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infusing XEMBIFY

Infuse XEMBIFY with confidence

XEMBIFY is an immune globulin replacement therapy that is given subcutaneously. This means that after being trained by a healthcare professional, you can infuse XEMBIFY at home or wherever is convenient for you. Be sure to follow your healthcare provider's instructions on how much and how often you should infuse.

Watch

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.

You can also follow the step-by-step instructions on how to infuse below.

Before the infusion

If the vial(s) of XEMBIFY is refrigerated, remove from the refrigerator prior to your infusion and allow the vial(s) to reach room temperature. This may take 60 minutes or longer. DO NOT apply heat to the vial(s) or place in the microwave. Instead, let the vial(s) warm to room temperature naturally

Infusing XEMBIFY

Step 1

Disinfect surface to be used for your infusion with an alcohol wipe. Allow the vial(s) of XEMBIFY to reach room temperature. Set up all of the supplies you will need. Wash and dry your hands thoroughly.

Step 2

Check the vial(s) of XEMBIFY. Confirm the name and expiration date. If the product is past the expiration date, if the liquid is cloudy or has particles, or if the vial shows any sign of tampering, do not use that vial. Contact your healthcare provider for guidance in that case.

Step 3

Remove the tamper-resistant seal and protective cap from the vial of XEMBIFY. Clean the rubber stopper with an alcohol wipe and allow to air-dry.

Step 4

Draw XEMBIFY into the syringe using either a needle or a transfer device. If you are using a needle, refer to Step 5. If using a transfer device, refer to Step 6.

Step 5

Attach the needle to the syringe tip and remove the cap. Pull the syringe plunger back to the level of XEMBIFY you want to withdraw. Place the vial on a flat surface, insert the needle and inject air. Turn the vial and syringe upside down. Make sure the needle is placed below the fluid level and withdraw XEMBIFY.

Step 6

Uncap the transfer device and attach it to the syringe. Place the vial on a flat surface and insert the device into the top of the vial. Turn the vial and syringe upside down and withdraw the desired amount of XEMBIFY. Then, remove the syringe and transfer device.

Step 7

Follow the pump manufacturer’s instructions to attach the infusion tubing and needle set to the syringe. Be sure to prime the administration tubing by filling it with XEMBIFY. Make sure the needle remains dry while priming.

Step 8

XEMBIFY is infused in the abdomen, thigh, upper arm, sides, back, or hip. Select one or more infusion sites as directed by your healthcare provider. Be sure to choose sites that are different from your last infusion.

Step 9

Prepare the infusion site(s) by cleaning with an alcohol wipe. The site(s) should be clean, dry, at least 2 inches apart, and 2 inches away from the belly button. Do not use more than 6 infusion sites at the same time.

Step 10

Grasp the skin between 2 fingers and insert the needle into the subcutaneous tissue, which is the innermost layer of your skin. Secure the needle with an adhesive dressing. Repeat for the other sites as needed.

Step 11

After securing the needle, make sure a blood vessel has not been entered. If you see blood when pulling back on the plunger, remove and discard the needle and tubing. Repeat steps 8-10 using a new needle and administration tubing and a new infusion site.

Step 12

Follow the pump manufacturer’s instructions to load the syringe and start the infusion. The infusion is complete when the syringe is empty. Use XEMBIFY within 2 hours of drawing up in a syringe to avoid the potential formation of particles caused by siliconized syringes.

Quick Reference Infusion Guide

You can also download the XEMBIFY Quick Reference Infusion Guide to keep on hand when you need it.

Download

After the infusion

Wash your hands again
Follow manufacturer's instructions to turn off the pump
Undo and discard any dressing or tape
Gently remove inserted needle(s)
Discard used needles and tubing in a sharps container
Store your supplies in a safe place
Follow manufacturer's instructions to care for the infusion pump

Record the infusion

Record each infusion in your Infusion Log Book by removing the peel-off labels with the product lot number(s) and expiration date(s) from the XEMBIFY vial(s) and sticking these into your Infusion Log Book.

Learn more about the Infusion Log Book and other resources so you can make every infusion of XEMBIFY as convenient and comfortable as possible.

Please see Important Safety Information and refer to full Prescribing Information for XEMBIFY.

Record each infusion in your Log Book and remember to share it with your healthcare provider at your next visit.

Subcutaneous IG Therapy FAQs

View our FAQs about infusing XEMBIFY for more information.

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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?

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.

Terms to Know

PI, primary humoral immunodeficiency disease

SCIG, subcutaneous immune globulin