XEMBIFY offers steady protection
In a clinical study, people taking XEMBIFY saw improvement in their symptoms of PI and the impact PI had on their lives. Within a year, people taking XEMBIFY experienced:
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Why Xembify?
Count on XEMBIFY
Keeping you protected throughout the day
XEMBIFY is a subcutaneous IG replacement therapy used to treat PI in patients 2 years of age and older.
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Why XEMBIFY?
Learn why XEMBIFY could be a good choice for you.
Xembify Connexions™ offers copay assistance of up to $10,000 per calendar year for XEMBIFY, which could mean $0 copay for eligible patients.*
Learn more about savings and support for XEMBIFY.
*Subject to terms and conditions.
0 serious bacterial infections 1*†
Fewer than 3 days of missed work/school due to infections 1
0 hospitalizations due to infections 1†
*One patient reported sepsis due to an animal bite, an event deemed unrelated to the treatment.
†Rate per subject-year: 0.049.
XEMBIFY maintains IgG levels in between doses1
Steady Protection
In a clinical trial, all patients maintained antibody levels above the commonly accepted level that helps fight infections.1
Maximum purity
Unique manufacturing process produces a product with a maximum percentage of IgG.2
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Getting Started on XEMBIFY
Hear Joanne, a retired nurse with PI, describe her experience with XEMBIFY and how she learned about self-infusion.
Proven protection with proven tolerability
As with any medication, there is a possibility of side effects. The most common side effects in a clinical study with PI patients who received XEMBIFY were3:
- Infusion-site reactions such as redness, pain, puffiness, swelling, bruising, nodule or scab formation, itching, and firmness
- Cough and diarrhea
In the clinical study, only 1 patient experienced headache, and the rate of headache was 1 in every 1000 infusions. No patients experienced fatigue.1
Tell your healthcare provider if you have or ever had3
- A serious reaction to other medicines that contain immune globulin
- An immunoglobulin A (IgA) deficiency
- A history of heart or blood vessel disease
- A risk factor for blood clots
- Inability to move over the course of a few hours
Discuss any side effects that concern you with your healthcare provider. You can also view the XEMBIFY full Prescribing Information, which is available to healthcare professionals.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
If you have any questions about XEMBIFY, you can view the XEMBIFY FAQs to learn more or call
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.
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Terms to Know
PI, primary humoral immunodeficiency disease
SCIG, subcutaneous immune globulin
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
WARNING: THROMBOSIS
- 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?
- 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
- 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
- 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 accompanying 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.
References
- Sleasman JW, Lumry WR, Hussain I, et al. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study. Immunotherapy. 2019;11(16):1371-1386.
- Alonso W, Vandeberg P, Lang J, et al. Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals. 2020;64:34-40.
- XEMBIFY® (immune globulin subcutaneous human-klhw) 20% Prescribing Information. Grifols.