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Generic Name: immune globulin (human) (i-MUNE-GLOB-ue-lin)
Brand Name: Examples include Flebogamma and Panglobulin NF

Flebogamma may increase the risk of serious and sometimes fatal kidney problems. Kidney problems are more common in patients using products that contain sucrose. The risk may be greater if you already have kidney problems or are older than 65 years old. You may also be at increased risk if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood (paraproteinemia), or if you are taking other medicines that may harm the kidney. Contact your doctor immediately if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Flebogamma may increase the risk of blood clots. The risk may be increased in older patients, if you will be confined to a bed or chair for a period of time, if you take estrogen products, or if you have certain catheters. The risk may also be increased if you have a condition that may increase your risk of blood clots, thick blood, heart problems, or a history of blood clots. Blood clots can occur if you do not have any of these conditions. Tell your doctor right away if you develop one-sided numbness or weakness; pain, redness, tenderness, warmth or swelling in the arms or legs; change in color of an arm or leg; chest pain or discomfort; shortness of breath; fast heartbeat; or coughing up blood. Discuss any questions or concerns with your doctor.

Flebogamma is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. Some brands of Flebogamma are also used to treat patients with idiopathic thrombocytopenic purpura (ITP). Some brands of Flebogamma are also used to prevent infection in certain patients who have leukemia. Some brands of Flebogamma are also used to treat Kawasaki syndrome. It may also be used for other conditions as determined by your doctor.

Flebogamma is an immune globulin. It works to prevent infection by providing antibodies that fight infection.

Do NOT use Flebogamma if:

  • you are allergic to any ingredient in Flebogamma or other immune globulin products
  • you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood
  • you have IgA deficiency and antibodies to IgA. Some brands of Flebogamma do not contain much IgA and may sometimes be used as directed by your doctor. Talk with your doctor.

Contact your doctor or health care provider right away if any of these apply to you.

Before using Flebogamma:

Some medical conditions may interact with Flebogamma. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have high levels of proline in your blood (hyperprolinemia)
  • if you have recently received any vaccinations or will be receiving a live vaccine (eg, measles, mumps)
  • if you have heart problems, blood vessel problems (eg, narrowed arteries), bleeding or blood clotting problems, thick blood, or a history of stroke, heart attack, or blood clots
  • if you will be confined to a bed or chair for a long period of time
  • if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, abnormal proteins or high protein levels in the blood, or asthma

Some MEDICINES MAY INTERACT with Flebogamma. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney.
  • Hydantoins (eg, phenytoin) because the risk of side effects may be increased
  • Vaccinations (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Flebogamma

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flebogamma may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Flebogamma:

Use Flebogamma as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Flebogamma is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • If you miss a dose of Flebogamma, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use Flebogamma.

Important safety information:

  • Some patients who have immune globulin therapy for the first time or who have not had it within the past 8 weeks may have a risk for certain side effects. These may include fever, chills, nausea, or vomiting. This may also happen in people who switch brands of immune globulin. Tell your doctor right away if you have any of these side effects.
  • Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Flebogamma. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, unusual drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
  • A certain brand of Flebogamma ( Gammaplex) should not be used if you are not able to tolerate fructose. This brand should also not be used in infants and babies when sucrose or fructose tolerance has not been tested. Discuss any questions or concerns with your doctor.
  • A certain brand of Flebogamma ( Privigen) should not be used if you have high proline blood levels (hyperprolinemia). Discuss any questions or concerns with your doctor.
  • You may need to wait for a period of time after you use Flebogamma before you receive a live vaccine (eg, measles, mumps). Talk with your doctor before you receive any vaccine.
  • If you are on a low-salt diet, talk with your doctor. Some brands of Flebogamma contain salt.
  • Diabetes patients - Some brands of Flebogamma may cause incorrect test results with some blood and urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
  • Some of these products contain latex in the packaging. If you are allergic to latex, ask your doctor or pharmacist if your product contains latex.
  • Flebogamma is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) from products made from human plasma. No cases of these problems have been found in patients who have used Flebogamma. Discuss any questions or concerns with your doctor.
  • Flebogamma may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Flebogamma.
  • Lab tests may be performed while you use Flebogamma. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Flebogamma with caution in the ELDERLY because they may be more sensitive to its effects, especially kidney failure problems and blood clots.
  • Use Flebogamma with extreme caution in CHILDREN. Safety and effectiveness of certain products have not been established for certain age groups. Check with your doctor or pharmacist if you have questions about the use of Flebogamma in a child.
  • PREGNANCY and BREAST-FEEDING: It is unknown if Flebogamma can cause harm to the fetus. If you become pregnant while taking Flebogamma, discuss with your doctor the benefits and risks of using Flebogamma during pregnancy. It is unknown if Flebogamma is excreted in breast milk. If you are or will be breast-feeding while you are using Flebogamma, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Flebogamma:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; diarrhea; dizziness; flushing; headache; mild stomach pain; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sluggishness; sore throat; stuffy nose; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue; unusual hoarseness); blue lips, hands, or feet; calf or leg pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; dark urine; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever or chills; increased or painful urination; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; sweating; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); unusual tiredness or weakness; vision problems; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Flebogamma:

Flebogamma is usually handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Flebogamma, please talk with your doctor, pharmacist, or other health care provider.
  • Flebogamma is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Flebogamma or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Flebogamma. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Flebogamma. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Flebogamma.

Issue Date: June 3, 2015