juluca dolutegravir sodium 50 mg rilpivirine hydrochloride 25 mg tablet film coated

1 INDICATIONS AND USAGE 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/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, a two-drug combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/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. ( 1 )

viiv healthcare company

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] product use in unapproved indication` `[7] nausea` `[8] pyrexia` `[9] diarrhoea` `[10] death`

4 years ago

OVAL PINK SV J3T

16 HOW SUPPLIED/STORAGE AND HANDLING Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side. Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13. Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

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juluca dolutegravir sodium 50 mg rilpivirine hydrochloride 25 mg tablet film coated

FDA Reported Adverse Reactions [1] drug ineffective [2] off label use [3] toxicity to various agents [4] completed suicide [5] drug abuse [6] product use in unapproved indication [7] nausea [8] pyrexia [9] diarrhoea [10] death

OVAL PINK SV J3T

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] product use in unapproved indication` `[7] nausea` `[8] pyrexia` `[9] diarrhoea` `[10] death`