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tenofovir DF (Rx)Brand and Other Names:Viread

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tenofovir disoproxil fumarate (ie, tenofovir DF)

tablet

  • 150mg
  • 200mg
  • 250mg
  • 300mg

powder, oral

  • 40mg/g of powder (ie, 1 scoopful)
more...

HIV Infection

Indicated in combination with other antiretroviral agents for treatment of HIV-1 infection

300 mg PO qDay

Also available combined with emtricitabine (Truvada), emtricitabine/efavirenz (Atripla), emtricitabine/rilpivirine (Complera)

Hepatitis B Infection

Indicated for chronic hepatitis B

300 mg PO qDay

Renal Impairment

CrCl ≥50 mL/min: Dose adjustment not necessary

CrCl 30-49 mL/min: 300 mg PO qODay

CrCl 10-29 mL/min: 300 mg PO q72-96hr

CrCl <10 mL/min: Not studied

Hemodialysis: 300 mg PO q7Days or ~12 hr after

Administration

Take with or without food

Administer at least 2 hours before or 1 hour after didanosine

Oral powder

  • Measure oral powder only with supplied dosing scoop
  • 1 level scoopful = 40 mg
  • 300 mg = 7.5 scoops
  • Mix oral powder in a container with 2-4 ounces of soft food not requiring chewing (eg, applesauce, baby food, yogurt); the entire mixture should be ingested immediately to avoid a bitter taste

Dosage Forms & Strengths

tenofovir disoproxil fumarate (ie, tenofovir DF)

tablet

  • 150mg
  • 200mg
  • 250mg
  • 300mg

powder, oral

  • 40mg/g of powder (ie, 1 scoopful)
more...

HIV Infection

<2 years: Safety and efficacy not established

>2 years: 8 mg/kg PO qDay; not to exceed 300 mg/day 

Hepatitis B Infection

Indicated for chronic hepatitis B in children aged 12 years or older

<12 years: Safety and efficacy not established

>12 years; <35 kg: Safety and efficacy not established

>12 years; >35 kg: 300 mg PO qDay 

Administration

Take with or without food

Administer at least 2 hours before or 1 hour after didanosine

Oral powder

  • Measure oral powder only with supplied dosing scoop
  • 1 level scoopful = 40 mg
  • 300 mg = 7.5 scoops
  • Mix oral powder in a container with 2-4 ounces of soft food not requiring chewing (eg, applesauce, baby food, yogurt); the entire mixture should be ingested immediately to avoid a bitter taste
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Interactions

Interaction Checker

tenofovir DF and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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            Adverse Effects

            >10%

            Asthenia (11%)

            Diarrhea (16%)

            Nausea (11%)

            Pain (12%)

            1-10%

            Anorexia

            Depression

            Myalgia

            Peripheral neuropathy

            Dyspepsia

            Rash

            Headache

            Vomiting

            Flatulence

            Abdominal pain

            Neutropenia

            Incr transaminases

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            Warnings

            Black Box Warnings

            Hepatitis B Treatment

            • Severe acute exacerbations of hepatitis B reported in patients who have discontinued therapy for hepatitis B
            • 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 therapy for hepatitis B may be warranted

            Lactic Acidosis

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

            Contraindications

            Hypersensitivity

            Concurrent or recent nephrotoxic drugs

            Cautions

            Should not be coadministered with combination antiretroviral agents containing tenofovir

            Immune reconstitution syndrome may occur if used in combination with other antiretroviral drugs

            Risk of lactic acidosis and severe hepatomegaly with all NRTIs

            Additive toxicity when coadministered with adefovir

            Acute exacerbations of hepatitis in patients with HBV if drug is stopped

            May cause redistribution/accumulation of body fat that may result in cushingoid appearance

            Renal toxicity

            • Increased risk of renal impairment; estimate CrCl in all patients before initiating and avoid concurrent or recent use of nephrotoxic drugs
            • 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: HIV+ women are advised not to breastfeed

            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

            NRTI; analog of adenosine 5'-monophosphate that inhibits HIV-1 reverse transcriptase by competing with AMP as substrate, which results in the inhibition of viral replication

            Absorption

            Bioavailability: 25% (fasting); increases ~40% with high-fat meal

            Peak Plasma Time: 1 hr (fasting); 2 hr (with food)

            Distribution

            Protein Bound: <7% to serum proteins

            Vd: 1.2-1.3 L/kg

            Metabolism

            Metabolism: not by CYP; converted intracellularly by hydrolysis to tenofovir, then phosphorylated to active tenofovir diphosphate

            Elimination

            Excretion: urine (70-80%) via filtration and active secretion, primarily as unchanged tenofovir

            Half-life: 17 hr

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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.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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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