Albendazole - Warnings and Precautions

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 albendazole if clinically significant changes in blood counts occur. ( 5.1 , 5.4 ) 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.

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.

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.

Elevations of liver enzymes may occur.

Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on albendazole therapy and discontinue if clinically significant elevations occur.

5.1 Bone Marrow Suppression Fatalities associated with the use of albendazole have been reported due to granulocytopenia or pancytopenia.

Albendazole 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 albendazole 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 albendazole if clinically significant decreases in blood cell counts occur.

5.2 Embryo-fetal Toxicity Albendazole may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate.

Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential.

Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy.

Immediately discontinue albendazole if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1 , 8.3 )] .

5.3 Risk of Neurologic Symptoms in Neurocysticercosis Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent 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.

5.4 Risk of Retinal Damage in Patients with Retinal Neurocysticercosis Cysticercosis may involve the retina.

Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions.

If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole-induced death of the parasite.

5.5 Hepatic Effects 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 ] .

Monitor liver enzymes (transaminases) 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.