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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 Gammagard Medication.  Gammagard, which is manufactured by Takeda and known as Gammagard liquid IV, is also known as immune globulin.  Additionally, it has been used for several years to treat and manage Alzheimer’s disease.

 

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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, resulting in memory loss and cognitive impairment, as seen in patients with Alzheimer’s disease. Immune globulins should be able to mitigate Aβ toxicity in the brain.

 

According to a 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 approved this drug 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. It is used to maintain muscle strength in adult patients with MMN.

 

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Gammagard Side Effects

This medication, like any other medication, has some well-known and potentially serious side effects. These include nausea, vomiting, and diarrhea. The importance of understanding what these are cannot be overstated. Aside from the fact that Immune globulins are used to treat adult patients with PI or MMN, side effects vary depending on the diagnosis and the route of administration utilized. What exactly is the condition being addressed? The following are some common side effects in both situations, in addition to the headaches:

 

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.

❖    SQ administration:

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

❖    MMN common side effects:

➢   headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

 

This section should be read to understand that not all of the well-known and severe side effects listed in this section are guaranteed to occur. If you are experiencing side effects and have questions, such as blood clots or kidney failure that are bothersome or do not disappear after some time, 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 to report them.

The Gammagard package insert contains additional information on these 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 if you are experiencing any side effects as soon as possible.

 

Common General Side Effects

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

 

Apart from the fact that they are referred to as common, these side effects are less likely to occur after the first few infusions are administered. Additionally, the following are some of the side effects of j1569 Gammagard liquid injection for MMN or Multifocal Motor Neuropathy:

 

 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

 

Ask an IVIg Specialist about Side Effects

 

Gammagard Warnings / Adverse Reactions

Aside from the common side effects of the Medication, severe side effects such as those listed below may occur while taking Gammagard sd. It is essential to be aware of the following warnings and adverse events when taking the Medication:

 Severe Side Effects

❖    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

➢   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

➢   Symptoms typically occur within 1 to 6 hours after treatment.

➢   Transmittable infectious agents

➢   Because this drug is made from human plasma, it may carry a risk of transmitting infectious agents

 

It is critical to recognize that not all of the warnings / adverse 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 if necessary. Examples of such conditions include blood clots and kidney failure, which can be distressing or persistent after some time. If you are experiencing severe side effects, seek emergency medical attention, call 1-800-FDA-1088, or contact your doctor as soon as possible to report them. Consider reading the Gammagard package insert if you want to learn more about these common and severe side effects warnings / adverse reactions in greater detail.

 

Gammagard Adverse Reactions

The adverse reactions of this medication are distinct from the side effects of the Medication. Adverse reactions are pharmacologic events that occur due to the administration of a medication that is not intended. The following are some signs of severe adverse reactions that may arise as a result of this Medication:

➢   Difficulty in 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

 

Consider the following scenario: a patient is experiencing signs and symptoms of severe adverse reactions caused by immune globulin, such as those listed in this section. Immediately seek and contact emergency services, dial 1-800-FDA-1088 or notify your doctor to avoid any unwanted events from occurring. The package insert for Gammagard sd contains additional information on these adverse reactions that you should read.

 

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Gammagard Precautions Contraindications

It is a highly beneficial medication, particularly for those who suffer from immunodeficiency. It is critical to understand, however, that not all patients can take it. You should not use it if you are:

➢   Allergic to immune globulin and blood products

➢   Having Selective or severe immunoglobulin A (IgA) deficiency

                          

Additionally, when a patient is receiving treatment, the following information is critical:

 

Gammagard Liquid With Vaccines

It 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 have any current 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 it can harm a developing fetus or impair reproduction capacity when administered to a pregnant woman. After 30 weeks of gestation, immunoglobulins increasingly cross the placenta from the maternal circulation. It should be used during pregnancy only when indicated.

 

Gammagard Liquid In Lactating Mothers

This drug is not known to be excreted in human milk. Since many drugs are excreted in human milk, caution should be used when administering Medication to a nursing woman.

 

Understanding the precautions for immune globulin will improve the efficacy of the therapy and assist the patient in avoiding adverse events. You must inform your doctor about your past medical history and any other pertinent health information before beginning this treatment with Gammagard liquid. To learn about additional precautions and warnings, consider reading the Gammagard liquid package insert.

 

Gammagard Formulation and Dosing

Image source: https://www.drugs.com/pro/gammagard-liquid.html

 

To combat viruses, bacteria, or other foreign bodies within the system, the body’s antibody levels must be increased, which Gammagard liquid does. It contains immunoglobulin G (IgG) that aids in the fight against Infection. Additionally, This drug comes in the following formulations:

 

Formulations

Gammagard IV

➢   Medication can be injected directly into the vein of the patient.

➢   Administered once every 3 to 4 weeks

➢   The dose is administered in a single location.

➢   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

➢   Medication is injected under the skin or fatty tissue

➢   Administered once a week

➢   The dose is administered in multiple sites, and the maximum number of concurrent sites should be limited to eight.

