Gammagard

Gammagard is used to treat primary immunodeficiency diseases (PI), multifocal motor neuropathy (MMN), and chronic inflammatory demyelinating polyneuropathy (CIDP). It is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection, and is often referred to as Gammagard liquid.

Gammagard liquid (Immune Globulin Infusion [Human] 10%) first gained FDA approval on April 27, 2005.

Gammagard Liquid ERC is a low IgA formulation of Gammagard that was FDA approved on June 30, 2025. It provides a safer treatment option for IgA-deficient patients with PI.

Gammagard is an immune globulin infusion (human), FDA-approved for:

• Primary humoral immunodeficiency (PI), as replacement therapy for adults and children 2 years and older
• Multifocal motor neuropathy (MMN) as maintenance therapy to improve muscle strength and disability in adults with MMN
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment in adults with CIDP.

Gammagard can cause the following serious reactions:

• 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.

Do not use if you have a history of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human).

• Gammard Liquid should not be used in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
• Discuss with a healthcare provider if Gammagard Liquid ERC can be used instead.

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 can cause fetal harm when administered to a pregnant woman or can affect reproductive 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 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.

Common Side Effects

The most common side effects of Gammagard are:

• Infusion site reactions such as pain, swelling, itching, rash, redness, bruising, warmth, or bleeding.

During your infusion of Gammagard, look out for the first signs of the following common side effects:

• Headache
• Migraine
• Fever
• Fatigue
• Itching
• Rash/Hives
• Cough
• Chest pain/tightness
• Pain in the extremities
• Diarrhea
• Infusion site leakage
• Joint pain
• Chills/Shaking chills
• Dizziness
• Nausea/Vomiting
• Faster heart rate
• Upper abdominal pain
• Increased blood pressure
• Muscle cramps
• Sore throat
• Heart murmur
• Asthma
• Ear pain
• Mouth ulcer/sores.

If any of the following problems occur after starting treatment with Gammagard, 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 kidneyproblem
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of blood clots
• 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.

Serious side effects and warnings

Gammagard carries a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure.

Thrombosis

There is a risk of thrombosis with immune globulin products, including Gammagard Liquid/Liquid ERC. The risk is higher in older people and those with prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, indwelling vascular catheters, hyperviscosity, cardiovascular risk factors, or using estrogens. Those at risk of thrombosis should be well-hydrated before administration and should be administered Gammagard at the lowest dose and infusion rate. Monitor for signs and symptoms of thrombosis and assess blood viscosity.

Renal dysfunction and acute renal failure

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.

Gammagard may also cause the following other serious side effects:

• Severe allergic reactions which can cause difficulty in breathing or skin rashes. Do not use in patients with a history of anaphylactic or severe allergic reactions to human immune globulin.
• High serum protein levels (hyperproteinemia), low sodium levels (hyponatremia), and increases in serum viscosity.
• Aseptic Meningitis Syndrome (AMS), pulmonary adverse reactions, and hemolytic anemia can also 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 have 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.

These are not all the possible side effects of Gammagard. 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 do not go away.

Whenever giving yourself treatment at home, you should have another responsible person present to helptreat side effects or get help if you have a serious adverse reaction occurs. Ask your healthcare providerwhether 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.

Gammagard works by providing a wide range of antibodies (IgG) that help fight bacterial and viral infections by coating pathogens for immune system destruction, and neutralizing other threats. It also contains antibodies that regulate immune system activity and interact with blood cells, although the exact mechanisms are not fully understood.

Gammagard belongs to the drug class called immune globulins.

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

• For patients with PI, infusions into the vein are usually given every 3 or 4 weeks, whereas infusions under the skin are given every week.
• You and your healthcare provider will decide which way is best for you.
• Most of the time, infusions under the skin are given at home by patients or caregivers.
• Although it is possible to give yourself infusions into the vein at home, they are more often given in a hospital or infusion center by a nurse.

Instructions for giving Gammagard Liquid under the skin (subcutaneously) are provided in the Instructions for Use brochure. Only use these products by yourself after you have been instructed by your healthcare provider.

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.

For patients with MMN and CIDP, Gammagard Liquid is given by IV infusion by a healthcare provider.

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

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.

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.

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. If you remove Gammagard from the refrigerator and store it at room temperature, do not put it back in the refrigerator.

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

Gammagard Liquid

Active: Human Immunoglobulin G 10% solution.

Inactive: Glycine.

Gammagard is manufactured by Takeda Pharmaceuticals U.S.A., Inc.,Cambridge, MA 02142.