Edurant
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FDA Labeling Changes
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Uses
EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naïve subjects [see Clinical Studies (14.1)].
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 (HIV-1 RNA ≥ 50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14.1)].
- Regardless of HIV-1 RNA at the start of therapy, more EDURANT treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [see Clinical Studies (14.1)].
- 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 [see Microbiology (12.4)].
- More subjects treated with EDURANT developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see Microbiology (12.4)].
EDURANT is not recommended for patients less than 18 years of age [see Use In Specific Populations (8.4)].
History
There is currently no drug history available for this drug.
Other Information
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.
The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6 ∙ HCl and its molecular weight is 402.88. Rilpivirine hydrochloride has the following structural formula:
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, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide and triacetin.
Sources
Edurant Manufacturers
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Janssen Products, Lp
![Edurant (Rilpivirine Hydrochloride) Tablet, Film Coated [Janssen Products, Lp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Edurant | Janssen Products, Lp
The recommended dosage of EDURANT in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet once daily taken orally with a meal [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. EDURANT is not recommended for patients less than 12 years of age.
Rifabutin Co-administration: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal [see Drug Interactions (7), Clinical Pharmacology (12.3)].
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