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Related to Hepsera: Tyzeka

adefovir dipivoxil


Pharmacologic class: Nucleotide reverse transcriptase inhibitor

Therapeutic class: Antiviral

Pregnancy risk category C

FDA Box Warning

• Severe acute hepatitis exacerbations have occurred after drug withdrawal. Monitor hepatic function closely for at least several months in patients who discontinue drug or other anti-hepatitis B therapy; if appropriate, resume such therapy.

• Long-term therapy may cause nephrotoxicity in patients with or at risk for underlying renal dysfunction. Monitor renal function closely and adjust dosage as needed.

• Human immunodeficiency virus (HIV) resistance may occur during therapy in patients with chronic hepatitis B infection who have unrecognized or untreated HIV infection.

• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) may occur with use of drug alone or combined with other antiretrovirals.


Inhibits hepatitis B virus (HBV) DNA polymerase and suppresses HBV replication


Tablets: 10 mg

Indications and dosages

Chronic HBV with active viral replication plus persistent elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or histologically active disease

Adults: 10 mg P.O. daily

Dosage adjustment

• Renal impairment


• Hypersensitivity to drug


Use cautiously in:

• lactic acidosis, renal or hepatic impairment

• elderly patients

• pregnant or breastfeeding patients

• children.


• Offer HIV testing before starting therapy. (Drug may increase resistance to antiretrovirals in HIV patients.)

• Give with or without food.

Adverse reactions

CNS: headache

GI: nausea, vomiting, diarrhea, abdominal pain, flatulence, dyspepsia, anorexia, pancreatitis

GU: renal dysfunction

Hepatic: severe hepatomegaly with steatosis, hepatitis exacerbation (if therapy is withdrawn)

Metabolic: lactic acidosis

Respiratory: pneumonia

Other: fever, infection, pain, antiretroviral resistance in patients with unrecognized HIV


Drug-drug. Acetaminophen, aspirin, indomethacin: granulocytopenia

Acyclovir, adriamycin, amphotericin B, benzodiazepines, cimetidine, dapsone, doxorubicin, experimental nucleotide analogue, fluconazole, flucytosine, ganciclovir, indomethacin, interferon, morphine, phenytoin, probenecid, sulfonamide, trimethoprim, vinblastine, vincristine: increased risk of nephrotoxicity

Drug-diagnostic tests. Amylase, blood glucose, blood urea nitrogen, creatine kinase, hepatic enzymes, lipase: elevated levels

Patient monitoring

• Monitor fluid intake and output.

• Watch for hematuria.

• Assess for signs and symptoms of lactic acidosis, especially in women and overweight patients.

• Check for liver enlargement.

• Monitor liver and kidney function test results.

• After therapy ends, monitor patient for evidence of serious hepatitis exacerbation.

Patient teaching

• Advise patient to take drug with or without food.

• Instruct patient to drink plenty of fluids to ensure adequate urine output.

• Advise patient to monitor urine output and color and to report significant changes.

• Tell patient that drug may cause weakness. Discuss appropriate lifestyle adjustments.

• Caution patient not to take over-the-counter analgesics without prescriber's approval.

• Inform patient that he'll undergo regular blood testing during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(a-def-oh-veer) ,


(trade name)


Therapeutic: antivirals
Pharmacologic: nucleotides
Pregnancy Category: C


Treatment of chronic hepatitis B in patients with evidence of active viral replication and either evidence of persistently elevated liver function tests or active disease (should be used with lamivudine to ↓ risk of resistance).


Converted to adefovir diphosphate which inhibits viral DNA polymerase (reverse transcriptase). Incorporation into viral DNA causes termination of the DNA chain.

Therapeutic effects

Decreased progression/sequelae of chronic hepatitis B infection.


Absorption: Rapidly converted from prodrug form (adefovir dipivoxil) to adefovir following oral administration; 59% bioavailable.
Distribution: 0.35–0.39 L/kg.
Metabolism and Excretion: Elimination is primarily renal as unchanged drug.
Half-life: 7.5 hr.

Time/action profile (blood levels)

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Contraindicated in: Hypersensitivity; Lactation: Provide formula or discontinue drug.
Use Cautiously in: Unrecognized HIV infection (may foster resistance); Patients with renal impairment or at risk of renal impairment (↑ risk of nephrotoxicity; dose adjustment recommended if CCr <50 mL/min); Liver disease or risk factors for liver disease (↑ risk of hepatotoxicity); Women, obese patients, patients with previous nucleoside exposure (↑ risk of lactic acidosis and hepatotoxicity); Geriatric: Greater risk of side effects due to greater risk of renal or cardiac disorders; Obstetric: Pregnant patients should be enrolled in the pregnancy registry for fetal outcome (1-800-258-4263); Pediatric: Children <12 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • headache


  • cough
  • pharyngitis
  • sinusitis


  • dyspepsia
  • hepatomegaly with steatosis (life-threatening)
  • abdominal pain
  • diarrhea
  • flatulence
  • ↑ liver enzymes
  • nausea
  • vomiting


  • hematuria
  • nephrotoxicity


  • pruritus
  • rash

Fluid and Electrolyte

  • lactic acidosis (life-threatening)


  • weakness


  • fever
  • HIV resistance


Drug-Drug interaction

Drugs that are renally excreted or alter renal function should be used cautiously as they may affect blood levels.Ibuprofen may increase blood levels.Should not be used with tenofovir -containing products.


Oral (Adults and Children ≥12 yr) 10 mg once daily.

Renal Impairment

Oral (Adults ) CCr 30–49 mL/min—10 mg every 48 hr; CCr 10–29 mL/min—10 mg every 72 hr; Hemodialysis patients—10 mg every 7 days following dialysis.

Availability (generic available)

Tablets: 10 mg

Nursing implications

Nursing assessment

  • May cause lactic acidosis and severe hepatomegaly with steatosis. Monitor patient for signs (increased serum lactate levels, elevated liver enzymes, liver enlargement on palpation). Therapy should be discontinued if clinical or laboratory signs occur.
  • Lab Test Considerations: Monitor viral load and CD4 cell count regularly during therapy in patients with HIV infection.Monitor liver function tests and hepatitis B virus levels throughout and following therapy. If therapy is discontinued, may cause severe exacerbation of hepatitis B.
    • Calculate creatinine clearance to determine dose prior to starting therapy.
    • Monitor renal function closely. May cause nephrotoxicity.

Potential Nursing Diagnoses

Risk for infection (Indications)
Noncompliance (Patient/Family Teaching)


  • Oral: Administer once daily with or without food.

Patient/Family Teaching

  • Instruct patient to take adefovir as directed and not to discontinue medication without consulting health care professional. Take missed dose as soon as it is remembered that day. Do not take more than 1 dose in a day. Consult health care professional if unsure of what to do. Discontinuation may result in exacerbation of hepatitis, usually within 12 wks of stopping. Regular liver function tests and hepatitis B virus levels are required if adefovir is discontinued. Advise the patient that adefovir does not cure hepatitis B, but may lower amount of hepatitis B in the body and decrease the ability of the virus to multiply and infect new liver cells. Instruct patient to read the Patient Information sheet prior to starting therapy.
  • Inform patient that an HIV test should be taken before starting adefovir and anytime when there is a chance patient was exposed to HIV.
  • Inform patient that adefovir does not reduce the risk of transmission of hepatitis B to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles, toothbrushes or razor blades, or donating blood to prevent spreading the hepatitis B virus to others.
  • Instruct patient to notify health care professional immediately if signs of lactic acidosis (weakness or tiredness, unusual muscle pain, dyspnea, stomach pain with nausea and vomiting, feelings of coldness especially in arms or legs, dizziness, lightheadedness, fast or irregular heartbeat) occur.
  • Caution patient to notify health care professional if signs of hepatotoxicity (jaundice, dark urine, light colored bowel movement, anorexia, nausea, bruising, lower stomach pain) occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patient to avoid breastfeeding and to notify health care professional if pregnancy is planned or suspected.
  • Emphasize the importance of regular blood tests to check hepatitis B virus levels, as well as renal and hepatic function.

Evaluation/Desired Outcomes

  • Decrease in progression of chronic hepatitis B. Patients with serum HBV levels >1000 copies/mL at week 48 of treatment are at greater risk for developing resistance and modification of therapy should be considered.
Drug Guide, © 2015 Farlex and Partners

Adefovir Dipivoxil

A nucleoside analogue antiviral which is effective against viral polymerases (hepadnaviruses, retroviruses—e.g., HIV—herpesviruses—e.g., CMV), and used to treat hepatitis B in adults who have evidence of active viral replication, increased LFTs, histologically active liver disease, and evidence of HBV resistant to other antivirals—e.g., lamivudine.
Benefits 48 weeks of adefovir dipivoxil results in histologic liver improvement, reduces serum HBV DNA and alanine aminotransferase (LFTs), and slows progression of chronic hepatitis B.
Adverse effects Renal toxicity requiring monitoring, asthenia, diarrhoea, dyspepsia, nausea, severe acute exacerbation of hepatitis B after discontinuing.
Mechanism of action Slows progression of chronic hepatitis B by interfering with viral replication and causing DNA chain termination after its incorporation into viral DNA.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.


A brand name for ADEFOVIR DIPIVOXIL.
Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
References in periodicals archive ?
Patients (84% for study 102 and 66% for study 103) who were originally randomised to Hepsera and were switched to Viread at the 48th week and received Viread in the following 192 weeks also maintained viral suppression.
Adefovir (Hepsera) is the most recent oral antiviral agent approved for chronic HBV.
Treatment with adefovir dipivoxil (Hepsera, Gilead Sciences) both prior to and following liver transplantation in patients with lamivudine-resistant chronic hepatitis B (HBV) infection, significantly improves virologic, biochemical, and clinical parameters, results of an open-label, compassionate use study indicate.
Participants will be given adefovir (brand name: Hepsera) or Viread to treat the hepatitis B.
Food and Drug Administration cleared Hepsera for marketing in the United States in September 2002.
Currently, Sigmapharm's product line consists of Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera tablets; Sodium Phenylbutyrate Powder, for urea cycle disorders, which is equivalent to Buphenyl powder; Acitretin Capsules, which is equivalent to Soriatane capsules, with a primary indication for the treatment of severe psoriasis; and Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable Liothyronine product on the market, with a recently Food and Drug Administration-approved shelf life of five years.
Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) said on Thursday that it has been notified that Sigmapharm Laboratories LLC has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA), seeking permission to manufacture and market a generic version of Hepsera (adefovir dipivoxil).
The rate of resistance after 4 years on adefovir dipivoxil (Hepsera) monotherapy is 18%.
Currently, Sigmapharm's product line consists of Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera tablets; Sodium Phenylbutyrate Powder, for urea cycle disorders, which is equivalent to Buphenyl powder; Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable liothyronine product on the market, with a shelf life of 36 months and soon to be 48 months; and Acitretin Capsules (AB-rated to Soriatane capsules), with a primary indication for the treatment of severe psoriasis.
Other Sigmapharm releases include Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable Liothyronine product on the market with a shelf life of 36 months; Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera Tablets; and Sodium Phenylbutyrate Powder, for urea cycle disorders, which is the first and only generic product equivalent to Buphenyl Powder.
Other antiviral product sales, including Viread, Hepsera and Emtriva, were down 6% to $233.1 million.
Adefovir dipivoxil was approved by the Food and Drug Administration in September 2002 for treatment of hepatitis B infection at a dosage of 10 mg/day, and is marketed as Hepsera by Gilead Sciences, the sponsor of this study.