velaglucerase alfa
Vpriv
NEW WARNING
The FDA has required prescribing information for velaglucerase alfa, a replacement enzyme used to treat type 1 Gaucher disease, to include a boxed warning about the risk for hypersensitivity reactions including anaphylaxis. Anaphylaxis has occurred in patients on enzyme replacement drugs early in therapy and after extended use.
The boxed warning includes that the drug should be initiated in a health care setting with medical monitoring and readily available support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (such as anaphylaxis) occurs, the drug infusion should be discontinued and appropriate medical treatment, including epinephrine, initiated.
Patients should be advised of the risk of life-threating hypersensitivity reactions and to seek immediate medical attention if symptoms occur.
Adverse effects from the use of velaglucerase alfa should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
sebelipase alpha
Kanuma
NEW WARNING
The FDA has required prescribing information for sebelipase alfa, a replacement enzyme used to treat lysosomal acid lipase deficiency, to include a boxed warning about the risk of hypersensitivity reactions including anaphylaxis. Anaphylaxis has occurred in patients on enzyme replacement drugs early in therapy and after extended use.
The boxed warning includes that the drug should be initiated in a health care setting with medical monitoring and readily available support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (such as anaphylaxis) occurs, the drug infusion should be discontinued and appropriate medical treatment, including epinephrine, initiated.
Patients should be advised of the risk of life-threating hypersensitivity reactions and to seek immediate medical attention if symptoms occur.
Adverse effects from the use of sebelipase alfa should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer