adefovir (Rx)

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

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg

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

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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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (3)

              • bacitracin

                adefovir and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

              • pretomanid

                pretomanid will increase the level or effect of adefovir by Other (see comment). Avoid or Use Alternate Drug. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.

              • tenofovir DF

                adefovir, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced nephrotoxicity. Avoid coadministration.

                adefovir increases levels of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. Avoid coadministration.

              Monitor Closely (19)

              • amikacin

                adefovir and amikacin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • amphotericin B deoxycholate

                adefovir and amphotericin B deoxycholate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.

              • cabozantinib

                adefovir will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity

              • capreomycin

                adefovir and capreomycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • carboplatin

                adefovir and carboplatin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • cidofovir

                adefovir and cidofovir both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.

              • cisplatin

                adefovir and cisplatin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • contrast media (iodinated)

                adefovir and contrast media (iodinated) both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • cyclosporine

                adefovir and cyclosporine both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                adefovir and elvitegravir/cobicistat/emtricitabine/tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • emtricitabine

                adefovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

              • ioversol

                adefovir and ioversol both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • neomycin PO

                adefovir and neomycin PO both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.

              • oxaliplatin

                adefovir and oxaliplatin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • peramivir

                adefovir increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

              • streptozocin

                adefovir and streptozocin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • tacrolimus

                adefovir and tacrolimus both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • teicoplanin

                adefovir and teicoplanin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • voclosporin

                voclosporin, adefovir. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (14)

              • acyclovir

                acyclovir and adefovir both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • cephaloridine

                adefovir and cephaloridine both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • colistin

                adefovir and colistin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • foscarnet

                adefovir and foscarnet both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • gentamicin

                adefovir and gentamicin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • ibuprofen

                ibuprofen increases levels of adefovir by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ibuprofen IV

                ibuprofen IV increases levels of adefovir by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • methoxyflurane

                adefovir and methoxyflurane both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • paromomycin

                adefovir and paromomycin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • pentamidine

                adefovir and pentamidine both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • polymyxin B

                adefovir and polymyxin B both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • streptomycin

                adefovir and streptomycin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • tobramycin

                adefovir and tobramycin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

              • vancomycin

                adefovir and vancomycin both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              adefovir oral
              -
              10 mg tablet
              adefovir oral
              -
              10 mg tablet
              Hepsera oral
              -
              10 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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