Gammagard liquid

Pronunciation: Gam-a-gard Lick-wid
Generic name: Immune Globulin Infusion [Human] 10%
Dosage form: liquid for intravenous or subcutaneous infusion
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 8, 2024.

What is Gammagard liquid?

Gammagard liquid (Immune Globulin Infusion [Human] 10%) is a ready-to-use liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. It may be given as:

• Replacement therapy for primary humoral immunodeficiency (PI) in adults and children two years of age or older. There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. Gammagard liquid works by replacing missing antibodies or IgG protein in PI patients
• Maintenance therapy to improve muscle strength and disability in adults with Multifocal Motor Neuropathy (MMN). MMN is a rare disease that causes muscle weakness that worsens over time. It affects the strength of the lower parts of the arms and hands more than the legs, usually without affecting the touch sensation.
• Treatment to improve neuromuscular disability and impairment in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare disease, thought to be an autoimmune condition in which the body's immune system targets the nerves, leading to muscle weakness and numbness, usually in the arms and legs. IgG is thought to reduce the damage to the nerve and assist in defending the nerve from harm.

Gammagard liquid was FDA approved on April 27, 2005.

Warnings

There is a risk of thrombosis with immune globulin products, including Gammagard liquid. The risk is higher in older people and in those with prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, indwelling vascular catheters, hyperviscosity, cardiovascular risk factors, or using estrogens. For those at risk of thrombosis, ensure they are hydrated before administration and administer Gammagard at the minimum dose and infusion rate. Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk.

May cause serious hypersensitivity reactions. Do not use in patients with a history of anaphylactic or severe allergic reactions to human immune globulin. Contraindicated in IgA deficient patients with antibodies to IgA.

Kidney problems including renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products including Gammagard liquid, especially those that contain sucrose. Gammagard liquid does not contain sucrose. Your healthcare provider will monitor your renal function, including blood urea nitrogen, serum creatinine, and urine output if you are at risk.

May also increase the risk of high serum protein levels (hyperproteinemia), and low sodium levels (hyponatremia) and increase the viscosity of serum. Aseptic Meningitis Syndrome (AMS), pulmonary adverse reactions, and hemolytic anemia can develop. Your healthcare provider will monitor you for these.

Because Gammagard liquid is made from human blood, it may carry a risk of transmitting infectious agents, such as viruses or Creutzfeldt-Jakob disease variants or agents.

The safety and effectiveness of Gammagard liquid has not been studied in:

• immunoglobulin-naïve patients with CIDP nor as maintenance therapy beyond 6 months
• pediatric patients below the age of 2 with PI or pediatric patients with MMN or CIDP.

Related/similar drugs

azathioprine, Imuran, Hizentra, Privigen, Betaseron, Octagam, Cuvitru

Before taking

Tell your healthcare provider if you have a known history of a severe allergic reaction to immune globulin or other blood products or a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

Also, tell your healthcare provider if you:

• Have a history of lung or kidney problems or low sodium levels
• Take estrogens
• Have an indwelling catheter
• A history of venous or arterial thrombosis or other coagulation disorders
• Are immobile
• Have other cardiovascular risk factors
• Have not been fully vaccinated
• Are pregnant or intend to become pregnant
• Are breastfeeding.

Pregnancy

It is not known if Gammagard liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Gammagard liquid should be given to a pregnant woman only if clearly indicated.

Breastfeeding

There is no information regarding the presence of Gammagard liquid in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Gammagard liquid and any potential adverse effects on the breastfed infant.

How should I use Gammagard liquid?

Gammagard liquid may be given into a vein (intravenously [IV]) or under the skin (subcutaneously [SC]).

IV infusions are usually given by a healthcare provider in a hospital or infusion center, although sometimes people can be taught how to give themselves an infusion. SC infusions are usually given at home by patients or caregivers. Only use Gammagard liquid by yourself after you have been instructed by your healthcare provider.

• For patients with PI, IV infusions are usually given every 3 or 4 weeks whereas SC infusions are given every week.
• For patients with MMN, infusions are given into a vein every 2 to 4 weeks.

What happens if I miss a dose?

If you miss a dose, administer the missed dose as soon as possible, and then resume your regular scheduled treatment.

What happens if I overdose?

With IV administration, an overdose of Gammagard liquid may lead to fluid overload and high serum viscosity. The risk increases in patients of an older age or with cardiac or renal impairment.

What are the side effects of Gammagard liquid?

Gammagard liquid can cause serious side effects including:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs, or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark-colored urine, swelling, fatigue, or difficulty breathing.

If any of the following problems occur after starting treatment with Gammagard liquid, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem.
• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
• Fever over 100°F. This could be a sign of an infection.

The following one or more possible reactions may occur after the administration of Gammagard. These generally go away within a few hours and are less likely after the first few infusions.

• Mild or moderate pain
• Swelling
• Itching
• Redness
• Bruising
• Warmth.

The most common side effects observed in 5% or more patients when given either intravenously or subcutaneously include:

• Headache
• Fatigue
• Fever, chills, or rigors
• Nausea, vomiting, or abdominal pain
• Pain in the extremities
• Diarrhea
• Migraine
• Dizziness
• Cough or sore throat
• Hives, rash, or itch
• Asthma
• Muscle, joint, or other pain
• Edema
• Cardiac murmur, increased heart rate, or blood pressure increases
• Infusion site reactions (with subcutaneous administration)
• Laboratory changes.

These are not all of the possible side effects of Gammagard liquid. You can ask your healthcare provider for a physician’s information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

To report suspected adverse reactions, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I avoid while receiving Gammagard liquid?

Gammagard liquid can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider that you take Gammagard liquid.

Storage

Store vials in their original boxes to protect them from light. Do not freeze. Store in the refrigerator or at room temperature.

• Refrigerate at 2° to 8°C (36°F to 46°F) for up to 36 months. Do not freeze.
• May be kept at room temperature (up to 25°C [77°F)) for up to 24 months.

Expiration dates for both storage conditions are printed on the outer carton and vial label. Do not use past the applicable expiration date.

Ingredients

Active: Human Immunoglobulin G.

Inactive: Glycine.

Not made with natural rubber latex.

Made from human plasma donated by healthy people.

Manufacturer

Takeda.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer