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Juluca Generic Name & Formulations
Legal Class
Rx
General Description
Dolutegravir 50mg, rilpivirine 25mg; tabs.
Pharmacological Class
HIV-1 integrase strand transfer inhibitor
(INSTI) + non-nucleoside reverse transcriptase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Juluca Indications
Indications
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 <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 Dosage and Administration
Adult
Take with a meal. 1 tab once daily. Concomitant rifabutin: take additional rilpivirine 25mg tab once daily during coadministration.
Children
Not established.
Juluca Contraindications
Contraindications
Concomitant dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone (more than a single dose), St. John's wort, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.
Juluca Boxed Warnings
Not Applicable
Juluca Warnings/Precautions
Warnings/Precautions
Discontinue immediately if severe skin or hypersensitivity reactions develop; monitor. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C; monitor for hepatotoxicity. Promptly evaluate if depressive symptoms occur. Severe renal impairment (CrCl <30mL/min) or ESRD: monitor frequently. Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (assess risks/benefits; consider alternative treatment at time of conception through 1st trimester or if pregnancy is confirmed). Pregnancy: exclude status prior to initiation. Advise individuals of reproductive potential to use effective contraception. Nursing mothers: not recommended.
Juluca Pharmacokinetics
See Literature
Juluca Interactions
Interactions
See Contraindications. Concomitant other HIV-1 antiretroviral therapy: not recommended. May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. May be antagonized by CYP3A inducers. May be potentiated by CYP3A inhibitors. Concomitant drugs with a known risk of Torsade de pointes: consider alternatives. Dolutegravir may potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). Drugs that increase gastric pH may result in decreased plasma concentration. Concomitant antacids, cation-containing products, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give Juluca 4hrs before or 6hrs after. Separate H2-receptor antagonists by at least 4hrs before or 12hrs after. Limit concomitant metformin dose to 1000mg/day; adjust metformin dose when starting or stopping Juluca; monitor closely. May be potentiated by clarithromycin, erythromycin, telithromycin; consider alternatives (eg, azithromycin). Concomitant methadone; monitor.
Juluca Adverse Reactions
Adverse Reactions
Diarrhea, headache; hypersensitivity reactions, DRESS, depressive disorders.
Juluca Clinical Trials
See Literature
Juluca Note
Notes
Register pregnant patients exposed to Juluca by calling (800) 258-4263.
Juluca Patient Counseling
See Literature
