adefovir dipivoxil


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Related to adefovir dipivoxil: Entecavir, Tenofovir

adefovir dipivoxil

Hepsera

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.

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• lactic acidosis, renal or hepatic impairment
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

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Hepatic: severe hepatomegaly with steatosis, hepatitis exacerbation (if therapy is withdrawn)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

Interactions

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.

adefovir dipivoxil

an antiviral agent used to treat chronic hepatitis B.

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.

adefovir dipivoxil

Virology A nucleotide analogue effective against the polymerases of hepadnaviruses, retroviruses, herpesviruses, used to treat hepatitis Be antigen in adults with evidence of active viral replication, ↑ LFTs, or histologically active liver disease Adverse effects Renal damage requiring monitoring, diarrhea, nausea; in Pts with HBeAg-positive chronic hepatitis B, 48 wks of adefovir dipivoxil resulted in histologic liver improvement, reduced serum HBV DNA and alanine aminotransferase levels, and ↑ rates of HBeAg seroconversion. See AIDS, Hepatitis B.

adefovir dipivoxil

An antiviral drug used to treat chronic HEPATITIS B. A brand name is Hepsera.
References in periodicals archive ?
Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B.
Adefovir meets an urgent, unmet medical need and presents a potential life-saving treatment option for pre- and post-liver transplant patients with lamivudine-resistant HBV who are at high risk for morbidity and mortality," concluded the Adefovir Dipivoxil Study 435 International Investigators in their report published in the December issue of Hepatology.
Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir and valganciclovir.
Abacavir 60mg + Lamivudine 30 mg Tab, Activated Charcoal IP, Acyclovir eye ointment 5gm, Adefovir Dipivoxil Tablets / Capsules 10 mg, Busulphan Tablets IP 2 mg, Carbimazole Tab.
Long-term efficacy and safety of adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B.
has submitted a Marketing Authorisation Application (MAA) to the European Medicines Evaluation Agency (EMEA) for adefovir dipivoxil 10 mg.
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.
The market will see a significant shift in brand use: older drugs like lamivudine or adefovir dipivoxil will lose market share to newer treatments, including entecavir, tenofovir, and PEGylated interferon therapies.
NEW ORLEANS -- Longterm adefovir dipivoxil treatment of patients with chronic hepatitis B who were negative for hepatitis B e antigen was safe and effective and produced a low rate of drug-resistant mutants.
A panel of specialists convened by Gilead Sciences, the manufacturer of adefovir dipivoxil, developed the guidelines in response to new data and the availability of more sensitive assays.