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Gammagard for IVIG Therapy

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Gammagard IVIG

Gammagard for IVIG Therapy

Immunoglobulin is a product composed of antibodies, which are proteins produced by the body to protect and aid in the fight against Infection. Gammagard is one of the most frequently used immunoglobulin products. It is made from the blood of thousands of donors.

Human plasma antibodies can be isolated from donated blood and used to make this medication.  Gammagard, also known as immune globulin and Gammagard liquid IV, is manufactured by Takeda Pharmaceutical Company. It has been used for several years to treat and manage Alzheimer’s disease.

Gammgard can also be used to treat primary immunodeficiency, which is characterized by an insufficient number of antibodies. Antibodies collected from healthy individuals are used to replace these missing antibodies. Gammagard is indicated for patients with this condition who are 2 years and older.

Gammagard is a 10% IgG solution (100 milligrams/ml) that is free of sucrose, added sugars, sodium, preservatives, and proline. As a result, this medication is ideal for individuals allergic to these additives.  

According to the manufacturer, Takeda, Gammagard can be both safe and effective. One reason for this is that all donors are screened for potential infections, and all human plasma is collected only at FDA-approved locations.

 

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Gammagard Treatment/Therapy

Gammagard Treatment/Therapy

Beta-Amyloid proteins, abbreviated as Aβ, are synthesized throughout the human body. When these proteins aggregate and form plaques in the brain, a neurodegenerative process can begin. This results in memory loss and cognitive impairment, as seen in patients with Alzheimer’s disease. Immune globulins have the ability to mitigate Aβ toxicity in the brain.

According to one report, patients with mild Alzheimer’s disease treated with Gammagard liquid have a higher level of Aβ antibodies in their serum and a lower level of clumped Aβ proteins in their brains.

Additionally, for over a year and a half, these patients’ MMSE (Mini-Mental State Exam) scores have remained stable. Another study reported improved changes in the level of human plasma cytokines in patients with mild to moderate Alzheimer’s disease. MRI scans revealed a reduction in the heart’s enlargement.

The FDA has also approved Gammagard to treat immunodeficiency and autoimmune diseases, including Primary Immunodeficiency (PI) and Multifocal Motor Neuropathy (MMN).

PI occurs when the body’s immune system is deficient and does not produce enough antibodies. Immunoglobulin therapy is required to keep patients with PI healthy.

MMN occurs when the immune system attacks the body’s nerves. Gammagard is used to maintain muscle strength in adult patients with MMN.

 

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Gammagard Side Effects

Gammagard has some well-known and potentially serious side effects, which include nausea, vomiting, and diarrhea. Side effects vary depending on the diagnosis and the route of administration utilized. Below are the common side effects for patients being treated for PI and MMN.

PI Common Side Effects

IV administration:

Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, edema peripheral, pruritus, and cardiac murmur.

Subcutaneous administration:

Infusion site (local) event, headache, fatigue, increased heart rate, pyrexia, upper abdominal pain, nausea, vomiting, asthma, increased systolic blood pressure, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in the extremities.

MMN Common Side Effects

Headache, chest discomfort, muscle spasms, muscle weakness, nausea, oropharyngeal pain, and pain in the extremities.

If you are experiencing side effects and have questions, contact a medical professional right away.

If you are experiencing severe side effects, seek emergency medical attention, call 1-800-FDA-1088, or contact your doctor as soon as possible.

The Gammagard package insert contains additional information on common and severe side effects.

Common Injection Site Side Effects

  • Mild to moderate pain
  • Swelling
  • Itchiness
  • Bruising
  • Redness
  • Low-grade fever
  • Warmth

Side effects such as those listed above are only noticeable at the injection site, and they will usually subside within a few hours. However, it is still important to inform your doctor as soon as possible if you are experiencing any side effects.

Common General Side Effects

  • Light headache
  • Migraine
  • Redness
  • Warmth
  • Fatigue
  • Low-grade fever
  • Itchiness
  • Rashes
  • Cough
  • Chest pain
  • Chills
  • Difficulty breathing
  • Dizziness
  • Nausea and vomiting
  • Increased heart rate
  • Increased blood pressure
  • Upper abdominal pain
  • Muscle cramps and weakness
  • Sore throat

Although common, these side effects are less likely to occur after the first few infusions are administered. 

