Immune globulin (intramuscular) IGIM

Immune globulin intramuscular (IGIM) is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

IGIM is used to prevent or reduce the severity of infection by hepatitis A, measles, chickenpox (varicella), and rubella. IGIM is also used to prevent or reduce the severity of other infections in individuals with immunoglobulin deficiencies.

IGIM may also be used for purposes not listed in this medication guide.

You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

IGIM can cause blood clots. To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;

• a history of stroke or blood clot;

• if you use estrogens (birth control pills or hormone replacement therapy);

• diabetes;

• if you are dehydrated;

• if you are 65 years or older;

• if you have been bed-ridden due to severe illness; or

• if you are using a catheter.

FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

IGIM is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

IGIM is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Your care provider will show you the best places on your body to inject the medication.

Do not inject IGIM into a vein or under the skin. Doing so can cause serious side effects on your kidneys or lungs.

Do not use IGIM if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

While using IGIM, you may need frequent blood tests.

Store in the refrigerator, do not freeze. Throw away any IGIM not used before the expiration date on the medicine label.

Call your doctor for instructions if you miss a dose of IGIM.

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to immune globulin intramuscular: intramuscular solution

Local

Local injection site pain and tenderness have occurred.[Ref]

Hypersensitivity

Hypersensitivity reactions have been rare, however, anaphylaxis has been reported. The mechanism has not been clearly established. Activation of the complement system by immune globulin aggregates present in the preparations has been suggested.[Ref]

Immunologic

All U.S. immune globulin products undergo viral inactivation and/or removal. No method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents.[Ref]

Some side effects of immune globulin intramuscular may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.