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Aldurazyme demonstrated safety profile.1,a
Serious adverse reactions reported with Aldurazyme treatment during clinical trials were anaphylactic and hypersensitivity reactions.
Warnings and Precautions
- Pre-existing upper airway obstruction may contribute to the severity of some reactions. Consider premedicating patients with antihistamines, with or without antipyretics. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation.
- Consider risks and benefits of re-administering ALDURAZYME following severe hypersensitivity reactions. Patients may be rechallenged using slower infusion rates which may be increased if tolerated to reach the recommended rate. If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
- Patients with an acute febrile or respiratory illness may be at greater risk for infusion reactions. Consider the patient’s clinical status prior to administration of ALDURAZYME and consider delaying the infusion.
- Evaluation of airway patency should be considered prior to initiating ALDURAZYME. Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these treatments readily available during infusion in the event of an infusion reaction or extreme drowsiness/sleep induced by antihistamine use.
- Use caution when administering ALDURAZYME to patients susceptible to fluid overload, or with an acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated. Consider a decreased total infusion volume and infusion rate when administering ALDURAZYME to these patients.
- ALDURAZYME may cause infusion-associated reactions (IARs). Consider pre-medicating with antihistamines, with or without antipyretics, however IARs may still occur in patients after receiving pre-medication. Discontinue immediately or adjust the infusion rate based on the severity of the reaction.
For additional details about these Warnings and Precautions, see the Important Safety Information below.
Aldurazyme has demonstrated a safety profile1,a
Serious adverse reactions reported with Aldurazyme treatment during clinical trials were anaphylactic and hypersensitivity reactions
The most common adverse reactions were infusion reactions. The frequency of infusion reactions decreased over time with continued use of Aldurazyme, and the majority of reactions were classified as being mild to moderate in severity.
In a clinical trial of patients 6 years and older, infusion reactions were reported in 32% (7 of 22) of Aldurazyme-treated patients.1 The most commonly reported infusion reactions were flushing, pyrexia, headache, and rash. Flushing occurred in 5 patients (23%) receiving Aldurazyme; the other reactions were less frequent.
Adverse Reactions that Occured in at Least 2 Patients More in the Aldurazyme Group than in the Placebo Group Among Adult and Pediatric with MPS I in Study 1 | ||
| (N=22) Aldurazyme n (%) | (N=23) Placebo n (%) | |
| Blood and lymphatic disorders | ||
| Thrombocytopenia | 2 (9) | 0 |
| Eye disorders | ||
| Corneal opacity | 2 (9) | 0 |
| General disorders and administration site conditions | ||
| Chest pain | 2 (9) | 0 |
| Face edema | 2 (9) | 0 |
| Gravitational edema | 2 (9) | 0 |
| Injection site pain | 2 (9) | 0 |
| Injection site reaction | 4 (18) | 2 (9) |
| Hepatobiliary disorders | ||
| Hyperbilirubinemia | 2 (9) | 0 |
| Infections and infestations | ||
| Abscess | 2 (9) | 0 |
| Upper respiratory tract infection | 7 (32) | 4 (17) |
| Nervous system disorders | ||
| Hyperreflexia | 3 (14) | 0 |
| Paresthesia | 3 (14) | 1 (4) |
| Skin and subcutaneous tissue disorders | ||
| Rash | 8 (36) | 5 (22) |
| Vascular disorders | ||
| Hypotension | 2 (9) | 0 |
| Poor venous access | 3 (14) | 0 |
aThe risks and benefits of treating mildly affected patients with the Scheie form have not been established.
AE=adverse event; IAR=infusion-associated reaction.
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Indication
References: 1. Aldurazyme (laronidase). Prescribing Information. Sanofi.
