Generic Name: entecavir
Company: Bristol-Myers Squibb
Approval Status: Approved
Generic Version Available: Yes
FDA-approved for the treatment of chronic hepatitis B infection in adults and children at least 2 years old with evidence of hepatitis B viral replication and active liver inflammation or damage. Baraclude is not recommended for persons coinfected with HIV/HBV who are not also receiving highly active antiretroviral therapy (HAART).
- Baraclude was approved by the U.S. Food and Drug Administration for use by adults with chronic hepatitis B on March 29, 2005. Approved for children ≥ 2 years on March 20, 2014.
- In clinical studies, 70 to 72 percent of participants with compensated liver disease who had no prior treatment showed improved liver biopsy results after 48 weeks of therapy.
Age 16 years and older and no prior treatment with nucleoside-inhibitors: 0.5 mg once daily. If lamivudine- or telbivudine-resistant: 1 mg once daily. For those with decompensated liver disease: 1 mg once daily. Dosage adjustment is recommended for people with kidney disease. Take on empty stomach (at least two hours after a meal and two hours before the next meal).
Children 2 years and older and weighing at least 10 kg, no prior treatment with nucleoside inhibitors and lamivudine-experienced: weight-based dosing. Take on empty stomach (at least two hours after a meal and two hours before the next meal).
Dosing Info: Treatment length is indefinite and depends on clinical outcomes. Do not change your dose or stop taking Baraclude without talking to your medical provider.
- The most common side effects are headache, fatigue, dizziness and nausea. Less frequently reported side effects include insomnia, diarrhea and stomach upset.
- Baraclude may cause severe liver problems or a serious condition called lactic acidosis (buildup of acid in the blood).
For a review of drug interactions, including prescription and over-the-counter medications and supplements that should not be taken with Baraclude or may require dose adjustments, consult the Baraclude package insert.
- There are no adequate, well-controlled studies in pregnant women who have taken Baraclude. Baraclude should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- The safety of breast feeding while taking Baraclude has not been established, and it is recommended that Baraclude be discontinued if breast-feeding.
For More Info: http://www.baraclude.bmscustomerconnect.com
Co-Pay Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Patient Assistance Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Last Reviewed: March 4, 2019