Hepavance Special Precautions

General Precautions: Patients should remain under the care of a physician while taking HEPAVANCE. They should discuss any new symptoms or concurrent medications with their physician.
Patients should be advised that treatment with HEPAVANCE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Patients should be advised to take HEPAVANCE on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
Patients should be advised to take a missed dose as soon as remembered unless it is almost time for the next dose. Patients should not take two doses at the same time.
Patients should be advised that treatment with HEPAVANCE will not cure HBV.
Patients should be informed that HEPAVANCE may lower the amount of HBV in the body, may lower the ability of HBV to multiply and infect new liver cells, and may improve the condition of the liver.
Patients should be informed that it is not known whether HEPAVANCE will reduce their chances of getting liver cancer or cirrhosis.
Severe Acute Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Patients Co-infected with HIV and HBV: HEPAVANCE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if HEPAVANCE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therefore, therapy with HEPAVANCE is not recommended for HIV/HBV co-infected patients who are not also receiving HAART. Before initiating HEPAVANCE therapy, HIV antibody testing should be offered to all patients. HEPAVANCE has not been studied as a treatment for HIV infection and is not recommended for this use.
Lactic Acidosis and Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors, including HEPAVANCE, alone or in combination with antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogue inhibitors to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors.
Lactic acidosis with HEPAVANCE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with HEPAVANCE 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).
Racial/Ethnic Groups: There are no significant racial differences in entecavir pharmacokinetics.
Renal Impairment: Dosage adjustment of HEPAVANCE is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or CAPD.
Liver Transplant Recipients: If HEPAVANCE treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with HEPAVANCE.
Use in Children: There are limited data available on the use of HEPAVANCE in lamivudine-experienced pediatric patients; HEPAVANCE should be used in these patients only if the potential benefit justifies the potential risk to the child. Since some pediatric patients may require long-term or even lifetime management of chronic active hepatitis B, consideration should be given to the impact of HEPAVANCE on future treatment options. The efficacy and safety of HEPAVANCE have not been established in patients less than 2 years of age. Use of HEPAVANCE in this age group has not been evaluated because treatment of HBV in this age group is rarely required.
Use in Elderly: Clinical studies of HEPAVANCE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.