Black Box Warning: More information
REMS: Ultomiris REMS
ravulizumab
Use of Ravulizumab is restricted to patients who meet the REMS program requirements and must be prescribed by a REMS certified prescriber.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Ultomiris: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf#page=41
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Use of Ravulizumab is restricted to patients who meet the REMS program requirements and must be prescribed by a REMS certified prescriber.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Ultomiris: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf#page=41