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Vivaglobin® is an effective therapy for PI you can self-administer subcutaneously—where and when it is most convenient for you. Because Vivaglobin® is the Ig therapy option that allows you to self-administer, it provides greater freedom and flexibility.

Freedom and flexibility
Like IVIg therapy, the Vivaglobin® Sub-Q way can help you stay healthy and avoid infections. Unlike IVIg therapy, however, Vivaglobin® doesn’t tie you to an IV pole. Instead, you infuse your Ig therapy using a portable pump that allows you greater freedom and flexibility as to where and when you decide to infuse your therapy. And Vivaglobin® allows you to move around and engage in normal activities around the house while you’re infusing.1

Vivaglobin® can be infused at home and therefore your family can spend more time together-even during infusions. Between school, work, and social functions, finding time for “quality time” together can be difficult. With Vivaglobin®, managing PI doesn’t have to take away from your family’s precious time together. And because Vivaglobin® therapy is fully portable, you can enjoy family vacations without having to worry about missing an infusion.

Steady-state serum levels
Another important benefit is that Vivaglobin® is infused weekly, so the level of Ig in your blood remains relatively constant. By contrast, IVIg is usually infused every 3 to 4 weeks, so levels peak after an infusion and then drop off until the next infusion.

steady state graph

A clinical study in the United States and Canada showed that weekly infusions of Vivaglobin® delivered “steady-state” immunoglobulin levels without the dips or “wear off” effect patients can experience near the end of their IVIg treatment cycle.1-3

Please see the Important Safety Information below.

Safety
Vivaglobin® is made from plasma—a portion of human blood—and as with all products made from plasma, the risk of transmitting disease can't be completely eliminated. However, CSL Behring (a world leader in researching and developing plasma-derived products) goes to considerable lengths and uses rigorous testing methods to remove or inactivate potential viruses to protect your safety.

  • All plasma used to produce Vivaglobin® is collected using methods that meet or exceed US Food and Drug Administration requirements
  • All plasma is collected in the United States
  • All plasma donors are screened carefully for prior exposure to certain viruses
  • All collected plasma is tested for potentially harmful viruses
  • The advanced manufacturing steps for Vivaglobin® include pasteurization by heating Vivaglobin® at 60o C for 10 hours
  • An additional process called ethanol-fatty alcohol/pH precipitation further purifies Vivaglobin®

During clinical studies, no cases of hepatitis A, B, or C virus; HIV; or parvovirus B19 (a mild rash illness that occurs mostly in children) were reported with the use of Vivaglobin®.

No serious adverse events in clinical trials
Vivaglobin® is proven safe for people with PI. The US/Canada clinical studies showed no serious adverse events in more than 3,600 infusions of Vivaglobin®.

Experience for more than 10 years in Europe
Vivaglobin® has been used safely by thousands of patients in Europe for more than a decade.

References:

  1. Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies—a prospective, multi-national study. J Clin Immunol. 2006;26:177-185.
  2. Nicolay U, Kiessling P, Berger M, et al. Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. J Clin Immunol. 2006;26:65-72.
  3. Ochs HD, Gupta S, Kiessling P, et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol.
    2006;26:265-273.

Next: Moving to Vivaglobin®