL; 6% had cirrhosis; and 72% had non-C/C IL28B alleles (CT or TT). Treatment outcomes in subjects treated with Zepatier for 12 weeks in the pooled immediate treatment group and intensive PK group are presented in Table 15 . Table 15: C-SURFER: SVR12 in Subjects with Severe Renal Impairment including Subjects on Hemodialysis who were Treatment-Naïve or had Failed Prior IFN or PegIFN RBV, with or without Cirrhosis, with Genotype 1 HCV Treated with Zepatier for 12 Weeks Regimen EBR + GZR 12 weeks (Immediate Treatment Group) N=122 * * Includes subjects (n=11) in the intensive PK group. SVR was achieved in 99% (115/116) of subjects in the pre-specified primary analysis population, which excluded subjects not receiving at least one dose of study treatment and those with missing data due to death or early study discontinuation for reasons unrelated to treatment response. Other includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal. Includes genotype 1 subtypes other than 1a or 1b. Overall SVR 94% (115/122) Outcome for subjects without SVR On-treatment Virologic Failure 0% (0/122) Relapse> <1% (1/122) Other 5% (6/122) SVR by Genotype GT 1a 97% (61/63) GT 1b 92% (54/59) SVR by Cirrhosis status No 95% (109/115) Yes 86% (6/7) SVR by Prior HCV Treatment Status Treatment-naïve 95% (96/101) Treatment-experienced 90% (19/21) SVR by Dialysis Status No 97% (29/30) Yes 93% (86/92) SVR by Chronic Kidney Disease Stage Stage 4 100% (22/22) Stage 5 93% (93/100) Clinical Trials with Genotype 4 HCV The efficacy of Zepatier in subjects with genotype 4 chronic HCV infection was demonstrated in C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, and C-SCAPE. C-SCAPE was a randomized, open-label trial which included treatment-naïve subjects with genotype 4 infection without cirrhosis. Subjects were randomized in a 1:1 ratio to EBR 50 mg once daily + GZR 100 mg once daily for 12 weeks or EBR 50 mg once daily + GZR 100 mg once daily + RBV for 12 weeks. In these combined studies in subjects with genotype 4 infection, 64% were treatment-naïve; 66% of the subjects were male; 87% were White; 10% were Black or African American; 22% had cirrhosis; and 30% had HCV/HIV-1 co-infection. In C-SCAPE, C-EDGE TN, and C-EDGE COINFECTION trials combined, a total of 66 genotype 4 treatment-naïve subjects received Zepatier or EBR + GZR for 12 weeks. In these combined trials, SVR12 among subjects treated with Zepatier or EBR + GZR for 12 weeks was 97% (64/66). In C-EDGE TE, a total of 37 genotype 4 treatment-experienced subjects received a 12- or 16-week Zepatier with or without RBV regimen. SVR12 among randomized subjects treated with Zepatier + RBV for 16 weeks was 100% (8/8). How Supplied/Storage and Handling Each Zepatier tablet contains 50 mg elbasvir and 100 mg grazoprevir, is beige, oval-shaped, film-coated, debossed with "770" on one side and plain on the other. The tablets are packaged into a carton (NDC 0006-3074-02) containing two (2) 14-count child-resistant dose packs for a total of 28 tablets. Store Zepatier in the original blister package until use to protect from moisture. Store Zepatier at 20 C to 25 C (68 F to 77 F); excursions permitted between 15 C to 30 C (between 59 F to 86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling ( Patient Information ). For patients receiving Zepatier with ribavirin, advise patients to read the FDA-approved patient labeling (Medication Guide) for ribavirin [see Warnings and Precautions (5.3) ] . Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection [see Warnings and Precautions (5.1) ]. Risk of ALT Elevations Inform patients to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discolored feces, and to consult their healthcare professional without delay if such symptoms occur [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Pregnancy Advise patients taking Zepatier with ribavirin to avoid pregnancy during treatment and within 6 months of stopping ribavirin and to notify their healthcare provider immediately in the event of a pregnancy [see Use in Specific Populations (8.1) ] . Drug Interactions Inform patients that Zepatier may interact with some drugs; therefore, advise patients to report the use of any prescription, non-prescription medication, or herbal products to their healthcare provider [see Contraindications (4) , Warnings and Precautions (5.4) , and Drug Interactions (7) ] . Storage Advise patients to store Zepatier in the original package until use to protect from moisture [see How Supplied/Storage and Handling (16) ] . Administration Advise patients to take Zepatier every day at the regularly scheduled time with or without food. Inform patients that it is important not to miss or skip doses and to take Zepatier for the duration that is recommended by the healthcare provider. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: MSD International GmbH, Ballydine, Clonmel, Ireland For patent information: www.merck.com/product/patent/home.html Copyright 2016-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. uspi-mk5172a-t-1702r002 Patient Information Zepatier (ZEP-ah-teer) (elbasvir and grazoprevir) tablets What you need to know about Zepatier Before you take this medicine, be sure you understand what it is for and how to take it safely. Keep this information. If you have questions about this medicine, ask your healthcare provider or pharmacist. Every time you get a refill, look at the Patient Information. There may be new information. Your healthcare provider may prescribe Zepatier with a medicine called ribavirin. Ribavirin is also known as Rebetol , Copegus , Ribasphere , and Moderiba . If you take Zepatier and ribavirin, be sure you read the Medication Guide for ribavirin. What is the most important information I should know about Zepatier? Zepatier can cause serious side effects, including, Hepatitis B virus reactivation : Before starting treatment with Zepatier, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus infection with Zepatier. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Zepatier. For more information about side effects, see the section " What are the possible side effects of Zepatier? " What is Zepatier ? Zepatier is a prescription medicine used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults. It is not known if Zepatier is safe or effective in children under 18 years old, people awaiting a liver transplant, or people who have had a liver transplant. Who should not take Zepatier? Do not take Zepatier if you have certain liver problems. What should I tell my healthcare provider before taking Zepatier? Before taking Zepatier, tell your healthcare provider about all of your medical conditions, including if you: have ever had hepatitis B virus infection have liver problems other than hepatitis C have ever taken any medicine for hepatitis C have HIV have had or are waiting for a liver transplant are pregnant or trying to get pregnant. Zepatier has not been studied in pregnant women. We do not know if Zepatier will harm your baby while you are pregnant. Males and females who take Zepatier and ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information. are breastfeeding or plan to breastfeed. We do not know if Zepatier gets in your breast milk and gets passed to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Zepatier. Are you taking other medicines? Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zepatier may affect the way other medicines work, and other medicines may affect how Zepatier works. Some medicines cannot be taken with Zepatier. Your healthcare provider can tell you if it is safe to take Zepatier with other medicines. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with this medicine. Do not start taking a new medicine without telling your healthcare provider. How do I take Zepatier? Take 1 Zepatier tablet at the same time every day. Zepatier comes in a blister package of individually-packaged tablets. Keep the tablets in this package until you are ready to take your dose. Take Zepatier exactly as your healthcare provider tells you to take it. Take Zepatier with or without food. Do not stop taking Zepatier without first talking with your healthcare provider. If you take more than your prescribed dose, call your healthcare provider right away. What if I forget to take Zepatier? Do not take two doses of Zepatier at the same time to make up for a missed dose. If you are not sure what to do, call your healthcare provider or pharmacist. It is important that you do not miss or skip doses of Zepatier during treatment. What are the possible side effects of Zepatier? Zepatier can cause serious side effects, including: Hepatitis B virus reactivation. See " What is the most important information I should know about Zepatier? " Signs of liver problems. Zepatier may cause increases in your liver-related blood tests . This could be a sign of serious liver problems. Your healthcare provider will do blood tests to check your liver before and during treatment with Zepatier. Tell your healthcare provider right away if you get any of the following symptoms or if they get worse during treatment with Zepatier: loss of appetite nausea and vomiting feeling tired or weak yellowing of your skin or eyes color changes in your stool Common side effects of Zepatier when used without ribavirin include: feeling tired headache nausea trouble sleeping