Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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
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.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
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.
Patient Handout
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.
Formulary
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