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JULUCA
Viral infections
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Drug Name:

JULUCA Rx

Generic Name and Formulations:
Dolutegravir 50mg, rilpivirine 25mg; tabs.

Company:
ViiV Healthcare

Therapeutic Use:

Indications for JULUCA:

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.

Adult:

Take with a meal. 1 tab once daily. Concomitant rifabutin: take additional rilpivirine 25mg tab once daily during coadministration.

Children:

Not established.

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.

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: increase monitoring. Elderly. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

HIV-1 integrase strand transfer inhibitor (INSTI) + non-nucleoside reverse transcriptase inhibitor.

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. May potentiate drugs eliminated via OCT2 or MATE1. 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.

Adverse Reactions:

Diarrhea, headache, insomnia, fatigue; immune reconstitution syndrome, lab abnormalities, hypersensitivity reactions, DRESS, hepatotoxicity, depressive disorders.

Note:

Register pregnant patients exposed to Juluca by calling (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—30

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