Tecavir

Each film coated tablet contains: Entecavir Monohydrate 0.53 mg equivalent to Entecavir 0.5 mg; Entecavir Monohydrate 1.06 mg equivalent to Entecavir 1 mg.

Entecavir monohydrate is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and one evidence of continuous increase in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when starting therapy with Entecavir monohydrate: Indication is based on the patient's histologic, virological, biochemical and serological responses adults on nucleoside-treatment-naive resistant to lamivudine with HBV infection chronic HBeAg-positive or HBeAg-negative and compensated liver disease; Virological, biochemical, serological and safety data are available from controlled studies in adult patients with chronic HBV infection and decompensated liver disease; Virological, biochemical, serological and safety data are available for a small number of adult patients with HIV/HBV coinfection who have previously received lamivudine therapy.

Compensated liver disease: Recommended dose of Entecavir monohydrate for infection chronic hepatitis B virus in adults and adolescents aged 16 years and over who have not received nucleoside analogue treatment is 0.5 mg once daily with or without food.
Recommended dose of Entecavir monohydrate in adults and adolescents (≥ 16 years) with a history of hepatitis B viremia while receiving lamivudine or lamivudine resistance mutations is known to be 1 mg once daily which should be taken on an empty stomach (at least 2 hours after meals and 2 hours before the next meal).
Decompensated liver disease: The recommended dose of Entecavir monohydrate in adults with decompensated liver disease are 1 mg once daily, which should be taken on an empty stomach (at least 2 hours after eating and 2 hours before the next meal).
Kidney disorders: In patients with renal impairment, Entecavir monohydrate clearance is decreased when it is creatinine clearance decreased. Dosage adjustments are recommended for patients with creatinine clearance <50 mL/minute, including patients on hemodialysis or Continuous Ambulatory Peritoneal Dialysis (CAPD), such as those shown in the table as follows: See Table 1.


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* if given on the day of hemodialysis, give Entecavir monohydrate after the hemodialysis session.
Liver Disorders: No dosage adjustment is required for patients with liver disorders.
Duration of Therapy: Optimal duration of treatment with Entecavir monohydrate for patients with viral hepatitis infection B chronic and the relationship between treatment and long-term outcomes such as cirrhosis and carcinoma hepatocellular unknown.

Hypersensitivity.

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.

Lactic acidosis and severe hepatomegaly with steatosis.
Compensated Liver Disease: The most common adverse reactions of any severity which at least have possible association with study drug for patients who are treated with Entecavir monohydrate, are headache, fatigue, dizziness, and nausea. Clinical side effects of moderate-to-severe intensity (degrees 2-4) * can be seen in the following table: See Table 2.


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Including events that can occur, may occur, certain events or relationships that do not known on the treatment regimen.
Exacerbation of Hepatitis after Discontinuation of Therapy: If Entecavir monohydrate is stopped regardless of therapeutic response, the rate flares post-therapy may be higher.
Decompensated Liver Disease: In patients receiving Entecavir monohydrate, the side effects most commonly present with treatment of all levels of severity, regardless of causality, occurs up to week 48 is peripheral edema, ascites, pyrexia, hepatic encephalopathy, and upper respiratory tract infection.

Since Entecavir monohydrate is mainly excreted through the kidneys, giving Entecavir monohydrate along with drugs that reduce kidney function or compete for tubular secretions can increase serum concentrations of either Entecavir monohydrate or the drug given simultaneously. Co-administration Entecavir Monohydrate with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not produce significant drug interactions. The effect of giving Entecavir monohydrate concurrently with other drugs that are excreted via the kidneys or known to affect renal function has not been evaluated, and should be monitored closely against side effects in patients when Entecavir monohydrate is used together with the drug.

Antivirals

J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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