emtricitabine/tenofovir AF (Rx)

Brand and Other Names:Descovy
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

emtricitabine/tenofovir alafenamide (AF)

tablet

  • 200mg/25mg

HIV Infection

Indicated in combination with other antiretroviral agents (ARTs)

1 tablet PO qDay

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment required
  • Severe (CrCl <30 mL/min): Not recommended

Hepatic impairment

  • Mild-to-moderate (Child Pugh class A or B): No dosage adjustment required
  • Severe (Child Pugh class C): Not studied

Dosing Considerations

Not indicated for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Prior to initiating, patients should be tested for hepatitis B virus infection

Estimated CrCl, urine glucose, and urine protein should be assessed before initiating therapy and monitored during therapy in all patients

For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information

Dosage Forms & Strengths

emtricitabine/tenofovir alafenamide (AF)

tablet

  • 200mg/25mg

HIV Infection

Indications

  • Indicated in combination with other antiretroviral agents (ARTs), for pediatric patients ≥12 yr and ≥35 kg
  • In combination with other ARTs other than protease inhibitors requiring a CYP3A inhibitor in adolescents and children weighing 25-35 kg

Dosing

  • <12 years: Safety and efficacy not established
  • ≥12 years and weight ≥35 kg: 1 tablet PO qDay

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment required
  • Severe (CrCl <30 mL/min): Not recommended

Hepatic impairment

  • Mild-to-moderate (Child Pugh class A or B): No dosage adjustment required
  • Severe (Child Pugh class C): Not studied

Dosing Considerations

Not indicated for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Prior to initiating, patients should be tested for hepatitis B virus infection

Estimated CrCl, urine glucose, and urine protein should be assessed before initiating therapy and monitored during therapy in all patients

Safety and effectiveness of drug coadministered with an HIV-1 protease inhibitor, administered with either ritonavir or cobicistat not established in pediatric patients <35 kg

HIV-1 Infection (<12 yr) (Orphan)

Orphan designation for treatment of human immunodeficiency virus type 1 (HIV-1) infection in children aged <12 yr

Sponsor

  • Gilead Sciences, Inc; 333 Lakeside Drive; Foster City, California 94404
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Interactions

Interaction Checker

and emtricitabine/tenofovir AF

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    Contraindicated

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        Significant - Monitor Closely

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            Adverse Effects

            1-10%

            Nausea (10%)

            Bone mineral density (BMD) decline >5% (10%)

            Diarrhea (7%)

            Creatine kinase ≥10 x ULN (7%)

            Headache (6%)

            Fatigue (5%)

            LDL-C >190 mg/dL (5%)

            Total cholesterol >300 mg/dL (2%)

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            Warnings

            Black Box Warnings

            Not approved for treatment of chronic hepatitis B virus (HBV) infection; safety and efficacy not established in patients coinfected with HIV-1 and HBV; severe acute exacerbations of hepatitis B reported in patients coinfected with HIV-1 and HBV who discontinued products containing emtricitabine and/or tenofovir DF; may occur with discontinuation of emtricitabine/tenofovir AF

            Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients coinfected with HIV-1 and HBV; discontinue ARTs; if appropriate, initiation of antihepatitis B therapy may be warranted

            Contraindications

            None

            Cautions

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with the use of nucleoside analogs in combination with other ARTs; suspended treatment with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

            Patients with HIV-1 should be tested for the presence of chronic HBV infection before initiating ART therapy; emtricitabine/tenofovir AF is not approved for treatment of chronic HBV infection, and safety and efficacy not established in patients coinfected with HIV-1 and HBV (see Black Box Warnings)

            Immune reconstitution syndrome reported with combination ART therapy, including emtricitabine; during initial phase of combination ART treatment, patients whose immune system responds may develop inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment; autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome) may also emerge

            New-onset or worsening renal impairment reported with tenofovir, including cases of acute renal failure and Fanconi syndrome

            Not for administration with other drugs containing emtricitabine or tenofovir disoproxil fumarate, or containing tenofovir alafenamide, including Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, or Viread; due to similarities between emtricitabine and lamivudine, do not coadminister with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir)

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            Pregnancy

            Pregnancy

            Pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263

            There are insufficient human data on use during pregnancy to inform a drug-associated risk of birth defects and miscarriage; tenofovir alafenamide (TAF) use in women during pregnancy has not been evaluated; however, emtricitabine (FTC) use during pregnancy has been evaluated in a limited number of women reported to the APR

            Available data from APR show no difference in risk of overall major birth defects for FTC (2.4%) compared with background rate for major birth defects of 2.7% in a U.S. reference population of Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage is not reported in the APR

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed infants, to avoid risking postnatal transmission of HIV

            FTC has been shown to be present in human breast milk; not known if TAF is present in human breast milk; tenofovir has been shown to be present in milk of lactating rats and rhesus monkeys after administration of TDF; not known if TAF is present in animal milk

            Not known if drug combination affects milk production or has effects on breastfed child; because of potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are receiving therapy

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Emtricitabine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation, interferes with HIV viral DNA polymerase and inhibits viral replication; cytosine analogue

            Tenofovir AF: NRTI prodrug of tenofovir; compared with tenofovir disoproxil fumarate (tenofovir DF, Viread), tenofovir alafenamide (AF) is a more targeted form of tenofovir that has demonstrated high antiviral efficacy at a dose that is 10 times lower than tenofovir DF, as well as an improved renal and bone safety profile; inhibits HIV-1 RT by competing with the natural substrate deoxyadenosine 5′-triphosphate and, after incorporation into DNA, by DNA chain termination

            Absorption

            Emtricitabine

            • Peak plasma time: 3 hr
            • Peak plasma concentration: 2.1 mcg/mL
            • Trough plasma concentration: 0.1 mcg/mL
            • AUC: 11.7 mcg•hr/mL

            Tenofovir

            • Peak plasma time: 1 hr
            • Peak plasma concentration: 0.16 mcg/mL
            • AUC: 0.21 mcg•hr/mL

            Distribution

            Emtricitabine

            • Protein Bound: <4%

            Tenofovir

            • Protein Bound: 80%
            • Vd: 1.2-1.3 L/kg

            Metabolism

            Emtricitabine

            • Not significantly metabolized
            • Metabolized by oxidation

            Tenofovir

            • Tenofovir AF (TAF) is hydrolyzed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate
            • In vitro studies have shown that TAF is metabolized to tenofovir by cathepsin A in PBMCs and macrophages and by CES1 in hepatocytes
            • Upon coadministration with the moderate CYP3A inducer probe efavirenz, TAF exposure was unaffected

            Elimination

            Emtricitabine

            • Half-life: 10 hr
            • Dialyzable: 30% removed by hemodialysis
            • Excretion: 70% urine; 13.7% feces

            Tenofovir

            • Half-life: 0.51 hr
            • Excretion: 31.7% feces; <1% urine
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            Administration

            Oral Administration

            For oral use only

            Swallow 1 capsule once daily with or without food

            Storage

            Store <30°C (86°F)

            Keep container tightly closed

            Dispense only in original container

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.