Viral infections:
Indications for: ODEFSEY
As a complete regimen for HIV-1 infection in patients who are antiretroviral treatment-naïve with HIV-1 RNA ≤100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Odefsey.
Adults and Children:
<12yrs (<35kg): not established. Test for HBV infection prior to and at initiation. ≥12yrs (≥35kg and CrCl ≥30mL/min): 1 tab once daily with food. Pregnancy (already on prior stable dose and with HIV-1 RNA <50 copies/mL): continue with 1 tab once daily; monitor viral load. Severe renal impairment (CrCl 15-<30mL/min) or ESRD (CrCl <15mL/min) not receiving chronic hemodialysis: not recommended.
ODEFSEY Contraindications:
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than a single dose), St. John’s wort.
Boxed Warning:
Post-treatment acute exacerbation of hepatitis B.
ODEFSEY Warnings/Precautions:
Discontinuation of emtricitabine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Underlying hepatitis B or C, or marked elevations in liver-associated tests; monitor for hepatotoxicity. Consider monitoring LFTs in those without pre-existing hepatic dysfunction or other risks. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to or when initiating, and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome occurs. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Prolongation of QTc interval with higher doses. Promptly evaluate if severe depressive symptoms occur. Discontinue immediately if severe skin or hypersensitivity reactions develop. ESRD (CrCl <15mL/min) receiving chronic hemodialysis: more monitoring and on hemodialysis days, give dose after session. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.
ODEFSEY Classification:
Nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor.
ODEFSEY Interactions:
See Contraindications. Concomitant other antiretroviral agents, antimycobacterials (eg, rifabutin): not recommended. May be potentiated by CYP3A, P-gp and BCRP inhibitors, antagonized by CYP3A or P-gp inducers. Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Concomitant drugs with a known risk for Torsade de Pointes; consider alternatives. Separate antacids by ≥2hrs before or 4hrs after rilpivirine; or H2-receptor antagonists by ≥12hrs before or ≥4hrs after rilpivirine; drugs that increase gastric pH may decrease rilpivirine plasma levels. Monitor for breakthrough fungal infections with concomitant azole antifungals. Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). Monitor methadone.
Adverse Reactions:
Headache, sleep disturbances; hepatotoxicity, new onset or worsening renal impairment, immune reconstitution syndrome.
Note:
Register pregnant patients in the Antiretroviral Pregnancy Registry by calling (800) 258-4263.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
