Zostavax

Zostavax is a vaccine that is used for adults 50 years of age or older to prevent shingles (also known as zoster).

Zostavax contains a weakened chickenpox virus (varicella-zoster virus). Zostavax works by helping your immune system protect you from getting shingles.

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

Common side effects of Zostavax include redness, pain, itching, swelling, hard lump, warmth, or bruising where the shot was given.

Zostavax is part of the drug class:

• Varicella zoster vaccines

 Tell your health care provider if you:

• have or have had any medical problems
• take any medicines, including non-prescription medicines, and dietary supplements
• have any allergies, including allergies to neomycin or gelatin
• had an allergic reaction to another vaccine
• are pregnant or plan to become pregnant
• are breast-feeding

Tell your health care provider if you expect to be in close contact (including household contact) with newborn infants, someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system. Your health care provider can tell you what situations you may need to avoid. 

Tell your doctor if you are pregnant or plan to become pregnant.

Zostavax is not recommeded in pregnant women. It is not known whether Zostavax can cause harm to an unborn baby when administered to a pregnant woman or can affect reproduction potential. However, naturally occurring varicella-zoster virus (VZV) infection is known to sometimes cause harm to an unborn baby. Therefore, Zostavax should not be given to pregnant women, and women of child bearing age should avoid becoming preganant for 3 months after getting Zostavax.

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Zostavax crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Zostavax.

Prevention of Herpes Zoster

Prevention of herpes zoster (shingles, zoster) in immunocompetent adults ≥50 years of age.1 2 6

Herpes zoster is caused by reactivation of varicella zoster virus (VZV) infection.1 2 6 Zoster vaccine is used to boost active immunity to VZV, thereby reducing risk of VZV reactivation.1 2 3 4 15 The vaccine may also reduce frequency, severity, and/or duration of postherpetic neuralgia (PHN) in those who develop herpes zoster despite vaccination.1 2 6

US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend that all adults ≥60 years of age receive a single dose of zoster vaccine, unless contraindicated.6 20 (See Contraindications under Cautions.)

ACIP and others state the vaccine can be used in those with or without a prior episode of herpes zoster, unless a medical condition is present that is considered a contraindication or precaution for use of the vaccine.6 19

ACIP does not currently recommend routine use of zoster vaccine in adults 50 through 59 years of age since risk of getting zoster and having prolonged pain after zoster is much lower in this age group than in those ≥60 years of age and there have been shortages and supply problems with the vaccine during the last several years.26 ACIP states the vaccine may be offered to individuals 50 through 59 years of age after considering whether the individual would have poor tolerance to zoster or PHN symptoms (e.g., patient has preexisting chronic pain, severe depression, or other comorbidities; hypersensitivity to or potential drug interactions with drugs used for zoster treatment; extenuating employment-related factors).26

Not indicated for treatment of herpes zoster or PHN.1 6 Not indicated for use in individuals with acute zoster infection in an attempt to prevent development of PHN.6

Not used for prevention of primary varicella infection (chickenpox).1 Not a substitute for varicella vaccine (Varivax).6

Not recommended for individuals of any age who have previously received varicella vaccine.6 Most individuals ≥50 years of age will not have received varicella vaccine.6

Not used in children, adolescents, or adults <50 years of age.1 6

In the U.S.

• Varivax
• Zostavax

In Canada

• Varilrix

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Vaccine

This section provides information on the proper use of a number of products that contain varicella virus vaccine. It may not be specific to Zostavax. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot under your skin (usually in the upper arms).

Children 12 months to 12 years of age should receive 2 doses of Varivax® vaccine, with the first dose given between 12 to 15 months and the second between 4 to 6 years. Teenagers and adults should receive 2 doses and wait 4 weeks between the first and second shot.

Adults receiving Zostavax® should receive only one dose of the vaccine unless your doctor tells you otherwise.

This vaccine comes with a patient information insert. Make sure you understand all of the information in the insert. Ask your doctor if you have any questions.

Tell your doctor before receiving this vaccine if you are severely ill or if you have a fever greater than 101.3 °F.

This vaccine needs to be given on a fixed schedule. If you or your child missed the scheduled dose, call your doctor or your child’s doctor for another appointment as soon as possible.

It is very important that you or your child return to your doctor’s office at the right time if you or your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after your child receive this vaccine.

Do not become pregnant for 3 months after receiving varicella virus vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

Zostavax® should not be used in place of Varivax®.

Zostavax® should not be used in children.

Tell your doctor that you or your child have received this vaccine:

• If you are to receive blood transfusions or other blood products within 5 months of receiving this vaccine.
• If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 2 months after receiving this vaccine.
• If you are to receive any other live virus vaccines within 1 month of receiving this vaccine.

This vaccine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the vaccine.

Do not take aspirin or medicines that contain aspirin (such as certain cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you or your child use to be sure it does not contain aspirin or salicylic acid.

