Drug: Baraclude
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)-4hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one, monohydrate. Its molecular formula is C12H15N5O3•H2O, 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.
Source: http://www.rxlist.com
The following adverse reactions are discussed in other sections of the labeling:
Body System/ Adverse Reaction Nucleoside-Naiveb Lamivudine-Refractoryc 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 reactiona 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% 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. 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 3. Table 3: Selected Treatment-Emergenta Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years
Test Nucleoside--Naiveb Lamivudine-Refractoryc 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 abnormalityd 35% 36% 37% 45% ALT > 10 x ULN and > 2 x baseline 2% 4% 2% 11% ALT > 5.0 x ULN 11% 16% 12% 24% Albumin < 2.5 g/dL < 1% < 1% 0 2% Total bilirubin > 2.5 x ULN 2% 2% 3% 2% Lipase ≥ 2.1 x ULN 7% 6% 7% 7% Creatinine > 3.0 x 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% Glycosuriae 4% 3% 4% 6% Hematuriaf 9% 10% 9% 6% 3 Platelets < 50,000/mm < 1% < 1% < 1% < 1% 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 x ULN and > 2 x 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. 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 log10/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 4 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 also WARNINGS AND PRECAUTIONS] Table 4: Exacerbations of Hepatitis During Off-Treatment Follow-up, Subjects in Studies AI463022, AI463027, and AI463026
Subjects with ALT Elevations > 10 x ULN and > 2 x Referencea BARACLUDE Lamivudine Nucleoside-naive HBeAg-positive 4/174 (2%) 13/147 (9%) HBeAg-negative 24/302 (8%) 30/270 (11%) Lamivudine-refractory 6/52 (12%) 0/16 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. 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]. 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 2 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 x baseline and > 10 x 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]. Liver Transplant Recipients Among 65 subjects receiving BARACLUDE in an open-label, post-liver transplant trial [see Use In Specific Populations], 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. Postmarketing Experience 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. Read the Baraclude (entecavir) Side Effects Center for a complete guide to possible side effectsLearn More »
- Exacerbations of hepatitis after discontinuation of treatment [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Body System/ Adverse Reaction Nucleoside-Naiveb Lamivudine-Refractoryc 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 reactiona 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% 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. 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 3. Table 3: Selected Treatment-Emergenta Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years
Test Nucleoside--Naiveb Lamivudine-Refractoryc 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 abnormalityd 35% 36% 37% 45% ALT > 10 x ULN and > 2 x baseline 2% 4% 2% 11% ALT > 5.0 x ULN 11% 16% 12% 24% Albumin < 2.5 g/dL < 1% < 1% 0 2% Total bilirubin > 2.5 x ULN 2% 2% 3% 2% Lipase ≥ 2.1 x ULN 7% 6% 7% 7% Creatinine > 3.0 x 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% Glycosuriae 4% 3% 4% 6% Hematuriaf 9% 10% 9% 6% 3 Platelets < 50,000/mm < 1% < 1% < 1% < 1% 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 x ULN and > 2 x 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. 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 log10/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 4 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 also WARNINGS AND PRECAUTIONS] Table 4: Exacerbations of Hepatitis During Off-Treatment Follow-up, Subjects in Studies AI463022, AI463027, and AI463026
Subjects with ALT Elevations > 10 x ULN and > 2 x Referencea BARACLUDE Lamivudine Nucleoside-naive HBeAg-positive 4/174 (2%) 13/147 (9%) HBeAg-negative 24/302 (8%) 30/270 (11%) Lamivudine-refractory 6/52 (12%) 0/16 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. 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]. 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 2 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 x baseline and > 10 x 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]. Liver Transplant Recipients Among 65 subjects receiving BARACLUDE in an open-label, post-liver transplant trial [see Use In Specific Populations], 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. Postmarketing Experience 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. Read the Baraclude (entecavir) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Recommended Dosage Compensated Liver Disease The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleosidetreatment-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 mutations 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. Oral Solution BARACLUDE (entecavir) Oral Solution contains 0.05 mg of entecavir per milliliter. Therefore, 10 mL of the oral solution provides a 0.5 mg dose and 20 mL provides a 1 mg dose of entecavir. Renal Impairment In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see CLINICAL PHARMACOLOGY]. 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 1. The once-daily dosing regimens are preferred. Table 1: Recommended Dosage Of BARACLUDE In Patients With Renal Impairment
Creatinine Clearance (mL/min) Usual Dose (0.5 mg) Lamivudine-Refractory or Decompensated Liver Disease (1 mg) ≥ 50 0.5 mg once daily 1 mg once daily 30 to < 50 0.25 mg once dailya OR 0.5 mg every 48 hours 0.5 mg once daily OR 1 mg every 48 hours 10 to < 30 0.15 mg once dailya OR 0.5 mg every 72 hours 0.3 mg once dailya OR 1 mg every 72 hours < 10 Hemodialysisb or CAPD 0.05 mg once dailya OR 0.5 mg every 7 days 0.1 mg once dailya OR 1 mg every 7 days 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. Hepatic Impairment No dosage adjustment is necessary for patients with hepatic impairment. 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.
