Rx Item-Juluca 50Mg/25Mg Tab 30 By Viiv Healthcare Dolutegravir/Rilpivirine Oral

For: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.
Generic Name : dolutegravir/rilpivirine
Route : ORAL
Dose Form : TABLET
Strength : 50 mg-25 mg
AHFS Therapeutic Classifications
08180812 HIV INTEGRASE INHIBITOR ANTIRETROVIRALS
08180816 HIV NONNUCLEOSIDE REV.TRANSCRIP. INHIB.
Active Ingredients
013796 rilpivirine HCl 700361473
015175 dolutegravir sodium 000000000
Inactive Ingredients
002272 mannitol 000069658
002432 lactose 064044515

These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA.

JULUCA (dolutegravir and rilpivirine) tablets, for oral use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
JULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as 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 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. (1)

DOSAGE AND ADMINISTRATION
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One tablet taken orally once daily with a meal. ( 2.1)
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Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Each 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). (3)

CONTRAINDICATIONS
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Previous hypersensitivity reaction to dolutegravir or rilpivirine. ( 4)
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Coadministration with dofetilide. ( 4)
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Coadministration with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response. ( 4)
WARNINGS AND PRECAUTIONS
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Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. 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. ( 5.1)
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Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended. ( 5.2)
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Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms. ( 5.3, 6.1)
ADVERSE REACTIONS
The most common adverse reactions (all Grades) observed in at least 2% of subjects were diarrhea and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

DRUG INTERACTIONS
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Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. ( 7.1)
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Refer to the full prescribing information for important drug interactions with JULUCA. ( 4, 5.4, 7)
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Drugs that induce or inhibit CYP3A4 or UGT1A1 may affect the plasma concentrations of the components of JULUCA. ( 7.3)
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Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA. ( 4, 7.3, 7.4)
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Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes. ( 7.3)
USE IN SPECIFIC POPULATIONS
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Lactation: Breastfeeding is not recommended due to the potential for HIV transmission. ( 8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2017

49702-0242-13
Item No.:RX715003 NDC No.49702024213 UPC No.:349702242135 NDC No. 49702-0242-13 49702-242-13 UPC/GTIN No. 3-49702-24213-5 MPN 24213

Juluca 50Mg/25Mg Tab 30 By Viiv Healthca
BRAND: COMBIVIR NDC: 49702-0242-13,49702024213 UPC: 349702-242135,349702242135 Viiv Healthcare

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49702-0242-13
Item No.:RX715003 NDC No.49702024213 UPC No.:349702242135 NDC No. 49702-0242-13 49702-242-13 UPC/GTIN No. 3-49702-24213-5 MPN 24213