You or your child may be able to pass the virus to other people after getting this vaccine. You or your child should avoid close contact with people at high risk for getting chickenpox for 6 weeks after receiving this vaccine. People who are most at risk of catching the virus from you are pregnant women, newborn babies, and people whose bodies cannot fight infection (such as with bone marrow disease, cancer drug treatment, or AIDS). Talk to your doctor about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Itching.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store Zostavax at home, talk with your doctor, nurse, or pharmacist about how to store it.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Zostavax. It is also not known whether Zostavax can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring VZV infection is known to sometimes cause fetal harm. Zostavax is not indicated in women of child-bearing age and should not be administered to pregnant females.

Vaccinees and health care providers are encouraged to report any exposure to Zostavax during pregnancy by calling (800) 986-8999.

Nursing Mothers

Zostavax is not indicated in women who are nursing. It is not known whether VZV is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if Zostavax is administered to a nursing woman.

Pediatric Use

Zostavax is not indicated for prevention of primary varicella infection (Chickenpox) and should not be used in children and adolescents.

Geriatric Use

The median age of subjects enrolled in the largest (N=38,546) clinical study of Zostavax was 69 years (range 59-99 years). Of the 19,270 subjects who received Zostavax, 10,378 were 60-69 years of age, 7,629 were 70-79 years of age, and 1,263 were 80 years of age or older.

No. 4963-00 Zostavax is supplied as follows: (1) a package of 1 single-dose vial of lyophilized vaccine, NDC 0006-4963-00 (package A); and (2) a separate package of 10 vials of diluent (package B).

No. 4963-41 Zostavax is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4963-41 (package A); and (2) a separate package of 10 vials of diluent (package B).

Handling and Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -15°C (+5°F) or colder.

Zostavax SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of -15°C or colder is acceptable for storing Zostavax.

Zostavax may be stored and/or transported at refrigerator temperature (2 to 8°C, 36 to 46°F) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2 to 8°C (36 to 46°F) that is not used within 72 hours of removal from -15°C (+5°F) storage should be discarded.

For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

Before reconstitution, protect from light.

The diluent should be stored separately at room temperature (20 to 25°C, 68 to 77°F), or in the refrigerator (2 to 8°C, 36 to 46°F).

Dist. by:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Issued December 2009

Printed in USA

9815611

[See FDA-Approved Patient Labeling (17.2).]

Instructions

The health care provider should question the vaccine recipient about reactions to previous vaccines. The health care provider should also inform the vaccine recipient of the benefits and risks of Zostavax. Patients should be provided with a copy of the Patient Information about Zostavax at the end of this insert, and be given an opportunity to discuss any questions or concerns.

Vaccinees should also be informed of the potential risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox.

Patients should be instructed to report any adverse reactions to their health care provider.

FDA-Approved Patient Labeling

Patient Information about
Zostavax® (pronounced "ZOS tah vax")
Generic name: Zoster Vaccine Live

You should read this summary of information about Zostavax1 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 contains a weakened chickenpox virus (varicella-zoster virus).

Zostavax works by helping your immune system protect you from getting shingles. 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.

Zostavax may not protect everyone who gets the vaccine. Zostavax cannot be used to treat shingles once you have it.

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

Shingles is caused by the same virus that causes chickenpox. Once you have had chickenpox, the virus can stay in your nervous system for many years. For reasons that are not fully understood, the virus may become active again and give you shingles. Age and problems with the immune system may increase your chances of getting shingles.

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.

Who should not get Zostavax?

You should not get Zostavax if you:

• are allergic to any of its ingredients.
• are allergic to gelatin or neomycin.
• have a weakened immune system (for example, an immune deficiency, leukemia, lymphoma, or HIV/AIDS).
• take high doses of steroids by injection or by mouth.
• are pregnant or plan to get pregnant.

You should not get Zostavax to prevent chickenpox.

Children should not get Zostavax.

How is Zostavax given?

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

What should I tell my health care provider before I get Zostavax?

You should tell your health care provider if you:

• have or have had any medical problems.
• take any medicines, including non-prescription medicines, and dietary supplements.
• have any allergies, including allergies to neomycin or gelatin.
• had an allergic reaction to another vaccine.
• are pregnant or plan to become pregnant.
• are breast-feeding.

Tell your health care provider if you expect to be in close contact (including household contact) with newborn infants, someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system. Your health care provider can tell you what situations you may need to avoid.

Can I receive Zostavax with other vaccines?

Talk to your health care provider if you plan to get Zostavax at the same time as the flu vaccine.

Zostavax should not be given at the same time as the PNEUMOVAX®2 23 vaccine. For more information about these vaccines, talk to your health care provider.

What are the possible side effects of Zostavax?

The most common side effects that people in the clinical studies reported after receiving the vaccine include:

• redness, pain, itching, swelling, warmth, or bruising where the shot was given.
• headache.

