How does RILPIVIRINE HYDROCHLORIDE work?

RILPIVIRINE HYDROCHLORIDE works through the following mechanism: 12.1 Mechanism of Action Rilpivirine is an antiviral drug [see Microbiology (12.4) ] ..

What are the most common side effects of RILPIVIRINE HYDROCHLORIDE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for RILPIVIRINE HYDROCHLORIDE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is RILPIVIRINE HYDROCHLORIDE the same as EDURANT?

EDURANT is a brand name for RILPIVIRINE HYDROCHLORIDE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

RILPIVIRINE HYDROCHLORIDE

Q: What is RILPIVIRINE HYDROCHLORIDE used for?

RILPIVIRINE HYDROCHLORIDE (brand name EDURANT) is a Electrolyte / Mineral indicated for 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.

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%

Community Discussions

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Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → RILPIVIRINE HYDROCHLORIDE openFDA label JSON → RILPIVIRINE HYDROCHLORIDE FAERS adverse-event reports → RILPIVIRINE HYDROCHLORIDE ClinicalTrials.gov → completed Phase 2+ trials of RILPIVIRINE HYDROCHLORIDE

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Formulations

Dosage Forms

Tablet

Route

Oral