Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
cobicistat
Gilead Sciences Ireland UC
V03AX03
cobicistat
Antivirals for systemic use
HIV Infections
Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.
Revision: 15
Authorised
2013-09-19
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TYBOST 150 MG FILM-COATED TABLETS cobicistat READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tybost is and what it is used for 2. What you need to know before you take Tybost 3. How to take Tybost 4. Possible side effects 5. How to store Tybost 6. Contents of the pack and other information 1. WHAT TYBOST IS AND WHAT IT IS USED FOR Tybost contains the active substance cobicistat. Tybost is used for the treatment of human immunodeficiency virus-1 (HIV-1) infection, the virus that causes acquired immune deficiency syndrome (AIDS). It is used in HIV-1 infected adults and adolescents aged 12 years and older: • weighing at least 35 kg (when co-administered with atazanavir 300 mg) or • weighing at least 40 kg (when co-administered with darunavir 800 mg). Tybost acts as a BOOSTER ( _enhancer_ ) of ATAZANAVIR OR DARUNAVIR (both protease inhibitors) to improve their effect (see section 3 of this leaflet). TYBOST DOES NOT DIRECTLY TREAT YOUR HIV, BUT BOOSTS THE LEVELS OF ATAZANAVIR AND DARUNAVIR in the blood. It does this by slowing down the breakdown of atazanavir and darunavir which will make them stay in the body for longer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYBOST DO NOT TAKE TYBOST • IF YOU ARE ALLERGIC TO COBICISTAT or any of the other ingredients of this medicine (listed in section 6 of this leaflet). • IF YOU ARE TAKING MEDICINES CONTAINING ANY OF THE FOLLOWING: - ALFUZOSIN, used to treat an enlarged prostate gland Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tybost 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of cobicistat. Excipient(s) with known effect Each tablet contains 59 micrograms sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older: • weighing at least 35 kg co-administered with atazanavir or • weighing at least 40 kg co-administered with darunavir. See sections 4.2, 4.4, 5.1 and 5.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Tybost is used in combination with atazanavir or darunavir, therefore the atazanavir or darunavir Summary of Product Characteristics should be consulted. Tybost must be taken orally, once daily with food. The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Tables 1 and 2. TABLE 1: DOSING REGIMENS IN ADULTS DOSE OF TYBOST DOSE OF HIV-1 PROTEASE INHIBITOR 150 mg once daily Atazanavir 300 mg once daily Darunavir 800 mg once daily 3 TABLE 2: DOSING REGIMENS IN ADOLESCENTS AGED 12 YEARS AND OLDER, WEIGHING ≥ 35 KG BODY WEIGHT (KG) DOSE OF TYBOST DOSE OF HIV-1 PROTEASE INHIBITOR ≥ 40 150 mg once daily Atazanavir 300 mg once daily Darunavir 800 mg once daily 35 to < 40 150 mg once daily Atazanavir 300 mg once daily If the patient misses a dose of Tybost within 12 hours of the time it is usually taken, th Perskaitykite visą dokumentą