diarrhea Common side effects of Zepatier when used with ribavirin include: low red blood cell counts (anemia) headache feeling tired shortness of breath rash or itching feeling irritable stomach pain depression joint pain If you have any side effect that bothers you or that does not go away, tell your healthcare provider. There may be other side effects to Zepatier that are not listed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information or medical advice call your doctor. Where should I keep Zepatier? Keep Zepatier in its original packaging (blister package) until you are ready to take it. Do not take the tablets out of the original blister package to store in another container such as a pill box. This is important because the tablets are sensitive to moisture. The package is designed to protect them. Keep Zepatier at room temperature. Keep Zepatier and all medicines out of the reach of children. General information about Zepatier Medicines are sometimes prescribed for purposes other than those listed in the patient information. Do not use Zepatier for a condition for which it was not prescribed. Do not give Zepatier to other people, even if they have the same condition. It may harm them. If you would like more information, talk with your healthcare provider or pharmacist. You can ask them for information about Zepatier that was written for health professionals. For more information, call Merck, the company that makes Zepatier, at 1-877-888-4231 or go to www.Zepatier.com. What are the ingredients in Zepatier? The active ingredients are: elbasvir and grazoprevir. The inactive ingredients are: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, and vitamin E polyethylene glycol succinate. The tablets are film-coated with a coating material containing the following inactive ingredients: carnauba wax, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: MSD International GmbH, Ballydine, Clonmel, Ireland For patent information: www.merck.com/product/patent/home.html The trademarks depicted herein are owned by their respective companies. Copyright 2016-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Issued: 2/2017 usppi-mk5172a-t-1702r001 PRINCIPAL DISPLAY PANEL - 50 mg/100 mg Tablet Dose Pack Carton NDC 0006-3074-02 Zepatier (elbasvir and grazoprevir) tablets 50 mg/100 mg Rx only 28 Tablets This carton contains a total of 28 tablets packaged within 2 dose packs. Each dose pack contains 14 blister units with one tablet per blister unit. Zepatier elbasvir and grazoprevir tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-3074 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELBASVIR (ELBASVIR) ELBASVIR 50 mg GRAZOPREVIR ANHYDROUS (GRAZOPREVIR ANHYDROUS) GRAZOPREVIR ANHYDROUS 100 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE COPOVIDONE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (3 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM CHLORIDE SODIUM LAURYL SULFATE TOCOPHERSOLAN CARNAUBA WAX FERROSOFERRIC OXIDE HYPROMELLOSE 2910 (15 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW TITANIUM DIOXIDE TRIACETIN Product Characteristics Color BROWN (Beige) Score no score Shape OVAL Size 21mm Flavor Imprint Code 770 Contains Packaging # Item Code Package Description 1 NDC:0006-3074-02 2 DOSE PACK in 1 CARTON 1 NDC:0006-3074-01 14 TABLET, FILM COATED in 1 DOSE PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208261 01/28/2016 Labeler - Merck Sharp & Dohme Corp. (001317601) Revised: 02/2017 Merck Sharp & Dohme Corp. Next Interactions Print this page Add to My Med List More about Zepatier (elbasvir / grazoprevir) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 34 Reviews Add your own review/rating Drug class: antiviral combinations Consumer resources Zepatier Zepatier (Advanced Reading) Professional resources Zepatier (AHFS Monograph) Related treatment guides Hepatitis C> ]} 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 Approval History Drug history at FDA Manufacturer Merck & Co., Inc. Drug Class Antiviral combinations Related Drugs antiviral combinations Harvoni , Truvada , Atripla , Genvoya , Triumeq , Stribild Hepatitis C Harvoni , Epclusa , ribavirin , Mavyret , Sovaldi , sofosbuvir , ledipasvir / sofosbuvir , Vosevi , Viekira Pak , daclatasvir , Daklinza , Pegasys , Intron A , Ribasphere , Olysio , sofosbuvir / velpatasvir , Rebetol , simeprevir , Moderiba , PegIntron , elbasvir / grazoprevir , glecaprevir / pibrentasvir , Roferon-A , More... Zepatier Rating 34 User Reviews 8.9 /10 34 User Reviews 8.9 Rate it! Zepatier Images Zepatier elbasvir 50 mg / grazoprevir 100 mg (770 ) View larger images} } fits
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