DESCOVY Dosage & Rx Info | Uses, Side Effects

Descovy Generic Name & Formulations

Legal Class

General Description

Emtricitabine, tenofovir alafenamide; 120mg/15mg, 200mg/25mg; tabs.

Pharmacological Class

Nucleoside analogues (reverse transcriptase inhibitors).

How Supplied

Tabs—30

Manufacturer

Gilead Sciences, Inc.

Generic Availability

Descovy Indications

Indications

HIV-1 infection: in combination with other antiretroviral agents in patients ≥35kg; or in combination with other antiretroviral agents other than protease inhibitors (PI) that require a CYP3A inhibitor in children ≥14–<35kg. Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1, excluding from receptive vaginal sex, in at-risk patients ≥35kg.

Limitations of Use

Effectiveness in individuals at risk of HIV-1 from receptive vaginal sex has not been evaluated.

Descovy Dosage and Administration

Adults and Children

Test for HBV infection prior to initiation. HIV treatment: <14kg or (concomitant PI plus ritonavir or cobicistat in children <35kg or adults with CrCl <15mL/min ± hemodialysis): not established. 14–<25kg (and CrCl ≥30mL/min): 1 tab (120mg/15mg) once daily; 25–<35kg: 1 tab (200mg/25mg) once daily; ≥35kg (and CrCl ≥30mL/min) or adults (with CrCl <15mL/min) receiving chronic hemodialysis (on hemodialysis days, give dose after session): 1 tab (200mg/25mg) once daily. PrEP: <35kg: not established. Confirm negative HIV-1 prior to initiation. ≥35kg (and CrCl ≥30mL/min) or adults (with CrCl <15mL/min) receiving chronic hemodialysis (on hemodialysis days, give dose after session): 1 tab (200mg/25mg) once daily. Both: severe renal impairment (CrCl 15–<30mL/min) or ESRD (CrCl <15mL/min) not receiving chronic hemodialysis: not recommended.

Descovy Contraindications

Contraindications

PrEP: unknown or positive HIV-1 status.

Descovy Boxed Warnings

Boxed Warning

Post-treatment acute exacerbation of Hepatitis B. Risk of drug resistance with Descovy use for HIV-1 PrEP in undiagnosed early HIV-1 infection.

Descovy Warnings/Precautions

Warnings/Precautions

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, anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Risk of drug resistance with use for PrEP in undiagnosed HIV-1 infection. Do not initiate for PrEP if signs/symptoms of acute HIV infection present; use approved test and confirm negative status prior to initiation, at least every 3 months during therapy, and upon diagnosis of any other STIs. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. 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. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.

Descovy Pharmacokinetics

See Literature

Descovy Interactions

Interactions

Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. Avoid with concurrent or recent use of nephrotoxic agents. Concomitant tipranavir/ritonavir, antimycobacterials (eg, rifabutin, rifampin, rifapentine), St. John's wort: not recommended. May be antagonized by anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin; consider alternatives. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs).

Descovy Adverse Reactions

Adverse Reactions

Nausea, diarrhea; new onset or worsening renal impairment, immune reconstitution syndrome.

Descovy

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