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
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 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 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
EDURANT is a human immunodeficiency virus type 1 (HIV-1)
specific, non-nucleoside reverse transcriptase inhibitor (NNRTI)
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.
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.
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
Patients may develop redistribution/accumulation of body fat or
immune reconstitution syndrome.
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.