Xembify (subcutaneous)

Pronunciation: zem-bee-fye
Generic name: immune globulin subcutaneous (human-klhw) 20%
Brand name: Xembify
Dosage forms: 20% solution for subcutaneous infusion ,
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 1, 2024.

What is Xembify?

Xembify is a ready-to-use solution containing immunoglobulin G (IgG) antibodies that may be given to protect patients aged 2 years and older with primary humoral immunodeficiencies (PI) against infection.

This includes but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Xembify (immune globulin subcutaneous, human-klhw) is a sterilized solution made from human plasma that is given as an infusion under the skin (subcutaneous infusion) at regular intervals from daily up to every 2 weeks (biweekly). Xembify supplies the body with a broad spectrum of IgG antibodies against bacterial, viral, parasitic, and mycoplasmal agents and their toxins. It also contains a spectrum of antibodies capable of interacting with and altering the activity of immune system cells.

Xembify gained FDA approval on July 3, 2019. Xembify's use was expanded to include treatment-naïve patients with PI on July 18, 2024, which allows patients to begin subcutaneous immunoglobulin treatment without first having intravenous administration.

Xembify side effects

The most common side effects with Xembify are:

redness, pain, swelling, bruising, itching, firmness, or nodules at the injection site
cough
diarrhea.

Serious side effects and warnings

Xembify carries a Boxed Warning for thrombosis.

Blood clots (thrombosis) may occur with immune globulin products, including Xembify. The risk of blood clots is highest in older adults or people with a history of blood clots or heart or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place. Seek urgent medical attention if you have any symptoms of blood clots which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, blue lips or extremities, unexplained rapid pulse, numbness or weakness on one side of the body.

Xembify may cause severe allergic reactions. Do not take Xembify if you are allergic to it or other immune globulin products. Call your doctor at once if you develop hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These symptoms could be signs of a serious allergic reaction.

Aseptic meningitis syndrome (an irritation of the lining around the brain) has been associated with the use of human immune globulin products including Xembify. It usually begins within several hours to 2 days following treatment. Seek urgent medical treatment if you develop symptoms such as a severe headache with or without nausea, vomiting, stiff neck, fever, sensitivity to light, painful eye movements, or fatigue.

Xembify can also harm your kidneys, especially if you have kidney disease or if you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination. Drink plenty of liquids while you are using Xembify to help improve your blood flow and keep your kidneys working properly.

Liver problems may also happen with Xembify. Call your healthcare provider if you have brown or red urine, a fast heart rate, or yellow skin or eyes.

You may not be able to use Xembify if you have ever had an allergic reaction to polysorbate 80, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before using this medicine

You should not use Xembify if:

you have had an allergic reaction to an immune globulin or blood product
you have immune globulin A (IgA) deficiency with antibodies to IgA
a condition called hyperprolinemia (high level of a certain amino acid in the blood).

This medicine can cause blood clots or kidney problems, especially in older adults or people with certain conditions. To make sure Xembify injection is safe for you, tell your doctor if you have ever had:

heart problems, blood circulation problems, or "thick blood"
a stroke or blood clot
kidney disease
diabetes
an infection called sepsis
if you use estrogens (birth control pills or hormone replacement therapy)
if you have been on long-term bed rest
if you have a central intravenous (IV) catheter in place.

Xembify is made from donated human plasma and may contain viruses or other infectious agents, such as the variant Creutzfeldt-Jakob disease (vCJD) agent. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

How is Xembify given?

Xembify is given under the skin (subcutaneously), using an infusion pump.

Most of the time, people can be taught how to administer the infusions themselves, or with a caregiver's help. Only administer it yourself if you have been instructed by your healthcare provider.
Self-infusion is different from giving yourself a shot.

Xembify can be administered at regular intervals from daily up to every two weeks (biweekly).

Your healthcare provider will work out what dose is best for you.

Up to 6 infusion sites can be used simultaneously to infuse Xembify, with at least 2 inches (5 cm) between sites avoiding bony prominences, visible blood vessels, scars, and any areas of inflammation (irritation) or infection. Rotate sites for each administration.

For patients switching to Xembify from intravenous immune globulin (IVIG)

Obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.
Establish the initial weekly dose in grams by converting the monthly (or every 3 weeks) IVIG dose into an equivalent weekly dose and increasing it by using a dose adjustment factor (1.37)
- Initial weekly dose (grams) = prior IVIG dose (in grams) × 1.37 dose (grams)/ number of weeks between IVIG doses.
Weekly: Begin Xembify one week after the last IVIG infusion.
Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week.
Biweekly dosing (every 2 weeks): Multiply the weekly dose by 2.

For patients switching to Xembify from subcutaneous immune globulin (IGSC)

Administer the same weekly dose (grams) as the weekly dose of prior IGSC treatment (grams).
Treatment-naïve patients: For patients starting IgG replacement (not switching from IVIG or IGSC) administer loading doses of 150 mg/kg/day for 5 consecutive days, followed by weekly administrations starting on day 8 at 150 mg/kg/week. Monitor IgG trough levels frequently every 2 weeks during the first 8 weeks.

Instructions for the self-administration of Xembify

Read the Xembify Package Insert for a full list of instructions.

Allow the solution to come up to room temperature 68-77°F (20-25°C). This may take at least 60 minutes.
Wash your hands, prepare a clean work surface, and assemble your needle.
Withdraw the correct amount of Xembify according to the dosage your healthcare provider has recommended for you and fill the pump reservoir.
Select and prepare the infusion site(s). Xembify may be administered into your upper, outer, arm, stomach area (but not within 2 inches of your belly button) or upper outer thighs.
Insert the needle into your preferred side and check its position.
Infuse Xembify as per the infusion pump directions and the maximum infusion rate.
- Up to 6 infusion sites can be used.
- The maximum volume per infusion site is 25 mL per site.
- The maximum infusion rate is less than or equal to 25 mL/hr/infusion site for children aged 2 to 10 years of age, or less than or equal to 35 mL/hr/infusion site for adults and children 10 years of age and older.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Xembify?

Vaccines may not work well for you while you are taking this medicine. Tell your doctor or healthcare professional that you are taking Xembify before getting a vaccine.

What other drugs will affect Xembify?

Xembify may interfere with the response to live virus vaccines such as measles, mumps, rubella (MMR) vaccine and varicella (chickenpox) vaccine. Therefore vaccines may not work as well as intended and may not fully protect you from disease. Tell your immunizing physician of recent therapy with Xembify.

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Store Xembify in the refrigerator, do not freeze. If needed, Xembify can be stored at room temperature for up to 6 months. If not used within that time, throw it away.

Do not return Xembify to the refrigerator if it was warmed to room temperature.

Do not use after the expiration date.

Xembify ingredients

Xembify, immune globulin subcutaneous, human-klhw, is a 20% ready-to-use sterile, nonpyrogenic solution of human immune globulin protein for subcutaneous administration.

The purity is ≥ 98% IgG with a sub-class distribution similar to that found in normal serum.

Active ingredients: 18% to 22% IgG protein

Inactive ingredients: 0.16 M to 0.26 M glycine and 10 to 40 mcg/mL polysorbate 80.

pH of 4.1 to 4.8.

Contains no preservatives and is not made with natural rubber latex.

Xembify is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography.