Privigen IGIV

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 intravenous 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.

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.

IGIV 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.

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.

IGIV is injected into a vein through an IV. You may be shown how to use an IV 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, IV tubing, and other items used to inject the medicine.

IGIV should not be injected into a muscle or under the skin.

IGIV is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not use IGIV if it has changed colors or has particles in it. Call your pharmacist for new medication. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles 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 IGIV, you may need frequent blood tests. Your kidney function may also need to be checked.

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

Some brands of IGIV should be stored in a refrigerator, while others can be kept at room temperature. Follow the storage instructions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

Privigen 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 Privigen 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.

Privigen 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 Privigen to help improve your blood flow and keep your kidneys working properly.

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

Stop using Privigen 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 Privigen side effects may include:

• mild headache;

• dizziness;

• tired feeling;

• back pain, muscle cramps;

• minor chest pain; or

• flushing (warmth, redness, or tingly feeling).

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.

Privigen 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 Privigen, 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.