adefovir (Rx)

Brand and Other Names:adefovir dipivoxil, Hepsera
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg
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Chronic Hepatitis B

10 mg PO qDay

Renal Impairment

CrCl ≥ 50 mL/min: Dose adjustment not necessary

CrCl 30-49 mL/min: 10 mg PO q48hr

CrCl 10-29 mL/min: 10 mg PO q72hr

Hemodialysis: 10 mg qWeek following dialysis

Dosage Forms & Strengths

tablet

  • 10mg
more...

Chronic Hepatitis B

<12 years old: Not recommended

≥12 years old: Administer as in adults, 10 mg PO qDay

Renal Impairment

CrCl ≥ 50 mL/min: Dose adjustment not necessary

CrCl 30-49 mL/min: 10 mg PO q48hr

CrCl 10-29 mL/min: 10 mg PO q72hr

Hemodialysis: 10 mg qWeek following dialysis

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Interactions

Interaction Checker

and adefovir

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hematuria (11% vs 10% in placebo-treated)

            Asthenia (13% vs. 14% placebo)

            Hepatitis exacerbation (25%)

            1-10%

            Nausea (5%)

            Flatulence (4%)

            Diarrhea (3%)

            Dyspepsia (3%)

            Headache (9%)

            Rash (1-10%)

            Pruritus (1-10%)

            Dyspepsia (5-9%)

            Cough (6-8%)

            Rhinitis (5%)

            Increased AST/ALT

            Abnormal liver function

            Renal failure

            Renal insufficiency

            Increased serum Cr (2-3%)

            Hypophosphatemia

            Postmarketing Reports

            Metabolism and nutrition disorders: Hypophosphatemia

            Gastrointestinal disorders: Pancreatitis

            Musculoskeletal system and connective tissue disorders: Myopathy, osteomalacia (manifested as bone pain and may contribute to fractures), both associated with proximal renal tubulopathy

            Renal and urinary disorders: Renal failure, Fanconi syndrome, proximal renal tubulopathy

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            Warnings

            Black Box Warnings

            Severe acute exacerbations of hepatitis reported following discontinuing drug; monitor hepatic function

            Chronic use may result in nephrotoxicity in patients with renal impairment or in those at risk of renal dysfunction; dose adjustment may be required

            Resistance to HIV NRTIs may emerge in patients with chronic hepatitis B in whom HIV infection is unrecognized or untreated

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogs alone or in combination with other antiretrovirals; obesity and prolonged nucleoside exposure may be risk factors

            Contraindications

            Hypersensitivity

            Concurrent use with products containing tenofovir disoproxil fumarate or tenofovir alafenamide

            Cautions

            Discontinuation may result in severe acute exacerbation of hepatitis B

            Patients who discontinue treatment: Monitor hepatic function for several months

            Patients with renal dysfunction: Risk of nephrotoxicity (monitor and adjust dose accordingly)

            Coadministration with drugs that reduce renal function may increase adefovir serum concentration

            Do not administer with tenofovir (additive toxicity)

            May increase HIV resistance in untreated patients who are HIV+

            Risk of lactic acidosis, severe hepatomegaly with steatosis

            To monitor fetal outcomes, Pregnancy Registry established: 1-800-258-4263

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            Pregnancy & Lactation

            Pregnancy

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

            Prospective pregnancy data from APR are not sufficient to adequately assess risk of birth defects, miscarriage or adverse maternal or fetal outcomes; adefovir disoproxil (ADV) use during pregnancy has been evaluated in a limited number of individuals reported to APR and the number of exposures to adefovir is insufficient to make a risk assessment compared to a reference population; estimated background rate for major birth defects is 2.7% in the U.S. reference population of Metropolitan Atlanta Congenital Defects Program (MACDP); estimated rate of miscarriage is not reported in APR; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes

            Animal data

            • In animal reproduction studies with oral ADV, no adverse developmental effects were observed at exposures (Cmax) 23 times higher in rats and 40 times higher in rabbits than those at recommended human dose (RHD)

            Lactation

            It is not known whether adefovir is present in human breast milk, affects human milk production, or has effects on breastfed infant

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            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

            Acyclic nucleotide analog; inhibits HBV DNA polymerase; inhibition blocks reverse transcriptase activity, which in turn reduces viral DNA synthesis

            Absorption

            Bioavailability: 59%

            Peak plasma time: 0.58-4 hr

            Peak plasma concentration: 18.4±6.26 ng/mL

            AUC: 220±70 ng•hr/mL

            Distribution

            Protein Bound: ≤ 4%

            Vd: 317-467 mL/kg

            Metabolism

            Rapidily converted to adefovir from the diester prodrug, adefovir dipivoxil

            Metabolites: Adefovir (active)

            Elimination

            Half-life: 7.48±1.65 hr

            Renal clearance: 231±48.9 mL/min

            Excretion: Urine; renal glomerular filtration, active tubular secretion

            Dialyzable: Yes

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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.

            Adding plans allows you to:

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