"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
COMPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA < 50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).
- The following points should be
considered when initiating therapy with COMPLERA in adult patients with no
antiretroviral treatment history:
- More rilpivirine-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 rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies].
- Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm³ experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm³ [See Clinical Studies (14)].
- The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology].
- More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology].
- The efficacy of COMPLERA was established in patients who
were virologicallysuppressed (HIV-1 RNA < 50 copies/mL) on stable
ritonavir-boosted protease inhibitor-containing regimen. The following points
should be met when considering replacing the current regimen with COMPLERA in
virologically-suppressed adults [See Clinical Studies]:
- Patients should have no history of virologic failure.
- Patients should have been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to switching therapy.
- Patients should currently be on their first or second antiretroviral regimen prior to switching therapy.
- Patients should have no current or past history of resistance to any of the three components of COMPLERA.
Additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound.
COMPLERA is not recommended for patients less than 18 years of age [See Use in Specific Populations].
DOSAGE AND ADMINISTRATION
The recommended dose of COMPLERA is one tablet taken orally once daily with food [See CLINICAL PHARMACOLOGY].
Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).
If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant®) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration [See DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
COMPLERA is available as tablets. Each tablet contains 200 mg of emtricitabine (FTC), 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of rilpivirine) and 300 mg of tenofovir disoproxil fumarate (tenofovir DF or TDF, equivalent to 245 mg of tenofovir disoproxil).
The tablets are purplish-pink, capsule-shaped, film-coated, debossed with “GSI” on one side and plain-faced on the other side.
Storage And Handling
COMPLERA tablets are purplish-pink, capsule-shaped, film-coated, debossed with “GSI” on one side and plain-faced on the other side. Each bottle contains 30 tablets (NDC 61958-1101-1), a silica gel desiccant, polyester fiber coil, and is closed with a child-resistant closure.
Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F) (see USP Controlled Room Temperature).
- Keep container tightly closed
- Dispense only in original container
- Do not use if seal over bottle opening is broken or missing.
Manufactured and distributed by: Gilead Sciences, Inc., Foster City, CA 94404. Rev: Sep 2014
Last reviewed on RxList: 11/17/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Complera Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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