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USP DI Vol. II - VARICELLAVIRUS VACCINE LIVE (Systemic)

VARICELLAVIRUS VACCINE LIVE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Varivax

In Canada?

  • Varilrix
  • Varivax III

Category

  • Immunizing agent (active)

Description

Varicella (var-i-SEL-ah)virus vaccine live is an immunizing agent used to prevent infection by thevaricella-zoster virus (VZV). The vaccine works by causing your body to produceits own protection (antibodies) against the virus.

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

Immunization against chickenpox is recommended for anyone 12 months ofage and older who has not had chickenpox. Immunization against chickenpoxis not recommended for infants younger than 12 months of age.

You can be considered to be immune to chickenpox only if you have receivedthe right number of varicella vaccine doses (1 dose if you are between 12months and 12 years of age; or 2 doses if you are 13 years of age or older).You also are considered to be immune if you have a doctor's diagnosis of aprevious chickenpox infection or if you have had a blood test showing thatyou are immune to varicella.

This vaccine is to be administered only by or under the supervision ofyour doctor or other health care professional. It is available in the followingdosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For varicella virus vaccine live, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to varicella virus vaccine live or to any form of the antibioticneomycin. Also tell your health care professional if you are allergic to anyother substances, such as gelatin.

Pregnancy?Tell your doctor if you are pregnant or if you intendto become pregnant within 3 months after receiving this vaccine. Studies oneffects in pregnancy have not been done in either humans or animals. It isnot known whether varicella vaccine can harm the fetus; however, natural varicellainfection can sometimes cause birth defects.

Breast-feeding?It is not known whether varicella vaccine viruspasses into breast milk. Although most medicines pass into breast milk insmall amounts, many of them may be used safely while breast-feeding. Motherswho receive this vaccine and who wish to breast-feed should discuss this withtheir doctor.

Children?Varicella virus vaccine live is not recommended foruse in infants up to 12 months of age. Varicella virus vaccine live has beentested in children 1 year of age and older and, in effective doses, has notbeen shown to cause different side effects or problems than it may cause inadults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof varicella virus vaccine live in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Before you receivevaricella virus vaccine, it is especially important that your health careprofessional know if you have received any of the following:

  • Treatment with x-rays or cancer medicines?Treatment may increasethe action of the vaccine causing an increase in vaccine side effects. Treatmentmay also interfere with the useful effect of the vaccine.

Other medical problems?The presence of other medicalproblems may affect the use of varicella virus vaccine live. Make sure youtell your doctor if you have any other medical problems, especially:

  • Blood abnormalities or
  • Leukemia (cancer of the blood) or
  • Lymphomas of any type (cancer of the immune system) or
  • Other cancerous tumors affecting the bones or immune system?Varicellashould not be used if you have any of these conditions.
  • Febrile illness?The symptoms of the condition may be confusedwith the possible side effects of the vaccine
  • HIV infection?Safety of using this vaccine in children andyoung adults with HIV is not known.
  • Immune deficiency condition (or family history of)?This conditionmay increase the chance and severity of side effects of the vaccine and/ormay decrease the useful effects of the vaccine
  • Tuberculosis?Natural varicella infection (chickenpox) may makethis condition worse; however, there have been no reports of the vaccine causingtuberculosis to become worse

Proper Use of This Medicine

Dosing?The dose of varicella virus vaccine live will be different fordifferent patients. The following information includes only the average dosesof varicella virus vaccine live.

  • For injection dosage form:
    • For prevention of varicella (chickenpox):
      • Adults and children 13 years of age and older?One dose injectedunder the skin, followed by a second dose four to eight weeks later.
      • Children 12 months to 12 years of age?One dose injected underthe skin. If your doctor decides to give a second dose of this vaccine, itshould be given at least 3 months later.
      • Children younger than 12 months of age?Use is not recommended.

Precautions After Receiving This Vaccine

Do not become pregnant for 3 months after receivingvaricella virus vaccine live without first checking with your doctor.

Tell your doctor that you have received this vaccine:

  • If you are to receive blood transfusions or other blood productswithin 5 months of receiving this vaccine.
  • If you are to receive varicella-zoster immune globulin (VZIG) orother immune globulins within 2 months after receiving this vaccine.
  • If you are to receive any other live virus vaccines within 1 monthof receiving this vaccine.

Do not take aspirin or aspirin products for 6 weeks after receiving thisvaccine.

Avoid contact with persons who may be at increased risk for getting chickenpoxfor 6 weeks after getting vaccinated. If you have questions about this, talkto your doctor.


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 mayneed medical attention.

    Check with your doctor as soon as possibleif any of the following side effects occur:

      More common

        Fever over 39 ?C (102 ?F)

    Less common

      Varicella-like skin rash

    Rare

      Black, tarry stools; blood in urineor stools; confusion; difficultyin breathing or swallowing; hives; irritability; itching, especially of feet or hands; muscle or joint pain; pinpoint red spots on skin; reddening of skin, especiallyaround ears; severe or continuing headache; stiff neck; swelling of eyes, face,or inside of nose; swelling of glands in neck; unusual bleeding or bruising; unusualtiredness or weakness, sudden and severe; vomiting

    Incidence not known

      Back pain, sudden and severe; bleedinggums; blistering, peeling, loosening of skin; blurred vision; chills; convulsions; headache, sudden and severe; inability to speak; inabilityto move arms and legs; itching; joint or muscle pain; large, flat, blue or purplishpatches in the skin; loss of bladder control; muscle spasm or jerking of all extremities; muscle weakness, sudden and progressing; painfulblisters on trunk of body; painful knees and ankles; raised red swellings on the skin, the buttocks,legs, or ankles; red irritated eyes; red skin lesions, often with a purple center; seizures; shakiness and unsteady walk; slurred speech; sores, ulcers, or whitespots in mouth or on lips; stomach pain; sudden loss of consciousness; suddennumbness and weakness in the arms and legs; temporaryblindness; unsteadiness, trembling, or other problemswith muscle control or coordination; weakness inarm and/or leg on one side of the body, sudden and severe; weakness of the muscles in your face

Other side effects may occur that usually donot need medical attention. However, check with your doctor if any of thefollowing side effects continue or are bothersome:

    More common

      Fever of 37.7 ?C (100 ?F) or higher but not above 39?C (102 ?F); pain, redness or soreness atinjection site

    Less common

      Abdominal pain; common cold; congestion; cough; diarrhea; nausea; sore throat

    Incidence not known

      Bacterial skin infections; body achesor pain; burning, crawling, itching, numbness, prickling,?pins and needles? or tingling feelings; chest pain; chills; dizziness; dryness or soreness of throat; hoarseness; pain, redness, swelling, tenderness,warmth on skin; red rash with watery, yellow-colored,or pus filled blisters; runny nose; shortness of breath; sneezing; tender, swollen glands in neck; thickyellow to honey-colored crusts; tightness in chest; voice changes; wheezing

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.


Developed: 12/01/1998
Revised: 11/18/2005