Overview: Gammagard is used for certain immune system problems or inflammatory conditions. Common side effects may include a headache, feeling tired, nausea, or a fever. Serious side effects are less common but may include kidney problems, breathing problems, blood disorders, or blood clots. While using Gammagard, contact your health care provider right away if you have swelling in your feet, ankles, or legs; trouble breathing; or a fast or abnormal heartbeat. With proper training, you may be able to use Gammagard at home.
Uses
What is Gammagard used for?
Gammagard (immune globulin, human) is commonly used in certain people for the following.
- To treat primary humoral immunodeficiency, which is a type of primary immunodeficiency
- To help with muscle strength in people with multifocal motor neuropathy
- To improve symptoms in people with chronic inflammatory demyelinating polyneuropathy (CIDP)
- To prevent infections in people with B-cell chronic lymphocytic leukemia
- To increase platelet levels and prevent or control bleeding in people with chronic idiopathic thrombocytopenic purpura
- To prevent coronary artery aneurysms in people with Kawasaki disease
These uses may vary, depending on the specific Gammagard product prescribed.
Gammagard may also be used for other conditions as determined by your health care provider.
How does Gammagard work (mechanism of action)?
Primary immunodeficiency and chronic lymphocytic leukemia are conditions where your body has trouble making its own antibodies or fighting infections. Gammagard provides certain human immunoglobulins, called IgG antibodies. Using it provides passive immunity, which helps to prevent certain infections, or make them less severe, in people with primary humoral immunodeficiency.
Gammagard seems to help with other immune-related conditions by affecting your body’s immune system.
How is Gammagard supplied (dosage forms)?
Brands and other names
- Gammagard
- Gammagard Liquid
- Gammagard Liquid ERC
- Gammagard S/D
- Iveegam
Dosage forms and strengths
Gammagard is available as an intravenous (IV) injection that is given by a health care provider. It is also available as a subcutaneous (under-the-skin) shot in the following form that you or a caregiver may give.
- 10% solution for injection, single-use vials
How should I store Gammagard?
If you or a caregiver will keep Gammagard at home, it should be stored in the original carton (to protect it from light) in the refrigerator, between 36 F and 46 F (2 C and 8 C). When kept in the refrigerator, it can be used for up to three years after the date the medicine was made (manufacturing date). It can be stored at room temperature, up to 77 F (25 C), for up to two years. Once it has been stored at room temperature, it should not be returned to the refrigerator. If it is not used within two years of being stored at room temperature, it should be thrown away. Do not freeze it or shake it. This medicine is a single-use product. Do not save unused medicine for a future dose. You should throw it away.
Side Effects
What are the most common side effects of Gammagard?
The most common side effects of Gammagard are listed below. These side effects may vary, depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.
- Headache, including migraines
- Tiredness
- Dizziness
- Nausea, vomiting, stomach pain, or diarrhea
- Muscle or joint pains
- Fever or chills
- Rash, hives, or itching
- Pain, itching, swelling, or redness near where the medicine is given
There may be other side effects of Gammagard that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Gammagard?
While less common, the most serious side effects of Gammagard are described below, along with what to do if they happen.
Severe Allergic Reactions. Gammagard may cause allergic reactions, which can be serious. Stop using Gammagard and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Gammagard may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). You may be at a higher risk of blood clots if you are over 65 years old, have certain health conditions, or take certain medicines. Drink plenty of fluids while you are using Gammagard. Your health care provider may need to check lab work results to see if you are at a higher risk of having a blood clot. Keep all of your appointments, including those for lab work, while using Gammagard. Stop using Gammagard and get emergency help if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Kidney Damage. Kidney damage can happen when using Gammagard. This damage can be severe, possibly leading to kidney failure or even death. You may be at a higher risk of kidney damage if you have diabetes, are overweight, or if you are dehydrated. Drink plenty of fluids while you are using Gammagard. Your health care provider may need to check lab work results to monitor your kidneys while you are using Gammagard. Keep all of your appointments, including those for lab work, while using Gammagard. Tell your health care provider right away if you have any of the following symptoms of kidney damage.
- Reduced need to pee
- Swelling in your feet, ankles, or legs
- Weakness or unusual tiredness
- A hard time catching your breath or chest pain/pressure
- Unexplained sudden weight gain
- Confusion
- Nausea
- Seizures
Blood Disorders. Gammagard may cause your red blood cells to be destroyed, which is called hemolytic anemia. Your health care provider may run tests and stop Gammagard if you have hemolytic anemia. Tell your health care provider right away if you have any of the following symptoms.
- Fatigue
- Increased heart rate
- Yellowing of skin or eyes
- Dark-colored urine (pee)
Lung Damage. If your body reacts a certain way to the antibodies in Gammagard, this can lead to fluid in your lungs (pulmonary edema) and a kind of lung damage called transfusion-related acute lung injury (TRALI). This usually happens within six hours of using Gammagard. Tell your health care provider right away if you have any of the following.
