XEMBIFY (immune globulin subcutaneous, human – klhw)

XEMBIFY (immune globulin subcutaneous, human – klhw)

SELF-ADMINISTRATION (subcutaneous infusion only)

Indications for Prior Authorization:

• Indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older
  • PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

Patients must meet the following criteria for the indication(s) above:

• Patient is 2 years of age or older, AND
• Prescribed by or in consultation with an immunologist or hematologist, AND
• Patient has a documented diagnosis of primary immunodeficiency, AND
• Decreased IgG concentrations documented on two or more occasions, AND
• Clinically significant functional deficiency of humoral immunity as evidenced by one of the following:
  • Documented failure to produce antibodies to specific antigens (diphtheria/tetanus toxoids/pneumococcal vaccine), OR
  • History of significant recurrent infections (e.g., requiring IV antibiotics, hospitalization, or consultation with an infectious disease specialist), AND
• Unable to tolerate IVIG therapy infusion-related adverse event (anaphylaxis, aseptic meningitis or limited venous access)

Dosing:

• Patients switching from another immune globulin subcutaneous product:
  • Weekly dose is the same as the prior immune globulin subcutaneous weekly dose
  • For subsequent dose adjustments, refer to product labeling
• Patients switching from IGIV therapy
  • Begin treatment one week after patient’s last immune globulin IVInitial weekly dosing (grams): divide previous immune globulin IV dose (grams) by the number of weeks between IV doses, then multiply this dose by 1.37 (dose adjustment factor)
    • Initial weekly = [Prior IVIG dose (in grams) × 1.37 dose (grams)]/number of weeks between IVIG doses
    • Frequent (2 to 7 times per week) dosing (grams): divide the calculated weekly dose by the desired number of times per week
    • For subsequent dose adjustments, refer to product labeling
    • Maximum rate of 25 mL per hour per infusion site

Contraindications:

• Anaphylactic or severe systemic reactions to human immunoglobulins or inactive ingredients of Xembify such as polysorbate 80
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity

Approval:

• 1 year