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Gamunex-C: The Immune Supplement

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Gamunex-C

Gamunex-C: The Immune Supplement

Gamunex-C is a type of sterile antibody solution that is extracted from human beings. Injections of this solution are given to patients suffering from a weak immune system or immune disorder. Gamunex-C injections help such patients combat infections.

What Is Gamunex-C?

Generic Name: Immune globulin intravenous (human), 10% Caprylate/Chromatography Purified, 10% Liquid Preparation 

Brand Name: Gamunex-C

Class of Drug: Immune globulins 

Gamunex-C is a combination of immune globulins (antibodies) that is used as a treatment for patients suffering from immunodeficiencies. There are a number of conditions where patients lack an optimally working immune system that produces antibodies to keep them safe from microorganism attacks. 

In such cases, Gamunex-C acts as an external source of antibodies that can boost the immune performance of the body.

 

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What Is Inside Gamunex-C?

An injection of Gamunex-C contains purified immunoglobulins (Ig) that are made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation, filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. 

 

Is Gamunex-C Safe?

Yes. Gamunex-C is a well-tolerated sterile solution of immunoglobulins. According to one study, intravenous immunoglobulin preparation (i.e., IGIV-C [Gamunex, 10%]) has good pharmacokinetics and tolerability.

 

Does Gamunex-C Increase Sugar Levels?

Unlike most antibody preparations, Gamunex-C does not contain sucrose (a type of sugar). Therefore, Gamunex does not increase sugar levels.

 

Does Gamunex-C Cause Weight Gain?

Gamunex weight gainFor a person with optimally working kidneys, Gamunex-C does not cause weight gain.

However, in cases where kidney function is compromised, there is a chance that a patient might experience serious kidney disease that can cause sudden, unexplained weight gain. But this weight gain is caused by the underlying kidney disease and it is not due to Gamunex-C infusions.

 

How Does Gamunex-C Work?

Gamunex-C is administered via the intravenous or the subcutaneous route. Whatever route it takes, the antibodies (immune globulins) in the solution are delivered into the body. These antibodies recognize and fight against harmful bacteria and other microorganisms. 

In autoimmune diseases, the healthy antibodies from the injection block the body’s immune system from attacking the body’s cells. This results in a reduction of cell death and inflammation caused by the auto-antibodies, thereby providing relief from symptoms.

 

Gamunex-C Storage

Gamunex-C is commercially available in vials of 1 g, 2.5 g, 5 g, 10 g, 20 g, and 40 g. It has a shelf life of 3 years but only if the vial is kept between 2 to 8 degrees Celsius (i.e., 36 to 46 degrees Fahrenheit) from the date of manufacture.

 

Does Gamunex-C Need To Be Stored in a Refrigerator?

The solution should be stored in the refrigerator for long-term usage. However, it can be stored at room temperature not to exceed 25 degrees Celsius for up to 6 months. After this period, the product must be discarded. 

Do not freeze Gamunex-C and discard any frozen solution.

 

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Gamunex-C Treatment/Therapy

Gamunex-C is indicated as a treatment modality for the following conditions:

Primary Immunodeficiency (PI)

Primary humoral immunodeficiency (PI) is a condition characterized by frequent infections caused by a deficiency of some classes of immunoglobulins. 

Gamunex-C is primarily indicated for conditions like primary immunodeficiency diseases (PID). IVIG therapies (intravenous immune globulins) are effective in the treatment of immunodeficiencies. The most prominent IVIG medications include Privigen, Gammaked, Gammaplex, Hizentra, and Gamunex-C.

Research shows that immunoglobulin replacement therapy is critical in many PIDs that affect antibody production. Immunoglobulin replacement therapy such as Gamunex-C was found to be effective for both adults and children with primary immunodeficiency diseases.

Pediatric PID patients can also benefit from IgG therapy via Gamunex-C infusion.

Congenital Agammaglobulinemia

Immunoglobulin therapy has shown promising results in alleviating symptoms of congenital agammaglobulinemia such as:

  • Fever
  • Sinusitis
  • Diarrhea 
  • Otitis media 

X-Linked Agammaglobulinemia

IgG replacement in patients suffering from X-linked agammaglobulinemia can impart symptomatic relief. According to one study, a median dose of 397 mg/kg IVIG was sufficient for keeping children free of infections.

This treatment also reduces the incidence of pneumonia and hospital admission in patients with agammaglobulinemia.

Wiskott-Aldrich Syndrome

The FDA has approved IV antibody treatment (including Gamunex-C) for Wiskott-Aldrich syndrome.

Eczema (red, irritated skin) is seen in this disease due to abnormal/nonfunctional immune system cells (i.e., white blood cells).

 

Idiopathic Thrombocytopenic Purpura (ITP)

Intravenous immunoglobulin treatment can work for ITP. Studies show that Gamunex for Idiopathic Thrombocytopenic purpura can improve the prognosis and help alleviate symptoms.

A randomized controlled trial concluded that starting intravenous immunoglobulin therapy early on for newly diagnosed idiopathic thrombocytopenic purpura patients can be beneficial.

 

Chronic Inflammatory Demyelinating Polyneuropathy (CIPD)

In one trial, Gamunex-C was found to be the best treatment option for the management of chronic inflammatory demyelinating polyneuropathy. The administration of Gamunex-C led to significant improvement in disability scores. The participants also experienced improvements in grip strength in both hands. 

The healthy antibodies from Gamunex-C block the immune and inflammatory processes that destroy the myelin sheath, leading to the improvement of symptoms.

Patients can see results in as little as 3 weeks from the start of therapy. Research has found IVIG therapy to be effective in improving motor symptoms of CIPD.

 

COVID-19

Individuals suffering from immune system disorders are more prone to COVID-19 infection. A  2020 study showed that Gamunex-C contains antibodies that are effective against SARS-CoV-2 (a virus that can lead to COVID-19).

It is also believed that high doses of IVIG (Gamunex-C) can improve symptoms in children suffering from severe coronavirus infection. However, there is a lack of evidence on its safety and tolerability.

One Chinese report noted that early administration of IVIG is beneficial in improving symptoms of immunodeficiency. In addition to its role in treating immunodeficient patients, immune globulins can be cross-reactive with COVID-19.

 

Contraindications of Gamunex

Gamunex-C infusion is contraindicated in the following cases:

History of Thrombosis

All immunoglobulins are proteins, and this makes the recipient of Ig therapy prone to developing thrombosis

Therefore, people who have suffered thrombosis or are at a risk should not receive Gamunex-C infusions. The risk factors include:

  • High levels of cholesterol in the body 
  • Diabetes 
  • Family history of arterial thrombosis 
  • Obesity 
  • Poor diet

 

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Presence of Underlying Cardiovascular Disease

As thrombosis is a likely adverse outcome of IVIG therapy, patients having underlying heart issues should not take Gamunex-C. Use caution when administering to patients 65 years and over.  

Some antibodies contain high quantities of sodium. Therefore, such solutions should be used cautiously in patients with cardiac conditions and hypertension.

Blood Circulatory and Renal Disorder

Patients suffering from blood circulatory disorders should also avoid IVIG therapies such as Gamunex-C.

Kidney problems are seen with human immune globulin. In some cases, the results can be devastating and even lead to death. This is especially true for IVIG therapies that contain sucrose. As Gamunex does not contain sucrose, it is a somewhat safer option. 

However, patients with compromised renal function must stay away from Gamunex-C as it can cause osmotic nephropathy.

IgA Deficiency

Gamunex-C is contraindicated in IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

One review found that anti-IgA antibodies are associated with the development of adverse reactions to intravenous immunoglobulin infusion.

Allergic Reaction

Individuals that have a hypersensitive allergic response to transfusions must not try any sort of IVIG therapy. This is because anaphylactic reactions can occur after the administration of gamma globulins.

 

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Gamunex Infusion/Administration

Injection of immune globulin 10% caprylate can be given into a vein or under the skin. This means Gamunex-C can be given as an IVIG infusion or a subcutaneous infusion.

IV Infusion

For intravenous infusion, Gamunex is given just like other IVIG therapies. The IV route is used for the treatment of primary immunodeficiencies (PI), immune thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). 

Note: You should not inject Gamunex-C intravenously if your doctor has instructed you to use subcutaneous infusion.

Subcutaneous Infusion

A Gamunex-C infusion pump is used to inject the solution subcutaneously. Patients must fill the pump reservoir and prepare the infusion pump. Subcutaneous infusion can be given at different sites of the body at the same time.

 

Gamunex-C Infusion Protocols

  1. The length of the infusion time depends on the condition being treated.
  2. You must follow the doctor’s instructions if infusing Gamunex-C at home.
  3. Gamunex-C must be given slowly (IV or subcutaneous).
  4. Do not shake the medication bottle. 
  5. Prepare a dose only when you are ready to get the injection (immediate use).
  6. Do not mix other medications with Gamunex-C in the same infusion.
  7. Get frequent blood tests to check for antibody titers. 
  8. Vials are designed for single-use; discard the vial after use. 
  9. Do not freeze Gamunex-C. 
  10. Do not inject Gamunex-C yourself if you do not fully understand the procedure. 
  11. Do not administer subcutaneously for CIPD and ITP patients.
  12. In the case of subcutaneous infusion, do not inject Gamunex-C into a blood vessel.

The administration tubing and Y-site connection tubing are used if needed. You can also use several different catheters for different sites. Your healthcare provider will inform you of the best sites for subcutaneous Gamunex-C infusion. 

All the items (needle, catheter, and tubing) are designed for one-time use only and must be discarded after use.

 

Goals in Administration of Gamunex-C

Dosage and Gamunex Infusion Rate 

As per FDA guidelines, the infusion rate of Gamunex-C for PI must be as follows:

Route of AdministrationDoseInitial Infusion Rate Maintenance Infusion Rate
IV (Intravenous)

300-600 mg/kg1 mg/kg/min

8 mg/kg/min
Every 3 to 4 weeks
Subcutaneous (SC)

1,37 x current IV dose in grams/IV
Dose interval in weeks
Adult: 20 mL/hr/site
Pediatric: 10 mL/hr/site to 15 mL/hr/site
Adult:
20 mL/hr/site
Pediatric:
10 mL/hr/site to 20 mL/hr/site
Every week

The infusion rate for ITP and CIPD should be as follows:

Indication Dosage Initial Infusion Rate Maintenance Infusion Rate
ITP 2 g/kg1 mg/kg/min8 mg/kg/min
CIPDLoading dose 2 g/kg
Maintenance dose 1 g/kg
2 mg/kg/min8 mg/kg/min
Every 3 weeks

Note: The above-mentioned infusion rates (as maintenance infusions) are valid only if the values are well tolerated.

 

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Precautions of Use

Gamunex-C should be used cautiously by:

Pregnant Women

Studies suggest that IVIG therapy is beneficial for pregnant mothers, especially for women that suffer from recurrent pregnancy loss (RPL). However, injected antibodies might interfere with fetal growth. Therefore, IVIG therapy should be used with caution in pregnant women.

Lactating Mothers

There is no information regarding the presence of Gamunex-C in human milk, even though there is a study that suggests that IgG is a natural component of breast milk. Therefore it should be used with caution in lactating women.

 

Cost of Gamunex-C

The price of Gamunex-C varies from pharmacy to pharmacy but on average 10 ml of Gamunex-C (10%) injectable solution costs around $150. The 10 ml dosage is available for $145 while the 25 ml and 50 ml preparations will cost you almost $350 and $690 respectively. 

 

Copay Assistance

Copay assistance and financial support programs for Gamunex-C are also offered by different companies. With these programs, you can save up to $2,500 over a period of 1 year.

You can benefit from the patient assistance programs if suffering from CIDP, PIDD, or other conditions for which Gamunex is indicated.

 

Warnings

You should discontinue using Gamunex-C and call your doctor if you experience the following signs of thrombosis:

Allergic Response

The following signs are usually seen on the site of infusion and other sites of the body:

  • Rash
  • Redness and itching of the skin 
  • Formation of blisters 
  • Swelling of the orofacial region (mouth, lips, face, tongue, etc.)
  • Breathing difficulties 

 

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Renal Function Disruption

IVIG and subcutaneous administration of Gamunex-C can compromise renal function. The initial signs include:

  • Inability to urinate 
  • Changes in urine color and quantity  

You must inform your doctor of these warning signs as soon as possible.

Changes in Blood Pressure

Hypotension or decrease of blood pressure can occur following Gamunex-C infusion. A spike in blood pressure is also observed in some patients. If you experience headache or dizziness from an Ig infusion, stop the infusion and notify a doctor.

Lung Issues

Gamunex-C infusion might take a toll on your lungs. Therefore, you should inform your doctor about any breathing issues such as shortness of breath or difficulty breathing. 

Fever and Fatigue

Fatigue and fever after Gamunex-C usage must be reported to your doctor.

Psychological Symptoms

Symptoms such as seizures and delirium (feeling confused) must be reported as soon as possible.

 

Side Effects of Gamunex-C

Gamunex side effectsGamunex-C is generally a well-tolerated and safe solution to be injected in the vein or under the skin. However, there are some side effects associated with its use that range from a mild rash to serious, life-threatening issues such as renal failure.

Common Side Effects

Most of the side effects occur on the infusion site and can be managed. The most commonly encountered non-serious side effects of Gamunex-C are:

  • Rash on skin that may be accompanied by redness and bruising
  • Itching on the injection site 
  • Pain/stiffness on infusion site 
  • Runny nose and sore throat (with cough)
  • Lethargy and bad moods
  • Headache
  • Dizziness 
  • Back pain (and muscle/joint pain)
  • Hypertension 

According to one study, the most common effects seen with 10% IVIG caprylate solution were headache, pyrexia (fever), pulmonary embolism, and vomiting. 

 

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Serious Side Effects

The most serious adverse effects of Gamunex-C are:

Thrombosis

There is a great risk of thromboembolism (i.e., formation of a blood clot) following IVIG infusion. IVIG 10% caprylate usage has a high chance of developing a thrombus in your body, especially if you are already suffering from atherosclerosis (or are obese). 

Thrombosis was not affected by any prophylactic management in a study and is therefore considered a risk associated with Gamunex-C. This blood clot formation can eventually lead to complications such as a heart attack, stroke, and heart failure.

Therefore it is important to keep the patient hydrated. Start with a low dose, and keep the infusion rate as low as possible. 

Renal Failure

Intravenous infusion of the antibody solution can put your kidneys at risk. Research has identified acute renal failure as an adverse reaction caused by intravenous immunoglobulin therapy.

Kidney compromise caused by immune globulin products such as Gamunex-C may present as edema in the peripherals of the legs, decrease in urination, sudden weight gain, and shortness of breath. 

Dehydration is also an unwanted outcome of immune globulin therapy.

Aseptic Meningitis

Serious inflammation of the meninges of the brain can put your life at risk. Aseptic meningitis is associated with IVIG therapy. One study suggests that it seldom happens and that when it does, aseptic meningitis is found in the transient form.

Hemolysis (and Anemia)

Breakdown of red blood cells following IVIG infusion can lead to the development of anemia, which is a serious complication of Gamunex-C. 

Hematoma

Do not administer Gamunex-C subcutaneously in patients with ITP because of the risk of a formation of a blue/black wound (pocket of blood) known as a hematoma.

Transmission of Infections

Because Gamunex-C is an infusion extracted from human blood, there is a possibility that harmful viruses such as variant Creutzfeldt-Jakob disease (vCJD) will be transferred.

 

Gamunex Drug Interactions

Gamunex-C can interfere with the action of live vaccines (mumps, measles, etc.). 

 

 

Gamunex-C vs. Other Immune Globulins

Gammagard and Gammaplex vs. Gamunex-C

Gammagard and Gammaplex are competitors of Gamunex-C.

Gamunex-C vs. Privigen

Both Gamunex and Privigen are identified as effective intravenous immunoglobulin replacement therapies for the management of primary humoral immunodeficiencies.

Gamunex vs. IVIG-SD

According to a randomized double-blind trial, Gamunex-C was found to be superior to IVIG-SD  therapy. Although the adverse reactions were similar, Gamunex-C significantly improved acute sinusitis and bronchiectasis in primary immune deficiency patients.

 

Conclusion

Gamunex-C is a 10% immune globulin solution prepared by caprylate/chromatography. The antibody solution can be given intravenously or subcutaneously and performs well in conditions such as PI, CIPD, ITP, and agammaglobulinemia. 

Because Gamunex-C is associated with an increased risk of thrombosis, renal failure, and hemolysis, it must be used with caution.

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