Zoster Vaccine Live (Bovine) Solution for injection

What is this medicine?

HERPES ZOSTER VIRUS VACCINE (HUR peez ZOS ter vahy ruhs vak SEEN) is a vaccine. It is used to prevent shingles in adults 60 years old and over. This vaccine is not used to treat shingles or nerve pain from shingles.

This medicine 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 these conditions:

• cancer like leukemia or lymphoma
• immune system problems or therapy
• infection with fever
• 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?

This vaccine is for injection under the skin. It is given by a health care professional.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use 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?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• adalimumab
• anakinra
• etanercept
• infliximab
• medicines to treat cancer
• medicines that suppress your immune system

This medicine may also interact with the following medications:

• immunoglobulins
• 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.

This vaccine, like all vaccines, may not fully protect everyone.

After receiving this vaccine it may be possible to pass chickenpox infection to others. Avoid people with immune system problems, pregnant women who have not had chickenpox, and newborns of women who have not had chickenpox. Talk to your doctor 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
• feeling faint or lightheaded, falls
• fever, flu-like symptoms
• pain, tingling, numbness in the hands or feet
• swelling of the ankles, feet, hands
• 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
• loss of appetite
• nausea, vomiting
• redness, pain, swelling at site where injected
• runny nose

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?

This drug is 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.