Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
LENACAPAVIR AS SODIUM
GILEAD SCIENCES ISRAEL LTD
J05AX31
SOLUTION FOR INJECTION
LENACAPAVIR AS SODIUM 309 MG/ML
S.C
Required
GILEAD SCIENCES IRELAND UC, IRELAND
LENACAPAVIR
Sunlenca solution for 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.
2023-05-23
Patient leaflet in accordance with the Pharmacists’ (Products) Regulations - 1986 This medicine is to be supplied by doctor’s prescription only Sunlenca ® solution for injection lenacapavir 463.5 mg/vial Active ingredients : Each ml contains – lenacapavir (as sodium) 309 mg Inactive and allergenic substances: see section 6 _“Additional information_ ”. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you . This leaflet contains essential information about this medicine. If you have any further questions, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. If you experience any side effects, talk to your doctor or pharmacist. Even if you experience any side effects that are not listed in this leaflet (see section 4). This medicine is intended for adults aged 18 years and over. 1. What is the medicine intended for Sunlenca solution for 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. Therapeutic group: Antivirals for systemic use, other antivirals. 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 infec Soma hati kamili
SUNLENCA ® SOLUTION FOR INJECTION (LENACAPAVIR (AS SODIUM) 463.5 MG) SOLUTION FOR S.C. INJECTION 1. NAME OF THE MEDICINAL PRODUCT Sunlenca 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 s.c. injection (injection). Clear, yellow to brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sunlenca solution for 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 is 600 mg per day taken orally. On treatment Day 8, the recommended dose is 300 mg taken orally. Then, on treatment Day 15, the recommended dose is 927 mg administered by subcutaneous inject Soma hati kamili