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

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    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

              Patient Education
              adefovir oral

              ADEFOVIR DIPIVOXIL - ORAL

              (a-DEF-oh-vir DYE-piv-OX-il)

              COMMON BRAND NAME(S): Hepsera

              WARNING: Severe worsening of hepatitis (rarely including death) has occurred when treatment with adefovir dipivoxil is stopped. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. If you are instructed to stop taking this medication, be sure to keep all doctor and lab appointments after you stop taking this drug.Rarely, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred in patients (especially if overweight) while using similar types of medication (nucleoside analogs such as didanosine or stavudine). Tell your doctor right away if you have unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, abdominal or stomach pain, drowsiness, muscle aches or weakness, trouble breathing (such as rapid breathing or very shallow breathing), or fast or irregular heartbeat.In patients with kidney disease, adefovir dipivoxil can cause kidney problems. Tell your doctor right away if you develop signs of kidney problems such as a change in the amount of urine.If you get or have HIV infection that is not being treated with medication, adefovir dipivoxil may cause your HIV infection to become untreatable with the usual HIV drugs (development of HIV resistance). Talk to your doctor or pharmacist for more details.

              USES: This medication is used to treat a chronic viral infection of the liver (hepatitis B) in people 12 years of age and older. It works by slowing the growth of the virus, helping to lower the amount of virus in your body. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others.This medication is a nucleotide analog.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking adefovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.Use this medication regularly to the get the most benefit from it. To help you remember, take it at the same time each day. Do not increase or decrease your dose or stop taking this medication unless directed to do so by your doctor or pharmacist. Refill your medication before it runs out.Treatment with adefovir alone is not appropriate for patients infected with both hepatitis B and HIV. An HIV test is recommended both before and during treatment to ensure you receive appropriate treatment. Consult your doctor or pharmacist for more information.Worsening of your condition, decreased response to treatment, or infection by resistant strains of the virus may occur during or after treatment. Tell your doctor right away of any new symptoms that occur during or after treatment.

              SIDE EFFECTS: See also Warning section.Weakness, headache, fever, increased cough, nausea, vomiting, diarrhea, or gas may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking adefovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney problems, liver transplant.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: cidofovir, nonsteroidal anti-inflammatory drugs (such as ibuprofen).Do not take products that contain tenofovir with this medication.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.To avoid spreading hepatitis B to others, practice "safer sex" and always use an effective barrier method (such as latex condoms/dental dams) during sexual activity. Do not share needles. Talk to your doctor or pharmacist for more details.Lab and/or medical tests (such as kidney function, liver function tests, and HIV tests) may be done while you are taking this medication. Keep all lab and medical appointments during and for several months after treatment. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, use it as soon as you remember that day. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.
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              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.