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

Privigen is used as a replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Privigen is also used to treat patients aged 15 years and older with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.

This medicine 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 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.

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

Privigen should not be injected into a muscle or under the skin.

Privigen is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take Privigen in larger or smaller amounts or for longer than recommended.

Do not use Privigen if it has changed colors or has particles in it. Call your pharmacist for new medication. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles 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 Privigen, you may need frequent blood tests. Your kidney function may also need to be checked.

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

Privigen can be stored at room temperature (up to 25°C [77°F] for up to 36 months, as indicated by the expiration date printed on the outer carton and vial label. Keep Privigen in its original carton to protect it from light. Follow the storage instructions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

You may not be able to use this medicine if:

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

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

• you are allergic to corn.

Privigen can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. To make sure Privigen is safe for you, tell your doctor if you have:

• 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.

Immune globulin 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 an appointment for your Privigen injection.

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

Ask your doctor before receiving a "live" vaccine while using Privigen. 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 Privigen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.

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, 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 Privigen side effects may include:

• headache, back pain, joint pain;

• fever, chills, sweating, warmth or tingling;

• stomach pain, nausea, diarrhea;

• increased blood pressure, fast heartbeats;

• dizziness, tiredness, lack of energy;

• stuffy nose, sinus pain; or

• pain, swelling, burning, or irritation around the IV needle.

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.

Privigen 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.