"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Patients should be counseled that allergic reactions may occur during ALDURAZYME treatment, including life-threatening anaphylaxis. Premedication and reduction of infusion rate may alleviate those allergic reactions associated with the infusion. The appropriate length of post-infusion monitoring is to be determined by the treating physician based on the individual patient's clinical status and infusion history [see WARNINGS AND PRECAUTIONS].
Patients should be advised to report any adverse reactions experienced while on ALDURAZYME treatment.
It is unknown how ALDURAZYME affects women during pregnancy, labor and delivery or while nursing, as no adequate and well-controlled clinical studies have been conducted in these patient populations [see Use In Specific Populations].
The full benefits of ALDURAZYME may not be evident for several months to years of treatment. To maintain treatment benefit, ALDURAZYME should be administered on a weekly basis as indicated.
Patients should be informed that a registry for MPS I patients has been established in order to better understand the MPS I disease, and to track clinical outcomes of patients with MPS I over time. Patients should be encouraged to participate, and advised that their participation is voluntary and may involve long-term followup. Information regarding the registry program may be found at www.MPSIregistry.com or by calling (800) 745-4447.
Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Aldurazyme Information
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