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Related to adefovir: telbivudine, Entecavir


(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
References in periodicals archive ?
The purpose of this review is to discuss four new anti-HIV agents: Sustiva[TM] (efavirenz), Ziagen[TM] (abacavir), Agenerase[TM] (amprenavir), and Preveon[R] (adefovir dipivoxil).
Virological resistance to lamivudine in five years was detected in 57.5% and to adefovir in 51.8%.
We retrospectively enrolled consecutive CHB patients who were treated with telbivudine (600 mg once daily) at Kaohsiung Veterans General Hospital from 2008 to 2010 in our two previous cohort studies, which were designed with two purposes: (1) to verify the roadmap model through adefovir add-on therapy at month 6 and (2) to investigate the role of genotype and the kinetics of quantitative hepatitis B surface antigen on the efficacy of telbivudine therapy [27].
To date, lamivudine and/or adefovir have been used in combination with HBIG and this has reduced the risk of recurrent hepatitis B to <10%.
In the phase III trial, 375 patients with chronic hepatitis B infection were randomized to either 300 mg/day tenofovir or 10 mg/day adefovir. The primary end points were suppression of viral DNA to below 400 copies/mL and reduction of at least 2 points in the Knodell necroinflammatory score without worsening of fibrosis.
Gilead Sciences, Inc., Foster City, CA announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for marketing approval of adefovir dipivoxil 10 mg.
One hundred and one patients were naive, and 49 patients experienced NA treatment (20 lamivudine, 18 entecavir, 8 adefovir dipivoxil, and 3 telbivudine) for a median of 24 months (range: 6–108 months), in which 38 patients with undetectable HBV DNA load and 12 patients with positive for serum HBV DNA load.
(1) Nucleos(t)ide analogues (NAs), including lamivudine (LAM), adefovir (ADV), telbivudine (LdT), entecavir (ETV), and tenofovir (TDF) were recommended by international guidelines for suppressing HBV replication, and have been shown to decrease the rate of complications.
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.