Varicella Zoster Immune Globulin

Varicella-zoster immune globulin is used to prevent exposure of varicella virus in high-risk individuals, such as adults and children with weakened immune system, pregnant women, premature babies, and babies younger than 1 year of age.

Varicella-zoster immune globulin works by giving your body the antibodies it needs to protect it against varicella-zoster virus (VZV). This is called passive protection. This passive protection lasts long enough to protect your body until your body can produce its own antibodies against VZV.

Varicella (commonly known as chickenpox) is an infection that is easily spread from one person to another. Chickenpox is usually a mild infection but sometimes it can cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease called Reye's syndrome.

This medicine is to be given only by or under the supervision of your doctor or other health care professional. This product is available in the following dosage forms:

• Powder for Solution
• Solution

Before using Varicella-zoster immune globulin, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of varicella-zoster immune globulin in children.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varicella-zoster immune globulin in the elderly. However, elderly patients are more likely to have blood clotting problems which may require caution in patients receiving this medicine.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to human immune globulin—Should not be used in patients with this condition.
• Bleeding problems
• Thrombocytopenia (low number of platelets), severe—Use with caution. May make these conditions worse.
• Immunoglobulin A (IgA) deficiencies—Varicella-zoster immune globulin may cause an allergic reaction to occur.

Proper usage of Varicella-zoster immune globulin requires strict adherence to your doctor’s orders. You will receive this medicine while you are in a hospital or clinic.

A doctor, nurse, or other trained health professional will give you this medicine. It is given as a shot in the upper arm (deltoid) or thigh muscle.

Before using Varicella-zoster immune globulin, there are some precautions you must take. It is very important that your doctor check you closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

Blood clotting problems may occur while you are receiving this medicine. This is more likely to occur if you are an elderly, or if you have a history of atherosclerosis (hardening of the fats in the arteries), heart and blood vessel problems, bleeding problems, or prolonged time of not standing up or sitting down.

Tell your doctor right away if you have chest pain, trouble breathing, numbness or weakness in your arm or leg, or on one side of your body, trouble seeing or speaking, or sudden or a severe headache.

This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

While you are being treated with varicella-zoster immune globulin, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccines (e.g., measles, mumps, rubella, varicella) should not be given within 3 months after receiving this medicine.

As with many medications, there are several potential side effects associated with Varicella-zoster immune globulin. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less Common:

• Chills
• Nausea
• Rash
• Unusual tiredness or weakness

Incidence Not Known:

• Hives
• Itching
• Redness of the skin
• Shortness of breath
• Swelling of the eyelids, face, lips, hands, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common:

• Headache
• Pain at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.