ALBENZA

2 DOSAGE AND ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). ALBENZA tablets should be taken with food. ( 2 ) Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles.

( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information. 1 Dosage Dosing of ALBENZA will vary depending upon the indication. ALBENZA tablets may be crushed or chewed and swallowed with a drink of water.

3 ) ]. 2 Concomitant Medication to Avoid Adverse Reactions Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. 3 ) ]. 1 )] . 5 )] . 2 )] .

6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. 1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs.

gov/medwatch. 1 Clinical Trials 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.

The adverse reaction profile of ALBENZA differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below. These symptoms were usually mild and resolved without treatment.

8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to ALBENZA. 1 ) ].

Immune System Disorders:

Hypersensitivity reactions, including rash and urticaria. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ALBENZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders:

Aplastic anemia, bone marrow suppression, neutropenia.

Eye Disorders:

Vision blurred.

Gastrointestinal Disorders:

5 WARNINGS AND PRECAUTIONS Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy.

Discontinue ALBENZA if clinically significant changes in blood counts occur. 4 ) Embryo-fetal Toxicity: Obtain pregnancy test in women of reproductive potential prior to therapy and avoid usage in pregnant women except in clinical circumstances where no alternative management is appropriate.

Discontinue therapy if pregnancy occurs and apprise patient of potential hazard to the fetus. 2 ) Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy.

3 ) Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. 4 ) Hepatic Effects. Elevations of liver enzymes may occur.

Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on ALBENZA therapy and discontinue if clinically significant elevations occur. 1 Bone Marrow Suppression Fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia.

ALBENZA may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts.

Discontinue ALBENZA if clinically significant decreases in blood cell counts occur. 2 Embryo-fetal Toxicity ALBENZA may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate.

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