What to Know About Immune Globulin (IG) Therapy
Download this guide to help you learn more about IG therapy and prepare for your conversation with your healthcare team.
XEMBIFY Self-Administration Video
Experience the freedom and flexibility of administering your own infusions with a routine that's convenient for you. Watch this instructional video designed to help you learn about XEMBIFY self-infusion so you can feel comfortable and prepared for therapy.
Living With PIDD Brochure
Use this brochure to help you better understand PI and your XEMBIFY treatment. Download this brochure below or call Xembify Connexions at 1-844-MYXEMBIFY (1-844-699-3624) Monday through Friday 8 AM to 8 PM ET to request a copy of this brochure.
Patients Resources Infusion
All of the following infusion resources are included in the XEMBIFY Patient Starter Kit, which is available to new patients through the specialty pharmacy. These resources are designed to make every infusion as convenient and comfortable as possible.
Patients resources quick
Quick Reference Infusion Guide
Follow the steps, illustrated on this large-format mat, to prepare and administer your infusions. Its water-resistant surface can be cleaned easily for repeated use.
Patients resources infusion log
Infusion Log Book
Track your infusions and how they felt, and remember to share your Infusion Log Book with your healthcare provider at every visit.
Once you have completed the Infusion Log Book included in the XEMBIFY Patient Starter Kit, you can order another one by calling Xembify Connexions: 1-844-MYXEMBIFY (1-844-699-3624) Monday through Friday 8 AM to 8 PM ET.
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Buzzy® Mini Personal
The Buzzy® Mini Personal uses a patented combination of cold and vibration to reduce the pain of injections.
Patients resources children
Resources for children
There are also resources available for children who start on XEMBIFY therapy. These materials include an educational book (Our Immune System, from the Immune Deficiency Foundation), and a therapy journal with crayons and stickers to help children be more involved and track their infusions.
These resources are also included in the XEMBIFY Patient Starter Kit, which are available to new patients through the specialty pharmacy.
To receive a new journal, call Xembify Connexions: 1-844-MYXEMBIFY (1-844-699-3624) Monday through Friday 8 AM to 8 PM ET.
Connecting you to helpful support organizations
There are many organizations dedicated to helping people manage PI and learn more about the condition.
THE IMMUNE DEFICIENCY FOUNDATION (IDF)
Patient and physician resource for the research and education of primary immune deficiency diseases.
THE JEFFREY MODELL FOUNDATION (JMF)
National resource center for primary immunodeficiency, patient and physician resource, including a patient message board, a physician research library, and CME course, for the research on and education about primary immunodeficiency.
THE INTERNATIONAL PATIENT ORGANISATION FOR PRIMARY IMMUNODEFICIENCIES (IPOPI)
An international organization keen on advancing PI clinical care through medical education and global collaboration.
Patients resources to identify
To identify additional organizations available to support you, please contact Xembify Connexions at 1-844-MYXEMBIFY (1-844-699-3624) Monday through Friday 8 AM to 8 PM ET.
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What Is PI?
Understand more about the symptoms of PI and how it's diagnosed.
Savings and Support
Learn more about Xembify Connexions for strong support from the start.
Learn about infusing XEMBIFY with this step-by-step video.
What is XEMBIFY®?
XEMBIFY® (immune globulin subcutaneous human–klhw) is a 20% immune globulin used in the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. XEMBIFY is for subcutaneous administration only.
IMPORTANT SAFETY INFORMATION
- Thrombosis (formation of blood clots within blood vessels) may occur with immune globulin products, including XEMBIFY. Before you take XEMBIFY, talk to your doctor if you:
- Are older
- Are sedentary (need to lie down or sit down) for long periods of time
- Are taking estrogen-containing medicines (birth control pills, hormone replacement therapy)
- Have a permanent intravenous (IV) catheter
- Have hyperviscosity of the blood (diseases such as multiple myeloma or other causes of elevated proteins in the blood)
- Have cardiovascular (heart) problems or previous history of stroke
- Thrombosis may occur even if you don't have any risk factors
- If you are at risk of thrombosis, your doctor may prescribe XEMBIFY at the minimum dose and infusion rate. Make sure you drink plenty of fluid before taking XEMBIFY. Make sure your doctor is checking you regularly for signs and symptoms of thrombosis and is checking your blood viscosity if you are at risk of hyperviscosity
Who should not use XEMBIFY?
- XEMBIFY should not be used if you have had a severe allergic reaction to human immune globulin, or if you have been told by a doctor that you are IgA deficient and have developed antibodies to IgA and hypersensitivity after exposure to a previous plasma product
What are possible serious side effects of XEMBIFY?
- Hypersensitivity. Severe allergic reactions may occur with immune globulin products, including XEMBIFY. If you have a severe allergic reaction, stop the infusion immediately and get medical attention. XEMBIFY contains IgA. If you have known antibodies to IgA, you may have a greater risk of developing potentially severe allergic reactions
- Aseptic meningitis syndrome (AMS). Aseptic meningitis is a non-infectious inflammation of the membranes that cover the brain. It causes a severe headache syndrome, which may occur with human immune globulin treatment, including XEMBIFY. If you are showing signs and symptoms of AMS, your doctor may conduct a thorough neurological evaluation including spinal tap (sampling fluid which surrounds the spinal cord) to rule out other causes of meningitis. Stopping human immune globulin treatment has resulted in the end of signs and symptoms within several days. Treatment may include analgesics (pain medicines) and/or a special procedure known as a "blood patch" to stop headache
- Kidney problems or failure. Kidney problems or failure may occur with use of human immune globulin products, especially those containing sucrose (sugar). XEMBIFY does not contain sucrose. If you have kidney disease or diabetes with kidney involvement, your doctor should perform a blood test to assess your hydration level and kidney function before beginning immune globulin treatment and at appropriate intervals thereafter. If your doctor determines that kidney function is worsening, they may discontinue treatment
- Hemolysis. Your doctor should monitor you for symptoms of hemolysis (destruction of red blood cells causing anemia, or low red blood cell count). If your doctor suspects hemolysis, they should perform additional tests to confirm
- Transfusion-related acute lung injury (TRALI). TRALI is a rare but serious syndrome characterized by sudden acute respiratory distress following transfusion. If your doctor suspects TRALI, they will monitor you for any other lung issues. TRALI may be managed with oxygen therapy
- Transmissible infectious agents. Because XEMBIFY is made from human blood, it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have been associated with the use of XEMBIFY
- Interference with lab tests. Because XEMBIFY contains a variety of antibodies, blood tests to determine antibody levels may be falsely elevated. Be sure to tell your doctor or lab technician that you are using XEMBIFY
What are other possible side effects of XEMBIFY?
- In clinical studies of XEMBIFY, some patients experienced local side effects (at the injection site) including pain, redness, puffiness, bruising, nodules, itching, firmness, scabbing and swelling at the site on the skin where the injection occurred. Some patients experienced non-injection-site side effects including cough and diarrhea.
- Use of XEMBIFY may interfere with the immune response to virus vaccines, such as vaccines for measles, mumps, rubella and varicella. Tell your doctor you are taking XEMBIFY before getting vaccinations
Please see full Prescribing Information for XEMBIFY.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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