Self-administered subcutaneously, Hizentra delivers consistent levels of immunoglobulin G (IgG) regardless of dosing schedule. Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once-weekly IgG replacement therapy to help protect people with PI against infections and was approved for biweekly (once every two weeks) dosing in September 2013.
PI is a group of serious diseases that compromise the immune system, leaving patients particularly vulnerable to infection. Approximately 250,000 Americans (or one person per 1,200) have been diagnosed with PI.
"Patient preferences on infusion frequency, time and volume can differ for many reasons, so having a treatment option like Hizentra that can be customized to fit individual lifestyles is important to both patients and the physicians who treat them," said Ralph S. Shapiro, M.D., Director of the Midwest Immunology Clinic.
"Most important, flexible dosing options with Hizentra give PI patients the freedom to manage their condition based on their specific needs, while still providing a consistent level of protection against infections."
FDA approval of flexible dosing for Hizentra is based on pharmacometrics (modeling and simulation). Clinical trials using these alternative Hizentra dosing regimens were not conducted.
"CSL Behring understands that managing a life-long disorder can be challenging as patients’ lifestyles and treatment requirements may change over time," said Bill Campbell, Senior Vice President, North America Commercial Operations, CSL Behring.
"Offering PI patients the option of dosing Hizentra at regular intervals from daily to once every two weeks further underscores our commitment to providing treatment options that improve patients’ lives."
More than 200 types of PIs exist. For individuals with PI, many of them children, infections may not improve as expected with usual treatments and may even keep returning. As a result, patients may face repeated rounds of antibiotics or hospitalization for treatment.
Repeated infections can lead to organ damage, which over time can become life-threatening. Some infections, such as meningitis, can even result in death.