Varicella Zoster Immune Globulin

Included as part of the PRECAUTIONS section.

Manifestations of an overdose of VARIZIG administered intramuscularly are expected to be pain and tenderness at the injection site.

You should not be treated with this medicine if:

• you have had an allergic reaction to an immune globulin; or

• you have immune globulin A (IgA) deficiency with antibody to IgA.

Tell your doctor if you have recently received a "live" vaccine. The vaccine may not work as well shortly after you receive varicella zoster immune globulin. Live vaccines include measles, mumps, and rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

To make sure varicella zoster immune globulin is safe for you, tell your doctor if you have:

• heart disease, coronary artery disease (hardened arteries);

• a bleeding or blood clotting disorder;

• blood circulation problems;

• a history of stroke or blood clot; or

• a condition for which you are on bed rest.

It is not known whether varicella zoster immune globulin will harm an unborn baby. However, chickenpox can cause birth defects, low birth weight, or a serious infection in the newborn. Therefore, this medicine may be given during pregnancy if you have a high risk of infection with varicella zoster virus.

It is not known whether varicella zoster immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Varicella zoster 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.

Since this medicine is usually given only once, you are not likely to miss a dose. Contact your doctor if you do not receive all recommended doses.

Usual Adult Dose for Varicella-Zoster:

12.5 units/kg IM in the gluteal muscle or other large muscle mass.
Minimum dose: 125 mg units.
Maximum dose: 625 units.

Usual Pediatric Dose for Varicella-Zoster:

12.5 units/kg IM in the gluteal muscle or other large muscle mass.
Minimum dose: 125 mg units.
Maximum dose: 625 units.

Postexposure Prophylaxis of Varicella

Postexposure prophylaxis of varicella (chickenpox) in individuals without evidence of varicella immunity who are at high risk for severe varicella disease and complications.1 27 46 100 Designated an orphan drug by FDA for passive immunization in exposed, susceptible individuals at risk for varicella complications.2

VZIG postexposure prophylaxis intended to reduce severity of varicella in susceptible, high-risk individuals;1 provides maximum benefit when administered as soon as possible (ideally within 96 hours) after VZV exposure.1 27 46 (See Dosage and Administration.) Manufacturer states there is no convincing evidence that VZIG reduces incidence of varicella after VZV exposure and no convincing evidence that VZIG would modify an established VZV infection.1

US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that evidence of varicella immunity includes any of the following: documentation of age-appropriate varicella vaccination (1 dose of varicella vaccine in preschool children ≥12 months of age or 2 doses in school-aged children, adolescents, and adults), laboratory evidence of immunity or laboratory confirmation of prior varicella infection, birth in US before 1980 (US birth before 1980 not considered evidence of immunity for immunocompromised individuals, pregnant women, or health-care personnel), or history of varicella or herpes zoster (shingles, zoster) diagnosed or verified by a health-care provider.27 Consider individuals without such evidence susceptible to varicella.27

Immunocompromised children, adolescents, and adults without evidence of varicella immunity exposed to VZV within the last 10 days should receive VZIG for postexposure prophylaxis.27 46 100 143 144 This includes those with primary or acquired immunodeficiency disorders (including HIV infection), neoplastic disease, or receiving immunosuppressive therapy.27 100 143 144 (See Individuals with Altered Immunocompetence under Cautions.) VZIG probably not necessary in those receiving immune globulin IV (IGIV) replacement therapy (≥400 mg/kg once monthly) if last IGIV dose was administered ≤3 weeks before exposure since such individuals are likely to be protected from VZV.27 100 143

Neonates whose mothers had signs and symptoms of varicella at time of delivery (i.e., from 5 days before to 2 days after delivery) should receive VZIG for postexposure prophylaxis.27 46 100 Such neonates are at risk of severe, potentially fatal varicella and should receive VZIG regardless of whether the mother received VZIG.27 VZIG not necessary in neonates whose mothers had signs and symptoms of varicella >5 days before delivery since such infants should be protected from severe varicella by transplacentally acquired maternal antibody.27 VZIG not indicated in full-term neonates exposed postnatally to varicella (including those born to mothers who develop varicella >48 hours after delivery).27 100 Some clinicians recommend VZIG in exposed neonates who have severe skin disease and were born to mothers without evidence of immunity.100

Certain premature neonates exposed to VZV during neonatal period should receive VZIG postexposure prophylaxis.27 46 100 Evaluate premature infants with substantial postnatal VZV exposure on an individual basis.27 VZIG recommended for premature neonates born at <28 weeks of gestation or with birthweight ≤1 kg who are exposed during neonatal period, regardless of mother's history of varicella or varicella vaccination.27 46 100 Also recommended for premature neonates born at ≥28 weeks of gestation who are exposed during neonatal period and have a mother without evidence of varicella immunity.27 46 100

Pregnant women without evidence of varicella immunity exposed to VZV within the last 10 days should receive VZIG postexposure prophylaxis.27 46 100

VZIG provides temporary passive immunity and may prevent or reduce severity of VZV infection if administered within 10 days after exposure.1 27 46 100

Vaccination with varicella vaccine is preferred for postexposure prophylaxis in immunocompetent individuals exposed to VZV who have not previously received age-appropriate varicella vaccination and do not have evidence of varicella immunity.27 100

When varicella vaccine is contraindicated or cannot be used and VZIG is unavailable, consider use of IGIV as an alternative since it contains anti-VZV.27 100

Make decision to administer VZIG on an individual basis, depending on whether patient lacks evidence of varicella immunity, exposure is likely to result in infection, and patient is at greater risk for varicella complications than the general population.27 100

ACIP states that exposures likely to result in varicella in susceptible individuals (i.e., those without evidence of varicella immunity) involve direct contact (i.e., face-to-face contact with an infectious person while indoors).27 Duration of face-to-face contact warranting postexposure prophylaxis with VZIG not certain.27 Some experts suggest VZIG if duration of close contact was >5 minutes; others define close contact as >1 hour.27 100 Susceptible individuals with continuous exposure to household members with varicella or disseminated herpes zoster are at greatest risk for infection.27 For hospital contacts, substantial exposure consists of sharing the same hospital room or direct face-to-face contact with an infectious person (e.g., health-care personnel).27

Do not use for postexposure prophylaxis of varicella in immunocompromised children, adolescents, or adults with past history of varicella, unless individual is undergoing bone marrow transplantation.1

VZIG not useful for treatment of clinical varicella or herpes zoster or for prevention of disseminated herpes zoster and not recommended for such use.27 100

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.

Pediatric

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

Geriatric

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

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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.

Applies to varicella zoster immune globulin: intramuscular powder for solution, intramuscular solution

Along with its needed effects, varicella zoster immune globulin 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 while taking varicella zoster immune globulin:

• Chills
• nausea
• rash
• unusual tiredness or weakness

• Hives
• itching
• redness of the skin
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet

Some side effects of varicella zoster immune globulin 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:

• Headache
• pain at the injection site

Data not available

Data not available