Vaccine Information: ZOSTAVAX (Page 4 of 5)

14.3 Long-Term Effectiveness Study in Individuals 50 Years of Age or Older

An interim analysis of a prospective observational cohort study conducted in a US integrated healthcare system database estimated vaccine effectiveness against HZ and PHN among 1,355,720 individuals 50 years of age and older, including 392,677 who received ZOSTAVAX. Age eligible individuals contributed person-time to the unvaccinated group and, once vaccinated with ZOSTAVAX, contributed person-time to the vaccinated group for the remainder of the study. Vaccine effectiveness (VE) against HZ and PHN was calculated using the incidence rates of protocol-defined first episode of HZ and PHN in the vaccinated and unvaccinated groups, including adjustments for calendar time, age, sex, race/ethnicity, healthcare resource utilization, comorbid conditions, and immunocompromise status. The gender and racial/ethnic distributions of study individuals were overall 53% female, 60% white, 15% Asian or Pacific Islander, 13% Hispanic, and 7% black or African American.

For individuals 50-59 years of age at the time of vaccination, the average VE against HZ over the first 3 years following vaccination was 60% (95% CI: 52, 66), with VE against HZ of 36% (95% CI: -55, 73) in the third year post-vaccination. For individuals 60-69 years of age, 70-79 years of age, and 80 years of age and older at the time of vaccination, the average VE against HZ over the first 5 years following vaccination was 49% (95% CI: 47, 52), 46% (95% CI: 43, 48), and 44% (95% CI: 38, 49), respectively, with VE against HZ of 34% (95% CI: 25, 42), 29% (95% CI: 18, 38), and 36% (95% CI: 12, 53), respectively, in the fifth year post-vaccination. Follow-up time for individuals 50-59 years of age was shorter because ZOSTAVAX was approved for use in this age group five years after approval for use in individuals 60 years of age and older.

Insufficient data were available at the time of the interim analysis to assess the outcome of PHN in individuals 50-59 years of age. For individuals 60-69 years of age, 70-79 years of age, and 80 years of age and older at the time of vaccination, the average VE against PHN over the first 5 years following vaccination was 72% (95% CI: 65, 77), 69% (95% CI: 62, 75), and 61% (95% CI: 47, 71), respectively, with VE against PHN of 61% (95% CI: 33, 77), 69% (95% CI: 44, 82), and 34% (95% CI: -49, 71), respectively, in the fifth year post-vaccination. The benefit of ZOSTAVAX in the prevention of PHN can be attributed in part to the effect of the vaccine on the prevention of HZ.

14.4 Concomitant Use Studies

In a double-blind, controlled substudy, 374 adults in the US, 60 years of age and older (median age = 66 years), were randomized to receive trivalent inactivated influenza vaccine (TIV) and ZOSTAVAX concurrently (N=188), or TIV alone followed 4 weeks later by ZOSTAVAX alone (N=186). The antibody responses to both vaccines at 4 weeks postvaccination were similar in both groups.

In another double-blind, controlled study, 882 adults in the US, 50 years of age and older (median age = 60 years), were randomized to receive quadrivalent inactivated influenza vaccine and ZOSTAVAX concurrently (N=440), or quadrivalent inactivated influenza vaccine alone followed 4 weeks later by ZOSTAVAX alone (N=442). The antibody responses to both vaccines at 4 weeks postvaccination were similar in both groups.

In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomized to receive ZOSTAVAX and PNEUMOVAX 23 concomitantly (N=237), or PNEUMOVAX 23 alone followed 4 weeks later by ZOSTAVAX alone (N=236). At 4 weeks postvaccination, the VZV antibody levels following concomitant use were significantly lower than the VZV antibody levels following nonconcomitant administration (GMTs of 338 vs. 484 gpELISA units/mL, respectively; GMT ratio = 0.70 (95% CI: 0.61, 0.80).

15 REFERENCES

  1. Reitschel RL, Bernier R. Neomycin sensitivity and the MMR vaccine. JAMA 1981;245(6):571.
  2. Atkinson WL, Pickering LK, Schwartz B, Weniger BG, Iskander JK, Watson JC. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR02):1-36.
  3. Rynn L, Cragan J, Correa A. Update on Overall Prevalence of Major Birth Defects-Atlanta, Georgia,1978-2005. CDC MMWR January 11, 2008/57(01);1-5.
  4. American College of Obstetricians and Gynecologists Frequently Asked Questions: Miscarriage and Molar Pregnancy; 2011.
  5. Coplan PM, Schmader K, Nikas A, Chan ISF, Choo P, Levin MJ, et al. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: Adaptation of the brief pain inventory. J Pain 2004;5(6):344-56.

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

Storage

To maintain potency, ZOSTAVAX must be stored frozen between -58°F and +5°F (-50°C and -15°C). Use of dry ice may subject ZOSTAVAX to temperatures colder than -58°F (-50°C).

Before reconstitution, ZOSTAVAX SHOULD BE STORED FROZEN at a temperature between -58°F and +5°F (-50°C and -15°C) until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature between -58°F and +5°F (-50°C and -15°C) is acceptable for storing ZOSTAVAX. Routine defrost cycling of a frost-free freezer is acceptable.

ZOSTAVAX may be stored and/or transported at refrigerator temperature between 36°F and 46°F (2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored between 36°F and 46°F (2°C to 8°C) that is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded. ZOSTAVAX should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator (36°F to 46°F, 2°C to 8°C).

For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90.

Before reconstitution, protect from light.

DO NOT FREEZE RECONSTITUTED VACCINE.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Question the patient about reactions to previous vaccines.
  • Provide a copy of the patient information (PPI) located at the end of this insert and discuss any questions or concerns.
  • Inform patient of the benefits and risks of ZOSTAVAX, including the potential risk of transmitting the vaccine virus to susceptible individuals, such as immunosuppressed or immunodeficient individuals or pregnant women who have not had chickenpox.
  • Instruct patient to report any adverse reactions or any symptoms of concern to their healthcare professional.


Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2006-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

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Patient Information about
ZOSTAVAX® (pronounced “ZOS tah vax”)
Generic name: Zoster Vaccine Live

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 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.

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 does not protect everyone, so some people who get the vaccine may still get shingles.

ZOSTAVAX cannot be used to treat shingles, or the nerve pain that may follow 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 medicines or receive treatment that might weaken your immune system (such as 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 or have taken 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 get ZOSTAVAX with other vaccines?

ZOSTAVAX can be given at the same time as inactivated flu vaccine.

Talk to your health care provider if you plan to get ZOSTAVAX at the same time as PNEUMOVAX® 23 because it may be better to get these vaccines at least 4 weeks apart.

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, hard lump, warmth, or bruising where the shot was given.
  • headache

The following additional side effects have been reported 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.
  • chickenpox
  • fever
  • hives at the injection site
  • joint pain
  • muscle pain
  • nausea
  • rash
  • rash at the injection site
  • shingles
  • swollen glands near the injection site (that may last a few days to a few weeks)
  • Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body)
  • loss of facial muscle movements

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.

Report the following to your doctor or your child’s doctor:

  • any adverse reactions following vaccination
  • exposure to ZOSTAVAX during pregnancy
  • exposure to ZOSTAVAX during the 3 months before getting pregnant.
    You may also report these events to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231, or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

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.

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.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2006-2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 08/2018

usppi-v211-i-fro-1808r019

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