Immune Globulin (Human), Intravenous

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KEY POINTS

• This medicine is given by IV to help boost the immune system in people with certain immune system problems.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious or life-threatening kidney problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immune serum globulin

Generic and brand names: immune globulin intravenous (human); Bivigam; Gammaplex; Gammaked (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) or injection (shot) to treat primary immunodeficiency (PI). This medicine helps boost the immune system in people with certain immune system problems.

This medicine may be used to treat other conditions as determined by your healthcare provider. Your healthcare provider will explain why you are receiving this medicine.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or immune globulin
• Bleeding disorders, blood clots, or blood vessel disease
• Diabetes
• Heart attack, stroke, atherosclerosis, or other heart disease
• Immunoglobulin A deficiency
• Intolerance to corn or fructose
• High triglycerides in the blood
• Kidney disease
• Low sodium level in the blood
• Migraines
• Problems with dehydration

If you have had treatment with an immune globulin, tell your healthcare provider if it has been 8 weeks or longer since your last dose.

Tell your healthcare provider if you have recently had an infection, a long period of bed rest or immobilization such as after major surgery or a broken bone in a cast.

Tell your healthcare provider about all the medicines you are taking. While receiving this medicine, some medicines may increase your risk of serious side effects, such blood clots or kidney problems.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

These IV infusions are given by your healthcare provider. They are usually given while you are in the hospital or clinic setting. You will be monitored closely while you are receiving this medicine. Keep all appointments for these infusions.

What should I watch out for?

This medicine may cause serious or life-threatening kidney problems or blood clots. Call your healthcare provider right away if you have:

• Less frequent urination
• Unexplained bloating or swelling
• Shortness of breath
• Chest pain
• Numbness or weakness (especially on one side of your body)
• Pain, swelling, warmth, redness, or a lump in your legs or arms

You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; fever; chills; nausea; vomiting; chest tightness; trouble breathing; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Problems urinating or urinating less often; unusual bruising or bleeding; unexplained stiff neck; shortness of breath; severe dizziness or fainting; chest pain; confusion; rapid or irregular heartbeat; painful eye movements; sensitivity to light; unusual tiredness or weakness; lower back or side pain; pinpoint red spots on the skin; dark urine; yellowing of the skin or eyes; severe nausea or vomiting; unexplained fever; blue lips, fingers, or feet; pain, swelling, warmth, redness, or a lump in your legs or arms; swelling in hands, ankles, or feet, or any unexplained swelling; sudden weight gain; severe skin rash, skin peeling or blisters.

Other: Tenderness, pain, or redness where the shot was given; headache; joint or muscle pain; leg cramps; flushing; sweating; stomach cramps; nausea; trouble sleeping; stuffy nose; diarrhea; mild dizziness; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Estrogen hormones such as conjugated estrogens (Premarin), esterified estrogens (Estratab, Menest), estradiol (Climara, Estrace, Estraderm, Vivelle), and estropipate (Ogen)
• Vaccines

Check with your healthcare provider before having any live-virus vaccines (such as shots for chickenpox, measles, mumps, and rubella). This medicine may interfere with your response to live vaccines for up to 6 months or longer after receiving this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.