Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Gilead Sciences Ireland UC
J05AR
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Antivirals for systemic use,
HIV Infections
Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,
Revision: 26
Authorised
2015-11-19
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER GENVOYA 150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 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 Genvoya is and what it is used for 2. What you need to know before you take Genvoya 3. How to take Genvoya 4. Possible side effects 5. How to store Genvoya 6. Contents of the pack and other information IF GENVOYA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT GENVOYA IS AND WHAT IT IS USED FOR Genvoya contains four active substances: • ELVITEGRAVIR, an antiretroviral medicine known as an integrase inhibitor • COBICISTAT, a booster (enhancer) of the effects of elvitegravir • EMTRICITABINE, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI) • TENOFOVIR ALAFENAMIDE, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI) Genvoya is a single tablet for the TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION in adults, adolescents and children 6 years of age and older, who weigh at least 25 kg. Genvoya reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GENVOYA DO NOT TAKE GENVOYA • IF YOU ARE ALLERGIC TO ELVITEGR Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. Excipients with known effect Each tablet contains 58 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed with “GSI” on one side of the tablet and “510” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows: • In adults and adolescents aged from 12 years and with body weight at least 35 kg • In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities. See sections 4.2, 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _Adults and paediatric patients aged 6 years and older, weighing at least 25 kg_ One tablet to be taken once daily with food. If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Genvoya by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Genvoya another tablet should be taken. _Elderly_ No dose adjustment of Genvoya is required in elderly patients (see sections 5.1 and 5.2). 3 _Renal impairment_ No dose Les hele dokumentet