Gammagard Liquid (for injection into a vein or under the skin) is used to treat primary immunodeficiency.

Gammagard Liquid is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura.

Gammagard Liquid is also used to treat certain debilitating nerve disorders that cause muscle weakness and can affect daily activities.

Gammagard Liquid may also be used for purposes not listed in this medication guide.

Gammagard Liquid can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.

Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

This medicine can also harm your kidneys, especially if you have kidney disease or if you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Gammagard Liquid is given as an infusion into a vein, or injected under the skin using an infusion pump. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Do not inject Gammagard Liquid into a vein if you have been instructed to give the medicine as a subcutaneous injection (under the skin).

How you give this medication, how often you use it, and the length of your infusion time will depend on the condition being treated.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not shake the medication bottle or you may ruin the medicine.

Gammagard Liquid must be given slowly. You may need to use several catheters to inject Gammagard Liquid into different body areas at the same time. Your healthcare provider will show you the best places on your body to inject the medication. Keep a diary of the days and times you gave the injection and where you injected it on your body.

Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

You may need frequent blood or urine tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Gammagard Liquid.

Store this medicine in its original carton in the refrigerator. Do not freeze Gammagard Liquid, and throw the medicine away if it has frozen.

Take the medicine out of the refrigerator and let it reach room temperature for up to 1 hour before injecting your dose.

You may also store Gammagard Liquid at room temperature.

You will need to use Gammagard Liquid within a certain number months. This will depend on the how you store the medicine (at room temperature, or in a refrigerator). Carefully follow the storage instructions provided with your medicine. Do not use the medicine after the expiration date on the label has passed.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use disposable injection items (needle, catheter, tubing) only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use this medicine if:

• you have had an allergic reaction to an Gammagard Liquid or blood product; or

• you have Gammagard Liquid A (IgA) deficiency with antibody to IgA.

Gammagard Liquid can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood";

• a stroke or blood clot;

• kidney disease;

• diabetes;

• an infection called sepsis;

• if you use estrogens (birth control pills or hormone replacement therapy);

• if you have been on long-term bedrest; or

• if you have a central intravenous (IV) catheter in place.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

Tell your doctor if you are pregnant or breastfeeding.

Gammagard Liquid is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Gammagard Liquid. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, itchy, chilled, sweaty, or have chest discomfort, fast heartbeats, severe headache, or pounding in your neck or ears.

Gammagard Liquid may cause serious side effects. Call your doctor at once if you have:

• a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;

• lung problems--chest pain, wheezing, trouble breathing, blue colored lips, fingers, or toes;

• signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or

• signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects of Gammagard Liquid may include:

• runny or stuffy nose, sinus pain, cough, sore throat;

• fever, chills, weakness;

• headache, back pain, muscle or joint pain;

• dizziness, tiredness, depressed mood;

• swelling in your hands or feet;

• skin rash, redness, or bruising;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• nausea, diarrhea, stomach pain, upset stomach;

• increased blood pressure; or

• redness, swelling, or itching where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gammagard Liquid can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect Gammagard Liquid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.