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.

Pregnancy testing is recommended before initiation of JULUCA in individuals of childbearing potential,

If JULUCA is co-administered with rifabutin, take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin co-administration.

Because JULUCA is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

JULUCA is contraindicated in patients:

• receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the
  risk for serious and/or life-threatening events
• receiving other co-administered drugs that significantly decrease rilpivirine plasma concentrations (Dofetilide Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin, Rifampin, Rifapentine Dexamethasone (more than a single dose treatment), St John’s wort (Hypericum perforatum), Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, and Rabeprazole)

Depressive disorders (including depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation) have been reported with rilpivirine.

Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury.

Drug-induced liver injury leading to acute liver failure has been reported with dolutegravir-containing products, including liver transplant with TRIUMEQ (abacavir, dolutegravir, and lamivudine).

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. Additionally, in some patients receiving dolutegravir-containing regimens, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn.

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.

Decreased bone mineral density.

Drugs that are contraindicated with JULUCA: dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexamethasone (more than a single dose treatment),st john’s wort, (hypericum perforatum), esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole.

Consider alternatives to JULUCA when co-administered with a drug with a known risk of Torsade de Pointes.

Dolutegravir, a component of JULUCA, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1, thus it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide and metformin.

Co-administration of dolutegravir with polyvalent cation-containing products may lead to decreased absorption of dolutegravir.

Co-administration of JULUCA and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.

Co-administration of JULUCA with drugs that increase gastric pH may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.

Dolutegravir is metabolized by uridine diphosphate (UDP)-glucuronosyl transferase (UGT)1A1 with some contribution from cytochrome P450 (CYP)3A. Dolutegravir is also a substrate of UGT1A3, UGT1A9, breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp) in vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentrations and reduce the therapeutic effect of dolutegravir.

Administer JULUCA 4 hours before or 6 hours after taking antacids.

Administer JULUCA 4 hours before or 6 hours after taking products containing polyvalent cations.

Administer JULUCA and supplements containing calcium or iron together with a meal or take JULUCA 4 hours before or 6 hours after taking these supplements.

An observational study showed an association between dolutegravir, a component of JULUCA, and an increased risk of neural tube defects when dolutegravir was administered at the time of conception and in early pregnancy. As there is limited understanding of reported types of neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, an alternative treatment to JULUCA should be considered at the time of conception through the first trimester of pregnancy.

Initiation of JULUCA is not recommended in individuals actively trying to become pregnant unless there is no suitable alternative. Counsel individuals of childbearing potential to consistently use effective contraception.

The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

GoToSource

• Use in patients under the age of 18. GoToSource

Myocarditis (inflammation of the heart muscle). GoToSource

Dyslipidemia (abnormal level of blood lipids). GoToSource

Respiratory tract infection, bronchitis, influenza and arthralgia. GoToSource

Skin rash, allergic reactions, liver injury and depression or mood changes. GoToSource

Lawsuits filed for birth defects.