Side Effects of J1569 Gammagard Liquid Injection for MMN

The following are some of the side effects of J1569 Gammagard liquid injection for MMN or multifocal motor neuropathy, which are less likely to occur:

  • Severe headache
  • Chest pain
  • Muscle spasms and weakness
  • Breathing difficulty
  • Nausea
  • Sore throat
  • Dizziness
  • Redness
  • Fever
  • Pain in the ears, hands, and feet

 

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Severe Side Effects

Severe side effects such as those listed below may occur while taking Gammagard SD:  

Allergic Reaction

  • Hives
  • Swelling in the mouth or throat
  • Skin itchiness
  • Trouble breathing
  • Wheezing
  • Dizziness with fainting

Brain Swelling

  • Nausea and vomiting
  • Stiff neck
  • Sensitivity to light

Kidney Problems

  • Reduced urination caused by kidney failure
  • Weight gain
  • Legs swelling (a sign of kidney failure)

Liver Problems

  • Yellow skin or eyes

Blood Clots

  • Pain and swelling of legs and arms
  • Brown, red, or dark-colored urine
  • Fast heart rate

Heart and Lung Complications

  • Chest pain
  • Trouble breathing
  • Blue lips and extremities

Infection

  • Fever over 100

Aseptic Meningitis Syndrome

  • Fever
  • Chills
  • Body aches
  • Sensitivity to light
  • Loss of appetite
  • Vomiting
  • Fatigue

Hemolysis (Destruction of Red Blood Cells)

  • Abnormal paleness of skin
  • Yellowish skin or eyes (signs of jaundice)
  • Dark urine
  • Fever
  • Weakness
  • Dizziness
  • Confusion

Transfusion-related Acute Lung Injury (Symptoms Typically Occur Within 1 to 6 Hours of Treatment):

  • Difficulty breathing or wheezing (signs of pulmonary edema)
  • Changes in the color of skin, confusion, cough, fast heart rate, rapid breathing, shortness of breath, slow heart rate, sweating (signs of hypoxia)
  • Fever
  • Transmittable infectious agents (Because this drug is made from human plasma, it may carry a risk of transmitting infectious agents)

It is important to recognize that not all of the warnings or side events listed in this section are likely to occur at any time. If a patient is experiencing an allergic reaction or severe side effects, contact a medical professional immediately and seek emergency care (call 1-800-FDA-1088, or contact your doctor as soon as possible). 

Consider reading the Gammagard package insert if you want to learn more about these common and severe side effects in greater detail.

 

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Adverse Reactions

Gammagard infusion

The adverse reactions to this medication are distinct from the side effects of the medication. Adverse reactions are pharmacologic events that occur due to the administration of medication. The following are some signs of severe adverse reactions that may arise as a result of using Gammagard:

  • Difficulty breathing
  • Skin rashes
  • Kidney failure
  • Blood clots in the heart and lung
  • Severe headache and fatigue
  • Fever
  • Chills
  • Painful eye movements
  • Sensitivity to light
  • Nausea and vomiting
  • Drowsiness
  • Dark-colored urine
  • Muscle swelling

If a patient is experiencing signs and symptoms of severe adverse reactions such as those listed in this section, contact emergency services, dial 1-800-FDA-1088, or notify your doctor immediately.

The package insert for Gammagard SD contains additional information on these adverse reactions.

 

Gammagard Precautions and Contraindications

Gammagard is a highly beneficial medication, particularly for those who suffer from immunodeficiency. However, not all patients can take Gammagard. 

You should not use Gammagard if:

  • You are allergic to immune globulin and blood products.
  • You have a selective or severe immunoglobulin A (IgA) deficiency.

Gammagard Liquid With Vaccines

Gammagard has been shown to impair the immune response and diminish the effectiveness of live vaccines such as MMR or chickenpox. Inform your immunizing physician if you are currently on immune globulins therapy.

Gammagard Liquid in Pregnancy

This medication is classified as a pregnancy category C medication, meaning no animal reproduction studies have been conducted. It is unknown whether Gammagard can harm a developing fetus or impair reproductive capacity when administered to a pregnant woman. 

After 30 weeks of gestation, immunoglobulins increasingly cross the placenta from the maternal circulation. Gammagard should be used during pregnancy only when indicated.

Gammagard Liquid in Lactating Women

This drug is not known to be excreted in human milk. However, since many drugs are excreted in human milk, caution should be used when administering Gammagard to someone who is breastfeeding.

 Understanding the precautions for immune globulin will improve the efficacy of the therapy and help prevent adverse outcomes. You should inform your doctor about your past medical history and any other pertinent health information before beginning this treatment.

 

Formulation, Injection Sites, and Dosing

The body’s antibody levels must be increased in order to combat viruses, bacteria, or other foreign bodies. Gammagard liquid contains the antibody, immunoglobulin G (IgG), which aids in the fight against Infection.

 

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Gammagard Injection Sites

Gammagard IV

  • This medication can be injected directly into the vein.
  • It is administered once every 3 to 4 weeks.
  • The dose is administered to a single site on the body.
  • A medical professional administers the medication.
  • The administration takes place in a hospital, clinic, or at a patient’s residence, but always in the presence of a medical professional.

 Gammagard SubQ

  • This medication is injected under the skin or fatty tissue.
  • It is administered once a week.
  • The dose is administered to multiple sites, and the maximum number of concurrent sites should be eight.
  • After receiving training from a medical professional, it is possible to self-administer.
  • Gammagard SubQ can be injected at home if a patient or caregiver is already familiar with proper administration and has received training.

 

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Dosing

IV (Intravenous) Administration for PI

Dose:

300 – 600mg/kg every 3 to 4 weeks. The dose will be adjusted based on the patient’s clinical response.

Initial infusion rate:

0.5 ml/kg/hr (0.8 mg/kg/min) for 30 minutes.

Maintenance infusion rate:

Every 30 minutes, increase (if tolerated) up to 5 ml per kilogram per hour (8 ml per kilogram per minute) 

IV (Intravenous) Administration for MMN

Dose:

0.5 to 2.4 grams/kg/month. The dose will be adjusted based on the patient’s clinical response.

Initial infusion rate:

0.5ml/kg /hr (0.8 mg/kg/min).

Maintenance infusion rate:

If tolerated, the infusion rate can be increased to 5.4 ml/kg/hr (9 mg/kg/min). 

SubQ Administration for PI

Dose:

The initial dose is 1.37 times the number of previous intravenous doses, divided by the number of weeks between intravenous doses. The maintenance dose is based on the clinical response of the patient.

Initial infusion rate:

  • 40 kg body weight and greater: 30 ml/site at 20 ml/hr/site.
  • Under 40 kg body weight: 20 ml/site at 15 ml/hr/site.

Maintenance infusion rate:

  • 40 kg body weight and greater: 30 ml/site at 20 to 30 ml/hr/site.
  • Under 40 kg body weight: 20 ml/site at 15 to 20 ml/hr/site

 

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Gammagard Uses

When the immune system is compromised, a patient is more susceptible to viruses and bacteria. Gammagard makes it possible for individuals to have a more robust immune system. 

In the United States, approximately 250,000 people have been diagnosed with primary immunodeficiency (PI). Fortunately, Gammagard has a variety of critical applications, which are discussed in more detail below. 

 

Sustaining Immunity Against Infection

Gammagard J code was administered every 3 to 4 weeks for 1 year to 61 patients with primary immunodeficiency. The dosage used was 300 – 600mg/kg. No bacterial infections occurred as a result of this treatment.

Additionally, none of these 61 patients required hospitalization for a primary infection other than a urinary tract infection, gastroenteritis, or ear infection. According to the same study, the medication’s side effects were tolerable, and the most frequently reported adverse effect was a mild headache, which occurred 5.2% of the time.

 

Treatment for Primary Immunodeficiency

PI is an insufficient immune response. It is inherited, and it can affect people of all ages and genders. Immunotherapy is required to maintain a PI patient’s health, and Gammagard is one of the drugs that can be used for this condition.

 

Management of MMN

Immune globulins such as Gammagard are used in adult patients with multifocal motor neuropathy as a maintenance therapy to improve muscle strength and disability. 

 

Gammagard Cost

In light of all the health benefits it provides, Gammagard is very reasonably priced. The cost of Gammagard IVIG may vary depending on the pharmacy or clinic that a patient visits, but the following is a rough estimate of the cost of this medication:

QuantityPrice Per unitPrice
10 milliliters$16.53$165.33
25 milliliters$15.96$399.10
50 milliliters$15.77$788.69
100 milliliters$15.68$1,567.88
200 milliliters$15.63$3,126.26
300 milliliters $15.62$4,684.64
 

Other IVIG brands include Gamunex-C and Privigen. Privigen is less expensive than Gammagard liquid, costing approximately $16 per 100 ml. Additionally, the starting dose of Privigen is only 50 ml. Gammagard liquid and Gamunex are similarly priced, but the former is more widely used.

 

Gammagard Copay Assistance

Gammagard Copay Assistance is available to patients who have been prescribed this drug to treat PI or MMN. Takeda offers an assistance program, which patients can enroll in independently or through a medical provider.

 

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Immune Globulin Shortage

There has been a global shortage of immune globulin, including Gammagard, for approximately a year and a half beginning in 2019. This shortage occurred as a result of decreased human plasma donations, particularly during the COVID-19 pandemic.

