November 24, 2015
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"The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.

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In Study 1, a 10 year-old patient was administered a dose of 10,856 lipase units per kg body weight of ZENPEP for a period of one day. The patient did not experience any adverse events as a result of the dose increase, nor did this patient experience any adverse events during a 44-day follow-up period. No abnormalities from analyses of safety labs (chemistry, hematology, urinalysis or uric acid) were noted.

Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see WARNINGS AND PRECAUTIONS].



This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/4/2014


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