Immunoglobulins, Normal Human, For Extravascular Adm.

Immunoglobulins is a prescription medicine used to treat primary immune deficiency (PI). It contains antibodies from human plasma, called immunoglobulin G (IgG), that healthy people have to fight germs (bacteria and viruses).

This medication works by temporarily providing the antibodies necessary to fight infection.

This medication comes as a liquid to be injected just under the skin (subcutaneously) using an infusion pump. It is usually given once every week or once every 2 weeks.

Common side effects include redness, swelling and itching at the injection site as well as headaches, nausea, and fatigue.

Immunoglobulins is a prescription medication approved as antibody replacement therapy for primary humoral immunodeficiency (PI) in adults and children 2 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Immunoglobulins, Normal Human, For Extravascular Adm. may be found in some form under the following brand names:

• Gammagard

• Gamunex-C

• Privigen

Serious side effects have been reported. See "Precautions" section.

Side effects are generally mild and tolerable and may include:

• Redness, swelling and itching at injection site
• Headache
• Blood pressure changes 
• Nausea
• Vomiting
• Dizziness
• Fever
• Fatigue
• Chills 
• Pain in the back, joints, arms and legs

Tell your healthcare provider if any side effect is bothersome or does not go away. These are not all the possible side effects of this medication. 

You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements.

Especially tell your healthcare provider if you have recently received a live vaccine as this medication may interefere with your body's response to live vaccines.

Also, medications that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot. Be sure to tell your healthcare provider if you are taking one of these medications.

Medications can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication there are no specific foods you must exclude from your diet.

Before receiving this medication, tell your healthcare provider if you:

• have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart)
• have a blood clotting disorder
• are inactive for long periods of time (such as long bed rest)
• if you use estrogens
• if you have thickening of your blood
• have a kidney problem
• have Type II diabetes mellitus
• are older than 65
• are dehydrated
• have a blood infection (sepsis)
• have high protein content in your blood
• are receiving other medicines that are harmful to your kidneys
• have an allergy to immune globulin

Tell your healthcare provider about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Animal reproduction studies have not been conducted. It is also not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. This medication should be given to a pregnant woman only if clearly indicated.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

It is not known whether this medication is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Infuse this medication only after you have been trained by your doctor or healthcare professional. Ask your doctor or healthcare professional about any instructions you do not understand.

• This medication should be injected into an area on your abdomen, thigh, upper arm, or side of upper leg/hip.
• Use a different site from the last time you infused the medication. New sites should be at least 1 inch from a previous site.
• Never infuse into areas where the skin is tender, bruised, red, or hard. Avoid infusing into scars or stretch marks.
• If you are using more than one injection site, be sure the injection sites are at least 2 inches apart.
• During an infusion, do not use more than 4 injection sites at the same time.
• You will need to have infusions once a week or every two weeks. It usually takes about 1 to 2 hours to complete one infusion; however, the infusion may take longer depending on what your doctor has prescribed for you.

If you have injected too much medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store at room temperature.

Keep this and all medications out of the reach of children.

WARNING: THROMBOSIS

• Thrombosis may occur with immune globulin products1-3, including this medication. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
• For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.