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

Vivaglobin subcutaneous (for injection under the skin) is used to treat primary immunodeficiency (PI). This includes, but is not limited to, the primary immunodeficiency in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

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

You should not use Vivaglobin if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Vivaglobin 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 Vivaglobin 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.

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

Vivaglobin subcutaneous is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. You may be shown how to use injections at home. Do not self-inject Vivaglobin 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.

Vivaglobin is usually given once every week. Follow your doctor's dosing instructions. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Vivaglobin must be given slowly, and the infusion can take about 1 hour to complete. You may need to use up to 4 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.

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 Vivaglobin 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.

Vivaglobin subcutaneous should not be injected into a vein.

Before injecting the medicine, test to make sure the infusion pump needle is not in a vein. To do this, gently pull back on the plunger of the syringe connected to the infusion tube. If blood flows back into the syringe, remove the catheter and tubing and throw them away. Start over with a new catheter and syringe, insert the needle in a new place on your body, and test for blood flow-back again.

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

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 Vivaglobin, 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 Vivaglobin.

Keep Vivaglobin in its original carton to protect it from light. Store in the refrigerator at 2–8°C (36–46°F). Do not freeze. Throw away any immune globulin that has become frozen. Take the medicine out and allow it to reach room temperature before preparing your dose.

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

You should not use Vivaglobin 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; or

• a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Immune globulin can harm your kidneys or cause blood clots. To make sure Vivaglobin 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;

• 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 Vivaglobin 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.

Vivaglobin 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 Vivaglobin.

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

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

Do not receive a "live" vaccine while using Vivaglobin. 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.

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

Stop using Vivaglobin 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, tired feeling, 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 Vivaglobin side effects may include:

• redness, bruising, itching, and swelling where the medicine was injected;

• nausea, vomiting, diarrhea, bloating, stomach pain;

• tired feeling, headache, migraine;

• mild itching or rash;

• back pain; or

• pain anywhere in your body.

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.

Vivaglobin 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.