Entecavir | Buy Entecavir Online
Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection.
• Entecavir tablets USP, 0.5 mg are white to off white, triangle shaped, biconvex, film-coated tablets, debossed with ‘J’ on one side and ‘110ʼ on the other side.
• Entecavir tablets USP, 1 mg are pink, triangle shaped, biconvex, film-coated tablets, debossed with ‘J’ on one side and ‘111’ on the other side.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
Entecavir Tablets, USP
Important Safety Information – This summary does not contain all details required for the safe and effective use of ENTECAVIR TABLETS. Please refer to the full prescribing information.
ENTECAVIR Tablets, Oral Use
Initial U.S. Approval: 2005
WARNING: SEVERE EXACERBATIONS OF HEPATITIS B, HIV/HBV CO-INFECTION, AND LACTIC ACIDOSIS WITH HEPATOMEGALY
Refer to the full prescribing information for the complete boxed warning.
Severe acute exacerbations of hepatitis B have occurred in patients who stopped anti-hepatitis B treatment, including entecavir. Liver function should be monitored closely for several months after stopping therapy. Restarting treatment may be necessary.
Entecavir is not recommended for HIV/HBV co-infected patients who are not receiving highly active antiretroviral therapy (HAART), due to the risk of developing resistance to HIV nucleoside reverse transcriptase inhibitors.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal outcomes, have been reported in patients treated with nucleoside analogues.
DOSAGE AND ADMINISTRATION
For patients aged 16 and older with compensated liver disease who have not previously received nucleoside inhibitor treatment: take 0.5 mg once daily.
For pediatric patients (aged 2 years and older, weighing at least 10 kg) who are nucleoside-inhibitor-treatment-naïve or have prior lamivudine experience: dosage is weight-based.
For patients aged 16 and older with lamivudine-refractory hepatitis B or known resistance to lamivudine or telbivudine: take 1 mg once daily.
For adults with decompensated liver disease: take 1 mg once daily.
For patients with renal impairment (creatinine clearance < 50 mL/min): dosage adjustment is recommended. (Refer to section 2.4)
Entecavir tablets should be taken on an empty stomach.
• Tablets: 0.5 mg and 1 mg
HOW SUPPLIED/STORAGE AND HANDLING
Entecavir tablets USP, 0.5 mg are white to off white, triangle shaped, biconvex, film-coated tablets, debossed with ʽJʼ on one side and ʽ110ʼ on the other side and supplied as:
Bottles of 30 tablets NDC 31722-833-30
Bottles of 90 tablets NDC 31722-833-90
Blister card of 10 unit dose tablets NDC 31722-833-31
Blister pack of 100 (10 x 10) unit dose tablets NDC 31722-833-32
Entecavir tablets USP, 1 mg are pink, triangle shaped, biconvex, film-coated tablets, debossed with ʽJʼ on one side and ʽ111ʼ on the other side and supplied as:
Bottles of 30 tablets NDC 31722-834-30
Bottles of 90 tablets NDC 31722-834-90
Blister card of 8 unit dose tablets NDC 31722-834-31
Blister pack of 80 (10 x 8) unit dose tablets NDC 31722-834-32
Storage
Entecavir tablets should be stored in a tightly closed container at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature]. Protect from light.
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PATIENT COUNSELING INFORMATION
Refer to the FDA-approved Patient Information for additional guidance.
Severe Hepatitis B Exacerbation After Stopping Treatment
Patients should be informed that stopping anti-hepatitis B treatment, including entecavir, can cause severe, acute flare-ups of hepatitis B. They should not discontinue entecavir without first consulting their healthcare provider. [See Warnings and Precautions]
Risk of HIV-1 Resistance in Co-infected Patients
Advise patients that if they have or acquire HIV infection and are not on effective HIV treatment, taking entecavir may contribute to HIV drug resistance.
Lactic Acidosis and Severe Hepatomegaly
Inform patients that lactic acidosis and severe liver enlargement with fat accumulation—sometimes fatal—have been reported with entecavir and similar medications. Patients should stop taking entecavir and contact their healthcare provider immediately if they experience symptoms suggestive of these conditions. [See Warnings and Precautions]
Missed Doses
Patients should be reminded to take entecavir consistently on an empty stomach—at least 2 hours after eating and 2 hours before the next meal. Missing doses may increase the risk of resistance. [See Dosage and Administration]
Treatment Duration
Explain that the optimal treatment length for chronic hepatitis B is not well established, and the connection between treatment response and long-term prevention of outcomes such as liver cancer remains unclear.
Instructions for Oral Solution Use
For patients using the oral solution, instruct them to hold the dosing spoon upright and fill it slowly to the prescribed dose mark. Rinse the spoon with water after each use. If measuring is difficult, patients or caregivers should refer to the Patient Information section for detailed instructions.
Pregnancy Registry
Inform patients that a pregnancy exposure registry is available to monitor outcomes in women exposed to entecavir during pregnancy.
Warnings and Precautions
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, HIV/HBV CO-INFECTION, AND LACTIC ACIDOSIS WITH HEPATOMEGALY
Severe acute exacerbations of hepatitis B have occurred in patients who discontinued anti-hepatitis B therapy, including entecavir. Close clinical and laboratory monitoring of liver function is recommended for several months after treatment is stopped. Restarting anti-hepatitis B therapy may be necessary in some cases. [See Warnings and Precautions]
Risk of HIV resistance: Limited clinical data suggest that using entecavir to treat chronic hepatitis B in patients with untreated HIV may lead to resistance to HIV nucleoside reverse transcriptase inhibitors. Entecavir is not recommended for patients co-infected with HIV and HBV unless they are also receiving highly active antiretroviral therapy (HAART). [See Warnings and Precautions]
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported in patients taking nucleoside analogues, either alone or with antiretrovirals.
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