Orata Special Precautions

Lactic acidosis and hepatomegaly with steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases has been reported with the use of nucleoside analogue alone or in combination with antiretroviral.
Exacerbations of hepatitis after discontinuation of treatment: Acute exacerbation of hepatitis has been reported in patients who have discontinued HBV therapy, including therapy with entecavir. The majority of post treatment exacerbations appear to be self-limited. However severe exacerbation including fatalities, may occur. The causal relationship of these event to discontinuation of the therapy is unknown. If appropriate, resumption of HBV therapy may be warranted.
Co-infection with HIV: Entecavir may cause the development of HIV resistance in chronic hepatitis B patients with unrecognized or untreated HIV infection. Not recommend for HIV/HBV coinfected patients unless also receiving highly active antiretroviral therapy regimen (HAART regimen).
Renal Impairment: Dosage adjustment of entecavir is recommended for patient renal impairment. (See Renal Impairment under Dosage & Administration.)
Liver Transplant Recipients: The safety and efficacy of entecavir in liver transplant recipients are unknown. If entecavir treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function eg, cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with entecavir.
Information for Patients: Should advice patients that entecavir inhibits virus replication but cannot cure a disease. No evidence supports that entecavir can reduce a risk of transmission of hepatitis B virus. Therefore, should advice patients to more adherence because in some case, stopping entecavir may cause more severe hepatitis B or serious liver problem.