The CSL Behring Commitment

Our Commitment to Patients

CSL Behring is passionate about safety, quality, and the consumers we serve. Our extensive research and development and range of support services demonstrate our ongoing commitment to all who rely on our products. We are deeply committed to providing the best possible therapies and services.

CSL Behring demonstrates its commitment to patients in many ways. Among other activities, we sponsor programs and support patient organizations benefiting people with primary immune deficiencies.

CSL Behring resources and services help consumers and families manage the daily challenges of living with a chronic disorder. CSL Behring operates Web sites that provide disease and product information. For example, in some countries, we can use our Web site to reach a patient, ask questions, or offer emotional support. CSL Behring works closely with patient organizations on a range of issues from education to advocacy. We work with legislators and regulators around the world to assure patient access and appropriate reimbursement for high-quality, safe, plasma-derived and recombinant products.

CSL Behring K.K. is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan. CSL Behring is working with the Plasma Protein Therapeutics Association and EFPIA Japan to develop a system that will allow simultaneous new drug submissions in Japan, Europe, and the United States. What’s more, these policy groups are trying to persuade the Japanese government to establish a more rational and easy-to-access process for reimbursement pricing. In the United States, CSL Behring has programs to help ensure that people who rely on our therapies can continue to receive these vital treatments during lapses in their health insurance.

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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

Our Commitment to Patients

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Please see accompanying full prescribing information for Vivaglobin^®.