Join us for a peer-to-peer discussion incorporating a clinical overview of XEMBIFY 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.
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®.
Upcoming Live Events
Tue 12:15 PM EDT
9.27.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Palumbo
Dr. Michael Palumbo
Thu 7:30 PM EDT
9.29.22 7:30 PM ET | Abbreviated: The Pursuit of Reliable Infection Protection in PIDD - Dr. Graffino
Dr. Donatella Graffino
Thu 12:15 PM EDT
10.13.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Settipane
Dr. Russell Settipane
Tue 12:15 PM EDT
10.25.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Palumbo
Dr. Michael Palumbo
Wed 12:15 PM EST
12.7.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Palumbo
Dr. Michael Palumbo
Past Live Events
Wed 12:30 PM EDT
6.22.22 12:30 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Palumbo
Dr. Michael Palumbo
Wed 11:30 AM EDT
5.25.22 11:30 AM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Karlin
Dr. Eric Karlin
Thu 6:30 PM EDT
5.19.22 6:30 PM ET | Case Study: 43-Year-Old Woman Who Discontinued IVIG - Dr. Rosenbach
Dr. Kevin Rosenbach
Thu 12:15 PM CDT
5.19.22 12:15 PM CT | Abbreviated: The Pursuit of Reliable Infection Protection in PIDD - Dr. Damin
Dr. Derek Damin
Tue 12:15 PM EDT
5.17.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD - Dr. Palumbo
Dr. Michael Palumbo
Thu 12:30 PM EDT
5.12.22 12:30 PM ET | Abbreviated: The Pursuit of Reliable Infection Protection in PIDD - Dr. Lotz
Dr. Douglas Lotz
Thu 12:00 PM EDT
4.21.22 12:00 PM ET | 3 Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Antonie Azar
Wed 2:00 PM EDT
4.20.22 2:00 PM ET | Case Study: 78-Year-Old Woman Currently on IVIG
Dr. Mark Ballow
Thu 6:30 PM EST
2.24.22 6:30 PM ET | 3 Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Jonathan Bayuk
Tue 12:15 PM EST
2.15.22 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Michael Palumbo
Tue 11:30 AM CST
1.11.22 11:30 AM CT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Bob Geng
Tue 6:30 PM CST
12.21.21 6:30 PM CT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Weily Soong
Thu 7:00 PM EST
12.16.21 7:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Kevin Rosenbach
Wed 12:15 PM MST
12.15.21 12:15 PM MT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Michael Volz
Wed 1:00 PM CST
12.15.21 1:00 PM CT | The Pursuit of Reliable Infection Protection in PIDD
Dr. William Lumry
Thu 6:00 PM CST
12.9.21 6:00 PM CT | The Pursuit of Reliable Infection Protection in PIDD
Dr. H. James Wedner
Wed 12:15 PM EST
12.8.21 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Christina Price
Thu 12:15 PM EDT
10.28.21 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Christopher Randolph
Wed 6:30 PM EDT
9.29.21 6:30 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Michael Palumbo
Thu 7:00 PM EDT
9.16.21 7:00 PM ET | 3 Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Kevin Rosenbach
Mon 12:00 PM PDT
8.16.21 12:00 PM PT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Bob Geng
Thu 7:00 PM EDT
8.12.21 7:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Joyce Yu
Thu 12:00 PM EDT
8.5.21 12:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Richard Wasserman
Wed 12:00 PM EDT
7.28.21 12:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Richard Wasserman
Thu 12:00 PM CDT
7.15.21 12:00 PM CT | Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Bob Geng
Wed 12:00 PM CDT
6.9.21 12:00 PM CT | The Pursuit of Reliable Infection Protection in PIDD
Dr. G. Wendall Richmond
Tue 12:30 PM EDT
5.4.21 12:30 PM ET | Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Mark Ballow
Thu 12:15 PM EDT
4.29.21 12:15 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Gavin Schwarz
Wed 12:00 PM MDT
4.28.21 12:00 PM MT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Jeffery Rumbyrt
Wed 12:15 PM PDT
4.21.21 12:15 PM PT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Joshua Jacobs
Wed 12:15 PM CDT
4.14.21 12:15 PM CT | Case Studies: The Pursuit of Reliable Infection Protection in PIDD
Dr. Derek Damin
Tue 12:00 PM EDT
4.6.21 12:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Douglas Lotz
Thu 7:00 PM EDT
3.25.21 7:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Donatella Graffino
Wed 6:30 PM EDT
3.24.21 6:30 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Tina Zecca
Wed 12:15 PM PDT
3.24.21 12:15 PM PT | The Pursuit of Reliable Infection Protection in PIDD
Dr. Joshua Jacobs
Wed 12:00 PM EDT
3.17.21 12:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Douglas Lotz
Wed 1:00 PM EST
2.10.21 1:00 PM ET | The Pursuit of Reliable Infection Protection in PIDD
Dr. Derek Damin