Baraclude

(Entecavir)

The active ingredient in Baraclude is entecavir and is used to treat chronic hepatitis B infection. It belongs to the drug class called nucleoside reverse transcriptase inhibitors (NRTIs).

Baraclude’s mechanism of action involves blocking the virus’s ability to make new viral DNA, stopping it from replicating. This reduces the amount of virus in the blood, helps protect the liver from further damage, and lowers the risk of complications such as cirrhosis and liver failure when taken long-term.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labelling, Instructions for Use, and Medication Guide before using Baraclude. However, the following is a synopsis of the general guidelines for the use of Baraclude:

• Baraclude is taken once daily by mouth.
• It should be taken on an empty stomach, at least 2 hours after a meal and 2 hours before the next meal.
• Baraclude is available as tablets and as an oral solution for patients who cannot swallow tablets.
• The dose depends on age, body weight, kidney function, and prior hepatitis B treatment history.
• Pediatric dosing is based on body weight and prescribed by a healthcare professional experienced in treating hepatitis B.
• Take Baraclude at the same time each day to maintain consistent antiviral activity.
• Do not skip doses, as missed doses can reduce effectiveness and increase the risk of viral resistance. If you miss a dose, take it as soon as you remember unless it is close to the time of your next dose. Do not take two doses at the same time to make up for a missed dose.

Some mild or common side effects of Baraclude seen in clinical trials include:

• Headache.
• Fatigue.
• Dizziness.
• Nausea.
• Stomach pain or abdominal discomfort.
• Diarrhea.
• Increased blood lactate levels.

Some individuals may experience serious side effects while using Baraclude. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Lactic acidosis may cause unusual muscle pain, trouble breathing, stomach pain, nausea, irregular heartbeat, or extreme weakness.
• Severe liver problems or worsening liver disease, including yellowing of the skin or eyes, dark urine, or swelling of the abdomen.
• Acute exacerbations of hepatitis B after stopping treatment.
• Allergic reactions and adverse reactions such as rash, hives, swelling of the face or throat, or trouble breathing.

These are not all of the possible side effects of Baraclude. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Baraclude, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease, including cirrhosis or decompensated liver disease.
• A history of liver transplant.
• Kidney disease or reduced kidney function.
• HIV infection or risk factors for HIV infection.
• A history of lactic acidosis.
• Pregnancy or plans to become pregnant.
• Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female and very overweight (obese).
• Patients co-infected with HIV and HBV should not take Baraclude without also receiving highly active antiretroviral therapy.
• Regular blood tests are required to monitor liver enzymes, HBV DNA levels, and kidney function during treatment.

Boxed Warning

Baraclude has a boxed warning for lactic acidosis and severe acute exacerbations of hepatitis B. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogue therapy. Severe acute exacerbations of hepatitis B have also been reported in patients who have discontinued anti-hepatitis B therapy. Liver function must be closely monitored for several months after stopping treatment.

It should not be used in patients with known hypersensitivity to entecavir or any component of the formulation.

Baraclude begins working immediately after treatment starts, but it may take weeks to months to see a measurable reduction in hepatitis B virus levels. Improvements in liver enzyme levels may occur earlier. Long-term treatment is often required to maintain viral suppression and reduce liver damage. Your healthcare provider will monitor treatment response using blood tests and clinical assessments.

When Baraclude is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other medications that affect kidney function may increase entecavir levels.
• Lamivudine or adefovir, which may affect antiviral resistance patterns.
• Tenofovir, which may require monitoring of kidney function when used together.

Baraclude is available in the following dosage forms and strengths:

• 0.5 mg and 1 mg tablets
• 0.05 mg/mL oral solution

It should be stored at room temperature, away from the reach of children or pets.

Baraclude is manufactured by Bristol-Myers Squibb.

Yes. Generic entecavir is available.

Do not stop taking Baraclude without talking to your healthcare provider. Stopping treatment can cause a serious worsening of hepatitis B infection. If treatment is discontinued, your healthcare provider will monitor your liver function closely for several months.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Baraclude may be used during pregnancy if the potential benefit outweighs the risk. Your healthcare provider may recommend enrollment in a pregnancy registry if you take it while you are pregnant.

It is not known if entecavir passes into breast milk. Breastfeeding is generally not recommended for people with hepatitis B infection unless advised otherwise by a healthcare professional.