This medication may cause serious (rarely fatal) kidney problems. The risk is higher in those who have kidney problems, diabetes, a serious blood infection (sepsis), a certain blood problem (paraproteinemia), or a severe loss of body fluids (dehydration), as well as in those who are older than 65 years or are taking other drugs that may harm the kidneys (e.g., gentamicin). Receiving this medication more slowly or using a less concentrated form of this drug may decrease the risk. Tell your doctor immediately if you notice shortness of breath, sudden weight gain, swelling of the hands/ankles/feet, a change in the amount/color of urine, or foamy/frothy urine.

This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots.

This medication is given by slow infusion into a vein by a health care professional. Do not inject this medication into a muscle or into the skin.

Follow all instructions for preparation and use. Do not mix with other medications or IV fluids. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Do not shake the medication. If this medication has been refrigerated, warm it to room temperature before giving. If you have questions about the use of this medication, consult your pharmacist.

Your health care professional will start the medication slowly while monitoring you closely. If you have few or no side effects, the medication will be given faster. Tell your health care professional immediately if you experience any side effects such as flushing, chills, muscle cramps, back/joint pain, fever, nausea, vomiting, or shortness of breath. The infusion may need to be stopped or given more slowly.

The dosage and frequency depends on your medical condition, weight, and response to treatment. For immune system problems, this medication is usually given once every 3 to 4 weeks. It may help to mark your calendar with a reminder. For blood problems (ITP), this medication may be given daily for 1 to 5 days the first time, with maintenance doses usually given one at a time based on your platelet count.

Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.

Flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting may occur. Tell your doctor or other health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising, fainting, fast/irregular heartbeat, unusual tiredness.

This medication may rarely cause serious problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if any of these side effects occur: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden/severe headaches, slurred speech, weakness on one side of the body, vision problems/changes.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Seek immediate medical attention if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.

Lung problems may rarely occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problems (e.g., blood clots, coronary artery disease, heart attack, heart failure, stroke), certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration), long periods of bed rest or inability to move around.

Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.

Tell your doctor of any recent/planned vaccinations. This medication may prevent a good response to live viral vaccines (e.g., measles, mumps, German measles). If you are vaccinated less than 14 days before receiving this medication or during the 11 months after receiving this medication, you may need to be vaccinated again or tested to see whether the vaccine was effective.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the kidneys.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may harm the kidneys (e.g., aminoglycosides such as gentamicin), "water pills" (diuretics such as furosemide).

This medication may interfere with certain tests (including certain blood sugar tests, blood type), possibly causing false test results. This can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Laboratory and/or medical tests (e.g., complete blood count, kidney/liver function tests, urine volume) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

It is important that each dose be used as scheduled. If you miss a dose, contact your doctor to establish a new dose schedule.

Some brands may be stored in the refrigerator, while other brands may be stored at room temperature. Check the product label or ask your pharmacist for the storage requirements for the brand you are using. Discard any unused product after opening the vial.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2009 Copyright(c) 2009 First DataBank, Inc.