What is this medication?
Antiretroviral, Integrase Inhibitor (Anti-HIV) and Reverse Transcriptase Inhibitor (Anti-HIV)
JULUCA (Dolutegravir/Rilpivirine) is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults.
How does this medication work?
Dolutegravir is an integrase inhibitor that stops HIV integrase by binding to the integrase active site and prevents retroviral DNA integration.
Rilpivirine, a non-nucleoside reverse transcriptase inhibitor, that binds to reverse transcriptase and blocks the RNA-dependent and DNA-dependent polymerase activities, including HIV-1 replication.
How should I take this medication?
Oral: Take one tablet (50mg/25mg) once daily.
Note: Prior to switching to JULUCA (Dolutegravir/Rilpivirine), patients must be virologically suppressed on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known resistance to dolutegravir or rilpivirine.
How to Take: Take with a meal. Take 4 hours before or 6 hours after antiacids, sucralfate, iron or calcium containing supplements, or buffered medications.
What should I watch for while using this medication?
Hypersensitivity reactions have been reported with dolutegravir and were characterized by severe skin and hypersensitivity reactions, acute liver injury, and depression. Discontinue JULUCA (Dolutegravir/Rilpivirine) immediately if signs or symptoms of severe skin or hypersensitivity reactions develop including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, mucosal involvement, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing. Hepatic adverse events have been reported in patients receiving a dolutegravir- or rilpivirine containing regimen. Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations. Drug-induced liver injury leading to acute liver failure has been reported with dolutegravir-containing products. Monitoring for hepatotoxicity is recommended. Depressive disorders (including depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation) have been reported with rilpivirine.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Rash, pruritis, fatigue, abdominal pain, abdominal discomfort, flatulence, nausea, upper abdominal pain, vomiting, reduced appetite, hepatobiliary-related side effects (cholecystitis, cholelithiasis, and hepatitis), depressive disorders (suicidal ideation, attempt, behavior, or completion). Psychiatric adverse reactions were also reported including anxiety, insomnia, sleep disorders, and abnormal dreams. Renal and urinary-related side effects reported such as as glomerulonephritis membranous, glomerulonephritis mesangioproliferative, nephrolithiasis, and renal impairment.
Nore this is not a complete list of side effects for JULUCA (Dolutegravir/Rilpivirine), only common ones.