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AURO-ENTECAVIR is a brand name for Entecavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
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, re-initiation of anti- hepatitis B therapy may be warranted (see ADVERSE REACTIONS: Exacerbations of Hepatitis After Discontinuation of Treatment). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including entecavir, alone or in combination with antiretrovirals.
Patients with decompensated liver disease may be at higher risk for lactic acidosis. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated.
Therapy with AURO-ENTECAVIR is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). (see WARNINGS AND PRECAUTIONS: Patients co-infected with HIV and HBV) General AURO-ENTECAVIR tablets contain lactose and are not recommended for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Carcinogenesis, Mutagenesis, Impairment of Fertility Positive carcinogenic results were found in two-year carcinogenicity studies with entecavir conducted in mice and rats. In male mice, increases in the incidences of lung adenomas were observed at exposures > 3 times the exposure in humans at 1 mg and lung carcinomas were observed in male and female mice at approximately 40 times the exposure in humans at 1 mg.
Tumor development was preceded by pneumocyte proliferation in the lung, which was not observed in rats, dogs, or monkeys administered entecavir, indicating that a key event in lung tumor development observed in mice likely was species specific.
Drug-related increased incidences of other types of tumors were seen at the highest entecavir exposures [in mice approximately 40 times and in rats 35 times (males) and 24 times (females) human exposure at 1 mg], including liver carcinomas in male mice, benign vascular tumors in female mice, brain microglial tumors in male and female rats, and liver adenomas and carcinomas in female rats.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Entecavir in Canada.
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6 mg/kg/day; equivalent to 24 times the exposure in humans at 1 mg) doses. (see TOXICOLOGY, Carcinogenesis, Mutagenesis, Impairment of Fertility for more detailed information). It is not known how predictive the results of rodent carcinogenicity studies may be for humans.
Entecavir was clastogenic to human lymphocyte cultures and in mouse lymphoma cells in vitro. Entecavir was not mutagenic in the Ames bacterial reverse mutation assay, a mammalian-cell Page 5 of 43 gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Entecavir was also negative in an oral micronucleus study and an oral DNA repair study in rats. In reproductive toxicology studies in which rats were administered entecavir at up to 30 mg/kg for up to 4 weeks, no evidence of impaired fertility was seen in males or females at systemic exposures >90 times those in humans at 1 mg.
In rodent and dog toxicology studies, seminiferous tubular degeneration was observed at ≥ 35 times the exposure in humans at 1 mg. No testicular changes were evident in monkeys administered entecavir for 1 year at 167 times the exposure in humans at 1 mg.
Liver Transplant Recipients The safety and efficacy of entecavir in liver transplant recipients are unknown. The potential for pharmacokinetic interaction between entecavir and the immunosuppressants cyclosporine A or tacrolimus was not formally evaluated.
If AURO-ENTECAVIR treatment is determined to be necessary for a liver transplant recipient who has received or is receiving cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with AURO-ENTECAVIR (see ACTION AND CLINICAL PHARMACOLOGY: Special Populations and DOSAGE AND ADMINISTRATION: Renal Impairment).
Renal Impairment Entecavir is predominantly eliminated by the kidney. Dosage adjustment of AURO- ENTECAVIR is recommended for patients with a creatinine clearance <50 mL/min, including patients on hemodialysis or CAPD [continuous ambulatory peritoneal dialysis] (see DOSAGE AND ADMINISTRATION: Renal Impairment).
Special Populations Patients co-infected with HIV and HBV Entecavir has not been evaluated in patients who are co-infected with HIV and HBV and are not concurrently receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated.
Therefore therapy with AURO-ENTECAVIR is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.
(See ACTION AND CLINICAL PHARMACOLOGY: Special Populations and Conditions, Patients Co-infected with HIV and HBV and CLINICAL TRIALS: Special Populations, Patients Co-infected with HIV and HBV). Before initiating AURO-ENTECAVIR therapy, HIV antibody testing should be offered to all patients.
Pregnant Women There are no adequate and well-controlled studies in pregnant women. AURO-ENTECAVIR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Entecavir caused […]