Vivaglobin® Insurance, Reimbursement, Coverage and Assistance Information

Ensuring that support is available to you, your healthcare team, and your patients

If you have product or medical questions about Vivaglobin, Medical Affairs is available to answer your questions directly at 1-800-504-5434

Comprehensive support with Vivaglobin^® is available to you and your healthcare team through the Vivaglobin^® Resource Center. Please call us at 1-877-VIVAGLOBIN (1-877-848-2456).

The Vivaglobin^® Resource Center is available from 8 AM to 8 PM, ET, Monday through Friday. With a simple call, you can reach a comprehensive support center and talk to a specialist
who will answer your questions. They’re never more than a phone call away, 5 days a week,
12 hours a day. They offer services such as:

Insurance verification—to determine whether an insurer will cover Vivaglobin^® and to obtain prior authorization, if needed
Reimbursement support—to get information on how insurers reimburse for Vivaglobin^®
Coverage appeals—to review denied claims, get appeal procedures, and receive suggestions for resubmission and assistance following up until issues are resolved

Get help with reimbursement
You can receive information on insurance matters, coverage, patient assistance, and more through our Reimbursement Resource Center. Visit the CSL Behring Reimbursement Resource Center or call 1-800-676-4266.

The Vivaglobin^® Resource Center also offers two important programs to ensure that your patients don’t experience a gap in treatment:

CSL Behring Assurance Program—designed to ensure that people who rely on Vivaglobin^® can continue to receive it even if they experience a lapse in third-party, private health insurance. It’s extra help when you need it. Learn more about the program.
The Patient Assistance Program—provides medically necessary therapies to qualified patients who are uninsured, underinsured, or unable to afford Vivaglobin^® Learn more about the program

ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-800-504-5434 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Next: Clinical Studies

Important Safety Information

Immune Globulin Subcutaneous (Human), Vivaglobin^®, is indicated for the treatment of patients with primary immunodeficiency (PI).

As with all immune globulin products, Vivaglobin^® is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations and in persons with selective immunoglobulin A deficiency who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Vivaglobin^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.

As with all immune globulin (Ig) products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella.

In clinical studies, administration of Vivaglobin^® has been shown to be safe and well tolerated in both adult and pediatric subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy were not studied in pediatric subjects under two years of age.

Please see accompanying full prescribing information for Vivaglobin^®.

Please see Patient Product Information

Please see full Prescribing Information

Ensuring that support is available to you, your healthcare team, and your patients

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Please see accompanying full prescribing information for Vivaglobin^®.