"Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Patients with LAL deficiency (also known as Wolman disea"...
CHEMET is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45 mcg/dL. CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment; the use of CHEMET should always be accompanied by identification and removal of the source of the lead exposure.
DOSAGE AND ADMINISTRATION
Start dosage at 10 mg/kg or 350 mg/m² every eight hours for five days. Initiation of therapy at higher doses is not recommended. (See Table II for Dosing chart and number of capsules.) Reduce frequency of administration to 10 mg/kg or 350 mg/m² every 12 hours (two-thirds of initial daily dosage) for an additional two weeks of therapy. A course of treatment lasts 19 days. Repeated courses may be necessary if indicated by weekly monitoring of blood lead concentration. A minimum of two weeks between courses is recommended unless blood lead levels indicate the need for more prompt treatment.
TABLE II : CHEMET (SUCCIMER) PEDIATRIC DOSING CHART
|LBS||KG||DOSE (MG)*||Number of CAPSULES*|
|*To be administered every 8 hours for 5 days, followed by dosing every 12 hours for 14 days.|
In young pediatric patients who cannot swallow capsules, CHEMET can be administered by separating the capsule and sprinkling the medicated beads on a small amount of soft food or putting them in a spoon and following with fruit drink.
Identification of the source of lead in the pediatric patient's environment and its abatement are critical to a successful therapy outcome. Chelation therapy is not a substitute for preventing further exposure to lead and should not be used to permit continued exposure to lead.
Patients who have received CaNa2EDTA with or without BAL may use CHEMET for subsequent treatment after an interval of four weeks. Data on the concomitant use of CHEMET with CaNa2EDTA with or without BAL are not available, and such use is not recommended.
100 mg capsules in bottle of 100 (NDC 55292-201-11).
Store between 15°C and 25°C and avoid excessive heat.
Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274, USA. For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. Revised: February 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/18/2013
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