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Anti Viral Antibiotics & HIV
    Home > Anti Viral Antibiotics & HIV > Adesera (Adefovir Dipivoxil)
 

Adesera (Adefovir Dipivoxil)
Select Ref Description Manufacturer Pack Size Strength Our Price
P971 Adesera (Adefovir Dipivoxil) Cipla 30 tabs 10 mg $ 52.06
Price is per pack & not per tab.. eg: if pack size is 10 tabs & price is $2.75 then for 100 tabs the price would be $27.50

What is it?


Adefovir Dipivoxil (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

Dosage and Administration


Chronic Hepatitis B

The recommended dose of Adefovir Dipivoxil (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.

Adefovir Dipivoxil (Hepsera) is not recommended for use in children less than 12 years of age.

Dose Adjustment in Renal Impairment

Significantly increased drug exposures were seen when Adefovir Dipivoxil (Hepsera) was administered to adult patients with renal impairment. Therefore, the dosing interval of Adefovir Dipivoxil (Hepsera) should be adjusted in adult patients with baseline creatinine clearance < 50 mL/min using the following suggested guidelines. 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 Adefovir Dipivoxil (Hepsera). Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

Dosage Forms And Strengths


Adefovir Dipivoxil (Hepsera) is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white and debossed with "10" and "GILEAD" on one side and the stylized figure of a liver on the other side.

Store in original container at 25 ° C (77 ° F), excursions permitted to 15-30 ° C (59-86 ° F).

Side Effects

Adverse reactions to Adefovir Dipivoxil (Hepsera) identified from placebo-controlled and open label studies include the following:

Asthenia
Headache
Abdominal pain
Diarrhea
Nausea
Dyspepsia
Flatulence
Increased creatinine
Hypophosphatemia

Special Risk Patients


Pre- and Post-Liver Transplantation Patients

Additional adverse reactions in pre- and post- liver transplantation patients with chronic hepatitis B and lamivudine-resistant hepatitis B:

Abnormal renal function
Renal failure
Vomiting
Rash
Pruritus

Warnings and Precautions


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 (Hepsera). 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 (Hepsera). If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Nephrotoxicity

Nephrotoxicity characterized by a delayed onset of gradual increases in serum creatinine and decreases in serum phosphorus was historically shown to be the treatment-limiting toxicity of adefovir dipivoxil therapy at substantially higher doses in HIV-infected patients (60 and 120 mg daily) and in chronic hepatitis B patients (30 mg daily). Chronic administration of Adefovir Dipivoxil (Hepsera) (10 mg once daily) may result in delayed nephrotoxicity. The overall risk of nephrotoxicity in patients with adequate renal function is low. However, this is of special importance in patients at risk of or having underlying renal dysfunction and patients taking concomitant nephrotoxic agents such as cyclosporine, tacrolimus, aminoglycosides, vancomycin and non-steroidal antiinflammatory drugs.

It is important to monitor renal function for all patients during treatment with Adefovir Dipivoxil (Hepsera), particularly for those with pre-existing or other risks for renal impairment. Patients with renal insufficiency at baseline or during treatment may require dose adjustment. The risks and benefits of Adefovir Dipivoxil (Hepsera) treatment should be carefully evaluated prior to discontinuing Adefovir Dipivoxil (Hepsera) in a patient with treatment-emergent nephrotoxicity.

Pediatric Patients

The efficacy and safety of Adefovir Dipivoxil (Hepsera) have not been studied in patients less than 18 years of age with different degrees of renal impairment and no data are available to make dosage recommendations in these patients. Caution should be exercised when prescribing Adefovir Dipivoxil (Hepsera) to adolescents with underlying renal dysfunction, and renal function in these patients should be closely monitored.

HIV Resistance

Prior to initiating Adefovir Dipivoxil (Hepsera) therapy, HIV antibody testing should be offered to all patients. Treatment with anti-hepatitis B therapies, such as Adefovir Dipivoxil (Hepsera), that have activity against HIV in a chronic hepatitis B patient with unrecognized or untreated HIV infection may result in emergence of HIV resistance. Adefovir Dipivoxil (Hepsera) has not been shown to suppress HIV RNA in patients; however, there are limited data on the use of Adefovir Dipivoxil (Hepsera) to treat patients with chronic hepatitis B co-infected with HIV.

Lactic Acidosis/Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals.

A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogs to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Adefovir Dipivoxil (Hepsera) should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Clinical Resistance

Resistance to adefovir dipivoxil can result in viral load rebound which may result in exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to liver decompensation and possible fatal outcome.

In order to reduce the risk of resistance in patients with lamivudine resistant HBV, adefovir dipivoxil should be used in combination with lamivudine and not as adefovir dipivoxil monotherapy.

In order to reduce the risk of resistance in all patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1000 copies/mL with continued treatment.

Overdose


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.


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