Journal: Drug Safety

Article Title: Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

doi: 10.1007/s40264-021-01125-4

Figure Lengend Snippet: Comparison of adverse events (AEs) reported in patients receiving imiglucerase in Mexico before and after Asbroder approval. Infusion-associated reactions are product-related AEs occurring within 24 h of the infusion. IAR infusion-associated reactions

Article Snippet: IAR infusion-associated reactions Fig. 2 a Most frequent (three or more) adverse events reported among Cerezyme cases. b Most frequent (three or more) adverse events reported among Asbroder cases During the post-Asbroder approval reporting period (11 October, 2015 to 1 March, 2018), 132 cases with 333 AEs were reported in patients while receiving imiglucerase therapy to the Sanofi GSD (Fig. ).

Techniques: Comparison

Journal: Drug Safety

Article Title: Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

doi: 10.1007/s40264-021-01125-4

Figure Lengend Snippet: a Most frequent (three or more) adverse events reported among Cerezyme cases. b Most frequent (three or more) adverse events reported among Asbroder cases

Article Snippet: IAR infusion-associated reactions Fig. 2 a Most frequent (three or more) adverse events reported among Cerezyme cases. b Most frequent (three or more) adverse events reported among Asbroder cases During the post-Asbroder approval reporting period (11 October, 2015 to 1 March, 2018), 132 cases with 333 AEs were reported in patients while receiving imiglucerase therapy to the Sanofi GSD (Fig. ).

Techniques:

Journal: Drug Safety

Article Title: Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

doi: 10.1007/s40264-021-01125-4

Figure Lengend Snippet: Imiglucerase cases attributed to Cerezyme or Asbroder

Article Snippet: IAR infusion-associated reactions Fig. 2 a Most frequent (three or more) adverse events reported among Cerezyme cases. b Most frequent (three or more) adverse events reported among Asbroder cases During the post-Asbroder approval reporting period (11 October, 2015 to 1 March, 2018), 132 cases with 333 AEs were reported in patients while receiving imiglucerase therapy to the Sanofi GSD (Fig. ).

Techniques:

Journal: Drug Safety

Article Title: Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

doi: 10.1007/s40264-021-01125-4

Figure Lengend Snippet: Asbroder vs Cerezyme discontinuation rates after Asbroder approval ( N = 132). AE adverse event

Article Snippet: IAR infusion-associated reactions Fig. 2 a Most frequent (three or more) adverse events reported among Cerezyme cases. b Most frequent (three or more) adverse events reported among Asbroder cases During the post-Asbroder approval reporting period (11 October, 2015 to 1 March, 2018), 132 cases with 333 AEs were reported in patients while receiving imiglucerase therapy to the Sanofi GSD (Fig. ).

Techniques:

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: A) Enzymatic reaction leading to the degradation of GlcCer in Cn catalyzed by beta-glucosidase (Cerezyme). B) Extracted cryptococcal GlcCer (8 µg) was treated in vitro with 200 mU/ml of Cerezyme for 1 hour at 37°C. The reaction was stopped, lipids extracted, and loaded on a TLC with a soy standard for GlcCer. The GlcCer was visualized with a resorcinol spray. C) The same amount of GlcCer was treated with 200 mU/ml of Cerezyme and the amount of GlcCer was analyzed with mass spectrometry, along with the amount of the reaction product, α-OH-Δ8-Me-Ceramide (Me-Ceramide). The GlcCer treated with Cerezyme showed complete hydrolysis in these conditions.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: In Vitro, Mass Spectrometry

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: Mass spectroscopy was used to analyze amount of GlcCer of wild-type H99 or Δgcs1 mutant strain treated with different concentrations of Cerezyme for 1 hour at 37°C normalized to phosphate (P i ). Enzyme treatment hydrolyzed GlcCer in a dose-dependent manner. *, P< 0.05 by Student t test, WT 100 or 200 versus untreated (−).

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Mass Spectrometry, Mutagenesis

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: Membrane integrity is indirectly measured using a dye, SYTOX, that fluoresces upon entering a cell, but is excluded from functional membranes. This is measured in arbitrary units of fluorescence (with background subtracted). The strains tested here were WT Cn and Δcap59 (A) and Δgcs1 (B). WT and Δ cap59 strains show increasing fluorescence when treated with Cerezyme (0, 200 mU/ml, or 400 mU/ml), but Δgcs1 remains unaffected by treatment. Δgcs1 also shows a much higher signal than other strains. *, P< 0.05 by Student t test, WT 200 mU/ml or 400 mU/ml versus untreated; #, P< 0.05 by Student t test, acapsular 200 mU/ml or 400 mU/ml versus untreated.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Membrane, Functional Assay, Fluorescence

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: I n vitro growth of Cn was assessed in minimal media, pH 7.2, at either 5% (A) or 0.04% (B) CO 2 with different concentrations of Cerezyme (0, 50, 100 or 200 U/mL). Treatment shows a dose-dependent inhibition of fungal growth. This growth reduction was not observed in the cells grown at low (0.04%) CO 2 . *, P< 0.05 by Student t test, WT 50 mU/ml or 100 mU/ml or 200 mU/ml versus untreated.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Inhibition

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: Mass spectrometry analysis of GlcCer of Cn recovered from the lung of infected mice for 24 (A) or 48 (B) hours. Enzyme treatment hydrolyzed GlcCer in a dose-dependent manner. *, P< 0.05 by Student t test, 24 or 48 hours 20 U/Kg or 30 U/Kg of Cerezyme versus untreated.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Mass Spectrometry, Infection

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: CBA/J mice (n = 10 per group) were infected with 5×10 5 Cn wild type H99 strain intranasally. Mice were treated with PBS, 20 U/kg or 40 U/kg of Cerezyme (Cz) immediately after the injection of fungal cells and every 2 days. The higher dose of Cz conveyed a protective effect to infected mice, showing a significant increase in survival (by Wilcoxon-Rank Sum test P <0.01, compared to PBS treated mice). The data are representative of two separate experiments.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Infection, Injection

Journal: PLoS ONE

Article Title: Surface Localization of Glucosylceramide during Cryptococcus neoformans Infection Allows Targeting as a Potential Antifungal

doi: 10.1371/journal.pone.0015572

Figure Lengend Snippet: Schematic of GlcCer localization during infection and the proposed effect of GlcCer reduction in Cerezyme treatment or Δgcs1 strain.

Article Snippet: Cerezyme was provided generously by the Genzyme Corporation.

Techniques: Infection