Safety

Zostavax (zoster vaccine live) suspension for subcutaneous injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)  

February 2016

Summary View

ADVERSE REACTIONS

Postmarketing
  • Eye Disorders: necrotizing retinitis (patients on immunosuppressive therapy)

 

August 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Infections and Infestations: Herpes zoster (vaccine strain)

PATIENT PACKAGE INSERT

What are the possible side effects of Zostavax

  • …shingles… 

 

March 2011

March 2011 Summary View

*Current Label information supercedes previous label changes 

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines
  • In a randomized clinical study, a reduced immune response to Zostavax as measured by gpELISA was observed in individuals who received concurrent administration of Pneumovax 23 and Zostavax compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

PATIENT INFORMATION

Can I get Zostavax with other vaccines?
  • 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.

 

January 2010

January 2010 Summary View

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines
  • Zostavax and Pneumovax 23 (pneumococcal vaccine) should not be given concurrently because concomitant use resulted in reduced immunogenicity of Zostavax.

PATIENT INFORMATION

Can I receive Zostavax with other vaccines?
  • Zostavax should not be given at the same time as the Pneumovax 23 vaccine. For more information about these vaccines, talk to your health care provider.

 

Page Last Updated: 03/14/2016
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