United States - English - NLM (National Library of Medicine)

physicians total care, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of hiv-1 infection in antiretroviral treatment-naive adult patients with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. this indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz [see clinical studies (14)] . the following points should be considered when initiating therapy with complera: - more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)] . - regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 exper

United States - English - NLM (National Library of Medicine)

viiv healthcare company - dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663) - dolutegravir 50 mg - juluca is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of juluca. juluca is contraindicated in patients:    •    with previous hypersensitivity reaction to dolutegravir or rilpivirine [see warnings and precautions (5.1)] .    •    receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see drug interactions (7)] .    •    receiving other coadministered drugs in table 1 that significantly decrease rilpivirine plasma concentrations [see drug interactions (7), clinical pharmacology (12.3)] . drug class contraindicated drugs in class clinical comment antia

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide - hiv infections - antivirals for systemic use - 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 known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml.,

Australia - English - Department of Health (Therapeutic Goods Administration)

viiv healthcare pty ltd - rilpivirine, quantity: 900 mg - injection, suspension - excipient ingredients: poloxamer; sodium hydroxide; citric acid monohydrate; water for injections; monobasic sodium phosphate monohydrate; glucose monohydrate - cabenuva (cabotegravir prolonged-release suspension for injection and rilpivirine prolonged-release suspension for injection) is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies per ml) and have no known or suspected resistance to either cabotegravir or rilpivirine (see section 5.1 pharmacodynamic properties, clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

viiv healthcare pty ltd - rilpivirine, quantity: 600 mg - injection, suspension - excipient ingredients: poloxamer; sodium hydroxide; citric acid monohydrate; glucose monohydrate; water for injections; monobasic sodium phosphate monohydrate - cabenuva (cabotegravir prolonged-release suspension for injection and rilpivirine prolonged-release suspension for injection) is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies per ml) and have no known or suspected resistance to either cabotegravir or rilpivirine (see section 5.1 pharmacodynamic properties, clinical trials).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - rilpivirine hydrochloride - tablet - 25mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - rilpivirine -

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - rilpivirine - injection, suspension, extended release - rilpivirine 300mg/ml

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - dolutegravir as sodium; rilpivirine as hydrochloride - film coated tablets - rilpivirine as hydrochloride 25 mg; dolutegravir as sodium 50 mg - dolutegravir and rilpivirine - juluca is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor

United States - English - NLM (National Library of Medicine)

a-s medication solutions - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® , a combination of two nucleoside analog hiv-1 reverse transcriptase inhibitors (nrtis) (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (nnrti) (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in patients 12 years of age and older with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below). - the following points should be considered when initiating therapy with complera in patients with no antiretroviral treatment history:   more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared