Entecavir is the generic equivalent of the brand-name drug Entecavir. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Entecavir through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions ( 5.3 )]. • In adults, the most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in pediatric pati…
Drug Interactions
7 DRUG INTERACTIONS Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology ( 12.3 )], coadministration of entecavir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of entecavir wit…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. (2.2) • Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. (2.3) • Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. (2.2) • Decompensated l…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment Inform patients that discontinuation of anti-hepatitis B therapy, including entecavir, may result in severe acute exacerbations of hepatitis B. Advise the patient to not discontinue entecavir without first informing their healthcare provider [see Warnings and Precautions ( 5.1 )]. Risk of Development of HIV-1 Resistance in Patients with HIV-1 Coinfection Inform patients that if they have or develop HIV infection and are not receivi…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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