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JAMP 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…
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5 mg/day (n=679), entecavir 1 mg/day (n=183), or lamivudine (n=858) for up to two years (Studies AI463022, AI463027 for nucleoside-naïve patients and studies AI463014, AI463026 for lamivudine-refractory patients). The safety profiles of entecavir and lamivudine were comparable in these studies.
The safety profile of entecavir 1 mg (n=51) in HIV/HBV co-infected patients enrolled in Study AI463038 was similar to that of placebo (n=17) through 24 weeks of blinded treatment and similar to that seen in non-HIV infected patients.
(See WARNINGS AND PRECAUTIONS – Special Populations: Patients Co-infected with HIV and HBV) The most common (≥ 3%) adverse events of any severity with at least a possible relation to study drug for entecavir-treated patients were headache, fatigue, dizziness, and nausea.
The most common adverse events among lamivudine-treated patients were headache, fatigue, and dizziness. One percent of entecavir-treated patients in these four studies compared with 4% of lamivudine-treated patients discontinued for adverse events or abnormal laboratory test results.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Clinical adverse reactions occurring in ≥ 3% of entecavir-treated patients during therapy in four clinical studies in which entecavir was compared with lamivudine, in addition to selected clinical adverse reactions that occurred in < 3% of patients are presented in Table 1.
5 mg n = 679 % Lamivudine 100 mg n = 668 % entecavir 1 mg n = 183 % Lamivudine 100 mg n = 190 % Gastrointestinal Nausea 3 2 4 3 Abdominal pain upper 3 2 2 5 Dyspepsia 2 2 3 <1 Diarrhea 1 <1 2 1 Vomiting 1 <1 1 <1 General Fatigue 5 5 9 6 Nervous System Headache 8 8 10 7 Dizziness 4 3 5 2 Somnolence 1 1 2 1 Psychiatric Insomnia 2 1 1 <1 a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Studies AI463022 and AI463027 Mean duration of therapy was 69 weeks for entecavir-treated and 63 weeks for lamivudine-treated patients. 5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in patients who experienced recurrent viremia on lamivudine therapy.
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 JAMP 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 JAMP 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 5 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.
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Mean duration of therapy was 73 weeks for entecavir-treated and 51 weeks for lamivudine-treated patients. Exacerbations of Hepatitis After Discontinuation of Treatment In the Phase 3 studies, a subset of patients was allowed to discontinue treatment at or after 52 weeks if they achieved a protocol-defined response to therapy.
An exacerbation of hepatitis or ALT flare was defined as ALT >10 X ULN and >2 X the patient’s reference level (minimum of the baseline or last measurement at end of dosing). As demonstrated in Table 2, a proportion of patients experienced post-treatment ALT flares.
If entecavir is discontinued without regard to treatment response, the rate of post-treatment flares could be higher. 10 Table 2: Exacerbations of Hepatitis During Off-Treatment Follow-up, Patients in Studies AI463022 , AI463027 and AI463026 Patients with ALT Elevations > 10xULN and >2 x Referencea entecavir Lamivudine Total Nucleoside-naïve 28/476 (6%) 43/417 (10%) HBeAg-positive 4/174 (2%) 13/147 (9%) HBeAg-negative 24/302 (8%) 30/270 (11%) Lamivudine-refractory 6/52 (12%) 0/16 a Reference is the minimum of the baseline or last measurement at end of dosing.
Median time to off-treatment exacerbation was 23 weeks for entecavir-treated patients and 10 weeks for lamivudine-treated patients. Abnormal Hematologic and Clinical Chemistry Findings Frequencies of selected treatment-emergent laboratory abnormalities reported during therapy in four clinical trials of entecavir compared with lamivudine are listed in Table 3.
2 mmol/L and ALT >10 X ULN and >2 X baseline. 11 b Studies AI463022 and AI463027. . Mean duration of therapy was 69 weeks for entecavir-treated and 63 weeks for lamivudine-treated patients. c Includes Study AI463026 and the entecavir 1-mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational, randomized, […]
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.
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 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 JAMP 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 JAMP ENTECAVIR (see ACTION AND CLINICAL PHARMACOLOGY: Special 6 Populations and DOSAGE AND ADMINISTRATION: Renal Impairment).
Renal Impairment Entecavir is predominantly eliminated by the kidney. Dosage adjustment of JAMP 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 JAMP 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 JAMP ENTECAVIR therapy, HIV antibody testing should be offered to all patients.
Pregnant Women There are no adequate and well-controlled studies in pregnant women. JAMP ENTECAVIR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Entecavir caused effects on […]