Varicella virus vaccine (Injection)

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Cough, chills, runny or stuffy nose, or cold-like symptoms
• High fever (at least 102 degrees F in children)
• Chicken pox
• Swollen glands where the shot was given
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Headache, or ear, joint, or muscle pain
• Mild skin rash, itching, or dryness
• Pain, redness, itching, swelling, rash, or a hard lump where the shot was given

Introduction

Varicella Virus Vaccine (var-i-SEL-a VYE-rus VAX-een)

Varivax® prevents chicken pox (varicella virus). Zostavax® prevents shingles (herpes zoster virus).

Brand Name(s)

Zostavax, Varivax

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Varivax® or Zostavax® should not be given to anyone who has had an allergic reaction to varicella virus vaccine, gelatin, or neomycin, or to a child who has a fever. You should not receive either vaccine if you are pregnant or you are planning pregnancy. Also, these vaccines should not be given to a person who has an immune system problem (such as AIDS or HIV, a blood or bone marrow disorder, active and untreated tuberculosis (TB)) or who is taking medicine that weakens the immune system (such as high doses of steroids or medicine to treat cancer). Varivax® and Zostavax® may make you sick if your immune system is already weak, because they are made from a live varicella virus. Zostavax® should not be given to children.

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other trained health professional will give you this medicine.
• Varivax®
  • Most people who need the Varivax® vaccine will need 2 shots. Children 12 months to 12 years of age should be give the second shot no sooner than 3 months after the first vaccine. Teenagers and adults should have a booster shot 4 to 8 weeks after the first vaccine. Your doctor can answer specific questions about your situation, especially if you need to follow a different schedule.
• Zostavax®
  • You should receive only 1 dose of Zostavax®, unless your doctor tells you otherwise.
  • Zostavax® should not be used in place of Varivax® to prevent chicken pox. Zostavax® should also not be used to treat shingles. Zostavax® is only preventive, although it may help ease pain if you get shingles even after receiving the vaccine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• It is important that Varivax® be given at the proper time. If a scheduled shot is missed, call your doctor to make another appointment as soon as possible.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Varivax® and Zostavax® should not be given with Pneumovax® pneumococcal vaccine. Tell your doctor about your vaccine history, or if you plan to get a flu shot or other vaccines.
• A child should not take any medicine that contains aspirin or another salicylate for at least 6 weeks after receiving Varivax®. Check the labels of any pain, headache, or cold medicine your child uses to be sure they do not contain aspirin or salicylic acid. In general, children should never be given aspirin because of the risk of Reye syndrome.
• You or your child should wait 2 months after receiving Varivax® to receive varicella zoster immune globulin (VZIG) or other immune globulin medicines. You or your child should wait at least 5 months after receiving immune globulin, VZIG, or a blood or plasma transfusion before you get the Varivax® vaccine.
• Tell your doctor if you or your child is using a medicine that weakens your immune system, such as a steroid or cancer medicine. Varivax® and Zostavax® may not work as well, or they could make you sick.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Avoid getting pregnant for 3 months after getting either the Varivax® or Zostavax® vaccine.
• Tell your doctor if you are breastfeeding before you are given Varivax® or Zostavax®.
• The virus that is in this vaccine could be passed to others, even if you (or your child) do not feel sick. Avoid close contact with anyone who has a high risk for chicken pox or shingles infection. The waiting time for Varivax® is at least 6 weeks. High-risk people include pregnant women, newborn babies, and people who cannot fight infection, such as patients who have bone marrow disease, cancer, or AIDS. Talk to your doctor if you might be with a high-risk person.
• Varivax® may not always prevent chicken pox. Zostavax® may not always prevent shingles.