Varicella-Zoster Virus Strain OKA/MERCK Live antigen Solution for injection

What is this medicine?

VARICELLA VIRUS VACCINE (var uh SEL uh VAHY ruhs vak SEEN) is used to prevent infections of chickenpox.

HERPES ZOSTER VIRUS VACCINE (HUR peez ZOS ter vahy ruhs vak SEEN) is used to prevent shingles in adults 50 years old and over. This vaccine is not used to treat shingles or nerve pain from shingles.

These medicines may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

• blood disorders or disease

• cancer like leukemia or lymphoma

• immune system problems or therapy

• infection with fever

• recent immune globulin therapy

• tuberculosis

• an unusual or allergic reaction to vaccines, neomycin, gelatin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

These vaccines are for injection under the skin. They are given by a health care professional.

A copy of Vaccine Information Statements will be given before each varicella virus vaccination. Read this sheet carefully each time. The sheet may change frequently. A Vaccine Information Statement is not given before the herpes zoster virus vaccine.

Talk to your pediatrician regarding the use of the varicella virus vaccine in children. While this drug may be prescribed for children as young as 12 months of age for selected conditions, precautions do apply. The herpes zoster virus vaccine is not approved in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up (booster) doses of varicella virus vaccine as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Follow-up (booster) doses are not needed for the herpes zoster virus vaccine.

What may interact with this medicine?

Do not take these medicines with any of the following medications:

• adalimumab

• anakinra

• etanercept

• infliximab

• medicines that suppress your immune system

• medicines to treat cancer

These medicines may also interact with the following medications:

• aspirin and aspirin-like medicines (varicella virus vaccine only)

• blood transfusions (varicella virus vaccine only)

• immunoglobulins (varicella virus vaccine only)

• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups.

These vaccines, like all vaccines, may not fully protect everyone.

After receiving these vaccines it may be possible to pass chickenpox infection to others. For up to 6 weeks, avoid people with immune system problems, pregnant women who have not had chickenpox, newborns of women who have not had chickenpox, and all newborns born at less than 28 weeks of pregnancy. Talk to your doctor for more information.

Do not become pregnant for 3 months after taking these vaccines. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• extreme changes in behavior

• feeling faint or lightheaded, falls

• fever over 102 degrees F

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches or pains

• chickenpox-like rash

• diarrhea

• headache

• low-grade fever under 102 degrees F

• loss of appetite

• nausea, vomiting

• redness, pain, swelling at site where injected

• sleepy

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

These drugs are given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.