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Aldurazyme® (laronidase) Continuing with Care


Support your patients as they commit to long-term treatment with Aldurazyme.

A long-term commitment

Patients and caregivers need to understand that staying on track with Aldurazyme infusions is an important part of the overall mucopolysaccharidosis type I (MPS I) management.1-3

  • Patients may need to receive ongoing infusions of Aldurazyme, even if their symptoms improve3,4
  • If long-term treatment is stopped, GAG levels may rise again, creating a recurrence of MPS I signs and symptoms3,4
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Actor portrayal.

When discussing MPS I with your patients, cover the following points1,5:

  • MPS I patients need long-term care. It is important that we understand and address patients' concerns for better long-term care
       

  • You could explain in patient-friendly terms that people with MPS I are deficient in the enzyme IDUA, which is responsible for breaking down the accumulation of GAG. When Aldurazyme is administered, it supplies the body with a source of the deficient enzyme and helps break down that accumulation of GAG. If the therapy is stopped, GAG can once again build up, which may lead to a recurrence of certain signs and symptoms
       

  • It is important to continue to monitor your patients' disease progression. Due to the progressive nature of MPS I, patients may need to receive ongoing infusions of Aldurazyme, even if their symptoms have improved
       

  • Patients and their families may expect quick results with Aldurazyme therapy. Consider explaining how results vary based on each patient’s own condition and response to the treatment. To maintain treatment benefit, Aldurazyme should be administered weekly as indicated
       

GAG=glycosaminoglycan; IDUA= α-L-iduronidase; MPS I=mucopolysaccharidosis type I.

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Overall safety profile

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. 2. Martins AM et al. J Pediatr. 2009;155(4)(suppl 2):S32-S46. 3. Anbu AT et al. J Inherit Metab Dis. 2006;29(1):230-231. 4. Laraway S et al. Outcomes of long-term treatment with laronidase in patients with mucopolysaccharidosis type I. J Pediatr. 2016;178:219-226.e1. 5. Neufeld EF, Muenzer J. The Mucopolysaccharidoses. In: Valle DL, Antonarakis S, Ballabio A, Beaudet AL, Mitchell GA. eds. The Online Metabolic and Molecular Bases of Inherited Disease. McGraw Hill; 2019. Accessed July 20, 2022. https://ommbid.mhmedical.com/content.aspx?bookid=2709&sectionid=225544161

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