Aldurazyme® Dosing and Administration

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For your patients on Aldurazyme, remember to check their weight and dose regularly.

Care should be taken to properly calculate the dose based on accurate and current body weight.

The importance of updating weight for accurate dosing

The recommended dose of Aldurazyme is 0.58 mg/kg of body weight administered once weekly as an intravenous infusion¹
Care should be taken to properly calculate the dose based on accurate and current body weight
Because the dose is weight-based, a change in patients' body weight will require an adjustment in the dose of Aldurazyme they receive¹
It is recommended to weigh patients at baseline and at least every 6 months or more frequently as needed to determine the appropriate dose

Aldurazyme is a once-weekly intravenous infusion¹

Appropriate medical support should be readily available when Aldurazyme is administered¹
Because of the potential for infusion reactions, it is recommended that patients receive pretreatment medications, including antihistamines and/or antipyretics, 60 minutes prior to the start of the infusion. However, IARs may still occur in patients after receiving pre-medication¹

Drug dosage is calculated based on the patient’s body weight¹

Each vial of Aldurazyme provides 2.9 milligrams (mg) of laronidase in 5.0 milliliters (mL) of solution and is intended for single-dose only. Do not use the vial more than one time¹
The concentrated solution for infusion must be diluted with 0.9% sodium chloride injection, USP, to a final volume of 50 mL, 100 mL or 250 mL, using aseptic techniques¹

Recommended dosage should be administered over approximately 3 to 4 hours¹

Patients weighing ≤2 to <4 kg the recommended total infusion volume is 50 mL
Patients weighing ≥4 to <20 kg the recommended total infusion volume is 100 mL
Patients weighing ≥20 kg the recommended total infusion volume is 250 mL
Initial infusion rate of 10 mcg/kg/h may be incrementally increased every 15 minutes, as tolerated until a maximum infusion rate of 200 mcg/kg/h is reached. Maximum rate is maintained for the remainder of the infusion. The total infusion time is approximately 3 to 4 hours
For patients with underlying cardiac or respiratory compromise and weighing up to 30 kg, physicians may consider diluting Aldurazyme in a volume of 100 mL and administering at a decreased infusion rate
Administer the diluted Aldurazyme solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 μm in-line filter

Table 1: Incremental Infusion Rate Steps and Volumes for Aldurazyme^® Infusion by Patient Weight
Patient Weight Range	Total Infusion Volume	Step 1 10 mcg/ kg/hr	Step 2 20 mcg/ kg/hr	Step 3 50 mcg/ kg/hr	Step 4 100 mcg/ kg/hr	Step 5 200 mcg/ kg/hr
Patient Weight Range	Total Infusion Volume	Infusion Rate in mL/hour
≥2 to <4 kg	50 mL	1	2	4	8	16
≥4 to <20 kg	100 mL	2	4	8	16	32
≥20 kg	250 mL	5	10	20	40	80

Aldurazyme vials should be refrigerated at 2°C to 8°C

It is important that vials¹:

Should not be frozen or shaken
Should be protected from light
Should not be used after the expiration date

Infusion bags should be used immediately after dilution with saline water. If not, it should be refrigerated at 2°C to 8°C for up to 36 hours.

For full reconstitution and administration instructions, please refer to the Instructions for Use.

Continue your patient’s treatment with Aldurazyme

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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

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

Aldurazyme® (laronidase) Dosing and Administration

For your patients on Aldurazyme, remember to check their weight and dose regularly.

The importance of updating weight for accurate dosing

Aldurazyme is a once-weekly intravenous infusion1

Drug dosage is calculated based on the patient’s body weight1

Recommended dosage should be administered over approximately 3 to 4 hours1

Table 1: Incremental Infusion Rate Steps and Volumes for Aldurazyme® Infusion by Patient Weight

Aldurazyme vials should be refrigerated at 2°C to 8°C

Continue your patient’s treatment with Aldurazyme

Indication

Limitations of Use:

Important Safety Information

Indication

Important Safety Information

Aldurazyme^® (laronidase) Dosing and Administration

Aldurazyme is a once-weekly intravenous infusion¹

Drug dosage is calculated based on the patient’s body weight¹

Recommended dosage should be administered over approximately 3 to 4 hours¹

Table 1: Incremental Infusion Rate Steps and Volumes for
Aldurazyme^® Infusion by Patient Weight