For: HIV Infection
Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a fixed-dose combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated as a complete regimen for the treatment of HIV-1 infection. ODEFSEY tablets are gray, capsule-shaped, and film coated with "GSI" debossed on one side and "255" on the other side. Each bottle contains 30 tablets (NDC 61958-2101-1), a silica gel desiccant, and a polyester coil, and is closed with a child-resistant closure.
Store below 30�C (86�F).
Keep container tightly closed.
Dispense only in original container. These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY.
ODEFSEY� (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use
Initial U.S. Approval: 2016
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warning.
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosage (2.2) 12/2019
Dosage and Administration, Not Recommended in Patients with Severe Renal Impairment (2.4) 12/2019
Warnings and Precautions, New Onset or Worsening Renal Impairment (5.5) 12/2019
Warnings and Precautions, Immune Reconstitution Syndrome (5.8) 12/2019
INDICATIONS AND USAGE
ODEFSEY is a three-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY. (1)
Limitations of Use:
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. (14.2,14.3)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating ODEFSEY, test for hepatitis B virus infection. Prior to or when initiating ODEFSEY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus (2.1)
Recommended dosage: one tablet taken orally once daily with a meal. (2.2)
For pregnant patients who are already on ODEFSEY prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. (2.3)
Renal impairment: ODEFSEY is not recommended in patients with estimated creatinine clearance of 15 to below 30 mL per minute, or below 15 mL per minute who are not receiving chronic hemodialysis. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg of FTC, 25 mg of RPV and 25 mg of TAF. (3)
CONTRAINDICATIONS
ODEFSEY is contraindicated when coadministered with drugs where significant decreases in RPV plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance. (4)
WARNINGS AND PRECAUTIONS
Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience with RPV-containing regimens, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develops and closely monitor clinical status, including hepatic serum biochemistries. (5.2)
Hepatotoxicity: Hepatic adverse events have been reported in patients receiving an RPV-containing regimen. Monitor liver-associated tests before and during treatment with ODEFSEY in patients with underlying hepatic disease or marked elevations in liver-associated tests. Also consider monitoring liver-associated tests in patients without risk factors. (5.3)
Depressive disorders: Severe depressive disorders have been reported. Immediate medical evaluation is recommended for severe depressive disorders. (5.4)
New onset or worsening renal impairment: Assessment of serum creatinine, estimated creatinine clearance, urine glucose, and urine protein when initiating ODEFSEY and during therapy on a clinically appropriate schedule in all patients. Also assess serum phosphorus in patients with chronic kidney disease. (5.5)
Concomitant use of ODEFSEY with drugs with a known risk to prolong the QTc interval of the electrocardiogram may increase the risk of Torsade de Pointes. (5.6)
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.7)
Immune reconstitution syndrome: May necessitate further evaluation and treatment. (5.8)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache and sleep disturbances. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
ODEFSEY is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. (7.1)
Consult the Full Prescribing Information prior to and during treatment for important drug interactions. (4, 5.6, 7)
USE IN SPECIFIC POPULATIONS
Pregnancy: Total rilpivirine exposures were generally lower during pregnancy compared to the postpartum period. (2.3, 8.1, 12.3).
Lactation: Breastfeeding not recommended due to the potential for HIV-1 transmission. (8.2)
Pediatrics: Not recommended for patients weighing less than 35 kg. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2019
