A New Rx for Immune Disorders

Shire's Cuvitru (immune globulin) approved to treat primary immunodeficiency

/ Author: 

(RxWiki News) The US Food and Drug Administration has approved a new treatment for a group of disorders that cause the immune system not to function the way it should.

This new treatment is Cuvitru (immune globulin, human, 20 percent solution), from Shire. It is available as an injection to be given under the skin.

The group of disorders this medication treats is referred to generally as primary immunodeficiency (PI) and is estimated to affect up to 6 million people across the world.

Normally, the body does a great job of protecting itself from viruses, bacteria and fungi. However, when the immune system is absent or does not function the way it should, it puts you at risk for infection.

Cuvitru was approved to treat patients 2 years of age and older.

Dr. Richard L. Wasserman, medical director of pediatric allergy and immunology at Medical City Children's Hospital, said in a press release that "The availability of Cuvitru as a high concentration, subcutaneous [immune globulin] provides primary immunodeficiency patients with the dosing flexibility that allows them to customize their therapy to best fit their individual needs."

This injection comes with a boxed warning regarding the risk of developing blood clots. There are some factors that may increase your risk for blood clots, such as advanced age, sitting or lying down for long periods of time and certain blood-clotting conditions.

Cuvitru is not recommended in those who have an allergy to immune globulin or who have had a severe allergic reaction to it in the past. In addition, this medication is not recommended for those patients who are immunoglobulin A-deficient with antibodies against immunoglobulin A.

Last Updated:
September 21, 2016