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EDURANT™ (rilpivirine hydrochloride) tablet, film coated

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED  
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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(DESCRIPTION) top of page

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: top of page

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 alpha, beta and gamma

INDICATIONS AND USAGE  top of page

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 top of page

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 top of page

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 top of page

ADVERSE REACTIONS
The most common adverse drug reactions to EDURANT (incidence > 2%) of at least moderate to severe intensity (geq 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  top of page

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

HOW SUPPLIED top of page

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
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