Gammagard is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Gammagard is used to treat primary immunodeficiency diseases (PI) in adults and children two years of age or older.

Gammagard is also used as maintenance therapy to improve muscle strength and disability in adult patients 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 arms and hands more than the legs, usually without affecting the touch sensation.

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 is made from human plasma that is donated by healthy people. It contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

Gammagard can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, using birth control pills or hormone replacement therapy, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or while having a central intravenous (IV) catheter in place.

Stop using Gammagard and call your doctor at once if you have ever had:

• signs of a blood clot in the brain - sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung - chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Immune globulin can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

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

Gammagard is injected into a vein through an IV, or injected under the skin using an infusion pump. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

How you give Gammagard, how often you receive it, and the length of your infusion time will depend on the condition being treated. Follow your doctor's dosing instructions. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

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

Gammagard comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

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

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not mix Gammagard with other medications in the same infusion. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine. Check the expiration date on the medicine container before using.

Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

While using Gammagard, you may need frequent blood tests.

Gammagard can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Gammagard.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store Gammagard the refrigerator or at room temperature. Do not freeze.

• if refrigerated: store at 2° to 8°C [36° to 46°F] for up to 36 months.
• if stored a room temperature: store at up to 25°C [77°F] for up to 24 months.

You should not use Gammagard if:

• you have had an allergic reaction to an immune globulin or blood product; or

• you have immune globulin A (IgA) deficiency with antibody to IgA.

Immune globulin can cause blood clots or kidney problems, especially in older adults or in people with certain conditions.

To make sure Gammagard is safe for you, 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 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. 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 to Gammagard: 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.

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 Gammagard side effects 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 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 interact with immune globulin, 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.