DRUG DESCRIPTION
ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated
varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a
sterile suspension for subcutaneous administration. Each 0.65-mL dose contains
a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV when
reconstituted and stored at room temperature for up to 30 minutes. Each dose
contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg
of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate
dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride;
residual components of MRC-5 cells including DNA and protein; and trace quantities
of neomycin and bovine calf serum. The product contains no preservatives.
What are the possible side effects of zoster vaccine live (Zostavax)?
You should not receive a second zoster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with shingles is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects...
Read All Potential Side Effects and See Pictures of Zostavax »
What are the precautions when taking zoster vaccine live (Zostavax)?
Before receiving this medication, tell your doctor or pharmacist if you are allergic to any vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before receiving this vaccination, consult your doctor or pharmacist if you have: immune system problems (e.g., due to HIV, cancer treatment, organ transplant), untreated active tuberculosis.
Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, previous reaction to other vaccine.
Caution is advised if you have regular...
Read All Potential Precautions of Zostavax »
Zostavax Consumer (continued)
SIDE EFFECTS: Redness, itching, swelling, warmth, bruising, and pain at the injection site may occur. Headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to any vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before receiving this vaccination, consult your doctor or pharmacist if you have: immune system problems (e.g., due to HIV, cancer treatment, organ transplant), untreated active tuberculosis.
Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, previous reaction to other vaccine.
Caution is advised if you have regular close contact with family/household members with weakened immune systems (e.g., due to cancer) or who may be pregnant. It is not known if infection may occur from close contact with someone who has received this vaccine. Consult your doctor for more details.
This vaccine is not recommended for use during pregnancy. Pregnancy should also be avoided for 3 months after receiving this vaccine. Consult your doctor for more details.
It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.
Zostavax Patient Information Including Side Effects
Brand Names: Zostavax
Generic Name: zoster vaccine live (Pronunciation: ZOS ter vak SEEN LYV)
- What is zoster vaccine live (Zostavax)?
- What are the possible side effects of zoster vaccine live (Zostavax)?
- What is the most important information I should know about zoster vaccine live (Zostavax)?
- What should I discuss with my health care provider before receiving zoster vaccine live (Zostavax)?
- How is zoster vaccine given (Zostavax)?
- What happens if I miss a dose (Zostavax)?
- What happens if I overdose (Zostavax)?
- What should I avoid before or after receiving zoster vaccine live (Zostavax)?
- What other drugs will affect zoster vaccine live (Zostavax)?
- Where can I get more information?
What is zoster vaccine live (Zostavax)?
Herpes zoster is caused by the same virus that causes chickenpox in children. When this virus becomes active again in an adult, it can cause herpes zoster, or shingles. Zoster vaccine is a live vaccine that helps prevent shingles.
This vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Zoster vaccine is used to prevent herpes zoster virus (shingles) in people age 60 and older.
Zoster vaccine will not treat shingles or nerve pain caused by shingles (post-herpetic neuralgia).
Zoster vaccine may also be used for purposes other than those listed in this medication guide.
What are the possible side effects of zoster vaccine live (Zostavax)?
You should not receive a second zoster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with shingles is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- fever, chills, sore throat, weakness, flu symptoms;
- breathing problems; or
- severe or painful skin rash.
Less serious side effects include:
- pain, redness, bruising, or swelling where the shot was given;
- diarrhea;
- headache; or
- mild skin rash.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about zoster vaccine live (Zostavax)?
You can still receive a vaccine if you have a minor cold. If you have tuberculosis, or any other severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
Becoming infected with herpes zoster (shingles) is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Do not receive this vaccine if you have leukemia or lymphoma (or other cancer affecting bone marrow), a history of allergic reaction to neomycin (Mycifradin, Neo-Fradin, Neo-Tab). You should not receive this vaccine if you are pregnant, or if you have active untreated tuberculosis, any type of cancer that affects bone marrow, or a weak immune system caused by disease (such as HIV or AIDS) or by receiving medications such as steroids or chemotherapy.
- Zostavax
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