Baraclude

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old):
• 0.5 mg once daily. (2.2)
• Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg:
• dosing is based on weight. (2.3)
• Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old):
• 1 mg once daily. (2.2)
• Decompensated liver disease (adults): 1 mg once daily. (2.2)
• Renal impairment:
• Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.4)
• BARACLUDE should be administered on an empty stomach. (2.1) 2.1 Timing of Administration BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). 2.2 Recommended Dosage in
• Adults Compensated Liver Disease The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve
• adults and adolescents 16 years of age and older is 0.5 mg once daily. The recommended dose of BARACLUDE in
• adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily. Decompensated Liver Disease The recommended dose of BARACLUDE for chronic hepatitis B virus infection in
• adults with decompensated liver disease is 1 mg once daily. 2.3 Recommended Dosage in Pediatric Patients Table 1 describes the recommended dose of BARACLUDE for pediatric patients 2 years of age or older and weighing at least 10 kg. The oral solution should be used for patients with body weight up to 30 kg. Table 1:
• Dosing Schedule for Pediatric Patients a Children with body weight greater than 30 kg should receive 10 mL (0.5 mg) of oral solution or one 0.5 mg tablet once daily. b Children with body weight greater than 30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg tablet once daily. Recommended Once-Daily Dose of Oral Solution (mL) Body Weight (kg) Treatment-Naïve Patients a Lamivudine-Experienced Patients b 10 to 11 3 6 greater than 11 to 14 4 8 greater than 14 to 17 5 10 greater than 17 to 20 6 12 greater than 20 to 23 7 14 greater than 23 to 26 8 16 greater than 26 to 30 9 18 greater than 30 10 20 2.4 Renal Impairment In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3) ] . Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred. Table 2:
• Recommended Dosage of BARACLUDE in Adult Patients with Renal Impairment a For doses less than 0.5 mg, BARACLUDE Oral Solution is recommended. b If administered on a hemodialysis day, administer BARACLUDE after the hemodialysis session. Creatinine Clearance (mL/min) Usual Dose (0.5 mg) Lamivudine-Refractory or Decompensated Liver Disease (1 mg) 50 or greater 0.5 mg once daily 1 mg once daily 30 to less than 50 0.25 mg once daily a OR 0.5 mg every 48 hours 0.5 mg once daily OR 1 mg every 48 hours 10 to less than 30 0.15 mg once daily a OR 0.5 mg every 72 hours 0.3 mg once daily a OR 1 mg every 72 hours Less than 10 Hemodialysis b or CAPD 0.05 mg once daily a OR 0.5 mg every 7 days 0.1 mg once daily a OR 1 mg every 7 days Although there are insufficient data to recommend a specific dose adjustment of BARACLUDE in pediatric patients with renal impairment, a reduction in the dose or an increase in the dosing interval similar to adjustments for
• adults should be considered. 2.5 Hepatic Impairment No dosage adjustment is necessary for patients with hepatic impairment. 2.6 Duration of Therapy The optimal duration of treatment with BARACLUDE for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• BARACLUDE was evaluated in two clinical trials of pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease.
• The exposure of BARACLUDE in nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease receiving 0.015 mg/kg (up to 0.5 mg once daily) or 0.03 mg/kg (up to 1 mg once daily), respectively, was evaluated in Study AI463028.
• Safety and efficacy of the selected dose in treatment-naïve pediatric subjects were confirmed in Study AI463189, a randomized, placebo-controlled treatment trial [see Indications and Usage (1) , Dosage and Administration (2.3) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ].
• There are limited data available on the use of BARACLUDE in lamivudine-experienced pediatric patients;
• BARACLUDE should be used in these patients only if the potential benefit justifies the potential risk to the child.
• Since some pediatric patients may require long-term or even lifetime management of chronic active hepatitis B, consideration should be given to the impact of BARACLUDE on future treatment options [see Microbiology (12.4) ].
• The efficacy and safety of BARACLUDE have not been established in patients less than 2 years of age.
• Use of BARACLUDE in this age group has not been evaluated because treatment of HBV in this age group is rarely required.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of BARACLUDE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
• Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.4) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed in other sections of the labeling:
• Exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning , Warnings and Precautions (5.1) ].
• Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions (5.3) ].
• In
• adults, the most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in pediatric patients were consistent with those observed in
• adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in
• Adults Compensated Liver Disease Assessment of adverse reactions is based on four studies (AI463014, AI463022, AI463026, and AI463027) in which 1720 subjects with chronic hepatitis B virus infection and compensated liver disease received double-blind treatment with BARACLUDE 0.5 mg/day (n=679), BARACLUDE 1 mg/day (n=183), or lamivudine (n=858) for up to 2 years. Median duration of therapy was 69 weeks for BARACLUDE-treated subjects and 63 weeks for lamivudine-treated subjects in Studies AI463022 and AI463027 and 73 weeks for BARACLUDE-treated subjects and 51 weeks for lamivudine-treated subjects in Studies AI463026 and AI463014. The safety profiles of BARACLUDE and lamivudine were comparable in these studies. The most common adverse reactions of any severity (≥3%) with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. The most common adverse reactions among lamivudine-treated subjects were headache, fatigue, and dizziness. One percent of BARACLUDE-treated subjects in these four studies compared with 4% of lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results. Clinical adverse reactions of moderate-severe intensity and considered at least possibly related to treatment occurring during therapy in four clinical studies in which BARACLUDE was compared with lamivudine are presented in Table 3. Table 3:
• Clinical Adverse Reactions a of Moderate-Severe Intensity (Grades 2‑4) Reported in Four Entecavir Clinical Trials Through 2 Years a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. b Studies AI463022 and AI463027. c Includes Study AI463026 and the BARACLUDE 1 mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational, randomized, double-blind study of three doses of BARACLUDE (0.1, 0.5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in subjects who experienced recurrent viremia on lamivudine therapy. Nucleoside-Inhibitor‑Naïve b Lamivudine- Refractory c Body System/ Adverse Reaction BARACLUDE 0.5 mg n=679 Lamivudine 100 mg n=668 BARACLUDE 1 mg n=183 Lamivudine 100 mg n=190 Any Grade 2–4 adverse reaction a 15% 18% 22% 23% Gastrointestinal Diarrhea <1% 0 1% 0 Dyspepsia <1% <1% 1% 0 Nausea <1% <1% <1% 2% Vomiting <1% <1% <1% 0 General Fatigue 1% 1% 3% 3% Nervous System Headache 2% 2% 4% 1% Dizziness <1% <1% 0 1% Somnolence <1% <1% 0 0 Psychiatric Insomnia <1% <1% 0 <1% Laboratory Abnormalities Frequencies of selected treatment-emergent laboratory abnormalities reported during therapy in four clinical trials of BARACLUDE compared with lamivudine are listed in Table 4. Table 4:
• Selected Treatment-Emergent a Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years a On-treatment value worsened from baseline to Grade 3 or Grade 4 for all parameters except albumin (any on-treatment value <2.5 g/dL), confirmed creatinine increase ≥0.5 mg/dL, and ALT >10 × ULN and >2 × baseline. b Studies AI463022 and AI463027. c Includes Study AI463026 and the BARACLUDE 1 mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational, randomized, double-blind study of three doses of BARACLUDE (0.1, 0.5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in subjects who experienced recurrent viremia on lamivudine therapy. d Includes hematology, routine chemistries, renal and liver function tests, pancreatic enzymes, and urinalysis. e Grade 3 = 3+, large, ≥500 mg/dL; Grade 4 = 4+, marked, severe. f Grade 3 = 3+, large; Grade 4 = ≥4+, marked, severe, many. ULN=upper limit of normal. Nucleoside-Inhibitor-Naïve b Lamivudine-Refractory c Test BARACLUDE 0.5 mg n=679 Lamivudine 100 mg n=668 BARACLUDE 1 mg n=183 Lamivudine 100 mg n=190 Any Grade 3–4 laboratory abnormality d 35% 36% 37% 45% ALT >10 × ULN and >2 × baseline 2% 4% 2% 11% ALT >5 × ULN 11% 16% 12% 24% Albumin <2.5 g/dL <1% <1% 0 2% Total bilirubin >2.5 × ULN 2% 2% 3% 2% Lipase ≥2.1 × ULN 7% 6% 7% 7% Creatinine >3 × ULN 0 0 0 0 Confirmed creatinine increase ≥0.5 mg/dL 1% 1% 2% 1% Hyperglycemia, fasting >250 mg/dL 2% 1% 3% 1% Glycosuria e 4% 3% 4% 6% Hematuria f 9% 10% 9% 6% Platelets <50,000/mm 3 <1% <1% <1% <1% Among BARACLUDE-treated subjects in these studies, on-treatment ALT elevations greater than 10 times the upper limit of normal (ULN) and greater than 2 times baseline generally resolved with continued treatment. A majority of these exacerbations were associated with a ≥2 log 10 /mL reduction in viral load that preceded or coincided with the ALT elevation. Periodic monitoring of hepatic function is recommended during treatment. Exacerbations of Hepatitis After Discontinuation of Treatment An exacerbation of hepatitis or ALT flare was defined as ALT greater than 10 times ULN and greater than 2 times the subject’s reference level (minimum of the baseline or last measurement at end of dosing). For all subjects who discontinued treatment (regardless of reason), Table 5 presents the proportion of subjects in each study who experienced post-treatment ALT flares. In these studies, a subset of subjects was allowed to discontinue treatment at or after 52 weeks if they achieved a protocol-defined response to therapy. If BARACLUDE is discontinued without regard to treatment response, the rate of post-treatment flares could be higher. [See Warnings and Precautions (5.1) .] Table 5:
• Exacerbations of Hepatitis During Off-Treatment Follow-up, Subjects in Studies AI463022, AI463027, and AI463026 a Reference is the minimum of the baseline or last measurement at end of dosing. Median time to off-treatment exacerbation was 23 weeks for BARACLUDE-treated subjects and 10 weeks for lamivudine-treated subjects. Subjects with ALT Elevations >10 × ULN and >2 × Reference a BARACLUDE Lamivudine Nucleoside-inhibitor-naïve HBeAg-positive 4/174 (2%) 13/147 (9%) HBeAg-negative 24/302 (8%) 30/270 (11%) Lamivudine-refractory 6/52 (12%) 0/16 Decompensated Liver Disease Study AI463048 was a randomized, open-label study of BARACLUDE 1 mg once daily versus adefovir dipivoxil 10 mg once daily given for up to 48 weeks in adult subjects with chronic HBV infection and evidence of hepatic decompensation, defined as a Child-Turcotte-Pugh (CTP) score of 7 or higher [see Clinical Studies (14.1) ] . Among the 102 subjects receiving BARACLUDE, the most common treatment-emergent adverse events of any severity, regardless of causality, occurring through Week 48 were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). Clinical adverse reactions not listed in Table 3 that were observed through Week 48 include blood bicarbonate decreased (2%) and renal failure (<1%). Eighteen of 102 (18%) subjects treated with BARACLUDE and 18/89 (20%) subjects treated with adefovir dipivoxil died during the first 48 weeks of therapy. The majority of deaths (11 in the BARACLUDE group and 16 in the adefovir dipivoxil group) were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. The rate of hepatocellular carcinoma (HCC) through Week 48 was 6% (6/102) for subjects treated with BARACLUDE and 8% (7/89) for subjects treated with adefovir dipivoxil. Five percent of subjects in either treatment arm discontinued therapy due to an adverse event through Week 48. No subject in either treatment arm experienced an on-treatment hepatic flare (ALT >2 × baseline and >10 × ULN) through Week 48. Eleven of 102 (11%) subjects treated with BARACLUDE and 11/89 (13%) subjects treated with adefovir dipivoxil had a confirmed increase in serum creatinine of 0.5 mg/dL through Week 48. HIV/HBV Co-infected The safety profile of BARACLUDE 1 mg (n=51) in HIV/HBV co-infected subjects enrolled in Study AI463038 was similar to that of placebo (n=17) through 24 weeks of blinded treatment and similar to that seen in non-HIV infected subjects [see Warnings and Precautions (5.2) ] . Liver Transplant Recipients Among 65 subjects receiving BARACLUDE in an open-label, post-liver transplant trial [see Use in Specific Populations (8.8) ] , the frequency and nature of adverse events were consistent with those expected in patients who have received a liver transplant and the known safety profile of BARACLUDE. Clinical Trial Experience in Pediatric Subjects The safety of BARACLUDE in pediatric subjects 2 to less than 18 years of age is based on two clinical trials in subjects with chronic HBV infection (one Phase 2 pharmacokinetic trial [AI463028] and one Phase 3 trial [AI463189]). These trials provided experience in 168 HBeAg-positive subjects treated with BARACLUDE for a median duration of 72 weeks. The adverse reactions observed in pediatric subjects who received treatment with BARACLUDE were consistent with those observed in clinical trials of BARACLUDE in