The following additional side effects have been reported in general use with Zostavax:

• allergic reactions, which may be serious and may include difficulty in breathing or swallowing. If you have an allergic reaction, call your doctor right away.
• fever
• hives at the injection site
• joint pain
• muscle pain
• rash
• rash at the injection site
• swollen glands near the injection site (that may last a few days to a few weeks)

Tell your healthcare provider if you have any new or unusual symptoms after you receive Zostavax. For a complete list of side effects, ask your health care provider.

What are the ingredients of 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?

Vaccinees and their health care providers are encouraged to call (800) 986-8999 to report any exposure to Zostavax during pregnancy.

This leaflet summarizes important information about Zostavax.

If you would like more information, talk to your health care provider or visit the website at www.Zostavax.com or call 1-800-622-4477.

Rx Only

Issued December 2009

9815611

Dist. by:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.

PRINCIPAL DISPLAY PANEL - Carton - 1 Single-dose Vial (0.65 mL)

A

NDC 0006-4963-00
1 Single-dose Vial (0.65 mL)

Zoster Vaccine Live
Zostavax®

STORE FROZEN

Oka/Merck strain. Human diploid cell (MRC-5) culture origin. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units).

Contains no preservative.
Contains trace quantities of neomycin.

Rx only

Manuf. and Dist. by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

PRINCIPAL DISPLAY PANEL - Carton - Sterile Diluent 10-0.7 mL Vials

No. 4309

10-0.7 mL Vials

STERILE DILUENT
FOR MERCK & CO., INC.
LIVE VIRUS VACCINES
(Sterile Water)

CONTAINS NO PRESERVATIVE

Rx only

B

This carton contains 10 diluent-containing vials. Use one diluent vial for reconstitution of one single dose vial of live virus vaccine.

Manuf. for:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By: Hollister-Stier Laboratories, LLC, Spokane, WA 99207, USA

Since Zostavax is given as a one-time injection, you are not likely to be on a dosing schedule.

You should not receive a second Zostavax 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 signs of an allergic reaction to Zostavax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, swollen glands, sore throat, flu symptoms;

• breathing problems; or

• severe or painful skin rash.

Common Zostavax side effects include:

• headache; or

• pain, warmth, redness, bruising, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Applies to zoster vaccine live: parenteral for injection for sub-q use

Side effects include:

Injection site reactions (erythema, pain/tenderness, swelling, pruritus, warmth, hematoma, induration), headache, extremity pain.

Use is contraindicated. AU TGA pregnancy category: B2 US FDA pregnancy category: Not formally assigned to a pregnancy category Comments: Avoid pregnancy for 1 to 3 months after receiving this vaccine.

Animal reproduction studies have not been conducted. It is not known whether this vaccine can cause fetal harm when administered to a pregnant woman. Naturally-occurring varicella-zoster virus (VZV) infection is known to sometimes cause fetal harm; therefore, this vaccine should not be administered to pregnant females. A Pregnancy Registry to monitor fetal outcomes following inadvertent administration of varicella vaccines at any time during pregnancy or within 3 months prior to conception was maintained for 19 years. As of March 2011, none of the over 800 women who received a varicella-containing vaccine delivered infants with abnormalities consistent with congenital varicella syndrome. All exposures to varicella-zoster vaccine during pregnancy or within three months prior to conception should be reported as suspected adverse reactions at www.vaers.hhs.gov. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

You should not receive this vaccine if you have:

• active untreated tuberculosis;

• leukemia, lymphoma, or other cancer affecting bone marrow;

• a history of allergic reaction to gelatin or neomycin (Mycifradin, Neo-Fradin, Neo-Tab);

• a weak immune system caused by disease (such as HIV or AIDS), or by receiving medications such as steroids or chemotherapy; or

• if you are pregnant.

To make sure zoster vaccine is safe for you, tell your doctor if you have:

• a history of allergic reaction to any vaccine;

• if you have received a "live" vaccine within the past 4 weeks; or

• if you have never had chickenpox.

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.

Tell your doctor if someone in your household has a weak immune system. For a short time after you receive a zoster vaccine, it is possible that the live virus could be passed from you to any person who has a weak immune system.

It is not known whether zoster vaccine is harmful to an unborn baby. However, this vaccine is not for use in pregnant women. Avoid getting pregnant for at least 3 months after you have received a zoster vaccine.

It is not known whether zoster vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Zoster vaccine is not approved for use by anyone younger than 18 years old.

Zoster vaccine is given as an injection (shot) under the skin. You will receive this vaccine in a doctor's office or other clinic setting.

Zoster vaccine is usually given as a one-time injection. Unless your doctor tells you otherwise, you will not need a booster vaccine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

If you develop a skin rash that looks like shingles after receiving this vaccine, avoid coming into contact with other people who have never had chickenpox (especially newborns, pregnant women, or someone with a weak immune system). Also avoid contact with these individuals if you develop a rash or other reaction where the vaccine was injected into your skin.

Do not receive any other "live" vaccine for at least 4 weeks after your zoster vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu (influenza) vaccine.