RILPIVIRINE HYDROCHLORIDE

Electrolyte / Mineral

Brand names: EDURANT, EDURANT PED

Oral

Mechanism of Action

12.1 Mechanism of Action Rilpivirine is an antiviral drug [see Microbiology (12.4) ] .

Indications

1 INDICATIONS AND USAGE EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific

000 copies/mL. ( 1.1 ). Limitations of Use: More EDURANT treated subjects with HIV-1 RNA greater than 100

000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100

000 copies/mL. ( 1.1

14 ) EDURANT is indicated in combination with VOCABRIA (cabotegravir)

in combination with other antiretroviral agents

Contraindications

• 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. Coadministration of EDURANT or EDURANT PED is contraindicated with drugs where significant decreases in rilpivirine plasma concentrations may occur
• which may result in loss of virologic response and possible resistance and cross-resistance. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Skin and Hypersensitivity Reactions: 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
Also consider monitoring liver functions tests in patients without pre-existing hepatic dysfunction or other risk factors
Patients with underlying hepatitis B or C virus infection, or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of EDURANT or EDURANT PED
A few cases of hepatic toxicity have been reported in adult patients receiving a rilpivirine-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors

Known Side Effects

1 documented side effects by frequency

Anxiety

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral