How GAMUNEX-C works to help people living with PIDD

PIDD affects people of any age

Y shaped antibody that helps fight infections

How does GAMUNEX-C treat PIDD?

GAMUNEX-C is an immune globulin (IG) therapy—a standard of care for PIDD. GAMUNEX-C is used to treat patients with PIDD who are 2 years of age and older.

IG therapy replaces missing proteins to help the immune system protect against germs and other threats. It is sometimes referred to as IG replacement therapy.

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.1 According to the Immune Deficiency Foundation, the most common infection for adults with PIDD is sinus infection.2,3

2 times fewer sinus infections

*Double-blind, parallel-group, multicenter, therapeutic equivalence trial of 172 patients with PIDD (95% with common variable immunodeficiency [CVID] or hypogammaglobulinemia) randomized to receive GAMUNEX-C (immune globulin [human], 10% caprylate/chromatography purified) or Gamimune N, 10%.

How will I receive GAMUNEX-C?

For the treatment of PIDD, GAMUNEX-C can be administered in one of two ways4:

Intravenous

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

Subcutaneous therapy means you get an infusion just below the skin. You can administer regular infusions 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

10% IVIG therapy for PIDD

10% SCIG therapy for PIDD

For the treatment of PIDD, Grifols also has a 20% subcutaneous immune globulin therapy.

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 the 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 the 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.

Learn more about GAMUNEX-C

Important Safety Information

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.

Terms to know

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

References

  1. 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.
  2. Boyle ML, Scalchunes C. Impact of intravenous immunoglobulin (IVIG) treatment among patients with primary immunodeficiency diseases. Pharmaceuticals Policy Law. 2008;10:133-146.
  3. About primary immunodeficiencies. Immune Deficiency Foundation website. http://primaryimmune.org/about-primary-immunodeficiencies. Accessed April 7, 2022.
  4. GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) Prescribing Information. Grifols.
  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.