Pronunciation:

ver-a-SEL-la VYE-rus vak-seen

Brand Names:

• Varivax
• Zostavax
• Varilrix

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Varicella virus vaccine live is an immunizing agent used to prevent infection by the varicella-zoster virus (VZV). The vaccine works by causing your body to produce its own protection (antibodies) against the virus.

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.

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

You can be considered to be immune to chickenpox only if you have received the right number of varicella vaccine doses (1 dose if you are between 12 months 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 a previous chickenpox infection or if you have had a blood test showing that you are immune to varicella.

Varicella virus vaccine is also used for the prevention of herpes zoster (commonly known as shingles) in people 60 years of age and older.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, 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—

Varivax® (for preventing chicken pox)—Varicella virus vaccine live is not recommended for use in infants up to 12 months of age. Varicella virus vaccine live has been tested in children 1 year of age and older and, in effective doses, has not been shown to cause different side effects or problems than it may cause in adults.

Zostavax® (for preventing shingles)—This vaccine should not be used in children.

Older adults—

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

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	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.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin
• Acyclovir
• Adalimumab
• Aldesleukin
• Alemtuzumab
• Altretamine
• Amonafide
• Amsacrine
• Asparaginase
• Aspirin
• Azacitidine
• Azathioprine
• Benorilate
• Bleomycin
• Broxuridine
• Busulfan
• Capecitabine
• Carboplatin
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Choline Salicylate
• Cisplatin
• Cladribine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dactinomycin
• Daunorubicin
• Daunorubicin Citrate Liposome
• Decitabine
• Docetaxel
• Doxifluridine
• Doxorubicin Hydrochloride
• Doxorubicin Hydrochloride Liposome
• Edatrexate
• Eflornithine
• Epirubicin
• Estramustine
• Etanercept
• Etoposide
• Floxuridine
• Fludarabine
• Fluorouracil
• Fotemustine
• Gallium Nitrate
• Gemcitabine
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Interferon Alfa
• Interferon Alfacon-1
• Interferon Beta
• Interferon Beta-1a
• Interferon Beta-1b
• Interferon Gamma
• Irinotecan
• Lomustine
• Magnesium Salicylate
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Mesalamine
• Methotrexate
• Mitolactol
• Mitomycin
• Mitotane
• Mitoxantrone
• Mycophenolic Acid
• Olsalazine
• Oxaliplatin
• Paclitaxel
• Pegaspargase
• Pentostatin
• Pipobroman
• Pirarubicin
• Plicamycin
• Procarbazine
• Raltitrexed
• Rilonacept
• Rituximab
• Salicylamide
• Salicylic Acid
• Salsalate
• Sirolimus
• Sodium Salicylate
• Sodium Thiosalicylate
• Streptozocin
• Tacrolimus
• Teceleukin
• Tegafur
• Temsirolimus
• Teniposide
• Thioguanine
• Thiotepa
• Topotecan
• Treosulfan
• Trimetrexate
• Trofosfamide
• Trolamine Salicylate
• Uracil Mustard
• Vinblastine
• Vincristine
• Vincristine Liposome
• Vindesine
• Vinorelbine

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

• AIDs or
• HIV infection—This vaccine should NOT be used.

• 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—Varicella virus vaccine should not be used if you have any of these conditions.

• Febrile illness—The symptoms of the condition may be confused with the possible side effects of the vaccine.

• Immune deficiency condition (or family history of)—This condition may increase the chance and severity of side effects with the vaccine and may decrease the useful effects of the vaccine.

• Shingles, history of—This vaccine has not been studied in these patients.

• Tuberculosis, active and untreated—This vaccine should NOT be used.

Proper Use of This Medicine:

Tell your doctor before receiving this vaccine if you are severely ill or if you have a fever greater than 101.3 °F.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

Precautions While Using This Medicine:

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

Zostavax® should not be used in place of Varivax®.

Zostavax® should not be used in children.

Tell your doctor that you have received this vaccine:

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

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

Avoid contact with persons who may be at increased risk for getting chickenpox for 6 weeks after receiving this vaccine. If you have questions about this, talk to 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 may need medical attention.

Check with your doctor as soon as possible if 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 urine or stools

confusion

difficulty in breathing or swallowing

hives

irritability

itching, especially of feet or hands

muscle or joint pain

pinpoint red spots on skin

reddening of skin, especially around ears

severe or continuing headache

stiff neck

swelling of eyes, face, or inside of nose

swelling of glands in neck

unusual bleeding or bruising

unusual tiredness or weakness, sudden and severe

vomiting

Incidence not known

Back pain, sudden and severe

bleeding gums

blistering, peeling, loosening of skin

blurred vision

chills

convulsions (seizures)

headache, sudden and severe

inability to speak

inability to move arms and legs

itching

joint or muscle pain

large, flat, blue or purplish patches in the skin

loss of bladder control

muscle spasm or jerking of all extremities

muscle weakness, sudden and progressing

painful blisters 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

shakiness and unsteady walk

slurred speech

sores, ulcers, or white spots in mouth or on lips

stomach pain

sudden loss of consciousness

sudden numbness and weakness in the arms and legs

temporary blindness

unsteadiness, trembling, or other problems with muscle control or coordination

weakness in the arm and/or leg on one side of the body, sudden and severe

weakness of the muscles in your face

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:

More common

Fever of 37.7 °C (100 °F) or higher, but not above 39 °C (102 °F)

pain, redness or soreness at injection site

Less common

Abdominal pain

common cold

congestion

cough

diarrhea

nausea

sore throat

Incidence not known

Bacterial skin infections

body aches or 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

thick yellow to honey-colored crusts

tightness in chest

voice changes

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.