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ALBENZA® (albendazole) tablets
View U.S. Prescribing Information Prescribing Infomration

See Full Prescribing Information for more information.

IMPORTANT SAFETY INFORMATION for ALBENZA® (albendazole) Tablets

Information for Patients:

Patients should be advised that:

  • Some people, particularly young children, may experience difficulties swallowing the tablets whole. In young children the tablets should be crushed or chewed and swallowed with a drink of water.
  • Albendazole may cause fetal harm; therefore, women of childbearing age should begin treatment after a negative pregnancy test.
  • Women of childbearing age should be cautioned against becoming pregnant while on albendazole or within 1 month of completing treatment.
  • During albendazole therapy, because of the possibility of harm to the liver or bone marrow, routine (every 2 weeks) monitoring of blood counts and liver function tests should take place.
  • Albendazole should be taken with food.

Contraindications

ALBENZA is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.

Warnings

Rare fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia. Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction. Blood counts should be monitored at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.

Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Patients should not become pregnant for at least 1 month following cessation of albendazole therapy. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of anticysticeral therapy.

Pre-existing neurocysticercosis may also be uncovered in patients treated with albendazole for other conditions. Patients may experience neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment; appropriate steroid and anticonvulsant therapy should be started immediately.

Cysticercosis may, in rare cases, involve the retina. Before initiating therapy for neurocysticercosis, the patient should be examined for the presence of retinal lesions. If such lesions are visualized, the need for anticysticeral therapy should be weighed against the possibility of retinal damage caused by albendazole-induced changes to the retinal lesion.

Laboratory Tests:

White Blood Cell Count: Albendazole has been shown to cause occasional (less than 1% of treated patients) reversible reductions in total white blood cell count. Rarely, more significant reductions may be encountered including granulocytopenia, agranulocytosis, or pancytopenia. Blood counts should be performed at the start of each 28-day treatment cycle and every 2 weeks during each 28-day cycle in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression and warrant closer monitoring of blood counts (see WARNINGS). Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.

Liver Function: In clinical trials, treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis (see ADVERSE REACTIONS).

Liver function tests (transaminases) should be performed before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing albendazole therapy based on individual patient circumstances. Restarting albendazole treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further albendazole usage. Laboratory tests should be performed frequently if albendazole treatment is restarted.

Patients with abnormal liver function test results are at increased risk for hepatotoxicity and bone marrow suppression (see WARNINGS). Therapy should be discontinued if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.

Theophylline:

Although single doses of albendazole have been shown not to inhibit theophylline metabolism (see Drug Interactions), albendazole does induce cytochrome P450 1A in human hepatoma cells. Therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment with ALBENZA.

Drug Interactions:

Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis patients.

Praziquantel: In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given albendazole alone. Mean Tmax and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following coadministration with albendazole (400 mg).

Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2- fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with albendazole (20 mg/kg/day) alone (n = 12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

Pregnancy:

Teratogenic Effects: Pregnancy Category C. Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits.

There are no adequate and well-controlled studies of albendazole administration in pregnant women. Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see WARNINGS).

Adverse Reactions

The adverse event profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease are described in the table below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects events that were reported by investigators to be at least possibly or probably related to albendazole.

Adverse Event Hydatid Disease Neurocysticercosis
Abnormal Liver Function Tests 15.6 < 1.0
Abdominal Pain6.0 0
Nausea/Vomiting3.76.2
Headache1.311.0
Dizziness/Vertigo1.2< 1.0
Raised Intracranial Pressure01.5
Meningeal Signs01.0
Reversible Alopecia1.6< 1.0
Fever1.00

The following adverse events were observed at an incidence of <1%:

Blood and Lymphatic System Disorders: Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia (see WARNINGS). Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression (see WARNINGS and PRECAUTIONS).

Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.

Postmarketing Adverse Reactions: In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of ALBENZA. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ALBENZA.

Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.

Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.

Renal and Urinary Disorders: Acute renal failure.

Indications and Usage

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.

ALBENZA is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

This indication is based on combined clinical studies, which demonstrated non-infectious cyst contents in approximately 80 to 90% of patients given ALBENZA for 3 cycles of therapy of 28 days each. Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of ≥ 25%) was seen in an additional 40%.

The efficacy of albendazole in the therapy of alveolar hydatid disease caused by Echinococcus multilocularis has not been clearly demonstrated in clinical studies. See Full Prescribing Information for more information.

