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emtricitabine/tenofovir DF (Rx)Brand and Other Names:Truvada

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

emtricitabine/tenofovir DF (ie, tenofovir disoproxil fumarate)

tablet

  • 200mg/300mg
more...

HIV Infection

Indicated for HIV-infected individuals in combination with other antiretroviral agents

One 200 mg/300 mg tablet PO qDay

Pre-exposure Prophylaxis (CDC Guidelines)

Indication for pre-exposure prophylaxis (PrEP) in HIV-negative adults at high risk of acquiring HIV infection; for use in conjunction with other methods to avoid HIV infection

One 200 mg/300 mg tablet PO qDay

Recommendation based on CDC guidelines located at the following website - http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

PrEP indications

  • Men who have sex with men (MSM) at substantial lrisk of HIV acquisition
  • Adult heterosexually active men and women at substantial risk of HIV acquisition
  • Adult injection drug users (IDU) at substantial risk of HIV acquisition
  • Heterosexually-active women and men whose partners are known to have HIV infection (ie, HIV-discordant couples) to protect the uninfected partner during conception and pregnancy so that an informed decision can be made in awareness of what is known and unknown about benefits and risks of PrEP for mother and fetus

Identifying individuals at high risk

  • The following factors help to identify individuals at high risk for HIV:
  • 1. Has partner(s) known to be HIV-1 infected, or
  • 2. Engages in sexual activity within a high prevalence area or social network and 1 or more of the following:
  • a) Inconsistent or no condom use
  • b) Diagnosis or sexually transmitted infections
  • c) Exchange of sex for commodities (eg, money, food, shelter, drugs)
  • d) Illicit drug use or alcohol dependence
  • e) Incarceration
  • f) Partner(s) of unknown HIV-1 status with any of the risk factors listed above

Hepatitis B Treatment in HIV Coinfection or Resistant HBV

One 200 mg/300 mg tablet PO qDay

Dosage Modifications

Renal impairment

  • HIV infection
    • CrCl ≥50 mL/min: Dose adjustment not necessary
    • CrCl 30-49 mL/min: One 200 mg/300 mg tablet PO q48hr
    • CrCl <30 mL/min: Do not administer
    • Hemodialysis: Do not administer
  • PrEP
    • CrCl ≥60 mL/min or greater: Dose adjustment not necessary
    • CrCl <60 mL/min: Do not use for pre-exposure prophylaxis

Hepatic impairment

  • Dose adjustment not necessary in moderate-to-severe hepatic impairment

Dosing Considerations

Not recommended for use as a component of a triple nucleoside regimen

Should not be coadministered with combination products that are complete regimens or already contain emtricitabine or tenofovir (eg, Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, Viread)

Do not coadminister with lamivudine-containing products (eg, Epivir, Combivir, Dutrebis, Epzicom, Triumeq, Trizivir) because of similarities between emtricitabine and lamivudine

In treatment experienced patients, use should be guided by laboratory testing and treatment history

Dosage Forms & Strengths

emtricitabine/tenofovir (ie, tenofovir disoproxil fumarate)

tablet

  • 100mg/150mg
  • 133mg/200mg
  • 167mg/250mg
  • 200mg/300mg
more...

HIV Infection

Indicated in combination with other ART agents for HIV-1 infection children weighing at least 17 kg who can swallow the tablet whole

Weight <17 kg: Safety and efficacy not established

Weight ≥17 kg

  • 17 to <22 kg: One 100 mg/150 mg tablet PO qDay
  • 22 to <28 kg: One 133 mg/200 mg tablet PO qDay
  • 28 to <35 kg: One 167 mg/250 mg tablet PO qDay
  • ≥35 kg: One 200 mg/300 mg tablet PO qDay

Dosing Considerations

Not recommended for use as a component of a triple nucleoside regimen

Should not be coadministered with combination products that are complete regimens or already contain emtricitabine or tenofovir (eg, Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, Viread)

Do not coadminister with lamivudine-containing products (eg, Epivir, Combivir, Dutrebis, Epzicom, Triumeq, Trizivir) because of similarities between emtricitabine and lamivudine

In treatment experienced patients, use should be guided by laboratory testing and treatment history

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Interactions

Interaction Checker

emtricitabine/tenofovir DF and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Note: includes adverse effects of any severity rating

            Diarrhea

            Nausea

            Fatigue

            Headache

            Dizziness

            Depression

            Insomnia

            Abnormal dreams

            Rash

            1-10%

            Note: includes adverse effects grade 2-4

            Diarrhea (9%)

            Nausea (9%)

            Fatigue (9%)

            Depression (9%)

            Sinusitis (8%)

            URI infections (8%)

            Dizziness (8%)

            Rash event (7%)

            Headache (6%)

            Nasopharyngitis (5%)

            Insomnia (5%)

            Vomiting (2%)

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            Warnings

            Black Box Warnings

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues (including emtricitabine) alone or in combination with other antiretrovirals

            Not FDA approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients coinfected with HBV and HIV

            Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued emtricitabine/tenofovir therapy

            Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue therapy

            Pre-exposure prophylaxis (PrEP)

            • Use for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use
            • Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir for a PrEP indication following undetected acute HIV-1 infection
            • Do not initiate emtricitabine/tenofovir for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed

            Contraindications

            Hypersensitivity

            Do not use as PrEP in HIV-infected individuals or individuals with unknown HIV status

            Use as monotherapy in HIV-infected patients

            Cautions

            Risk of potentially fatal lactic acidosis and severe hepatomegaly with steatosis with all NRTIs

            Do not coadminister with other drugs containing emtricitabine or tenofovir

            Severe exacerbation of hepatitis B may occur upon discontinuation

            Risk of immune reconstitution syndrome

            Redistribution/ accumulation of body fat observed in patients receiving antiretroviral therapy

            Early virologic failure reported in HIV-infected patients; monitor and consider treatment modification

            If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection; while receiving therapy for PrEP HIV-1 screening tests should be repeated at least every 3 months

            Renal toxicity

            • Increased risk of new onset or worsening renal impairment
            • Estimate CrCl in all patients before initiating
            • Routinely monitor calculated creatinine clearance and serum phosphorus
            • Avoid use with CrCl <30 mL/min, hemodialysis, or concurrent or recent use of nephrotoxic drugs

            Bone effects of tenofovir

            • Bone mineral density may decrease
            • Osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported
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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: excretion in milk unknown/not recommended

            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: Nucleoside Reverse Transcriptase Inhibitor (NRTI); following hydrolysis and phosphorylation, inhibits HIV-1 reverse transcriptase by competing with AMP as substrate

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            Administration

            Oral Administration

            May take with or without food

            Swallow tablet whole; do not chew, crush, break, or dissolve

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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