Generic name: emtricitabine 200mg, rilpivirine hydrochloride 25mg, tenofovir alafenamide fumarate 25mg
Dosage form: tablet
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Testing Prior to Initiation of ODEFSEY
Prior to initiation of ODEFSEY, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.2)].
Estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating ODEFSEY therapy and should be monitored during therapy in all patients [see Warnings and Precautions (5.10)].
ODEFSEY is a 3-drug fixed dose combination product containing 200 mg of emtricitabine (FTC), 25 mg of rilpivirine (RPV), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of ODEFSEY is one tablet taken orally once daily with a meal in the following patient population: adults and in pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg and a creatinine clearance greater than or equal to 30 mL per minute [see Clinical Pharmacology (12.3)].
Testing After Initiation of ODEFSEY
In virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound [see Clinical Studies (14)].
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