"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
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.
ALBENZA 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 ALBENZA to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of ALBENZA therapy and for one month after end of therapy. Immediately discontinue ALBENZA if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations].
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.
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 ALBENZA-induced death of the parasite.
In clinical trials, treatment with ALBENZA 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 ALBENZA therapy based on individual patient circumstances. Restarting ALBENZA treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further ALBENZA usage. Perform laboratory tests frequently if ALBENZA treatment is restarted.
Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [see Bone Marrow Suppression]. Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.
Unmasking Of Neurocysticercosis In Hydatid Patients
Undiagnosed neurocysticercosis may be uncovered in patients treated with ALBENZA for other conditions. Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term carcinogenicity studies were conducted in mice and rats.
No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis).
In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation.
Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m²).
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies of ALBENZA administration in pregnant women. ALBENZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
ALBENZA should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing ALBENZA to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of ALBENZA therapy and for one month after end of therapy. If a patient becomes pregnant while taking this drug, ALBENZA should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
ALBENZA has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m², respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m²) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m²), administered during gestation days 6 to 15.
ALBENZA is excreted in animal milk. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALBENZA is administered to a nursing woman.
Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of ALBENZA in children appears to be similar to that in adults.
In patients aged 65 and older with either hydatid disease or neurocysticerosis, there was insufficient data to determine whether the safety and effectiveness of ALBENZA is different from that of younger patients.
Patients With Impaired Renal Function
The pharmacokinetics of ALBENZA in patients with impaired renal function has not been studied.
Patients With Extra-Hepatic Obstruction
In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of albendazole sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent ALBENZA were measurable in only 1 of 5 patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/29/2015
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