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Intended For US Audiences Only.

WHAT IS PI?

PI occurs when a person’s immune system doesn’t work correctly or when parts of the system are missing. As a result, the immune system can’t make enough antibodies to fight infections effectively.

HOW COMMON IS PI?

The exact prevalence of PI is unknown. In the United States, it is estimated that 1 in 2,000 children and 1 in 600 households are diagnosed with PI. Patients with PI often get one infection after another. These infections may never really improve as expected and may recur over time.

150,000 to 360,000

PEOPLE ARE DIAGNOSED WITH PI

Source: Jiang F, Torgerson TR, Ayars AG. Allergy Asthma Clin Immunol. 2015.

150,000 to 360,000

PEOPLE ARE DIAGNOSED WITH PI

Source: Jiang F, Torgerson TR, Ayars AG. Allergy Asthma Clin Immunol. 2015.

WHAT CAUSES PI?

There’s no single cause. Many PI disorders are inherited, which means that the condition is passed down from one or both parents. Some immune system defects are caused by genetic factors in a person’s DNA. At one time, it was thought that PI was a disease of infants and small children. Now we know the symptoms of PI can appear later in life.

The following list shows 10 warning signs of PI.
You may have experienced one or more of them.

Icon for ear infections
Four or more new ear infections
within 1 year
Icon for sinus infections
Two or more serious sinus
infections within 1 year
Icon for antibiotics
Two or more months on
antibiotics with little effect
Icon for pneumonia
Two or more types of pneumonia
within one year
Icon for infant weight
Failure of an infant to gain weight
or grow normally
Icon for organ
Recurrent, deep skin or organ
abscesses
Icon for fungal infection
Persistent thrush in mouth or
fungal infection on skin
Icon for intravenous antibiotics
Need for intravenous antibiotics
to clear infections
Icon for infections
Two or more deep-seated
infections, including septicemia
Icon for family
A family history of PI

WHAT ARE SOME WAYS TO HELP PREVENT INFECTIONS?

There is no way to prevent primary immunodeficiency disorders because their causes are genetic. But you can take steps to help prevent infections that can occur due to a weakened immune system. Discuss the tips below with your doctor before giving them a try.

Icon for washing hands

Wash your hands regularly

Especially after being in public, and before eating

Icon for healthy diet

Eat a healthy diet

Follow your doctor’s recommendation for a balanced diet

Icon for sleep schedule

Set a sleep schedule

Try to get the same number of hours of sleep every night

Icon for stay active

Stay active

With your doctor’s approval, try light exercise – it may improve your overall health

Icon for oral hygiene

Practice good oral hygiene

Brush your teeth at least twice a day, and floss every night before bed

Icon for illness-causing germs

Limit exposure to illness-causing germs

Don’t give up your pandemic habits. Avoid people who are sick and practice social distancing

Icon for stress levels

Reduce stress levels

By exercising, meditating, or setting a sleep schedule. High stress levels can affect your immune system

Icon for vaccines

Ask your doctor about vaccines

Make sure you’re up to date on the vaccinations you need

HOW IS PI TREATED?

One of the most common treatments for PI is immune globulin (Ig) replacement. Ig is a component of plasma. Plasma is the yellow-colored liquid left over when red blood cells are removed from whole blood that is donated by people with healthy immune systems. Ig is removed from the collected plasma and purified. It is then used to treat a variety of conditions, including PI.

Ig treatment can improve the health and quality of life for many patients with PI

Fewer respiratory tract (lung) infections | Less time spent in the hospital | Fewer missed work/school days
Group 131

Fewer respiratory tract (lung) infections

Group 130

Less time spent in the hospital

Group 129

Fewer missed work/school days

Important Safety Information for BIVIGAM®

BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

WARNING: RISK OF BLOOD CLOTS (THROMBOSIS), POOR KIDNEY FUNCTION, AND KIDNEY FAILURE

  • Blood clots may happen with intravenous immune globulin products, including BIVIGAM. Before taking BIVIGAM, talk to your doctor if you:
    • Are of advanced age
    • Are unusually sedentary (long periods of sitting down or inactive)
    • Have a history of blood clots in the veins or arteries, cardiovascular (heart) problems or previous history of stroke
    • Are taking estrogen-containing medicines (birth control pills, hormone replacement therapy)
    • Have a permanent intravenous (IV) catheter
    • Have hyperviscosity (poor blood flow) of the blood (diseases such as multiple myeloma or other causes of elevated proteins in the blood)
  • Kidney problems, kidney failure, and death are more common in people who are taking human immune globulin products, especially those containing sucrose (sugar). BIVIGAM does not contain sucrose. Let your doctor know if you have kidney disease or diseases with kidney involvement, have a history of diabetes, or are older than 65 years of age. Your doctor should check your hydration level, blood infection risk, protein levels, and if you are taking any drugs that may damage your kidneys.
  • If you are at risk for blood clots or kidney problems, your doctor should adjust your starting dose of BIVIGAM and monitor your blood flow.

