| Initial U.S. Approval: 2011
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
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
| 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.
|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 depressive disorders.
Patients may develop redistribution/accumulation of body fat or immune reconstitution syndrome.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Mothers should not breastfeed due to the potential for HIV transmission.
| 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.
| Package Insert data:
Product of Ireland
EDURANT™ is the trademark of Tibotec Pharmaceuticals
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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