emtricitabine (Rx)

Brand and Other Names:Emtriva
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 200mg

oral solution

  • 10mg/mL
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HIV Infection

Capsule: 200 mg PO qDay

Oral Solution: 240 mg PO qDay

Renal Impairment

CrCl 50 mL/min or more: capsule 200 mg PO qDay; oral solution: 240 mg PO qDay

CrCl 30-49 mL/min: capsule 200 mg PO q48hr; oral solution: 120 mg PO qDay

CrCl 15-29 mL/min: capsule 200 mg PO q72hr; oral solution: 80 mg PO qDay

CrCl <15 mL/min: capsule 200 mg PO q96hr; oral solution: 60 mg PO qDay

Administration on day of hemodialysis: Administer after dialysis

Dosage Forms & Strengths

capsule

  • 200mg

oral solution

  • 10mg/mL
more...

HIV Infection

Indicated for treatment of HIV infection in combination with other antiretroviral agents

Oral solution

  • <3 months: 3 mg/kg PO qDay 
  • 3 months to 17 years: 6 mg/kg PO qDay; not to exceed 240 mgday (note: oral solution has 20% lower plasma exposure, so maximum daily dose is higher for the oral solution)

Capsule (weight >33 kg)

  • 200 mg PO qDay

Renal Impairment

Reduce dose and/or increase dosing interval

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Interactions

Interaction Checker

and emtricitabine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequencies based on combination treatment

            >10%

            Diarrhea (21-25%)

            Dizziness (21-25%)

            Headache (21-25%)

            Insomnia (21-25%)

            Rash (21-25%)

            Asthenia (16-20%)

            Nausea (16-20%)

            Rhinitis (16-20%)

            Abdominal pain (11-15%)

            Abnormal dreams (11-15%)

            Incr CK (11-15%)

            Incr cough (11-15%)

            Neuritis (11-15%)

            Paresthesia (11-15%)

            1-10%

            Depressive symptoms (6-10%)

            Dyspepsia (6-10%)

            Vomiting (6-10%)

            Incr triglycerides (6-10%)

            Myalgia (6-10%)

            <1%

            Lactic acidosis/severe

            Hepatomegaly with steatosis, including fatal cases; severe acute exacerbation of hepatitis B in patients coinfected with HIV-1 and HBV

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            Warnings

            Black Box Warnings

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

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

            Severe acute exacerbations of hepatitis B (HBV) reported in patients who are coinfected with HIV-1 and HBV and have discontinued therapy; hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue drug; if appropriate, initiation of anti-hepatitis B therapy may be warranted

            Contraindications

            Hypersensitivity

            Cautions

            All patients with HIV-1 should be tested for presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy; safety and efficacy of emtricitabine not established in patients coinfected with HBV and HIV-1; patients infected with HBV and treated with emtricitabine, the exacerbations of hepatitis B were associated with liver decompensation and liver failure; hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue therapy; if appropriate, initiation of anti-Hepatitis B therapy may be warranted

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogs, either alone or in combination with other antiretrovirals; suspend therapy in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)

            Should not be coadministered with combination antiretroviral agents containing emtricitabine or lamivudine

            Dose reduction recommended in patients with impaired renal function

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) reported to occur in the setting of immune reconstitution; however, time to onset is more variable, and can occur many months after initiation of treatment

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that 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

            Available data from the APR show no increase in overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) compared with background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage for individual drugs is not reported in APR

            Animal data

            • In animal reproduction studies, no adverse developmental effects were observed when FTC was administered at exposures ≥60 times that of recommended daily dose of drug

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1

            Based on published data, FTC has been shown to be present in human breast milk; it is not known if FTC 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 taking drug

            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

            Nucleoside reverse transcriptase inhibitor (NRTI); cytosine analog phosphorylated to emtricitabine 5'-triphosphate causing inhibition of HIV and RNA dependent DNA polymerase

            Pharmacokinetics

            Bioavailability: 93%

            Protein Bound: <4%

            Metabolism: Oxidation

            Dialyzable: 30% removed by hemodialysis

            Excretion: Urine (86%); feces (14%)

            Half-Life: 10 hr

            Peak PlasmaTime: 1-2 hr

            Concentration: 1.8±0.7 mcg/m

            LAUC: 10±3.1 hr.mcg/mL

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            Administration

            Oral Administration

            May take with or without food

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            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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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.