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IMPORTANT SAFETY INFORMATION for ALBENZA® (albendazole) Tablets

Information for Patients:

Patients should be advised that:

  • Some people, particularly young children, may experience difficulties swallowing the tablets whole. In young children the tablets should be crushed or chewed and swallowed with a drink of water.
  • Albendazole may cause fetal harm; therefore, women of childbearing age should begin treatment after a negative pregnancy test.
  • Women of childbearing age should be cautioned against becoming pregnant while on albendazole or within 1 month of completing treatment.
  • During albendazole therapy, because of the possibility of harm to the liver or bone marrow, routine (every 2 weeks) monitoring of blood counts and liver function tests should take place.
  • Albendazole should be taken with food.

Contraindications

ALBENZA is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.

Warnings

Rare fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia. Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction. Blood counts should be monitored at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.

Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Patients should not become pregnant for at least 1 month following cessation of albendazole therapy. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of anticysticeral therapy.

Pre-existing neurocysticercosis may also be uncovered in patients treated with albendazole for other conditions. Patients may experience neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment; appropriate steroid and anticonvulsant therapy should be started immediately.

Cysticercosis may, in rare cases, involve the retina. Before initiating therapy for neurocysticercosis, the patient should be examined for the presence of retinal lesions. If such lesions are visualized, the need for anticysticeral therapy should be weighed against the possibility of retinal damage caused by albendazole-induced changes to the retinal lesion.

Laboratory Tests:

White Blood Cell Count: Albendazole has been shown to cause occasional (less than 1% of treated patients) reversible reductions in total white blood cell count. Rarely, more significant reductions may be encountered including granulocytopenia, agranulocytosis, or pancytopenia. Blood counts should be performed at the start of each 28-day treatment cycle and every 2 weeks during each 28-day cycle in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression and warrant closer monitoring of blood counts (see WARNINGS). Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.

Liver Function: In clinical trials, treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis (see ADVERSE REACTIONS).

Liver function tests (transaminases) should be performed before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing albendazole therapy based on individual patient circumstances. Restarting albendazole treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further albendazole usage. Laboratory tests should be performed frequently if albendazole treatment is restarted.

Patients with abnormal liver function test results are at increased risk for hepatotoxicity and bone marrow suppression (see WARNINGS). Therapy should be discontinued if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.

Theophylline:

Although single doses of albendazole have been shown not to inhibit theophylline metabolism (see Drug Interactions), albendazole does induce cytochrome P450 1A in human hepatoma cells. Therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment with ALBENZA.

Drug Interactions:

Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis patients.

Praziquantel: In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given albendazole alone. Mean Tmax and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following coadministration with albendazole (400 mg).

Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2- fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with albendazole (20 mg/kg/day) alone (n = 12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

Pregnancy:

Teratogenic Effects: Pregnancy Category C. Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits.

There are no adequate and well-controlled studies of albendazole administration in pregnant women. Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see WARNINGS).

Adverse Reactions

The adverse event profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease are described in the table below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects events that were reported by investigators to be at least possibly or probably related to albendazole.

Adverse Event Hydatid Disease Neurocysticercosis
Abnormal Liver Function Tests 15.6 < 1.0
Abdominal Pain6.0 0
Nausea/Vomiting3.76.2
Headache1.311.0
Dizziness/Vertigo1.2< 1.0
Raised Intracranial Pressure01.5
Meningeal Signs01.0
Reversible Alopecia1.6< 1.0
Fever1.00

The following adverse events were observed at an incidence of <1%:

Blood and Lymphatic System Disorders: Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia (see WARNINGS). Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression (see WARNINGS and PRECAUTIONS).

Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.

Postmarketing Adverse Reactions: In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of ALBENZA. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ALBENZA.

Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.

Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.

Renal and Urinary Disorders: Acute renal failure.

Indications and Usage

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.

ALBENZA is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

This indication is based on combined clinical studies, which demonstrated non-infectious cyst contents in approximately 80 to 90% of patients given ALBENZA for 3 cycles of therapy of 28 days each. Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of ≥ 25%) was seen in an additional 40%.

The efficacy of albendazole in the therapy of alveolar hydatid disease caused by Echinococcus multilocularis has not been clearly demonstrated in clinical studies. See Full Prescribing Information for more information.