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1 Indications & Usage Nevirapine Extended-Release Tablets Are Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Human Immunodeficiency Virus (Hiv-1) Infection In Adults And Pediatric Patients 6 Years Of Age Or Older With A Body Surface Area (Bsa) Of 1.17 M 2 Or Greater [See Clinical Studies ( 14.1 , 14.2 )]. Limitations Of Use: Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Extended-Release Tablets Are Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: • Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3 Or • Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3 [See Warnings And Precautions ( 5.1 )]. • Nevirapine Extended-Release Tablets Are An Nnrti Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Human Immunodeficiency Virus (Hiv-1) Infection In Adults And Pediatric Patients 6 Years Of Age Or Older With A Bsa Of 1.17m 2 Or Greater. ( 1 ) Limitations Of Use: Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Extended-Release Tablets Are Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: • Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3 • Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3 ( 1 , 5.1 ).
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