immune globulin (intravenous and subcutaneous)

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Pronunciation: im MYOON GLOB yoo lin

Brand: Gammagard, Gammaked, Gamunex-C

What is the most important information I should know about immune globulin?

This medicine can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.

Stop using immune globulin and call your doctor at once if you have:

  • signs of a blood clot in the brain --sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
  • signs of a blood clot in the heart or lung --chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs.

Immune globulin can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

What is immune globulin?

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

Immune globulin intravenous and subcutaneous (for injection into a vein or under the skin) is used to treat primary immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), or chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is also used to improve muscle strength in adults with multifocal motor neuropathy.

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

What should I discuss with my healthcare provider before taking immune globulin?

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.

Immune globulin can harm your kidneys or 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);
  • kidney disease;
  • diabetes;
  • a serious infection called sepsis;
  • hyperproteinemia (too much protein in the blood);
  • paraproteinemia (abnormal proteins in the blood);
  • 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.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

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.

Immune globulin 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.

How should I use immune globulin?

Immune globulin is injected into a vein through an IV, or injected under the skin using an infusion pump. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

How you give this medication, how often you receive it, and the length of your infusion time will depend on the condition being treated. Follow your doctor's dosing instructions. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not inject immune globulin into a vein if you have been instructed to give the medicine as a subcutaneous injection (under the skin).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Immune globulin must be given slowly. You may need to use several catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions. Keep a diary of the days and times you gave the injection and where you injected it on your body.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not mix immune globulin with other medications in the same infusion. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine. Check the expiration date on the medicine container before using.

Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items 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 immune globulin, you may need frequent blood tests.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using immune globulin.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store this medicine in its original carton in the refrigerator. Do not freeze immune globulin, and throw away the medication if it has become frozen.

You may take the medicine out of the refrigerator and allow it to reach room temperature 1 hour before preparing your dose. Do not heat the medicine before using.

You may also store immune globulin for up to 6 months at room temperature. Keep away from moisture and heat.

Throw away any unused immune globulin after the expiration date on the label has passed.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a blood clot in the brain --sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
  • signs of a blood clot in the heart or lung --chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs;
  • signs of a kidney problem --swelling, rapid weight gain, and little or no urinating;
  • liver problems --fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
  • lung problems --chest pain, trouble breathing, blue lips, pale or blue colored appearance in your fingers or toes; or
  • signs of new infection --high fever, flu symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting.

Common side effects may include:

  • dizziness, tired feeling;
  • sore throat;
  • joint or muscle pain;
  • diarrhea; or
  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about immune globulin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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