Lumizyme Injection, Powder, For Solution
Product Images NDC 58468-0160

Product Visual Gallery

This gallery contains 3 technical images submitted to the FDA as part of the official labeling for Lumizyme (NDC 58468-0160). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Genzyme Corporation, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Lumizyme 01)

A line graph depicting Forced Vital Capacity (FVC) Upright as a percentage of predicted mean over study visits in weeks. It compares two groups: Alglucosidase alfa (solid red line) and Placebo (dashed blue line). The Alglucosidase alfa group maintains higher FVC percentages consistently across the 0 to 78 week period compared to the placebo group, which shows a decline. A note indicates use of ANCOVA least squares means adjusting for baseline values.*

FDA Label Image

Figure 2 (Lumizyme 02)

A line graph comparing the six-minute walk test mean total distance in meters over study visits in weeks between Alglucosidase alfa and placebo groups. The Alglucosidase alfa group shows an initial increase in walk distance peaking around week 38, while the placebo group remains relatively stable with slight fluctuations. The graph includes a legend differentiating the two groups and a note about ANCOVA adjustment for baseline values.*

FDA Label Image

Lumizyme-figure-3 (Lumizyme 03)

The image shows a carton label for Lumizyme (alglucosidase alfa) injection powder for solution with a strength of 50 mg per vial. It is indicated for intravenous infusion only and labeled as prescription-only. The label includes storage instructions to refrigerate between 2°C and 8°C, protect from light, and notes no preservatives are present. The product is labeled by Genzyme Corporation, Cambridge, MA, with origin Belgium, and features a barcode and GTIN 00358468016010.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.