Adefovir

Adefovir is an antiviral drug [See Microbiology ( 12.4 )].

• Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.ICD-10: B18.1

• Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.contraindicated

One tablet containing 10 mg adefovir dipivoxil once daily orally with or without food. ( 2.1 ) Dose adjustment in renal impairment for adults ( 2.2 ) Creatinine Clearance (mL/min) Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Greater than or equal to 50 30 to 49 10 to 29 Hemodialysis Patients Recommended dose and dosing interval 10 mg every 24 hours 10 mg every 48 hours 10 mg every 72 hours 10 mg every 7 days following dialysis No dose recommendations for ( 2.1 ): Non-hemodialysis patients with creatinine clearance less than 10 mL per minute. Adolescent patients with renal impairment. 2.1 Chronic Hepatitis B The recommended dose of adefovir dipivoxil tablets in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown. Adefovir dipivoxil tablets are not recommended for use in children less than 12 years of age. 2.2 Dose Adjustment in Renal Impairment Significantly increased drug exposures were seen when adefovir dipivoxil tablets were administered to adult patients with renal impairment [See Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] . Therefore, the dosing interval of adefovir dipivoxil tablets should be adjusted in adult patients with baseline creatinine clearance less than 50 mL per minute using the following suggested guidelines (See Table 1 ). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.

Severe acute exacerbations of hepatitis: Monitor hepatic function closely at repeated intervals for at least several months in patients who discontinue adefovir dipivoxil. ( 5.1 ) Nephrotoxicity: Monitor renal function during therapy for all patients, particularly those with pre-existing or other risks for renal impairment. Dose adjustment may be required. ( 5.2 ) HIV Resistance: Offer HIV testing to all patients prior to initiating adefovir dipivoxil. Untreated HIV may result in HIV resistance. ( 5.3 ) Lactic acidosis and severe hepatomegaly with steatosis: If suspected, suspend treatment. ( 5.4 ) Coadministration with Other Products: Do not administer adefovir dipivoxil concurrently with VIREAD ® or other tenofovir-containing products. ( 5.5 ) Clinical Resistance: For patients with lamivudine-resistant HBV use adefovir dipivoxil in combination with lamivudine. For all patients, consider modifying treatment in case serum HBV DNA remains above 1000 copies/mL with continued treatment. ( 5.6 ) 5.1 Exacerbation of Hepatitis after Discontinuation of Treatment Severe acute exacerbation of hepatitis has been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with adefovir dipivoxil. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least several months in patients who discontinue adefovir dipivoxil. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

The following adverse reactions are discussed in other sections of the labeling: Severe acute exacerbations of Hepatitis [ S ee Boxed Warning , Warnings and Precautions (5.1) ] Nephrotoxicity [See Boxed Warning , Warnings and Precautions (5.2) ] Most common adverse reaction (incidence greater than 5%) in compensated liver disease patients were asthenia, headache, abdominal pain and nausea. ( 6.1 ) The most common adverse reaction in pre- and post- transplantation lamivudine-resistant liver disease patients was increased creatinine. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with adefovir dipivoxil. Adverse reactions to adefovir dipivoxil identified from placebo-controlled and open label studies include the following: asthenia, headache, abdominal pain, diarrhea, nausea, dyspepsia, flatulence, increased creatinine, and hypophosphatemia.

• Pediatrics: Not recommended in children less than 12 years of age. ( 2.1 , 8.4 , 14.4 ) Renal Impairment: Dose adjustment may be required. ( 2.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adefovir dipivoxil during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263. Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the 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 the APR and the number of exposures to adefovir is insufficient to make a risk assessment compared to a reference population. The estimated background rate for major birth defects is 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The estimated rate of miscarriage is not reported in the APR. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background rate of miscarriage in the U.S. general population is 15–20%.

Metabolism

Adult Subjects The pharmacokinetics of adefovir have been evaluated in healthy volunteers and patients with chronic hepatitis B. Adefovir pharmacokinetics are similar between these populations.

Doses of adefovir dipivoxil 500 mg daily for 2 weeks and 250 mg daily for 12 weeks have been associated with gastrointestinal side effects. If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Following a 10 mg single dose of adefovir dipivoxil, a four-hour hemodialysis session removed approximately 35% of the adefovir dose.

• Aug 29, 2013ANDAANDA202051Sigmapharm Labs Llc
• Jul 6, 2018ANDAANDA205459Apotex

1. 1Drug Resistance27522%
2. 2Osteomalacia22418%
3. 3Hypophosphataemia16313%
4. 4Osteoporosis15412%
5. 5Pathogen Resistance15212%
6. 6Drug Ineffective1269.9%
7. 7Viral Mutation Identified1239.7%
8. 8Bone Pain1189.3%
9. 9Fanconi Syndrome Acquired987.7%
10. 10Arthralgia836.5%
11. 11Fanconi Syndrome786.2%
12. 12Viral Load Increased776.1%
13. 13Blood Alkaline Phosphatase Increased645.0%
14. 14Gait Disturbance604.7%
15. 15Pain604.7%

The 10 most recently updated of 146 ClinicalTrials.gov registrations naming Adefovir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Halting Nucleoside Analogues in Chronic Hepatitis B
  Active not recruiting · Interventional · 120 enrolled · Seng Gee Lim
  NCT04102176updated 2025-07-14
• Prevention of Recurrent Hepatitis B After Liver Transplantation
  Completed · Observational · 317 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT00059267updated 2024-11-15
• Carvedilol for Prevention of Esophageal Varices Progression
  Unknown · Interventional · 240 enrolled · Beijing Friendship Hospital
  NCT03736265updated 2022-12-01
• Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders
  Completed · Observational · 60 enrolled · Pacific Health Foundation
  NCT00704106updated 2022-11-14
• Effects of Antiviral Therapy on Patients With HBV-related HCC
  Completed · Observational · 494 enrolled · First Affiliated Hospital Xi'an Jiaotong University
  NCT05406089updated 2022-06-21
• Study Comparing the Safety of Switching From Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir Before Adefovir Dipivoxil Monotherapy in Patients With Chronic Hepatitis B
  Completed · Phase 4 · Interventional · 40 enrolled · Thomas Jefferson University
  NCT00307242updated 2021-11-12
• A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
  Completed · Interventional · 300 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00000892updated 2021-11-04
• The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
  Completed · Phase 2 · Interventional · 300 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00001087updated 2021-11-01
• Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
  Withdrawn · Phase 2 · Interventional · 0 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00051077updated 2021-11-01
• A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
  Completed · Phase 2 · Interventional · 90 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00033163updated 2021-11-01

Frequently asked questions

How does Adefovir work?

Adefovir is an antiviral drug [See Microbiology ( 12.4 )].

What is Adefovir used for?

According to FDA labeling, Adefovir carries indications including: Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Adefovir?

Adefovir is classified as Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitors, Decreased Reverse Transcription to DNA, Increased Immunologically Active Molecule Activity.

What are the brand names for Adefovir?

Adefovir is marketed under brand names including Hepsera.

What are the contraindications for Adefovir?

Adefovir labeling lists contraindications including: Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.. Always consult the full prescribing information and a clinician.