Hepsera
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FDA Labeling Changes
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Uses
HEPSERA is 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.
For patients 12 to <18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function.
History
There is currently no drug history available for this drug.
Other Information
HEPSERA® is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV).
The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy]-phosphinyl]-methoxy]ethyl]adenine. It has a molecular formula of C20H32N5O8P, a molecular weight of 501.48 and the following structural formula:
Adefovir dipivoxil is a white to off-white crystalline powder with an aqueous solubility of 19 mg/mL at pH 2.0 and 0.4 mg/mL at pH 7.2. It has an octanol/aqueous phosphate buffer (pH 7) partition coefficient (log p) of 1.91.
HEPSERA tablets are for oral administration. Each tablet contains 10 mg of adefovir dipivoxil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc.
Sources
Hepsera Manufacturers
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Excella Gmbh
![Hepsera (Adefovir Dipivoxil) Tablet [Excella Gmbh]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hepsera | Excella Gmbh
2.1 Chronic Hepatitis BThe recommended dose of HEPSERA in chronic hepatitis B patients for patients ≥12 years of age with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.
HEPSERA is not recommended for use in children less than 12 years of age.
2.2 Dose Adjustment in Renal ImpairmentSignificantly increased drug exposures were seen when HEPSERA was administered to adult patients with renal impairment [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of HEPSERA should be adjusted in adult patients with baseline creatinine clearance <50 mL/min using the following suggested guidelines (see Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.
Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with HEPSERA. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1. Dosing Interval Adjustment of HEPSERA in Adult Patients with Renal Impairment Creatinine Clearance (mL/min)* ≥50 30–49 10–29 Hemodialysis Patients * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. 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
dialysisThe pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients.
No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [see Warnings and Precautions (5.2)].
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Gilead Sciences, Inc.
Hepsera | Gilead Sciences, Inc.
2.1 Chronic Hepatitis BThe recommended dose of HEPSERA 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.
HEPSERA is not recommended for use in children less than 12 years of age.
2.2 Dose Adjustment in Renal ImpairmentSignificantly increased drug exposures were seen when HEPSERA was administered to adult patients with renal impairment [See Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of HEPSERA 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.
Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with HEPSERA. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1 Dosing Interval Adjustment of HEPSERA in Adult Patients with Renal Impairment Creatinine Clearance (mL/min)* Greater than or equal to 50 30–49 10–29 Hemodialysis Patients * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. 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
dialysisThe pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 mL per minute; therefore, no dosing recommendation is available for these patients.
No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [See Warnings and Precautions (5.2)].
![Hepsera (Adefovir Dipivoxil) Tablet [Gilead Sciences, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60adac4-57c2-4089-aefc-1a77a48676fc&name=hepsera-02.jpg)
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