Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 May 2017

Indication(s)

Immunodeficiency
Carimune NF is indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), e.g., common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency. Carimune NF is preferable to intramuscular Immune Globulin (Human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level, in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. The infusions must be repeated at regular intervals.

Immune Thrombocytopenic Purpura (ITP)
Acute
A controlled study was performed in children in which Carimune was compared with steroids for the treatment of acute (defined as less than 6 months duration) ITP. In this study sequential platelet levels of 30,000, 100,000, and 150,000/μL were all achieved faster with Carimune than with steroids and without any of the side effects associated with steroids. However, it should be noted that many cases of acute ITP in childhood
resolve spontaneously within weeks to months. Carimune has been used with good results in the treatment of acute ITP in adult patients.36-38 In a study involving 10 adults with ITP of less than 16 weeks duration, Carimune therapy raised the platelet count to the normal range after a 5 day course. This effect lasted a mean of over 173 days, ranging from 30 to 372 days.

Chronic
Children and adults with chronic (defined as greater than 6 months duration) ITP have also shown an increase (sometimes temporary) in platelet counts upon administration of Carimune. Therefore, in situations that require a rapid rise in platelet count, for example prior to surgery or to control excessive bleeding, use of Carimune should be considered. In children with chronic ITP, Carimune therapy resulted in a mean rise in platelet count of 312,000/μL with a duration of increase ranging from 2 to 6 months.
Carimune therapy may be considered as a means to defer or avoid splenectomy. In adults, Carimune therapy has been shown to be effective in maintaining the platelet count in an acceptable range with or without periodic booster therapy. The mean rise in platelet count was 93,000/μL and the average duration of the increase was 20–24 days. However, it should be noted that not all patients will respond. Even in those patients who do respond, this treatment should not be considered to be curative.

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Category Value
Authorisation number BLA102367
Orphan designation No
Product NDC 44206-417; 44206-418
Date First Approved 10-02-2009
Marketing authorisation holder CSL Behring AG