Adult Dosing

Treatment of chronic Hepatitis B

• 10 mg PO daily

Pediatric Dosing

Treatment of chronic Hepatitis B

• 12 yrs: 10 mg PO daily

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of chronic hepatitis B

• Hypersensitivity to any of the ingredients of the product

• Severe acute hepatitis exacerbations have been reported when drug was discontinued. Monitor hepatic function closely for several months if discontinuing treatment. Restart treatment if needed
• Chronic use of adefovir may result in nephrotoxicity in patients at risk of renal disease or with preexisting renal dysfunction. Monitor renal function closely and adjust dose as needed
• HIV resistance may emerge in chronic hepatitis B patients with untreated or unrecognized HIV when treated with adefovir
• Incidences of lactic acidosis and severe hepatomegaly with steatosis including fatal cases have been reported with the use of adefovir and other nucleoside analogues

Renal Dose Adjustment (Based on CrCl)

• 50 mL/min: 10 mg PO q24 hrs
• 49-20 mL/min: 10 mg PO q48 hrs
• 19-10 mL/min: 10 mg PO q72 hrs
• <10 mL/min: Not defined
• Hemodialysis: 10 mg q7 days following dialysis. No supplement required

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not indicated

• Monitor hepatic function closely for several months if discontinuing treatment as severe acute hepatitis exacerbations have been reported when drug was discontinued. Restart treatment if needed [US Black box warning]
• In patients at risk of renal disease or with preexisting renal dysfunction chronic use of adefovir may result in nephrotoxicity. Therefore monitor renal function closely and adjust dose as needed [US Black box warning]
• HIV antibody testing is recommended prior to initiating therapy. HIV resistance may emerge in chronic hepatitis B patients with untreated or unrecognized HIV when treated with adefovir [US Black box warning]
• Therapy may cause lactic acidosis and severe hepatomegaly with steatosis with the use of adefovir and other nucleoside analogues [US Black box warning]. Females, obese and prolonged nucleoside exposure may be at higher risk
• Concomitant use with tenofovir disoproxil fumarate not recommended

Cautions: Use cautiously in

• Renal impairment
• Risk factors for renal disease
• Risk factors for hepatic disease
• Nephrotoxic agent Use
• Long term nucleoside analogue use
• Pre/post liver transplant
• Discontinuation of drug
• Geriatric population

Pregnancy Category:C

Breastfeeding: Safety Unknown. Adefovir has not been studied in nursing mothers being treated for hepatitis B infection. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 January 2011).Manufacturer recommends discontinuation of breastfeeding, or postponing of treatment (taking into account the importance of the drug to the mother).

• CNS: Headache, asthenia
• RESP: Cough, pharyngitis, sinusitis
• GI: Dyspepsia, hepatomegaly with steatosis, abdominal pain, hepatotoxicity, hepatic failure, pancreatitis, diarrhea, flatulence, increased liver enzymes, nausea, vomiting, abdominal pain
• DERM: Pruritus, rash
• METABOLIC: Lactic acidosis, hypophosphatemia
• MUSC: Weakness, myopathy
• GU: Hematuria, nephrotoxicity, renal failure, proximal tubular nephropathy, Fanconi syndrome, elevated serum creatinine
• MISC: Fever, HIV resistance, osteomalacia, HBV exacerbation

• Antiviral; inhibits viral DNA polymerase. Incorporation into viral DNA causes termination of the DNA chain
• Following oral administration, adefovir dipivoxil (prodrug) is converted to adefovir
• Mainly metabolized by phosphorylation; CYP450: unknown
• Renally excreted: 45% unchanged
• Half-life: 7.5 hrs

US Trade Name(s)

• Hepsera

US Availability

adefovir (generic)

• TABS: 10 mg

Hepsera

• TABS: 10 mg

Canadian Trade Name(s)

• Hepsera

Canadian Availability

Hepsera

• TABS: 10 mg

UK Trade Name(s)

• Hepsera

UK Availability

Hepsera

• TABS: 10 mg

Australian Trade Name(s)

• Hepsera

Australian Availability

Hepsera

• TABS: 10 mg

[Outline]

Antimicrobials

Antiviral (HIV) Agents

NRTIs

Infectious Disease

Antiviral (HIV) Agents

NRTIs

Pricing data from www.DrugStore.com in U.S.A.

• Hepsera 10 MG TABS [Bottle] (GILEAD SCIENCES)
  30 mg = $1056.04
  90 mg = $3055.13

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Hepsera 10 MG Oral Tablet

Ingredient(s): Adefovir

Imprint: GILEAD;10

Color(s): White

Shape: Round

Size (mm): 7.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Excella GmbH

DEA Schedule:
Non-Scheduled

Drug Name: Hepsera 10 MG Oral Tablet

Pill Image:

[
See full size image]

Ingredient(s): Adefovir

Imprint: GILEAD;10

Color(s): White

Shape: Round

Size (mm): 7.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Gilead Sciences, Inc.

DEA Schedule:
Non-Scheduled