When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to human immune globulin, or if you have fructose or sucrose intolerance, or an immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of hypersensitivity.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin, into a muscle, or into a vein.
• A nurse or other trained health professional will give you this medicine.
• If you will give this medicine to yourself at home, your health caregiver will show you how to use the medicine and where to give yourself the injections. Make sure you understand all instructions.
• Use a new needle and syringe each time you inject your medicine.
• Allow this medicine to reach room temperature before using it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor, pharmacist, or home health caregiver for instructions.
• Storage instructions: If you store this medicine at home, ask your pharmacist or health caregiver how to store it. Some brands should be stored at room temperature, away from heat and direct light. Other brands must be stored in the refrigerator.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how immune globulin works. Tell your doctor about any medicine you use that affects your kidneys, or if you are also using heparin.
• Talk to your doctor before you get any vaccine while you are receiving immune globulin. Some vaccines may not work as well while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney problems, anemia or blood clotting problems, diabetes, heart disease, atherosclerosis, a history of heart attack or stroke, idiopathic thrombocytopenic purpura (ITP), or protein problems such as paraproteinemia or hyperproteinemia. Tell your doctor if you have an allergy to corn or latex, you had a recent infection, or you have other problems with your immune system.
• This medicine may cause the following problems:
  
  • Serious kidney problems
  • Blood clots in your heart, lungs, or brain
  • Hemolysis (bleeding) or hemolytic anemia
  • Aseptic meningitis syndrome (AMS)
  • Serious lung problems
  • Low sodium or high protein levels in your blood
• This medicine is made from donated human blood. Some human blood products have transmitted viruses, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blue lips or fingernails, trouble breathing
• Change in how much or how often you urinate
• Chills, cough, sore throat, nausea, or vomiting during the infusion
• Confusion, weakness, muscle twitching
• Dark, red, or brown urine
• Fast, slow, pounding, or uneven heartbeat
• Fever higher than 100 degrees Fahrenheit (37.7 degrees Celsius)
• Lightheadedness, dizziness
• Pain in your lower leg (calf), numbness or weakness in your arm or leg or on one side of your body
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe back, stomach, chest, or side pain
• Stiff neck, headache, nausea, vomiting, fever, eye pain, eye sensitivity to light
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach pain or upset
• Low fever
• Mild headache or back, joint, or muscle pain
• Pain, itching, burning, redness, swelling, warmth, or a lump under your skin where the shot is given
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088