5.4.21 12:30 PM ET | Case Studies: The Pursuit of Reliable Infection Protection in PIDD | The Pursuit of Reliable Infection Protection in PIDD

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Description

Join us for a peer-to-peer discussion incorporating a clinical overview of XEMBIFY (immune globulin subcutaneous, human – klhw) as well as case-based learning for the treatment of patients ≥2 years of age with primary immunodeficiency diseases. Learn more about the unique caprylate chromatography purification process of XEMBIFY. This process yields maximum IgG level and maximum monomeric activity for proven efficacy and tolerability in the treatment of patients with PIDD, ages 2 years and older.

Please see Important Safety Information about XEMBIFY below and refer to the full Prescribing information for complete prescribing details.

Attendee audio and video will be available for this program to enhance audience participation and discussion.

Registration will close 4 hours prior to the presentation start time.

INDICATION
XEMBIFY ^® (immune globulin subcutaneous human–klhw) is a 20% immune globulin indicated for treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. XEMBIFY is for subcutaneous administration only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS

Thrombosis may occur with immune globulin products, including XEMBIFY. Risk factors may include: advanced age, prolonged immobilization, estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors
For patients at risk of thrombosis, administer XEMBIFY at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity

Contraindications
XEMBIFY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Warnings and Precautions
Hypersensitivity. Severe hypersensitivity reactions may occur with immune globulin products, including XEMBIFY. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY contains IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Thrombosis. Thrombosis may occur following treatment with immune globulin products, including XEMBIFY. Thrombosis may occur in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Aseptic meningitis syndrome (AMS) . AMS may occur with human immune globulin treatment, including XEMBIFY. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuation of treatment has resulted in remission within several days without sequelae.

Renal dysfunction/failure . Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose. XEMBIFY does not contain sucrose. Ensure patients are not volume-depleted prior to starting infusion. In patients at risk due to preexisting renal insufficiency or predisposition to acute renal failure, assess renal function prior to the initial infusion of XEMBIFY and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation.

Hemolysis. XEMBIFY may contain blood group antibodies that may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis. If signs and symptoms are present after infusion, perform confirmatory lab testing.

Transfusion-related acute lung injury (TRALI) . Noncardiogenic pulmonary edema may occur in patients following treatment with immune globulin products, including XEMBIFY. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.

Transmissible infectious agents . Because XEMBIFY is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD, or CJD have ever been associated with the use of XEMBIFY.

Interference with lab tests. After infusion of XEMBIFY, passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

Adverse Reactions
The most common adverse reactions in ≥5% of subjects in the clinical trial were local adverse reactions, including infusion-site erythema (redness), infusion-site pain, infusion-site swelling (puffiness), infusion-site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions including cough and diarrhea.

Drug Interactions
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (eg, measles, mumps, rubella, and varicella).

Please see full Prescribing Information for XEMBIFY®.

Contributors

Mark Ballow, MD

Professor of Pediatrics
Division of Allergy & Immunology at Johns Hopkins All Children's Hospital
Dept. of Pediatrics, Morsani College of Medicine, University of South Florida
St. Petersburg, FL

Mark Ballow, MD, is currently Professor in the Departments of Pediatrics at the University of South Florida, Morsani College of Medicine at John Hopkins All Children’s Hospital in St Petersburg, Florida in the Division of Allergy/Immunology. Dr. Ballow received his medical degree from the University of Chicago School of Medicine, Chicago, Illinois. He then completed an internship and residency in pediatrics at Yale-New Haven Hospital in New Haven, Connecticut, followed by a fellowship at the University of Minnesota Hospitals in Minneapolis, Minnesota in Clinical Immunology under the mentorship of Dr. Robert Good. After finishing his time in the Army at Walter Reed Hospital, Dr. Ballow joined the Department of Pediatrics, UConn School of Medicine in Farmington, CT. From 1988 to 2012 Dr. Ballow was Chief of the Division of Allergy, Immunology and Pediatric Rheumatology at Women and Children’s Hospital of Buffalo an affiliate hospital of SUNY Buffalo, School of Medicine and Biomedical Sciences, Training Program Director of the Allergy/Immunology fellowship program, and Director of the Immunobiology Laboratory. Dr. Ballow is board certified in Pediatrics, Allergy and Immunology, and Clinical Laboratory Immunology. Dr. Ballow was the President (2010-2011) of the American Academy of Allergy, Asthma and Immunology (AAAAI). Dr. Ballow is also a member of the American College of Allergy, Asthma and Immunology, and the Clinical Immunology Society. He was a member of the Blood Product Advisory Committee of CBER/FDA. He currently serves on the medical advisory committee for the Immune Deficiency Foundation (IDF) and is consulting medical director for the IDF. Dr. Ballow is on the editorial boards of Journal of Allergy and Clinical Immunology: In Practice, and Annals of Allergy, Asthma and Immunology. Hewas co-editor for Current Opinion in Allergy and Clinical Immunology between 2001-2018. Dr. Ballow is author or coauthor of more than 180 peer-reviewed papers, 50 books/book chapters or monographs, and more than 100 abstracts. He serves on the Data Safety Monitoring Boards for four pharmaceutical Phase III trials and has participated in a number of Phase III clinical trials for immunoglobulin products. His areas of research interest are primary immune deficiency disorders, and immunoglobulin (IVIG) replacement therapy, and its mechanisms of action.

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Description

Contributors

Mark Ballow, MD