Product Approval Information - Licensing Action

Patient Information about
ZOSTAVAX® (pronounced "ZOS tah vax")
Generic name: [Zoster Vaccine Live (Oka/Merck)]

You should read this summary of information about ZOSTAVAX* before you are vaccinated. If you have any questions about ZOSTAVAX after reading this leaflet, you should ask your health care provider. This information does not take the place of talking about ZOSTAVAX with your doctor, nurse, or other health care provider. Only your health care provider can decide if ZOSTAVAX is right for you.

What is ZOSTAVAX and how does it work?

ZOSTAVAX is a vaccine that is used for adults 60 years of age or older to prevent shingles (also known as zoster).

ZOSTAVAX works by helping your immune system protect you from getting shingles and the associated pain and other serious complications. If you do get shingles even though you have been vaccinated, ZOSTAVAX may help prevent the nerve pain that can follow shingles in some people.

As with any vaccine, ZOSTAVAX may not protect everyone who receives the vaccine.

ZOSTAVAX cannot be used to treat shingles once you have it. If you do get shingles, see your health care provider within the first few days of getting the rash.

What do I need to know about shingles and the virus that causes it?

Shingles is a rash that is usually on one side of the body. The rash begins as a cluster of small red spots that often blister. The rash can be painful. Shingles rashes usually last up to 30 days, and for most people the pain associated with the rash lessens as it heals.

People who have problems with their immune system may have a greater risk of getting more widespread rashes and longer-lasting pain.

Shingles is caused by the same virus that causes chickenpox. Once a person has had chickenpox, the virus can live, but remain inactive, in one or more nerve roots in your body for many years. For reasons that are not fully understood, the virus may become active again. Age and problems with the immune system may increase your risk of getting shingles.

Can I get ZOSTAVAX?

You can receive ZOSTAVAX if you are 60 years of age or older, but only your health care provider can decide if ZOSTAVAX is right for you.

Who should not receive ZOSTAVAX?

You should not receive ZOSTAVAX if you:

are allergic to any of its ingredients. This includes allergies to gelatin or neomycin.
have a disease or condition that causes a weakened immune system such as an immune deficiency, including leukemia, lymphoma, HIV/AIDS or are taking high doses of steroids by injection or by mouth.
have active TB (tuberculosis) that is not being treated.
are pregnant or may be pregnant.

What should I tell my health care provider before I receive ZOSTAVAX?

You should tell your health care provider if you:

have or have had any medical problems.
are taking any medications, including those that might weaken your immune system.
have any allergies, including allergies to neomycin or have had an allergic reaction to another vaccine.
become pregnant within 3 months of getting the vaccine. Vaccine recipients are encouraged to report any exposure to ZOSTAVAX during pregnancy by calling (800) 986-8999.
are breast-feeding.
have had s hingles in the past.
may be in close contact (including household contact) with someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system.

How is ZOSTAVAX given?

ZOSTAVAX is given as a single dose by injection under the skin.

What are the possible side effects of ZOSTAVAX?

Redness, pain, swelling, itching, warmth, and bruising at the site where the injection was given, and headache were the most common side effects that people in the clinical studies reported after receiving the vaccine. Talk to your health care provider about other possible side effects.

Call your health care provider right away if any medical condition you have gets worse or you develop any new or unusual symptoms after you receive ZOSTAVAX.

What are the ingredients in ZOSTAVAX?

Active Ingredient: a weakened form of the varicella-zoster virus.

Inactive Ingredients: sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride.

What else should I know about ZOSTAVAX?

This leaflet summarizes information about ZOSTAVAX. If you would like more information, talk to your health care provider or visit the website: www. ZOSTAVAX.com<.

Rx Only

Issued May 2006

Manuf. and Dist. by: Merck & Co., Inc., Whitehouse Station, NJ 08889, USA