"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Patients and caregivers should be counseled that reactions related to administration and infusion may occur during NAGLAZYME treatment, including life-threatening anaphylaxis. Premedication and reduction of infusion rate may alleviate those reactions associated with the infusion [see WARNINGS AND PRECAUTIONS].
Patients should be advised to report any adverse reactions experienced while on NAGLAZYME treatment.
Clinical Surveillance Program
Patients should be informed that a Clinical Surveillance Program has been established in order to better understand the variability and progression of the disease in the population as a whole, and to monitor and evaluate long-term treatment effects of NAGLAZYME. The Clinical Surveillance Program will also monitor the effect of NAGLAZYME on pregnant women, nursing mothers and their offspring, and determine if NAGLAZYME is excreted in breast milk. Patients should be encouraged to participate and advised that their participation is voluntary and may involve long-term follow-up. For more information call 1-800-983-4587.
Last reviewed on RxList: 12/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Naglazyme Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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