Vivaglobin subcutaneous

You should not use this medicine 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 subcutaneous 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;

• 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.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Vivaglobin (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.

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.

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.

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.

Applies to immune globulin subcutaneous: subcutaneous solution

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Fever or chills.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Feeling very tired or weak.
• Seizures.
• Bloating.
• Feeling confused.
• Swelling.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• Any unexplained bruising or bleeding.
• Mood changes.
• Muscle or joint pain.
• Change in speech.
• Change in eyesight.
• Blurred eyesight.
• Shakiness.
• Sweating a lot.
• Very bad belly pain.
• Dark urine or yellow skin or eyes.
• Very bad irritation where the shot was given.
• Lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.