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XEMBIFY offers infection protection you can trust with proven tolerability1,2

In a clinical study, people taking XEMBIFY had:

Bacterial infections icon

0 serious bacterial infections1*†

Hospitalizations icon

0 hospitalizations due to infection1†

Infusion reactions icon

0 serious infusion reactions, nausea, or fatigue, and fewer than 1 headache per 1000 infusions1,2

Missed days icon

Fewer than 3 days of work or school missed due to infections1

*One patient reported sepsis due to an animal bite, an event deemed unrelated to the treatment.1
†Rate per subject-year: 0.049.1

Consistent protection between doses—XEMBIFY raises your IgG levels quickly and keeps them there1

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In an average of 3 days, most people in a clinical trial treated with XEMBIFY had IgG levels above the commonly accepted level to fight infections1

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In the clinical trial, IgG levels stayed above the commonly accepted level, delivering uninterrupted infection protection, even between doses1 

What does this mean? When IgG levels are maintained, you can get continuous infection protection without feeling sick because your treatment has started wearing off3

XEMBIFY was proven tolerable in clinical studies2

As with any medication, there is a possibility of side effects. The most common side effects in a clinical study of patients with PI who received XEMBIFY were:

  • Infusion-site reactions, such as redness, pain, puffiness, swelling, bruising, nodule or scab formation, itching, and firmness
  • Cough and diarrhea

 

Tell your healthcare provider if you have or ever had2

  • 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
  • An inability to move over the course of a few hours

 

Get infection protection with a low rate of headaches1

In the clinical study, 1 patient experienced headache, and the rate of headache was 1 in every 1000 infusions.1

Count on the power of pure protection

Count on the power of pure protection with XEMBIFY, an IG therapy that contains ≥ 98% IgG and is designed to replace what your body doesn’t make itself 2,4

All IG is made from human plasma, but not all IG is the same. XEMBIFY is made by Grifols, which has more than 20 years of experience making IG therapy for patients with PI.5,6

The unique process used to make XEMBIFY yields a maximum percentage (≥ 98%) of IgG, which helps prevent infections.1,2,4

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 
1-800-FDA-1088 (1-800-332-1088).

 

If you have any questions about XEMBIFY, you can view the XEMBIFY FAQs to learn more or call 1-844-MYXEMBIFY (1-844-699-3624) Monday through Friday, 8 AM to 8 PM ET.

 

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.2

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Terms to Know

IG, immune globulin; PI, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin.

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

  1. 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.
  2. XEMBIFY Prescribing Information, Grifols. July 2024.
  3. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146-160.
  4. 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.
  5. Siegel J. Immune globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharmacy Practice News. April 11, 2024. Accessed August 21, 2025. https://www.pharmacypracticenews.com/Monographs-and-Whitepapers/Article/04-24/Immune-Globulins-Therapeutic-Pharmaceutical-Cost-and-Administration-Considerations/73454
  6. Data on file, Grifols.