Creatinine Clearance (mL/min) Usual Dose (0.5 mg) Lamivudine-Refractory or Decompensated Liver Disease (1 mg) ≥ 50 0.5 mg once daily 1 mg once daily 30 to < 50 0.25 mg once dailya OR 0.5 mg every 48 hours 0.5 mg once daily OR 1 mg every 48 hours 10 to < 30 0.15 mg once dailya OR 0.5 mg every 72 hours 0.3 mg once dailya OR 1 mg every 72 hours < 10 Hemodialysisb or CAPD 0.05 mg once dailya OR 0.5 mg every 7 days 0.1 mg once dailya OR 1 mg every 7 days 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. Hepatic Impairment No dosage adjustment is necessary for patients with hepatic impairment. 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.
Source: http://www.rxlist.com
Since entecavir is primarily eliminated by the kidneys [see CLINICAL PHARMACOLOGY], coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of BARACLUDE with other drugs that are renally eliminated or are known to affect renal function have not been evaluated, and patients should be monitored closely for adverse events when BARACLUDE is coadministered with such drugs. Read the Baraclude Drug Interactions Center for a complete guide to possible interactions Learn More »
Source: http://www.rxlist.com
BARACLUDE® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating therapy with BARACLUDE:
- This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease [see Clinical Studies].
- Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see ADVERSE REACTIONS and Clinical Studies].
- Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see WARNINGS AND PRECAUTIONS and Clinical Studies].
Source: http://www.rxlist.com
None. Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose.
Source: http://www.rxlist.com
Dosage Forms And Strengths
This monograph has been modified to include the generic and brand name in many instances.
- 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.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Severe Acute Exacerbations Of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir [see ADVERSE REACTIONS]. 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. Patients Co-Infected With HIV And HBV BARACLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated [see Microbiology]. Therefore, therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving HAART. Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use. Lactic Acidosis And Severe Hepatomegaly With Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including BARACLUDE, alone or in combination with antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogues to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Patient Counseling Information See FDA-approved patient labeling (PATIENT INFORMATION). Information about Treatment Physicians should inform their patients of the following important points when initiating BARACLUDE treatment:
This monograph has been modified to include the generic and brand name in many instances.
- Patients should remain under the care of a physician while taking BARACLUDE. They should discuss any new symptoms or concurrent medications with their physician.
- Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
- Patients should be advised to take BARACLUDE on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
- Patients using the oral solution should be instructed 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.
- Patients should be advised to take a missed dose as soon as remembered unless it is almost time for the next dose. Patients should not take two doses at the same time.
- Patients should be advised that treatment with BARACLUDE will not cure HBV.
- Patients should be informed that BARACLUDE may lower the amount of HBV in the body, may lower the ability of HBV to multiply and infect new liver cells, and may improve the condition of the liver.
- Patients should be informed that it is not known whether BARACLUDE will reduce their chances of getting liver cancer or cirrhosis.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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