Aldurazyme® (laronidase) Safety Profile

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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.

For additional details about these Warnings and Precautions, see the Important Safety Information below.

Aldurazyme has demonstrated a safety profile^1,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

ALDURAZYME^® (laronidase) is indicated for the treatment of adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.

Limitations of Use:

The safety and effectiveness of treating mildly affected patients with the Scheie form have not been established.
The effect of ALDURAZYME on central nervous system manifestations of the disorder has not been determined.

Important Safety Information

WARNING: HYPERSENTIVITIY REACTIONS INCLUDING ANAPHYLAXIS, and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION

Hypersensitivity Reactions Including Anaphylaxis
Patients treated with ALDURAZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to ALDURAZYME may be considered.

Acute Respiratory Complications Associated with Administration
Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring.

Warnings and Precautions
Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.

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.

Acute Respiratory Complications Associated with Administration: See Boxed WARNING.

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.

Acute Cardiorespiratory Failure:

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.

Infusion-Associated Reactions:

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.

Adverse Reactions
Patients 6 months of age and older

The most common adverse reactions reported in ≥10% of patients were infusion reactions, which included pyrexia, chills, blood pressure increased, tachycardia, and oxygen saturation decreased.

Patients 6 years of age and older

The most common adverse reactions reported in ≥10% of patients were rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.

Please see Full Prescribing Information including Boxed WARNING for Aldurazyme.

Indication

Important Safety Information

References: 1. Aldurazyme (laronidase). Prescribing Information. Sanofi.

Aldurazyme® (laronidase) Safety Profile and Side Effects

Aldurazyme demonstrated safety profile.1,a

Warnings and Precautions

Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.

Acute Respiratory Complications Associated with Administration: See Boxed WARNING.

Acute Cardiorespiratory Failure:

Infusion-Associated Reactions:

Aldurazyme has demonstrated a safety profile1,a

Serious adverse reactions reported with Aldurazyme treatment during clinical trials were anaphylactic and hypersensitivity reactions

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

Get started with Aldurazyme – Thinking about prescribing Aldurazyme?

Indication

Limitations of Use:

Important Safety Information

Indication

Important Safety Information

Aldurazyme^® (laronidase) Safety Profile and Side Effects

Aldurazyme demonstrated safety profile.^1,a

Aldurazyme has demonstrated a safety profile^1,a