Formula & Concentration

NF, Nanofiltered, Immune Globulin Intravenous (Human)

Manufacturer

CSL Behring

Indications

Immunodeficiency

Immune Globulin Intravenous (Human) Lyophilized Preparation, Carimune® NF, Nanofiltered
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.30, 32-34 Carimune® NF is preferable to intramuscular Immune Globulin (Human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28, 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.
Please see DOSAGE AND ADMINISTRATION section.

Immune Thrombocytopenic Purpura (ITP)
Acute®
A controlled study was performed in children in which Carimune 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.29,35 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.39

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®.35, 39-43 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.40,43Carimune® therapy may be considered as a means to defer or avoid splenectomy.42-44In 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.39, 40 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.

Product Options

Package Size

NDC #

Presentation

6 Gram

44206-0417-06

Vial

12 Gram

44206-0418-12

Vial

Shelf Life and Storage

24 Months

Carimune® NF should be stored at room temperature not exceeding 30°C (86°F). The preparation should not be used after the expiration date printed on the label.