Tecavir Special Precautions

Severe Acute Exacerbation of Hepatitis B: Acute exacerbations of severe hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir monohydrate. Function of the liver should be closely monitored with clinical and laboratory follow-up at least during several months in a patient who discontinuing anti-hepatitis B therapy. If appropriate, initiate therapy anti-hepatitis B can be done.
Patients coinfected with HIV and HBV: Entecavir monohydrate has not been evaluated in HIV/HBV coinfected patients who are not coinfected concurrently receiving effective HIV treatment. Limited clinical testing shows there is potential for resistance to HIV-NRTIs if Entecavir monohydrate is used to treat chronic hepatitis B virus infection in patients with untreated HIV infection. Therefore, therapy with Entecavir monohydrate is not recommended for HIV/HBV coinfected patients who are also does not accept HAART. Before starting Entecavir monohydrate therapy, an HIV antibody test is mandatory offered to all patients. Entecavir monohydrate 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 due to the use of nucleoside analogues, including Entecavir monohyrate, single or deep combination with other antiretrovirals. Most of these cases occur in women. Obesity and Prolonged exposure to nucleoside agents can be a risk factor. Special attention must be performed when administering nucleoside analogues to patients with risk factors for liver disease; However, other cases have also been reported in patients with no known risk factors. Incident lactic acidosis due to use of Entecavir monohydrate has been reported, often associated with liver decompensation, other serious medical conditions, or drug exposure. Patients with disease decompensated liver may have a higher risk for lactic acidosis. Treatment with Entecavir monohydrate should be postponed in any currently patient who perform clinical or laboratory trials that show lactic acidosis or hepatotoxicity (that may include hepatomegaly and steatosis even in the absence of elevated transaminases real).
Kidney disorders: Entecavir monohydrate dosage adjustment is recommended for patients with creatinine clearance <50 mL / min, including patients on hemodialysis or CAPD.
Liver Transplant Recipients: Data regarding the safety and efficacy of Entecavir monohydrate in liver transplant recipients are still limited. Renal function should be monitored before and during Entecavir monohydrate therapy liver transplant recipients who are given immunosuppressants that can affect kidney function, such as cyclosporine or tacrolimus.