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Generic Name: immune globulin (human) (i-MUNE GLOB-ue-lin)
Brand Name: Gamunex

Gamunex may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood. You may also be at increased risk if you are over 65 years old or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Gamunex is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It is used in patients with a certain blood problem (chronic immune thrombocytopenic purpura; ITP) to raise platelet levels. This helps to prevent bleeding or allows patients with ITP to have surgery. Gamunex is also used in patients with a certain nervous system problem (chronic inflammatory demyelinating polyneuropathy; CIDP). It helps to improve muscle problems and to prevent relapse of muscle problems. It may also be used for other conditions as determined by your doctor.

Gamunex is an immune globulin. It works to prevent infection by providing antibodies that fight infection. Exactly how it works to treat ITP and CIDP is not known.

Do NOT use Gamunex if:

  • you are allergic to any ingredient in Gamunex or to immune globulin (human)
  • 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 immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of allergic reaction to IgA

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

Before using Gamunex:

Some medical conditions may interact with Gamunex. 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 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), 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, a weakened immune system, abnormal proteins or high protein levels in the blood, or asthma
  • if you have a history of migraine headaches

Some MEDICINES MAY INTERACT with Gamunex. 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 unexpected hypersensitivity reactions may occur
  • Live vaccines (eg, measles, mumps, rubella) because their effectiveness may be decreased by Gamunex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gamunex 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 Gamunex:

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

  • Gamunex is usually given as an injection at your doctor's office, hospital, or clinic.
  • Do not use Gamunex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not use Gamunex if it has ever been frozen.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Gamunex, contact your doctor right away.

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

Important safety information:

  • Gamunex may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Gamunex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Gamunex. 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.
  • You may need to wait for a period of time after you use Gamunex before you receive a live vaccine (eg, measles, mumps). Talk with your doctor before you receive any vaccine.
  • Gamunex is made from human plasma. There is an extremely low risk of developing a viral infection (eg, parvovirus, hepatitis A) or Creutzfeldt-Jakob disease (CJD) after using Gamunex. Discuss any questions or concerns with your doctor.
  • Gamunex may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Gamunex.
  • Lab tests, including kidney function, blood thickness, and antibody levels, may be performed while you use Gamunex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Gamunex with caution in the ELDERLY because they may be more sensitive to its effects, especially kidney problems and blood clots.
  • Use Gamunex 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 Gamunex in a child.
  • PREGNANCY and BREAST-FEEDING: It is not known if Gamunex can cause harm to the fetus. If you become pregnant while taking Gamunex, contact your doctor. You will need to discuss the benefits and risks of using Gamunex during pregnancy. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you are using Gamunex, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gamunex:

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; chills; cough; diarrhea; ear pain; fatigue; flushing; headache; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; stuffy nose; weakness.

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); calf pain or tenderness; chest pain or tightness; confusion; coughing up blood; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; 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; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, nausea, stomach pain, loss of appetite, unusual tiredness); symptoms of parvovirus infection (eg, fever, drowsiness, chills, runny nose, rash, joint pain); unusual bruising or bleeding; vision problems; wheezing.

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 Gamunex:

Gamunex is usually handled and stored by a health care provider. If you are using Gamunex at home, store Gamunex as directed by your pharmacist or health care provider. Keep Gamunex out of the reach of children and away from pets.

General information:

  • If you have any questions about Gamunex, please talk with your doctor, pharmacist, or other health care provider.
  • Gamunex 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 Gamunex 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 Gamunex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gamunex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Gamunex.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.