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Cuvitru FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved September 13, 2016)
Brand name: Cuvitru
Generic name: immune globulin subcutaneous (human)
Dosage form: Injection
Company: Shire plc
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 timeline for Cuvitru

Sep 14, 2016Approval Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency

Further information

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