What is BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]?
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is a prescription medicine to help adults and pediatric patients 2 years of age and older with primary immunodeficiency fight and prevent infections. BIVIGAM is for intravenous administration only. BIVIGAM is made from healthy human blood/plasma.

Who should not use BIVIGAM?
BIVIGAM should not be used if you had a severe allergic reaction to human immune globulin or if you have been told by a doctor that you are immunoglobulin A (IgA) deficient and have developed antibodies to IgA and hypersensitivity after exposure to a previous plasma product.

What are possible warnings and precautions with taking BIVIGAM?
If you take BIVIGAM or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism). Thrombosis may occur even if you do not have any risk factors.

Your doctor should perform blood tests to see if you are at risk for poor blood flow (hyperviscosity). These tests will check for the presence of other proteins in the blood that might put you at risk of blood clots.

Kidney problems or failure. Kidney problems, kidney failure, and death may occur with use of human immune globulin products. If your doctor determines that you are at risk of kidney problems, they should monitor your with routine blood and urine tests.

Aseptic meningitis syndrome (AMS). Aseptic meningitis is a non-infectious inflammation of the membranes that cover the brain. It causes a severe headache, which may occur with human immune globulin treatment, including BIVIGAM. AMS usually happens within a few hours to 2 days after treatment. AMS is more commonly associated with higher doses of treatment and/or after rapid infusion. Your doctor may perform a neurological exam, including spinal tap (sampling fluid which surrounds the spinal cord) to evaluate your condition and to rule out other causes of meningitis.

People taking human immune globulin products, including BIVIGAM, may experience hyperproteinemia (high levels of protein in the blood), hyponatremia (low levels of sodium in the blood), and hyperviscosity (poor blood flow). Your doctor may perform certain blood tests and monitor you to minimize any of the above risks.

Hemolysis. Hemolysis refers to the destruction of red blood cells. Immune globulin products, including BIVIGAM, may contain certain antibodies that can result in the rupturing of red blood cells. Your doctor should monitor you for signs and symptoms of hemolysis. People taking human immune globulin products may experience lung-related side effects, including transfusion-related acute lung injury (TRALI). TRALI is a rare but serious syndrome characterized by sudden acute respiratory distress following transfusion. Your doctor should monitor you for lung-related side effects and may conduct tests to check for the presence of certain white blood cells (anti-neutrophils) in the drug or your blood.

Transmissible infectious agents. Because BIVIGAM 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. Your doctor will report to the manufacturer any cases of suspected infections spread by the product.

Interference with lab tests. Because BIVIGAM contains a variety of antibodies that are infused into your body, blood tests may provide misleading interpretations. Be sure to tell your doctor, nurse, or lab technician that you are using BIVIGAM.

Interactions with medicines. BIVIGAM can make vaccines (like measles, mumps, rubella, and chicken pox vaccines) less effective in your body. Before you get any vaccines, tell your healthcare provider that you take BIVIGAM.

What are other possible side effects of BIVIGAM?

In clinical studies of BIVIGAM, some patients experienced the following serious side effects:

  • Vomiting
  • Dehydration

The most common side effects included:

  • Headache
  • Fatigue
  • Reaction at the site of infusion
  • Nausea
  • Sinus inflammation (sinusitis)
  • Blood pressure increase
  • Diarrhea
  • Dizziness
  • Loss of energy (lethargy)

These are not all the possible side effects of BIVIGAM. Talk to your healthcare provider about any side effect that bothers you or that does not go away.

You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit www.fda.gov/medWatch or call 1-800-FDA-1088.

For more information about BIVIGAM, please see full Prescribing Information.

The information on this site is intended for audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.

© 2023 ADMA Biologics, Inc. All rights reserved. BIVIGAM® is a registered trademark of ADMA Biologics, Inc. ADvantage Ig™ is a trademark of ADMA Biologics, Inc. PARTNER IN PROTECTION™ is a trademark of ADMA Biologics, Inc.