• adults. Adverse drug reactions reported in greater than 1% of pediatric subjects included abdominal pain, rash events, poor palatability (“product taste abnormal”), nausea, diarrhea, and vomiting. 6.2 Postmarketing Experience Data from Long-Term Observational Study Study AI463080 was a randomized, global, observational, open-label Phase 4 study to assess long-term risks and benefits of BARACLUDE (0.5 mg/day or 1 mg/day) treatment as compared to other standard-of-care HBV nucleos(t)ide analogues in subjects with chronic HBV infection. A total of 12,378 patients were treated with BARACLUDE (n=6,216) or other HBV nucleos(t)ide treatment [non-entecavir (ETV)] (n=6,162). Patients were evaluated at baseline and subsequently every 6 months for up to 10 years. The principal clinical outcome events assessed during the study were overall malignant neoplasms, liver-related HBV disease progression, HCC, non-HCC malignant neoplasms, and death. The study showed that BARACLUDE was not significantly associated with an increased risk of malignant neoplasms compared to other standard-of-care HBV nucleos(t)ides, as assessed by either the composite endpoint of overall malignant neoplasms or the individual endpoint of non-HCC malignant neoplasms. The most commonly reported malignancy in both the BARACLUDE and non-ETV groups was HCC followed by gastrointestinal malignancies. The data also showed that long-term BARACLUDE use was not associated with a lower occurrence of HBV disease progression or a lower rate of death overall compared to other HBV nucleos(t)ides. The principal clinical outcome event assessments are shown in Table 6. Table 6:
• Principal Analyses of Time to Adjudicated Events - Randomized Treated Subjects Analyses were stratified by geographic region and prior HBV nucleos(t)ide experience. a 95.03% CI for overall malignant neoplasm, death, and liver-related HBV disease progression; 95% CI for non-HCC malignant neoplasm and HCC. b One subject had a pre-treatment HCC event and was excluded from the analysis. c Overall malignant neoplasm is a composite event of HCC or non-HCC malignant neoplasm. Liver-related HBV disease progression is a composite event of liver-related death, HCC, or non-HCC HBV disease progression. CI = confidence interval; N = total number of subjects. Number of Subjects with Events Endpoint c BARACLUDE N=6,216 Non-ETV N=6,162 Hazard Ratio [BARACLUDE:Non-ETV] (CI a ) Primary Endpoints Overall malignant neoplasm 331 337 0.93 (0.800, 1.084) Liver-related HBV disease progression 350 375 0.89 (0.769, 1.030) Death 238 264 0.85 (0.713, 1.012) Secondary Endpoints Non-HCC malignant neoplasm 95 81 1.10 (0.817, 1.478) HCC 240 b 263 0.87 (0.727, 1.032) Limitations of the study included population changes over the long-term follow-up period and more frequent post-randomization treatment changes in the non-ETV group. In addition, the study was underpowered to demonstrate a difference in the non-HCC malignancy rate because of the lower than expected background rate. Adverse Reactions from Postmarketing Spontaneous Reports The following adverse reactions have been reported during postmarketing use of BARACLUDE. Because these reactions were reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to BARACLUDE exposure. Immune system disorders:
• Anaphylactoid reaction. Metabolism and nutrition disorders:
• Lactic acidosis. Hepatobiliary disorders:
• Increased transaminases. Skin and subcutaneous tissue disorders:
• Alopecia, rash.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-approved patient labeling (Patient Information).
• Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment Inform patients that discontinuation of anti-hepatitis B therapy, including BARACLUDE, may result in severe acute exacerbations of hepatitis B.
• Advise the patient to not discontinue BARACLUDE without first informing their healthcare provider [see Warnings and Precautions (5.1) ].
• Risk of Development of HIV-1 Resistance in Patients with HIV-1 Coinfection Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, BARACLUDE may increase the risk of development of resistance to HIV medication [see Warnings and Precautions (5.2) ].
• Lactic Acidosis and Severe Hepatomegaly Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to BARACLUDE.
• Advise patients to contact their healthcare provider immediately and stop BARACLUDE if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.3) ].
• Missed Dosage Inform patients that it is important to take BARACLUDE on a regular dosing schedule on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal) and to
• avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.1) ].
• Treatment Duration Advise patients that in the treatment of chronic hepatitis B, the optimal duration of treatment is unknown.
• The relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known.
• Instructions for Use Inform patients using the oral solution to hold the dosing spoon in a vertical position and fill it gradually to the mark corresponding to the prescribed dose.
• Rinsing of the dosing spoon with water is recommended after each daily dose.
• Some patients may find it difficult to accurately measure the prescribed dose using the provided dosing spoon; therefore, patients/caregivers should refer to the steps in the Patient Information section that demonstrate the correct technique of using the provided dosing spoon to measure the prescribed BARACLUDE dose.
• Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BARACLUDE during pregnancy [see Use in Specific Populations (8.1) ].

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS
• BARACLUDE 0.5 mg film-coated tablets are white to off-white, triangular-shaped, and debossed with “BMS” on one side and “1611” on the other side.
• BARACLUDE 1 mg film-coated tablets are pink, triangular-shaped, and debossed with “BMS” on one side and “1612” on the other side.
• BARACLUDE oral solution, 0.05 mg/mL, is a ready-to-use, orange-flavored, clear, colorless to pale yellow, aqueous solution. Ten milliliters of the oral solution provides a 0.5 mg dose and 20 mL provides a 1 mg dose of entecavir.
• Tablets: 0.5 mg and 1 mg (3 , 16)
• Oral solution: 0.05 mg/mL (3 , 16)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• BARACLUDE ® (entecavir) Tablets and Oral Solution are available in the following strengths and configurations of plastic bottles with child-resistant closures:
• Product Strength and Dosage Form Description Quantity NDC Number 0.5 mg film-coated tablet White to off-white, triangular-shaped tablet, debossed with “BMS” on one side and “1611” on the other side. 30 tablets 0003-1611-12 1 mg film-coated tablet Pink, triangular-shaped tablet, debossed with “BMS” on one side and “1612” on the other side. 30 tablets 0003-1612-12 0.05 mg/mL oral solution Ready-to-use, orange-flavored, clear, colorless to pale yellow, aqueous solution in a 260 mL bottle. 210 mL 0003-1614-12 BARACLUDE Oral Solution is a ready-to-use product; dilution or mixing with water or any other solvent or liquid product is not recommended.
• Each bottle of the oral solution is accompanied by a dosing spoon that is calibrated in 0.5 mL increments up to 10 mL.
• Storage BARACLUDE Tablets should be stored in a tightly closed container at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
• Store in the outer carton to protect from light.
• BARACLUDE Oral Solution should be stored in the outer carton at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
• Protect from light.
• After opening, the oral solution can be used up to the expiration date on the bottle.
• The bottle and its contents should be discarded after the expiration date.

Quoted from the official label, section “How Supplied”.

What is in it

• BARACLUDE ® is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[( 1S,3R,4S )-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6 H -purin-6-one, monohydrate. Its molecular formula is C 12 H 15 N 5 O 3
• H 2 O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula:
• Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C. BARACLUDE film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. BARACLUDE 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients:
• lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). BARACLUDE Oral Solution is available for oral administration as a ready-to-use solution containing 0.05 mg of entecavir per milliliter. BARACLUDE Oral Solution contains the following inactive ingredients:
• maltitol, sodium citrate, citric acid, methylparaben, propylparaben, and orange flavor. entecavir structure.jpg

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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