Standard DoseAdult (age 16 and older): Treatment-naïve with no resistance, one 0.5 mg tablet once daily on an empty stomach (no food 2 hours before or 2 hours after taking pill); if lamivudine or telbivudine (brand name Tyzeka, discontinued since December 2016) resistant, 1 mg once daily on an empty stomach. Adult with decompensated liver disease: 1 mg once per day. Dose adjustments needed for individuals with kidney disease. See positivelyaware.com/baraclude and consult a medical provider for more detail.
Pediatric (ages 2–15): Weight-based dosing required. It’s complicated, and should be managed in consultation with an experienced medical provider.
AWPbrand, 0.5 mg and 1 mg tablets: $1,647 / month
generic, 0.5 mg and 1 mg tablets: $1,300 / month
Potential Side Effects and Toxicity
Potential side effects and adverse events
Baraclude is a very well-tolerated medication with minimal side effects. When side effects do occur, they include headache, fatigue, dizziness, and nausea. There are two potential serious side effects when taking Baraclude: (1) Lactic acidosis: The build-up of lactic acid in the blood that could be fatal. Signs and symptoms of lactic acidosis include feeling very weak or excessively fatigued, difficulty breathing, stomach pain with nausea and vomiting, feeling cold and chills (especially in arms and legs), dizziness and light-headedness, fast or irregular heartbeat, or unusual muscle pain. If you experience any of these symptoms contact your medical provider immediately; (2) Two liver conditions, hepatomegaly (enlarged liver) or steatosis (fatty liver), may occur. Signs and symptoms of these liver conditions include: yellowing of the eyes and/or skin (jaundice), dark colored urine, light colored stools, nausea, loss of appetite, and pain, achiness or tenderness of the liver (lower right side of the belly, below the ribcage and next to the belly button).
Potential Drug Interactions
Be sure to tell your medical provider or pharmacist about all the medications, supplements, and herbs you take, whether they are prescribed, over-the-counter, or illicit, before starting this regimen; report any changes as they happen. Baraclude is safe to take with all HIV medications, with no drug interactions. Baraclude is eliminated by the kidneys, so it should be avoided with any medications that could negatively affect the kidneys, including chronic use or high doses of NSAIDS (non-steroidal anti-inflammatory drugs, such as Advil, Aleve, ibuprofen, naproxen, or Motrin).
Baraclude will not cure HBV—no HBV medication will cure you—but it can decrease your risk of long-term complications such as cirrhosis or liver cancer. Baraclude is one of three preferred medications (including Viread and pegylated interferon) for the treatment of HBV in both mono- and HBV/HIV co-infected persons. Although Baraclude is not an HIV medication, it does have some activity against HIV. It should not be taken by itself if you are living with HIV. If you are co-infected with HBV/HIV, you should not treat HBV without also treating your HIV. You should be checked for resistance to Epivir (lamivudine) before starting Baraclude: Epivir resistance decreases the effectiveness of Baraclude at the 0.5 mg dose, and must be increased to 1 mg.
Dosage requirements for patients with kidney disease:
|Creatinine clearance (mL/min)||Treatment-naive: 0.5 mg||Lamivudine-refractory, lamivudine/telbivudine resistant, or decompensated cirrhosis: 1 mg|
|50 or greater||0.5 mg once per day||1 mg once per day|
|30 to 49||0.25 mg once per day or 0.5 mg every 48 hours||0.5 once per day or 1 mg every 48 hours|
|10 to 29||0.15 mg once per day or 0.5 mg every 72 hours||0.3 mg once per day or 1 mg every 72 hours|
|Less than 10 or on dialysis||0.05 mg once per day or 0.5 mg every 7 days||0.1 mg once per day or 1 mg every 7 days|
NOTES: Doses less than 0.5 mg daily should be given as the oral solution (liquid).
If a person is on hemodialysis, Baraclude should be given after the dialysis session. See pediatric treatment table online.