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Home > Drugs > EDURANT (rilpivirine hydrochloride) tablet

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Initial U.S. Approval: 2011
DESCRIPTION
EDURANT (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). EDURANT is available as a white to off-white, film-coated, round, biconvex, 6.4 mm tablet for oral administration. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.

Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.

Each EDURANT tablet also contains the inactive ingredients croscarmellose sodium, magnesium stearate, lactose monohydrate, povidone K30, polysorbate 20 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide and triacetin.

Clinical pharmacology

CLINICAL PHARMACOLOGY
Microbiology
Mechanism of Action

Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1) and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ

Indications and usage 

EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated:

In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve adult patients.

The following points should be considered when initiating therapy with EDURANT:

More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.

The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.

More subjects treated with EDURANT developed lamivudine/emtricitabine associated resistance compared to efavirenz.

Contraindications

Co-administration of EDURANT 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.

Precautions

WARNINGS AND PRECAUTIONS
Caution should be given to prescribing EDURANT with drugs that may reduce the exposure of rilpivirine.
 
Caution should be given to prescribing EDURANT with drugs with a known risk of Torsade de Pointes.

Depressive Disorders: Severe depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) have been reported. Immediate medical evaluation is recommended for severe depressive disorders.

Patients may develop redistribution/accumulation of body fat or immune reconstitution syndrome.

DRUG INTERACTIONS
EDURANT should not be used in combination with NNRTIs.
Co-administration of EDURANT with drugs that induce or inhibit CYP3A4 may affect the plasma concentrations of rilpivirine.
Co-administration of EDURANT with drugs that increase gastric pH may decrease plasma concentrations of rilpivirine.
Refer to the Full Prescribing Information for other drugs that should not be co-administered with EDURANT and for other drugs that may require a change in dose or regimen.

USE IN SPECIFIC POPULATIONS
Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk. Pregnancy registry available.

Nursing Mothers: Mothers should not breastfeed due to the potential for HIV transmission.

Adverse reactions

ADVERSE REACTIONS
The most common adverse drug reactions to EDURANT (incidence > 2%) of at least moderate to severe intensity (≥ Grade 2) were depression, insomnia, headache and rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage and administration 

25 mg (one 25 mg tablet) taken once daily with a meal.

How supplied

25 mg tablets

Referencee

Package Insert data: 

Product of Ireland
Finished Product Manufactured by:
Janssen-Cilag S.p.A., Latina, Italy
Manufactured for:
Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., Raritan NJ 08869

EDURANT™ is the trademark of Tibotec Pharmaceuticals
© Tibotec, Inc. 2011
Issued May 2011

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

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