➢   After receiving training from a medical professional, it is possible to self-administer.

➢   Can be infused at home if a patient or caregiver is already familiar with proper administration and has received training.

 

 

An insufficient number of antibodies characterizes primary immunodeficiency. Thus, antibodies collected from healthy individuals are used to replace these missing antibodies. It is indicated for patients two years of age and older on the FDA label. Nonetheless, only a medical provider can advise a patient on the optimal treatment administration, dosage strength, and adjustment.

 

Gammagard is a 10% IgG solution (100 milligrams/mL) free of sucrose, added sugars, sodium, preservatives, and proline. As a result, this Medication is ideal for individuals allergic to these additives. Additionally, the following information pertains to its dosing:

 

 

Dosing

IV (Intravenous) Administration for PI

❖    Dose:

➢   300-600mg/kg every 3-4 weeks, and 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 milliliters per kilogram per hour (8 milliliters per kilogram per minute)

 

IV (Intravenous) Administration for MMN

❖    Dose:

➢   Range 0.5 to 2.4 grams/kg/month and 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:

➢   Infusion rate could be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min)

 

SubQ Administration for PI

❖    Dose:

➢   The initial Dose is 1.37 × previous intravenous doses divided by # of weeks between intravenous doses. The maintenance dose is based on the clinical response of the patient

❖    Initial Infusion Rate:

➢   40 kg BW and greater:

■     30 mL/site at 20 mL/hr/site

➢   Under 40 kg BW:

■     20 mL/site at 15 mL/hr/site

❖    Maintenance Infusion Rate:

➢   40 kg BW and greater:

■     30 mL/site at 20 to 30 mL/hr/site

➢   Under 40 kg BW:

■     20 mL/site at 15 to 20 mL/hr/site

 

Gammagard Uses

People are searching for the best medicine today due to the COVID-19 pandemic and related health issues. It is critical for each individual’s body to have a more robust immune system, which This medication is constantly providing. When the immune system is compromised, a patient is more susceptible to viruses and bacteria. In the United States, approximately 250,000 people have been diagnosed with PI. Fortunately, this medication therapy has a variety of critical applications, particularly during this pandemic period. The following are some of the advantages:

 

Sustaining Immunity Against Infection

Gammagard J code was administered every three to four weeks for one year to 61 patients with primary immunodeficiency at a dose of 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 are tolerable. The most frequently reported adverse effect is a mild headache, which occurs at a rate of 5.2 percent.

 

Treatment for Primary Immunodeficiency

PI is an insufficient immune response. It is inherited, and it can affect people of all ages and genders. To maintain patients’ health with PI, immunotherapy is required, and this drug may be used.

 

Management of MMN

The immune globulins are used in adult patients with Multifocal Motor Neuropathy as a maintenance therapy to improve muscle strength and disability.

 

Takeda, the manufacturer, assures patients regarding the Medication’s efficacy and safety. One reason for this is that all donors will be screened for potential infections, and all human plasma will be collected only at FDA-approved blood establishments.

 

Gammagard Cost

Image source: https://www.gammagard.com/mmn/side-effects

This drug is very reasonably priced compared to the health benefits it provides, particularly at this time of the pandemic. 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
 

  

Apart from this, other 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 50 mL. Gammagard liquid vs. Gamunex price is nearly identical, but the former is more widely used.

Gammagard Copay Assistance

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

 

Immune Globulin Shortage

Image source: https://www.washingtonpost.com/health/a-severe-shortage-hits-a-drug-used-for-cancer-immune-disorders-epilepsy-causing-cancelled-treatments-and-rationing/2019/11/01/f2be3c4e-e93a-11e9-9c6d-436a0df4f31d_story.html

 

According to news reports, there has been a global shortage of immune globulin, including the brand 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 approved Gammagard liquid and extended its shelf life. This ensures that it will never 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 for 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 and 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.

➢   To ensure your safety, record your infusion in your logbook.

 

 

If a patient is administering the Medication at home, it is critical to keep the following information in mind to ensure that it has the maximum effect possible:

 

 

➢   Visually inspect the drug 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.

➢   The vials are only intended for single use. Any vial entered should be used immediately. Discard any vials that are only partially used.

➢   Before using, allow the refrigerated product to come to room temperature.

➢   Avoid microwaving, shaking, or combining the Medication with other products.

 

FAQs

What is Gammagard Used to Treat?

It is a medication that is used to treat immunodeficiency and autoimmune diseases. Apart from these two applications, it is also used to treat Alzheimer’s disease. Additionally, Gammagard liquid is used to treat patients aged two years and older with Primary Immunodeficiency and adult patients who have Multifocal Motor Neuropathy.

 

Is Gammagard an Immunosuppressant?

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

 

What Antibodies are in Gammagard?

This drug contains immunoglobulin G (IgG). These antibodies are isolated and synthesized from healthy individuals’ plasma.

 

When Do You Use Gammagard?

This medication has a plethora 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

 

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