Gammagard

Pronunciation: i-MUNE GLOB-ue-lin
Generic Name: Immune Globulin (Human)
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 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.

Serious kidney problems occur more commonly in patients who receive immune globulin intravenous (IGIV) products that contain sucrose. Gammagard does not contain sucrose.

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). 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


• 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), thick blood, or a blood clotting disorder; 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 or low blood volume, a blood infection, a weakened immune system, a condition called paraproteinemia, high protein levels in the blood, high blood triglyceride levels, asthma, 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 hypersensitivity reactions may occur


• Live vaccines (eg, measles, mumps, and 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.

• If you will be using Gammagard at home as an injection under the skin (subcutaneous injection), an extra patient leaflet is 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 under the skin, be sure NOT to inject it into a muscle or vein. Be sure you know how and where to inject Gammagard (eg, into the abdomen, thigh, upper arm).


• 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. This effect 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 syndrome 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 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 and immune globulin levels, blood thickness, urine output, 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. 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 Gammagard 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:

Chills; cough; diarrhea; dizziness; flushing; headache; joint or back pain; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; tiredness or weakness; vomiting.

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); blue lips, arms, hands, legs, or feet; calf pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; dark urine; fainting; fast or irregular heartbeat; fever; mental or mood changes; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe stomach or back pain; shortness of breath or trouble breathing; slurred speech; swelling; symptoms of aseptic meningitis (eg, severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, severe nausea and vomiting); symptoms of kidney problems (eg, decreased urination, lower back or flank pain, shortness of breath, swelling or bloating, sudden weight gain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; 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.

General information:

• 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 is a summary only. It does not contain all information about Gammagard. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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