Generic Name: immune globulin (human) (i-MUNE GLOB-ue-lin)
Brand Name: Examples include Gammagard and Gamunex-C
Gammagard 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 a condition called paraproteinemia. You may also be at an increased risk if you are older than 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.
Serious kidney problems occur more commonly in patients who receive immune globulin intravenous (IV) products that contain sucrose. Gammagard does not contain sucrose.
Discuss any questions or concerns with your doctor.
Gammagard 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.
Gammagard is used for:
Providing antibodies to help prevent infection in certain patients who have a weakened immune system. Some brands of Gammagard are also used to treat patients with idiopathic thrombocytopenic purpura (ITP) or chronic inflammatory demyelinating polyneuropathy (CIDP). Some brands may be used to improve muscle strength in patients with a condition called multifocal motor neuropathy (MMN). It may also be used for other conditions as determined by your doctor.
Gammagard is an immune globulin. It works by providing antibodies that fight infection.
Do NOT use Gammagard if:
- you are allergic to any ingredient in Gammagard or to another 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 Gammagard:
Some medical conditions may interact with Gammagard. 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 antibodies to IgA
- if you have recently received any vaccines, will be receiving a live vaccine (eg, measles, mumps, rubella), have been exposed to measles, or are at risk of measles exposure (eg, traveling to an area where measles is common)
- if you have heart problems, blood vessel problems (eg, narrowed arteries), blood clotting problems, thick blood, or a history of a stroke, a heart attack, or blood clots; or if you are at risk of any of these problems
- if you have diabetes, dehydration, high or low blood volume, a blood infection, a weakened immune system, abnormal proteins or high protein levels in the blood, high blood triglyceride levels, asthma, or kidney problems, or are at risk of kidney problems
- if you have a history of migraine headaches
- if you are very overweight or will be confined to a bed or a chair for a long period of time
- if you have recently used another immune globulin product
Some MEDICINES MAY INTERACT with Gammagard. 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 allergic reactions may occur
- Live vaccines (eg, measles, mumps, rubella) because their effectiveness may be decreased by Gammagard
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gammagard 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 Gammagard:
Use Gammagard as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet may be available with Gammagard. Talk to your pharmacist if you have questions about this information.
- Gammagard is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Gammagard at home, a health care provider will teach you how to use it. Be sure you understand how to use Gammagard. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- If you will be using Gammagard as an injection or infusion under the skin, be sure NOT to inject it into a muscle or vein. Be sure you know how and where to inject Gammagard. Do not use a site that is very bony.
- Be sure to rotate infusion sites as directed by your health care provider.
- Do not use Gammagard if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not use Gammagard if it has ever been frozen.
- Do not shake Gammagard.
- Do not mix Gammagard with any other medicine.
- Do NOT use Gammagard as an injection under the skin for ITP or CIDP. If you have ITP or CIDP, it should only be given as an injection in your vein at your doctor's office, hospital, or clinic. Discuss any questions or concerns with your doctor.
- Throw away any medicine that is left in the vial after you use a dose of Gammagard.
- 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 Gammagard, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Gammagard.
Important safety information:
- Gammagard may cause dizziness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Gammagard 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 immunoglobulin medicines. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
- Gammagard may cause live vaccines (eg, measles, mumps) to be less effective. Talk with your doctor before you receive any vaccine while you are using Gammagard.
- Gammagard is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Gammagard. Discuss any questions or concerns with your doctor.
- Gammagard may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Gammagard.
- Lab tests, including antibody levels, blood thickness, and kidney function, may be performed while you use Gammagard. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Gammagard with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems and blood clots.
- Caution is advised when using Gammagard in CHILDREN; they may be more sensitive to its effects, especially fever or vomiting.
- Gammagard should be used with extreme caution in CHILDREN with CIDP or MMN. It should also be used with extreme caution if given as an injection under the skin in CHILDREN. Safety and effectiveness have not been established.
- PREGNANCY and BREAST-FEEDING: It is not known if Gammagard can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gammagard while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Gammagard, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Gammagard:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Chills; cough; diarrhea; dizziness; flushing; headache; joint or back pain; mild sore throat; mild stomach pain; muscle pain, weakness, or cramps; mild pain, swelling, bruising, warmth, or redness at the injection site; nausea; runny or stuffy nose; tiredness or weakness; vomiting.
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); blue lips, fingers, or toes; blurred vision or other vision problems; calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain; confusion; coughing up blood; dark or red urine; ear pain; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever; mental or mood changes; mouth sores; numbness of the face, arm, or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; severe or persistent pain, swelling, or redness at the injection site; shortness of breath or trouble breathing; sluggishness; speech problems; sudden nausea or vomiting; sudden unusual sweating; swelling of the hands, ankles, or feet; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, shortness of breath, swelling or bloating, sudden weight gain); symptoms of liver problems (eg, pale stools, nausea, stomach pain, loss of appetite); unusual bruising or bleeding; unusual tiredness or weakness; wheezing; 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 Gammagard:
Store Gammagard in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Gammagard may be stored at room temperature under 77 degrees F (25 degrees C) for a period of time. Check with your pharmacist about how long your brand of Gammagard may be stored at room temperature. Follow the storage instructions for Gammagard very closely. Do not use it if the expiration date on the container has passed. Store away from heat and light. Do not store in the bathroom. Keep Gammagard out of the reach of children and away from pets.
- If you have any questions about Gammagard, please talk with your doctor, pharmacist, or other health care provider.
- Gammagard 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 Gammagard 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 Gammagard. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gammagard. 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 Gammagard.
Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.