Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
Lenacapavir sodium
Gilead Sciences Ireland Unlimited Company
J05AX
lenacapavir
Antivirals for systemic use
HIV Infections
Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1).Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).
Revision: 01
Authorised
2022-08-17
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUNLENCA 464 MG SOLUTION FOR INJECTION lenacapavir This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - 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 Sunlenca is and what it is used for 2. What you need to know before you are given Sunlenca 3. How Sunlenca is given 4. Possible side effects 5. How to store Sunlenca 6. Contents of the pack and other information 1. WHAT SUNLENCA IS AND WHAT IT IS USED FOR Sunlenca contains the active substance lenacapavir. This is an antiretroviral medicine known as a capsid inhibitor. Sunlenca is a long acting medicine and IS USED IN COMBINATION WITH OTHER ANTIRETROVIRAL MEDICINES to treat type 1 human immunodeficiency virus (HIV), the virus that cause acquired immunodeficiency syndrome (AIDS). It is used to treat HIV infection in adults with limited treatment options (for example when other antiretroviral medicines are not sufficiently effective or are not suitable). Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in your body. This will improve the function of your immune system (the body’s natural defences) and reduce the risk of developing illnesses linked to HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUNLENCA _ _ DO NOT RECEIVE SUNLENCA • If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6) • If you are taking any of these medicines: - RIFAMPICIN Baca dokumen lengkap
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Sunlenca 464 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial contains lenacapavir sodium equivalent to 463.5 mg of lenacapavir in 1.5 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, yellow to brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be prescribed by a physician experienced in the management of HIV infection. Each injection should be administered by a healthcare professional. Prior to starting lenacapavir, the healthcare professional should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses. In addition, the healthcare professional should counsel patients about the importance of adherence to an optimised background regimen (OBR) to further reduce the risk of viral rebound and potential development of resistance. If Sunlenca is discontinued, it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of Sunlenca (see section 4.4). Posology _Initiation _ On treatment Day 1 and Day 2, the recommended dose of Sunlenca Baca dokumen lengkap