Clinical Information
Gen. Code and Des.
67413 rilpivirine HCl ORAL TABLET 25 MG
GCN and Des.
29963 rilpivirine HCl ORAL TABLET 25 MG
Strength
25MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8180816 HIV NONNUCLEOSIDE REV.TRANSCRIP. INHIB.
Active Ingredients
13796 rilpivirine HCl 700361473
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
EDURANT- rilpivirine hydrochloride tablet, film coated
Janssen Products, LP
1 INDICATIONS AND USAGE
? EDURANT� , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-na�ve patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
? Limitations of Use:
? 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)].
2 DOSAGE AND ADMINISTRATION
? 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)].
3 DOSAGE FORMS AND STRENGTHS
25 mg white to off-white, film-coated, round, biconvex, tablet of 6.4 mm, debossed with "TMC" on one side and "25? on the other side. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.
