immune globulin (intravenous and subcutaneous)

What is the most important information I should know about immune globulin?

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.

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.

What is immune globulin?

Immune globulin intravenous and subcutaneous (for injection into a vein or under the skin) is used to treat primary immunodeficiency.

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

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

Immune globulin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using immune globulin?

• 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. 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.

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.

How should I use immune globulin?

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.

Immune globulin 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.

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.

Immune globulin must be given slowly. You may need to use several catheters to inject this medicine 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 immune globulin.

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

You will need to use immune globulin 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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using immune globulin. 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.

What are the possible side effects of immune globulin?

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.

• 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 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.

What other drugs will affect immune globulin?

Immune globulin 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 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about immune globulin.