Cuvitru Approval History
- FDA approved: Yes (First approved September 13th, 2016)
- Brand name: Cuvitru
- Generic name: immune globulin subcutaneous (human)
- Dosage form: Injection
- Company: Shire US, Inc.
- Treatment for: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).
Cuvitru is a ready-to-use injection administered via subcutaneous infusion at regular intervals from daily up to every two weeks.
Common side effects include infusion site reactions, headache, nausea, fatigue, diarrhea, and vomiting.
Development History and FDA Approval Process for Cuvitru
|Sep 14, 2016||Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.