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

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

emtricitabine/tenofovir DF/efavirenz

Note: tenofovir disoproxil fumarate (ie, tenofovir DF)

tablet

  • 200mg/300mg/600mg
more...

HIV Infection

1 tablet PO qDay on empty stomach (preferably qHS)

Dosage Modification

  • Rifampin coadministration in patient ≥50 kg: An additional 200 mg/day of efavirenz is recommended
  • Rifampin decreases level or effect of efavirenz by CYP3A4 induction

Renal & Hepatic Impairment

Moderate-to-severe (CrCl <50 mL/min): Not recommended

Hepatic Impairment

Mild hepatic impairment (Child-Pugh class A): Caution advised; no dosage adjustment required

Moderate or severe hepatic impairment (Child-Pugh Class B, C): Not recommended

Administration

Dosing at bedtime may increase tolerability to nausea/vomiting

Dosage Forms & Strengths

emtricitabine/tenofovir DF/efavirenz

Note: tenofovir disoproxil fumarate (ie, tenofovir DF)

tablet

  • 200mg/300mg/600mg
more...

HIV Infection

<12 years: Safety and efficacy not established

≥12 years and <40 kg: Not recommended

≥12 years and ≥40 kg: 1 tab PO qDay on empty stomach

Dosage Modification

  • Rifampin coadministration in patient ≥50 kg: An additional 200 mg/day of efavirenz is recommended
  • Rifampin decreases level or effect of efavirenz by CYP3A4 induction

Renal & Hepatic Impairment

Moderate-to-severe (CrCl <50 mL/min): Not recommended

Hepatic Impairment

Mild hepatic impairment (Child-Pugh class A): Caution advised; no dosage adjustment required

Moderate or severe hepatic impairment (Child-Pugh Class B, C): Not recommended

Administration

Dosing at bedtime may increase tolerability to nausea/vomiting

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Interactions

Interaction Checker

emtricitabine/tenofovir DF/efavirenz 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%

            Hypercholesterolemia (22%)

            1-10%

            Depression (9%)

            Dizziness (8%)

            Fatigue (9%)

            Insomnia (5%)

            Somnolence (4%)

            Abnormal dreams (4%)

            Rash (7%)

            Increased triglycerides (4%)

            Hyperglycemia (2%)

            Nausea (9%)

            Vomiting (2%)

            Incrased serum amylase (8%)

            Neutropenia (3%)

            Increased ALT (2%)

            Increased alkaline phosphatase (1%)

            Increased creatinine (9%)

            Hematuria (3%)

            Sinusitis (8%)

            Upper respiratory infection (8%)

            Nasopharyngitis (5%)

            <1%

            Gycosuria

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            Warnings

            Black Box Warnings

            emtricitabine

            • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues 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

            tenofovir

            • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy
            • Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue therapy
            • Resumption of antihepatitis B therapy may be warranted
            • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with nucleoside analogues alone or in combination

            Contraindications

            Hypersensitivity

            Concurrent administration with voriconazole

            Cautions

            (All NRTIs): Risk of potentially fatal lactic acidosis and severe hepatomegaly with steatosis

            Do not coadminister with drugs containing emtricitabine, tenofovir, lamivudine, or efavirenz

            Rash may occur; for patients with history of life-threatening rash (eg, Stevens-Johnson syndrome), discontinue therapy if severe rash develops

            Increased risk of renal impairment; estimate CrCl in all patients before initiating and avoid concurrent or recent use of nephrotoxic drugs

            History of hepatitis B or C

            May cause CNS depression (avoid hazardous tasks)

            May cause redistribution of fat (cushingoid appearance)

            Immune resonstitution syndrome may occur

            Use caution in patients with a history of seizures

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

            Caution in patients with predisposition to pshychological reactions

            Hepatic impairment

            • Not recommended with moderate-to-severe hepatic impairment because there are insufficient data
            • Patients with mild hepatic impairment may be treated with Atripla at the approved dose
            • Efavirenz extensively metabolized by CYP450; limited clinical experience in patients with hepatic impairment
            • Monitor liver enzymes in patients treated with other medications associated with liver toxicity

            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

            See also individual drugs

            • Emtricitabine
            • Tenofovir
            • Efavirenz
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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excretion in milk unknown/contraindicated

            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.

            more...
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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

            Efavirenz: Non-nucleoside reverse transcriptase inhibitor (NNRTI); binds to reverse transcriptase and blocks DNA polymerase activity; does not require phosphorylation for activity

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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