Pronunciation:

var-i-SEL-a-ZOS-ter i-MUNE GLOB-ue-lin

Brand Names:

• Varicella Zoster Immune Globulin
• Varizig

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

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

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

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 or
• 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 Use of This Medicine:

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 upper arm (deltoid) or thigh muscle.

Precautions While Using This Medicine:

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 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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.