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Cerezyme has an established safety profile1
Safety was evaluated in clinical trials and a long-term observational monitoring database1,2
Adverse reactions
The following adverse reactions associated with the use of imiglucerase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
System Organ Class |
Adverse Reactions |
| Nervous system disorders | Dizziness, headache |
| Cardiac disorders | Tachycardia |
| Vascular disorders | Cyanosisa, flushinga, hypotensiona, hypertensiona |
| Respiratory, thoracic, and mediastinal disorders | Cougha, dyspneaa, pneumonia, pulmonary hypertension |
| Gastrointestinal disorders | Abdominal pain, diarrhea, nausea, vomiting |
| Immune system disorders | Anaphylaxisa, hypersensitivity |
| Skin and subcutaneous tissue disorders | Angioedemaa, pruritusa, rash, urticariaa |
| Musculoskeletal and connective tissue disorders | Back pain |
| General disorders and administration site conditions | Chest discomforta, chills, fatigue, infusion-site burning, infusion-site discomfort, infusion-site swelling, pyrexia |
aSigns and symptoms suggestive of hypersensitivity reactions, including anaphylaxis, and other infusion-associated reactions.1
Adverse reactions reported in pediatric patients 2 years of age and older were similar to adults.1
10-year analysis of an international safety monitoring database1
A retrospective, observational, 10-year analysis reviewed the safety profile of Cerezyme established over 10 years after approval (1994–2004) based on worldwide postmarketing experience and data collected through immunosurveillance.a
The most frequently reported treatment-related AEs fell under 3 body systems
These AEs were nonserious, infusion-associated reactions, and most AEs showed a consistent distribution across the time intervals.
Top 3 system organ-class categories of related AEs and the 3 most frequently reported AEs for those categories for Cerezyme from 1997 to 20041,b
Treatment-related AEs |
All AEs | |
| Total | 852 | 2931 |
| General disorders and administration site reactions | 161 | 455 |
| Pyrexia | 25 | 80 |
| Chills | 21 | 55 |
| Chest discomfort | 22 | 44 |
| Skin and subcutaneous tissue disorders | 117 | 325 |
| Pruritus | 28 | 82 |
| Rash | 23 | 67 |
| Urticaria | 24 | 60 |
| Respiratory, thoracic, and mediastinal disorders | 88 | 298 |
| Dyspnea | 28 | 75 |
| Cough | 12 | 32 |
| Throat irritation | 9 | 11 |
aSmall-scale production limited the use of Cerezyme during the early postapproval period of 1994 to 1997, resulting in a small number of treated patients and reported AEs during this time period.1
bEach of these events was found to occur in <1% of the total patient population. Each event may have occurred more than once in any individual patient.
Most of the related AEs were temporally related to the infusion of Cerezyme and typical of immune-mediated reactions.1
- These types of AEs were predominantly self-limited and effectively managed by either decreasing the rate of infusion or pretreatment with antihistamines, which generally decreased the frequency of these events
- In patients with significant reactions, temporary modifications in dose were made in addition to lowering the infusion rate and pretreatment with antihistamines
- Over time, most patients tolerated Cerezyme at the regular infusion rate without additional pretreatment with antihistamine
- Only 4 patients with significant infusion reactions subsequently discontinued enzyme replacement therapy
Cerezyme showed consistent rates of reported events over time.1
AE=adverse event.
Indication
References: 1. Starzyk K, Richard S, Yee J, Smith SE, Kinga W. Mol Genet Metab. 2007;90(2):157-163. 2. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA.