- Trouble breathing
- Chest pain
- Fever
- Lips turn blue
Risk of Infection. The process to make Gammagard involves the use of human substances. It is possible that these substances may carry germs that can cause infections. While steps are taken to reduce this risk, there is still a small chance you could get an infection. Some infections may not cause symptoms. Keep all medical appointments, so your health care provider can monitor your health. Talk with your health care provider about any concerns you may have.
Central Nervous System Swelling. Gammagard may irritate the tissue that surrounds your brain and spinal cord, leading to aseptic meningitis. Tell your health care provider right away if you have any of the following symptoms of meningitis.
- Severe headache
- Stiff neck
- Sleepiness
- Fever
- Light sensitivity
- Painful eye movements
- Nausea or vomiting
Warnings & Precautions
Who should not use Gammagard?
Allergies to Ingredients. People who are allergic to any of the following should not use Gammagard.
- Gammagard
- Gammagard Liquid
- Gammagard Liquid ERC
- Gammagard S/D
- Human immune globulin
- Iveegam
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Gammagard.
Immunoglobulin A (IgA) Antibodies. If you do not have enough of your own IgA, have antibodies to IgA, and a history of an allergic reaction to human immune globulin, you should not use Gammagard. Gammagard has some IgA in it. These things make you more likely to have a severe allergic reaction to Gammagard.
What should I know about Gammagard before using it?
Do not use Gammagard unless it has been prescribed to you by a health care provider. Use it as prescribed.
Do not share Gammagard with other people, even if they have the same condition as you. It may harm them.
Keep Gammagard out of the reach of children. Since this medicine may be kept in a refrigerator, take special care to keep it away from children who also use the refrigerator if you store it at home.
Some forms of this medicine can be injected under the skin. If this is how you are using it, make sure that you or a caregiver understands how to properly prepare and use Gammagard. If the liquid is cloudy, has particles in it, or has changed color, you should not use it. You should also rotate where you give the shot to avoid using the same site over and over. If you have any questions, talk to your health care provider.
If you give yourself Gammagard at home, you should keep a log of your doses, including the following information.
- Date and time of dose
- Dose used
- Lot number from the vial used for the dose
- Any side effects
It is normal to have mild pain, itching, swelling, or redness near where you use Gammagard. These reactions usually go away on their own. But if the pain, itching, swelling, or redness is not going away or seems to be getting worse, contact your health care provider.
Keep all of your health care appointments while using Gammagard, including those for lab work. Your health care provider will likely check lab work results to see how Gammagard is working for you and to watch for side effects.
Tell all of your health care providers that you are using Gammagard, especially if they are ordering lab tests for you. Using Gammagard may affect certain test results. Knowing that you are using it can help your health care providers understand your lab work results.
People who are 65 or older can have a greater risk of some Gammagard side effects. Talk to your health care provider about your risks if you are in this age group.
What should I tell my health care provider before using Gammagard?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Gammagard is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Unable to get up and move around normally or a long-term lack of movement
- Blood clotting problems or a history of a blood clot
- Take or use estrogen
- Central vascular catheters
- Hyperviscosity
- Heart problems
- Kidney problems
- Diabetes
- High levels of protein in your blood
- Low levels of sodium in your blood (hyponatremia)
- Older than 65 years old
- Dehydration or volume depletion
- Paraproteinemia
- Sepsis
Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Gammagard. Tell your health care provider about any vaccines you have recently received or have scheduled.
Pregnancy. It is not known if or how Gammagard could affect a pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Gammagard while you are pregnant or trying to get pregnant.
Breastfeeding. It is not known if Gammagard passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Gammagard while breastfeeding.
How can I get more information about Gammagard?
For more information about Gammagard, you can visit the drugmaker’s websites at www.gammagard.com, www.takedapatientsupport.com, or www.immunedisease.com. Or you can call them at 877-825-3327.
Interactions
Does Gammagard interact with foods or drinks?
There are no known interactions between Gammagard and foods or drinks.
It is unknown if drinking alcohol will affect Gammagard, but heavy drinking can slow your immune response and make it harder for your body to fight infections if you have primary immunodeficiency or chronic lymphocytic leukemia.
Does Gammagard interact with other medicines (drug interactions)?
Gammagard may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Gammagard?
If you or someone else has used too much Gammagard, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Gammagard?
Missing doses of Gammagard can cause it to not work as well over time. So it is important not to miss or skip doses.
If your health care provider gives you Gammagard at a hospital, clinic, or at home, they will make sure you are receiving it as scheduled. If you miss an appointment to get your Gammagard dose, call to make another appointment as soon as possible.
If you use Gammagard at home and you miss a dose, contact your health care provider for advice on what to do.