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IMPORTANT SAFETY INFORMATION

Contraindications

• Do not use JULUCA in patients with previous hypersensitivity reaction to dolutegravir or rilpivirine
• Do not use JULUCA in patients receiving dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone (>1 dose), St. John’s wort, and proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole)

Warnings and precautions

Skin and Hypersensitivity Reactions:

• Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
• Severe skin and hypersensitivity reactions have been reported during postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens and have been accompanied by fever and/or organ dysfunctions, including elevations in hepatic serum biochemistries
• Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

• Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure) in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
• 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 with the use of JULUCA. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
• Monitoring for hepatotoxicity is recommended

Embryo-Fetal Toxicity:

• Assess the risks and benefits of JULUCA and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
• Pregnancy testing is recommended before use of JULUCA. Individuals of childbearing potential should be counseled on the consistent use of effective contraception

Depressive Disorders:

• Depressive disorders (including depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation) have been reported with rilpivirine
• Promptly evaluate patients with severe depressive symptoms

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

• The concomitant use of JULUCA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
• Rilpivirine doses 3 and 12 times higher than the recommended dose can prolong the QTc interval. Consider alternatives to JULUCA when coadministered with a drug with a known risk of Torsade de Pointes. Consider the potential for drug interactions prior to and during therapy with JULUCA and monitor for adverse reactions

Adverse reactions

The most common adverse reactions (incidence ≥2%, all Grades) with JULUCA were diarrhea (2%), headache (2%), and nausea (2%).

Drug interactions

• Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
• Coadministration of JULUCA with drugs that induce or inhibit UGT1A1 and/or CYP3A may affect plasma concentrations
• Drugs that increase gastric pH may decrease plasma concentrations of the components of JULUCA
• Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes
• When coadministering JULUCA with rifabutin, take an additional 25 mg tablet of rilpivirine with JULUCA once daily with a meal
• Administer JULUCA 4 hours before or 6 hours after taking antacids, polyvalent cation-containing products or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications
• Consult the full Prescribing Information for JULUCA for more information on potentially significant drug interactions, including clinical comments

Use in specific populations

• Pregnancy: There are insufficient human data on the use of JULUCA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of JULUCA and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester
• Rilpivirine Exposure During Pregnancy: Total rilpivirine exposures were generally lower during pregnancy compared with the postpartum period
• Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
• Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of JULUCA. Counsel individuals of childbearing potential taking JULUCA on the consistent use of effective contraception

INDICATION

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 <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA. JULUCA should be taken with a meal

To report suspected side effects, contact ViiV Healthcare at 1-888-825-5249 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for JULUCA.