Juluca

JULUCA- dolutegravir sodium and rilpivirine hydrochloride tablet, film coated
ViiV Healthcare Company

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 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.

2 DOSAGE AND ADMINISTRATION

2.1 Pregnancy Testing before Initiation of JULUCA

Pregnancy testing is recommended before initiation of JULUCA in individuals of childbearing potential [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

2.2 Recommended Dosage

The recommended dosage of JULUCA is one tablet taken orally once daily with a meal [see Clinical Pharmacology (12.3)]. One tablet of JULUCA contains 50 mg of dolutegravir and 25 mg of rilpivirine.

2.3 Recommended Dosage with Rifabutin Coadministration

If JULUCA is coadministered with rifabutin, take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration [see Drug Interactions (7.4)].

3 DOSAGE FORMS AND STRENGTHS

JULUCA tablets are pink, oval, biconvex tablets debossed with “SV J3T” on one side. Each film-coated tablet contains 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride).

4 CONTRAINDICATIONS

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)].

Table 1. Drugs That are Contraindicated with JULUCA

Drug Class

Contraindicated Drugs in Class

Clinical Comment

Antiarrhythmic

Dofetilide

Potential for serious and/or life-threatening events due to the potential for increased dofetilide plasma concentrations.

Anticonvulsants

Carbamazepine

Oxcarbazepine

Phenobarbital

Phenytoin

Potential for significant decreases in rilpivirine plasma concentrations due to cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response.

Antimycobacterials

Rifampin

Rifapentine

Glucocorticoid (systemic)

Dexamethasone

(more than a single-dose treatment)

Herbal Products

St John’s wort

(Hypericum perforatum)

Proton Pump Inhibitors

e.g., Esomeprazole Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response.

5 WARNINGS AND PRECAUTIONS

5.1 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. These events were reported in less than 1% of subjects receiving dolutegravir in Phase 3 clinical trials.

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. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries. During the Phase 3 clinical trials of rilpivirine, treatment-related rashes with at least Grade 2 severity were reported in 3% of subjects. No Grade 4 rash was reported [see Adverse Reactions (6.2)].

Discontinue JULUCA 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 [oral blisters or lesions], conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including laboratory parameters with liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with JULUCA after the onset of hypersensitivity may result in a life-threatening reaction [see Contraindications (4)].

5.2 Hepatotoxicity

Hepatic adverse events have been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen [see Adverse Reactions (6.1)]. 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. Cases of hepatic toxicity, including elevated serum liver biochemistries and hepatitis, have also been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. 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). Monitoring for hepatotoxicity is recommended.

5.3 Embryo-Fetal Toxicity

An ongoing observational study showed an association between dolutegravir 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 the association of reported types of neural tube defects with dolutegravir use, inform individuals of childbearing potential, including those actively trying to become pregnant, about the potential increased risk of neural tube defects with JULUCA. 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 [see Use in Specific Populations (8.1. 8.3)].

Pregnancy testing is recommended before initiation of JULUCA in individuals of childbearing potential [see Dosage and Administration (2.1)].

Individuals of childbearing potential should be counseled on the consistent use of effective contraception [see Use in Specific Populations (8.1, 8.3)].

JULUCA may be considered during the second and third trimesters of pregnancy if the expected benefit justifies the potential risk to the pregnant woman and the fetus.

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