HCG contamination of alglucerase: clinical implications in low-dose regimen.

Author(s): Cohen Y, Elstein D, Abrahamov A, Hirsch H, Zimran A

Affiliation(s): Gaucher Clinic, Shaare-Zedek Medical Center, Jerusalem, Israel.

Publication date & source: 1994-11, Am J Hematol., 47(3):235-6.

Publication type: Research Support, Non-U.S. Gov't

Alglucerase (Ceredase) is currently the treatment of choice for patients with symptomatic Gaucher disease. The contamination of this placental enzyme with human chorionic gonadotropin (hCG) has raised concern regarding possible endocrinological complications. We examined 32 patients treated with low-dose alglucerase and 27 untreated patients as controls, and found no significant clinical differences between the two groups: no prepubertal children were affected, no menstrual irregularities were reported, and all hCG levels were well within normal range. Conversely, our finding of a statistically significant difference between the groups underscores the importance of initiating parallel studies of hCG contamination in patients receiving high-dose protocol.