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ODEFSEY
Viral infections
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Drug Name:

ODEFSEY Rx

Generic Name and Formulations:
Emtricitabine 200mg, rilpivirine 25mg, tenofovir alafenamide 25mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

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) for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Odefsey.

Adults and Children:

Test for HBV infection prior to initiation. <12yrs (<35kg): not established. ≥12yrs (≥35kg): 1 tab once daily with food. Severe renal impairment (CrCl <30mL/min): not recommended.

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.

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted (esp. in those with 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. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl, serum creatinine, serum phosphorus, urine glucose, urine protein prior to and during therapy in all patients; discontinue if significant renal dysfunction or Fanconi syndrome occurs. Prolongation of QTc interval with higher doses. Promptly evaluate if severe depressive symptoms occur. Discontinue immediately if severe skin or hypersensitivity reactions develop. Severe hepatic impairment. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid with concurrent or recent use of nephrotoxic agents. Concomitant 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 activity (eg, cyclosporine) 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) or H2-receptor antagonists by (≥12hrs before or ≥4hrs after). Monitor for breakthrough fungal infections with concomitant azole antifungals. Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). Monitor methadone.

Pharmacological Class:

Nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor.

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 Availability:

NO

How Supplied:

Tabs—30

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