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Baraclude

Name: Baraclude
Brand: Bristol Myers
Availability: InStock

Enetecavir

Prescription required

$3609.00

0.5mg · 3 × 30 tablets · 3 months supply

BrandBranded medicine· By Bristol Myers

$1203.00 per month

Strength

How long a supply?

1 month$1203.00 a monthOne-off$1203.00

3 months$1203.00 a monthOne-off$3609.00

6 months$1203.00 a monthOne-off$7218.00

Supplied from Israel

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Annual cost

$14436a year at this pack size

Prescription required

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0.5mg

1mg

FDA boxed warningSevere acute exacerbations of hepatitis b, patients co-infected with hiv and hbv, and lactic acidosis and hepatomegaly

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted.

BARACLUDE is not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors.

Read this with the rest of the clinical information

About Baraclude

Overview

Baraclude contains entecavir, an antiviral medicine for chronic hepatitis B infection. It is indicated for adults and children aged 2 years and older when the virus is actively multiplying and there are persistently raised liver enzymes or liver tissue evidence of active disease. It works by blocking an enzyme the hepatitis B virus needs to copy its genetic material, helping limit viral multiplication.

What it treats

Chronic hepatitis B infection in adults and children aged 2 years and older who have active viral replication and either persistently elevated liver enzymes (ALT or AST) or active liver disease confirmed by tissue examination.

Safety information

Side effects

Common side effects of Baraclude include headache, tiredness, dizziness and nausea. Side effects seen in children were consistent with those seen in adults. Serious risks include a severe worsening of hepatitis B after stopping treatment, lactic acidosis (a buildup of lactic acid in the blood), and severe liver enlargement with fat buildup. Contact your doctor if you suspect a serious side effect. If lactic acidosis or severe liver enlargement with fat buildup is suspected, treatment should be suspended by your healthcare professional. Liver function must be monitored closely for at least several months after stopping Baraclude.

FDA boxed warning

Severe acute exacerbations of hepatitis b, patients co-infected with hiv and hbv, and lactic acidosis and hepatomegaly

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

• Seek medical attention immediately if your hepatitis B worsens after stopping Baraclude. • Seek medical attention immediately if a buildup of lactic acid in the blood or severe liver enlargement with fat buildup is suspected. These conditions can be fatal.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The label lists no contraindications for Baraclude. However, the following warnings and cautions apply: • If you also have HIV, Baraclude is not recommended unless you are receiving highly active antiretroviral therapy (HAART). • Severe worsening of hepatitis B can occur after stopping treatment. Liver function should be monitored closely for at least several months after discontinuation. • Treatment should be suspended if lactic acidosis (a buildup of lactic acid in the blood) or severe liver enlargement with fat buildup is suspected. • Safety and effectiveness data are limited in liver transplant recipients.

Interactions

Baraclude (entecavir) is mainly cleared from the body by the kidneys. Medicines that reduce kidney function or compete with entecavir for removal by the kidneys may increase blood levels of either medicine. Tell your doctor if you take medicines that affect kidney function or are cleared by the kidneys; close monitoring for side effects may be needed. No significant interactions were found in studies with lamivudine, adefovir dipivoxil or tenofovir disoproxil fumarate. Interactions involving the liver’s CYP450 enzyme system are unlikely.

Using Baraclude

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] (DailyMed, retrieved 19 September 2026).

Patient information and references

Official and supporting information to read alongside advice from your prescriber or pharmacist.

Patient information leaflet (PDF)

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