Gammagard Liquid ERC

Gammagard Liquid ERC is used as replacement therapy for primary humoral immunodeficiency (PI) in adults and children 2 years and older. It is also used to treat adults with Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is a single-dose liquid medicine that contains immunoglobulin G (Human) (IgG) antibodies that protect the body against infection.

Gammagard Liquid ERC is a low IgA formulation of Gammagard that provides a safer treatment option for IgA-deficient patients with PI. It is made from human plasma that has been donated by healthy people.

• The low IgA content (≤2 µg/mL) in Gammagard Liquid ERC minimizes a person's exposure to IgA protein, reducing the likelihood of triggering an anti-IgA antibody reaction and allowing for safer immunoglobulin treatment.
• Gammagard Liquid ERC will eventually replace Gammagard S/D, which will cease manufacture at the end of December 2027.

Gammagard Liquid ERC (low IgA Immune Globulin Infusion [Human] 10%) gained FDA approval on June 30, 2025.

Gammagard Liquid ERC can cause the following serious reactions and carries a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure:

• 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.

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

Do not use Gammagard Liquid ERC if you have a known history of a severe allergic reaction to immune globulin or other blood products, or if you are IgA deficient with antibodies against IgA and a history of hypersensitivity. If you have such a history, talk to your healthcare provider to determine if Gammagard Liquid ERC can be given to you.

Common Side Effects

The most common side effects of Gammagard Liquid ERC are those that occur at the site of the infusion. These generally go away within a few hours and are less likely after the first few infusions, and may include:

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

During the infusion of Gammagard Liquid ERC, 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.

Serious Side Effects

If any of the following problems occur after starting treatment with Gammagard Liquid ERC, stop theinfusion immediately and contact your healthcare provider or call emergency services. These could be signsof 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.

These are not all the possible side effects of Gammagard Liquid ERC. You can ask your healthcareprovider for a physician's information leaflet. Tell your healthcare provider about any side effect that bothersyou 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 occur. Ask your healthcare providerwhether you should have rescue medications, such as antihistamines or epinephrine.Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at1-800-FDA-1088.

Gammagard Liquid ERC is a replacement therapy that contains a wide range of IgG antibodies (IgG) that help fight bacterial and viral infections. It also includes antibodies that can interact with and influence immune system cells and other cells in the body, although the exact mechanisms are not fully understood.

Gammagard Liquid ERC belongs to the drug class called Immune Globulins.

Gammagard Liquid ERC is given into a vein (intravenously) or under the skin (subcutaneously).

• 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 ERC 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.

Gammagard Liquid ERC 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 ERC.

Tell your healthcare provider if you are pregnant, plan to become pregnant, or are nursing.

Store vials in their original boxes to protect them from light. Do not freeze Gammagard Liquid ERC.

You can store Gammagard Liquid ERC in the refrigerator or at room temperature.

• The maximum storage time depends on the storage temperature you choose.
• Refrigerator Temperature: at 2° to 8°C (36° to 46°F) for up to 36 months.
• Room Temperature: up to 25°C (77°F) for up to 24 months.
• The refrigerator and room temperature expiration dates are printed on the vial labels and the box.

Always check the expiration date. You should not use the product after the expiration date.

Note: If you remove Gammagard Liquid ERC from the refrigerator and store it at room temperature, do not refrigerate it again.

Gammagard Liquid ERC

Active ingredients: Human normal immunoglobulin 10% solution with less than or equal to 2 µg/mL IgA per mL.

Inactive ingredients: Glycine, Water for Injection, Hydrochloric acid

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