What is PIDD and how does GAMUNEX-C treat it?

PIDD AFFECTS PEOPLE OF ANY AGE

What's happening inside the body?

Primary immunodeficiency disease (PIDD) is a genetic disease that occurs in people of any age who were born with an immune system that is either absent or defective in its ability to function.1

When a part of the immune system doesn't work the way it should, the body lacks the antibodies needed to fight off infection.1,2

If bouts of pneumonia occur within a short time period, or sinus, ear, or lung infections become persistent, it might indicate PIDD.1 Discuss medical history with a healthcare professional if you think you or your loved one may have PIDD.

PIDD as a disease itself is not contagious, and a person with PIDD is not a threat to other people. However, a person with PIDD is more susceptible to infections and illnesses from other people. PIDD has no connection with AIDS (acquired immunodeficiency syndrome).

Download a full list of PIDD warning signs:

10 PIDD warning signs for adults

10 PIDD warning signs (general)


How does GAMUNEX-C treat PIDD?

ANTIBODY: Helps the body fight off infection

IG therapy is the standard treatment for PIDD. GAMUNEX-C provides the antibodies needed to help the body fight off infection and is approved to treat PIDD in patients 2 years of age and older.

Will GAMUNEX-C work for PIDD?

In a large study where patients with PIDD received Gamimune® N, 10% [immune globulin intravenous (human)]* or GAMUNEX-C, the patients receiving GAMUNEX-C had 2 times fewer sinus infections.3 According to the Immune Deficiency Foundation, the most common infection for adults with PIDD is sinus infection.1,3

How will I receive GAMUNEX-C?

Based on your needs as a patient, you may receive GAMUNEX-C one of two ways:

INTRAVENOUS: Administered through a vein, typically in your arm
SUBCUTANEOUS: Administered through an injection, just below the skin
  • Intravenous therapy is when you get an infusion through a vein, typically in your arm. It will most likely be at a doctor's office, hospital, infusion center, or may be in your home, as determined by your treating physician
  • Subcutaneous therapy means you get an injection just below the skin. You can administer regular injections to yourself with a portable pump that regulates the rate of infusion. DO NOT inject GAMUNEX-C into a blood vessel or directly into a muscle

GAMUNEX-C was proven effective to treat PIDD both intravenously and subcutaneously in patients 2 years of age and older.4,5

Will I experience any side effects with GAMUNEX-C?

The most common side effects in a clinical study with PIDD patients who received subcutaneous injections of GAMUNEX-C were:

  • Infusion-site reactions such as redness, swelling, and itching
  • Extreme tiredness
  • Pain in the region of the head or neck; a runny nose, nasal congestion, sneezing, cough, and sputum production
  • Joint pain
  • Loose stools
  • Sensation of unease and discomfort in the upper stomach
  • Swelling of the tissue lining the sinuses
  • Inflammation of the airways that carry air to your lungs
  • A feeling of unhappiness, sadness, melancholy, gloom, hopelessness, or low spirits
  • Red rash or bumps, itchy, swollen, and tender skin with or without blisters or a burning feeling
  • Severe throbbing pain or a pulsing sensation, usually on just one side of the head
  • Muscle pain
  • Familiar infectious diseases such as the common cold or flu
  • Raised body temperature or fever

In clinical studies with PIDD patients who got GAMUNEX-C intravenously, the most common side effects were: 

  • Cough
  • Irritation and inflammation of the mucous membrane inside the nose
  • Sore throat caused by inflammation of the back of the throat
  • Pain in the region of the head or neck
  • A condition in which your airways narrow and swell and produce extra mucus
  • Sensation of unease and discomfort in the upper stomach
  • Raised body temperature or fever
  • Loose stools
  • Swelling of the tissue lining the sinuses
 

The most serious side effect for PIDD patients taking GAMUNEX-C was:

  • A flare-up of an existing type of anemia (autoimmune pure red cell aplasia)

Understanding and Treating PIDD

For treatment and disease information, download the PIDD brochure.

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GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is approved to treat primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. If you have PIDD, you may take GAMUNEX-C under the skin (subcutaneously) or in a vein (intravenously). GAMUNEX-C is also approved to treat idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. If you have ITP or CIDP, you may only take GAMUNEX-C intravenously. 

If you take GAMUNEX-C or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism), 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, unexplained rapid pulse, numbness, or weakness on one side of the body. You are more likely to develop a blood clot if you have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are elderly, if you have a blood clotting disorder, if you are inactive for long periods of time (such as long bed rest), if you use estrogens, or if you have thickening of your blood. For patients at risk, GAMUNEX-C should be administered at the lowest dose and slowest infusion rate that is practical. However, blood clots may occur in the absence of any of the known risk factors. Patients should be well hydrated by drinking enough water before GAMUNEX-C is administered. Tell your doctor immediately if your medical history is similar to what is described here, and especially if you start having any of these symptoms while taking GAMUNEX-C.

If you take GAMUNEX-C or a similar immune globulin product intravenously, you could experience serious kidney disease and death. You may have symptoms of decreased urination, sudden weight gain, swelling in your legs (edema), or shortness of breath. You are more likely to develop serious kidney disease if you already have a kidney problem, have Type II diabetes mellitus, or are older than 65. You are more likely to develop serious kidney disease if you are dehydrated, have a blood infection (sepsis), have high protein content in your blood, or if you are receiving other medicines that are harmful to your kidneys. Tell your doctor immediately if your medical history is similar to what is described here, and especially if you start having any of these symptoms while taking GAMUNEX-C.

You are more likely to develop serious kidney disease if you take an intravenous immune globulin product that contains sugar (sucrose).  GAMUNEX-C does not contain sugar. If your situation makes you more likely to experience serious kidney disease, you should take GAMUNEX-C at the lowest concentration available and the slowest infusion rate that is practical.

Do not take GAMUNEX-C if you have an allergy to immune globulin. Tell your doctor if you have had a serious reaction to other medicines that contain human immune globulin. Also tell your doctor if you have immunoglobulin A (IgA) deficiency. If you have a serious reaction while taking GAMUNEX-C, stop taking it immediately and tell your doctor.

Periodic monitoring of kidney function and urine output is particularly important in patients more likely to experience severe kidney disease.

You could experience other serious and life-threatening problems due to immune globulin. You could get aseptic meningitis (a type of brain inflammation with symptoms of severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea, and vomiting), a blood problem called hemolytic anemia (common symptoms include increased heart rate, fatigue, yellow skin or eyes, and dark-colored urine), and/or a lung problem called transfusion-related acute lung injury (commonly referred to as TRALI). TRALI is a condition where you build up fluid in the lungs (called pulmonary edema) that is not the result of heart failure.

If you have higher than normal body fluid volumes or if you have a condition where increasing body fluid volume may be a concern, a higher dose, such as 1g/kg for 1-2 days, is not recommended.

Because GAMUNEX-C 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.

You may not take GAMUNEX-C subcutaneously if you have ITP. If you have ITP and take GAMUNEX-C subcutaneously, you could experience a very serious and life-threatening black and blue wound (hematoma, which is a pocket of blood within a tissue).

After you take GAMUNEX-C, your blood antibody levels may rise, which could cause some blood antibody tests to give false results.

The most common side effects in a clinical study with PIDD patients who got subcutaneous injections of GAMUNEX-C were infusion-site reactions such as redness, swelling, and itching; extreme tiredness; pain in the region of the head or neck; a runny nose, nasal congestion, sneezing, cough, and sputum production; joint pain; loose stools; a sensation of unease and discomfort in the upper stomach; swelling of the tissue lining the sinuses; inflammation of the airways that carry air to your lungs; a feeling of unhappiness, sadness, melancholy, gloom, hopelessness, or low spirits; red rash or bumps, itchy, swollen, and tender skin with or without blisters or a burning feeling; a severe throbbing pain or a pulsing sensation, usually on just one side of the head; muscle pain; familiar infectious diseases such as the common cold or flu; and raised body temperature or fever. In clinical studies with PIDD patients who got GAMUNEX-C intravenously, the most common side effects were cough; irritation and inflammation of the mucous membrane inside the nose; sore throat caused by inflammation of the back of the throat; pain in the region of the head or neck; a condition in which your airways narrow and swell and produce extra mucus; a sensation of unease and discomfort in the upper stomach; raised body temperature or fever; loose stools; and swelling of the tissue lining the sinuses. In a clinical study with CIDP patients who got GAMUNEX-C intravenously, the most common side effects were pain in the region of the head or neck; raised body temperature or fever; abnormally high blood pressure; feelings of coldness accompanied by shivering; a noticeable change in the texture or color of your skin such as your skin becoming scaly, bumpy, itchy, or otherwise irritated; a sensation of unease and discomfort in the upper stomach; joint pain; and abnormal physical weakness or lack of energy. In clinical trials with ITP patients who got GAMUNEX-C intravenously, the most common side effects were pain in the region of the head or neck; a discoloration of the skin resulting from bleeding underneath, typically caused by bruising; vomiting, fever, nausea, rash, abdominal pain, back pain, and a pain or an uncomfortable feeling in the upper middle part of your stomach.

The most serious side effects in clinical studies were a blood clot to the lung (pulmonary embolism) in 1 patient with a history of this condition (in CIDP), a flare-up of an existing type of anemia (autoimmune pure red cell aplasia) in 1 patient (in PIDD), and heart inflammation (myocarditis) in 1 patient (in ITP).

Please see accompanying full Prescribing Information for GAMUNEX-C.

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.

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References

  1. About primary immunodeficiencies. Immune Deficiency Foundation website. http://primaryimmune.org/about-primary-immunodeficiencies. Accessed November 8, 2016.
  2. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007;27(5):497-502.
  3. Boyle ML, Scalchunes C. Impact of intervenous immunoglobulin (IVIG) treatment among patients with primary immunodeficiency diseases. Pharmaceuticals Policy Law. 2008;10:133-146.
  4. Roifman CM, Schroeder H, Berger M, et al. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: a randomized double-blind trial. Int Immunopharmacol. 2003;3(9):1325-1333.
  5. Wasserman RL, Irani A-M, Tracy J, et al. Pharmacokinetics and safety of subcutaneous immune globulin (human), 10% caprylate/chromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010;161(3):518-526.

Terms to know

IG=immune globulin, CIDP=chronic inflammatory demyelinating polyneuropathy, PIDD=primary immunodeficiency disease, ITP=idiopathic thrombocytopenic purpura, sub Q=subcutaneous, IV=intravenous