Hizentra (Immune Globulin Subcutaneous [Human]) 20% Liquid for Primary Immunodeficiency

Hizentra (immune globulin subcutaneous [human]) 20% Liquid is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults and children ages 2 and older with primary humoral immunodeficiency (PI). PI is a genetic condition in which your body cannot make enough antibodies to fight infections.

How Hizentra Works and How It’s Taken

Hizentra is an immune globulin medicine. It contains antibodies called immunoglobulin G (IgG). These antibodies help fight many bacteria and viruses.

In PI, Hizentra helps reduce infections caused by low or missing antibody protection.

Doctors prescribe Hizentra when adults and children ages 2 and older need replacement therapy for PI, a group of conditions in which the body does not make enough antibodies. PI includes several immune system conditions, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra is given as an infusion under the skin (subcutaneous). For PI, it can be given at regular times from every day up to every two weeks. With training from a healthcare provider, some people can give Hizentra at home.

Typical Dosing for Primary Immunodeficiency

The dose of Hizentra for PI is based on each person’s needs. Doctors use the person’s treatment response and IgG blood levels to adjust the dose.

For people switching from intravenous (IV) immune globulin, the starting weekly dose is based on the previous dose. The previous dose in grams is multiplied by 1.37 and then divided by the number of weeks between doses.

For people switching from subcutaneous (SC) immune globulin, the previous weekly dose is usually maintained. For every-two-week dosing, the weekly dose is doubled.

For dosing two to seven times per week, the weekly dose is divided by the number of doses per week.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Hizentra Side Effects

In clinical studies of Hizentra for PI in adults and children ages 2 and older, the most common side effects occurred in at least 5 percent of people. These include:

Infusion-site reactions (swelling, redness or discoloration, warmth, pain, bruising, or itching where the medicine is infused)
Headache
Diarrhea
Fatigue
Back pain
Nausea
Pain in extremity (pain in arms or legs)
Cough
Upper respiratory tract infection (cold-like symptoms)
Rash
Pruritus (itching)
Vomiting
Upper abdominal pain
Migraine
Arthralgia (joint pain)
General pain
Falls
Nasopharyngitis (sore throat and stuffy or runny nose)

Serious Side Effects and Warnings

Hizentra can cause serious side effects that may require immediate medical attention. These include:

Thrombosis — Blood clots can cause pain or swelling in an arm or leg, sudden shortness of breath, chest pain, or sudden weakness or numbness on one side of the body.
Hypersensitivity — Severe allergic reactions, including anaphylaxis, can cause hives, chest tightness, wheezing, low blood pressure, or swelling of the face, tongue, or throat.
Aseptic meningitis syndrome (AMS) — Noninfectious inflammation around the brain and spinal cord can cause severe headache, stiff neck, fever, light sensitivity, nausea, or vomiting.
Renal dysfunction — Kidney problems, including acute kidney failure, can cause decreased urination, sudden weight gain, swelling, or shortness of breath.
Hemolysis — Breakdown of red blood cells can cause fatigue, fast heart rate, yellowing of the skin or eyes, or dark urine.
Transfusion-related acute lung injury (TRALI) — This serious lung reaction can cause severe breathing problems, low oxygen, fever, or fluid in the lungs.
Transmission of infectious agents — Because Hizentra is made from human blood, there is a risk of passing on infections, even though screening and manufacturing steps are used to reduce this risk.

Get medical help right away if you think you are having a serious reaction.

How To Save on Hizentra

CSL Behring, the manufacturer of Hizentra, offers the Hizentra Connect Patient Support Program. Eligible people with commercial insurance may pay as little as $0. If you have government insurance or no insurance, the program also provides information about other financial assistance options that may be available.

The Hizentra Connect Patient Support Program also offers help navigating health insurance coverage, including prior authorizations and appeals, as well as a Patient Assistance Program for eligible people who are uninsured or underinsured.

To learn more, visit the Hizentra Connect Patient Support Program or call 877-355-4447.

What To Know Before Taking Hizentra

Before starting Hizentra for PI, your doctor may check your IgG antibody blood level to help guide dosing.

Hizentra may affect how well live virus vaccines work. These include measles, mumps, rubella, and varicella vaccines. Tell the doctor giving vaccines that you are using Hizentra.

Tell your doctor if you have any allergies to immune globulin subcutaneous (human) or any ingredients in Hizentra, including polysorbate 80.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Some medicines, such as those that contain estrogen, may increase your risk of a blood clot. An example is some birth control pills.

Before starting Hizentra, tell your doctor if you have heart or blood vessel disease, blood clots, thick blood, or if you have been unable to move around for some time.

Do not take Hizentra if you:

Have had a severe allergic reaction to human immune globulin or any ingredient in Hizentra, including polysorbate 80
Have hyperprolinemia type 1 or 2
Have IgA deficiency with antibodies against IgA and a history of hypersensitivity

Hizentra is also FDA-approved for maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

If you are pregnant, planning to become pregnant, or breastfeeding while taking Hizentra, talk with your doctor about the risks and benefits.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Hizentra for PI?

In studies of people with PI, no one had a serious bacterial infection during the efficacy period.

In a U.S. study, 38 people were included in the efficacy analysis. The study included a 12-month efficacy period after an initial three-month period. During the efficacy period, the annual rate of any infection was 2.76 infections per person-year.

Average IgG trough levels increased from 1,009 milligrams per deciliter before the study to 1,253 milligrams per deciliter during the efficacy period.

In a European study, 46 people were included in the efficacy analysis. No serious bacterial infections occurred during the efficacy period. The annualized rate of any infection was 5.18 infections per person.

How long does Hizentra take to work for PI?

In clinical study results, people with PI were followed for 10 to 15 months. In these studies, no serious bacterial infections were reported during the efficacy periods.

The study results do not give one exact time when everyone should expect to feel a benefit. After switching to Hizentra, doctors may check IgG trough levels after two to three months. IgG trough levels are antibody levels measured before the next dose.

These blood tests help doctors decide if the dose needs to be changed.

What tests or monitoring are needed with Hizentra for primary immunodeficiency?

Before starting Hizentra after IV immune globulin, your doctor should check your serum IgG trough level. This is an antibody blood level measured before the next dose. It helps guide your dose.

After switching to Hizentra, your doctor may check your IgG trough level again after two to three months. Your dose may be changed based on your IgG level and how well treatment is working.

Some people may need extra monitoring. People at risk for blood clots may need monitoring for signs and symptoms of thrombosis. People at risk for thick blood may need blood viscosity testing.

People at risk for kidney problems may need kidney function tests, such as blood urea nitrogen, serum creatinine, and urine output. Your doctor may also monitor for signs of hemolysis, which is breakdown of red blood cells, or lung reactions such as TRALI.