Fortunately, the FDA has approved Gammagard liquid and extended its shelf life, thus reducing the chance it will be in short supply.

 

Tips While on Treatment

If a patient is being treated outside of their home with immune globulins, the following are some helpful tips on what to do during the treatment:

  • Bring a book, a movie, or other relaxing material to keep you occupied during the infusion, which can last between 2 to 6 hours.
  • Relax and sit comfortably.
  • Inform the nurse if you feel uneasy at any point during the infusion.
  • Inform your doctor of any adverse reactions you experience.
  • Record your infusion in your logbook.

 If a patient is administering the medication at home, it is important to: 

  • Visually inspect the product upon receipt for particulate matter and discoloration before administration. This medication is a colorless or pale yellow solution that is clear or slightly opalescent. It should not be used if the solution is cloudy, turbid, or contains particulates.
  • Keep vials refrigerated until use.
  • Use any vial that has been opened immediately since the vials are only intended for single use. Discard any vials that are only partially used.
  • Allow the refrigerated product to reach room temperature before using.
  • Avoid microwaving, shaking, or combining the medication with other products.

 

FAQs

What is Gammagard Used To Treat?

Gammagard is used to treat immunodeficiency, autoimmune diseases and Alzheimer’s disease. In addition, Gammagard liquid is used to treat patients who are 2 years and older with primary immunodeficiency, as well as adult patients who have multifocal motor neuropathy. 

Is Gammagard an Immunosuppressant?

Gammagard is classified as an immunosuppressant because it is used to treat autoimmune conditions.

What Antibodies are in Gammagard?

Gammagard contains immunoglobulin G (IgG). These antibodies are isolated and synthesized from the plasma of healthy individuals.

When Do You Use Gammagard?

The medication has a multitude of applications and benefits. It may be used in the following situations, depending on the treatment prescribed by a physician:

  • If a patient has primary immunodeficiency (PI) or multifocal motor neuropathy (MMN).
  • When there is a need to prevent bacterial infections in patients with hypogammaglobulinemia (low levels of immune globulin).
  • If a patient is having recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia.

 

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REFERENCES:

  1. Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2. PMID: 18466176.
  2. Drug Shortage Detail: Immune Globulin, Intravenous or Subcutaneous (Human). (2021, July 7). ASHP. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527&loginreturnUrl=SSOCheckOnly
  3. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%. (2021). GAMMAGARD. https://www.gammagard.com/primary-immunodeficiency/patient
  4. Hahn AF, Beydoun SR, Lawson V; IVIG in MMN Study Team, Oh M, Empson VG, Leibl H, Ngo LY, Gelmont D, Koski CL. A controlled trial of intravenous immunoglobulin in multifocal motor neuropathy. J Peripher Nerv Syst. 2013 Dec;18(4):321-30. doi: 10.1111/jns5.12046. PMID: 24725024.
  5. Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, Buckley R, Chinen J, El-Gamal Y, Mazer BD, Nelson RP Jr, Patel DD, Secord E, Sorensen RU, Wasserman RL, Cunningham-Rundles C; Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006 Apr;117(4 Suppl):S525-53. doi: 10.1016/j.jaci.2006.01.015. Erratum in: J Allergy Clin Immunol. 2006 Jun;117(6):1483. Dosage error in article text. PMID: 16580469.
  6. Paris: More Trial News, Mixed at Best | ALZFORUM. (2011, August 2). Alzforum. https://www.alzforum.org/news/conference-coverage/paris-more-trial-news-mixed-best
  7. Relkin NR, Szabo P, Adamiak B, Burgut T, Monthe C, Lent RW, Younkin S, Younkin L, Schiff R, Weksler ME. 18-Month study of intravenous immunoglobulin for treatment of mild Alzheimer disease. Neurobiol Aging. 2009 Nov;30(11):1728-36. doi: 10.1016/j.neurobiolaging.2007.12.021. Epub 2008 Feb 21. PMID: 18294736.
  8. Szabo P, Mujalli DM, Rotondi ML, Sharma R, Weber A, Schwarz HP, Weksler ME, Relkin N. Measurement of anti-beta amyloid antibodies in human blood. J Neuroimmunol. 2010 Oct 8;227(1-2):167-74. doi: 10.1016/j.jneuroim.2010.06.010. Epub 2010 Jul 31. PMID: 20638733.
  9. Toronto: In Small Trial, IVIg Slows Brain Shrinkage | ALZFORUM. (2010, April 20). Alzforum. https://www.alzforum.org/news/conference-coverage/toronto-small-trial-ivig-slows-brain-shrinkage
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