Shingrix

(Zoster Vaccine Recombinant)

Shingrix is a recombinant zoster vaccine. The active ingredient in Shingrix is the Varicella Zoster Virus Glycoprotein E antigen. The vaccine also contains an adjuvant, which increases the immunogenicity of the vaccine, or the ability of the body to form an immune response against the antigen.

Together, the ingredients allow your body to recognize the virus if it becomes reactivated and to build an immune response against it.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Shingrix. However, the following is a synopsis of the general guidelines for the use of Shingrix:

The vaccine comes in a powder form and must be reconstituted with the adjuvant solution by your healthcare provider before administration.

Shingrix is an intramuscular injection (into the muscle), generally given in the upper arm. It should be administered by a healthcare provider.

Two doses are required for Shingrix vaccine efficacy. You should receive your second dose 2-6 months after the first dose of Shingrix. When you receive your first dose of Shingrix, ask your healthcare provider for a follow-up appointment to make sure you receive both doses.

The most common side effects of Shingrix seen in clinical trials as compared to placebo include:

-Pain, redness, and swelling at the injection site

-Headache

-Gastrointestinal or digestive complaints

-Myalgia (muscle pain)

-Tiredness

-Fever and chills

Some individuals may experience serious side effects while using Shingrix. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Difficulty breathing, swelling of the lips or throat, hives, or other symptoms of an allergic reaction.

These are not all of the possible side effects of Shingrix. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Shingrix, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have had a recent shingles infection, a previous adverse reaction to a vaccine, or if you are acutely ill at the time of your appointment.

In a post-marketing study, individuals 65 years of age and older had an increased risk of Guillain-Barré syndrome (an immune response against nerves) in the 42 days following Shingrix vaccination. However, it is unclear if Shingrix is the cause of these reactions.

Shingrix is indicated for the prevention of herpes zoster in people 50 years of age or older, or people 18 years of age and older who are at risk of shingles due to immunodeficiency or immunosuppression.

Shingrix is not indicated for:

-People belonging to other age groups

-The prevention of chicken pox

-People who are allergic to the active or inactive ingredients of the formulation

Shingrix requires 2 doses, spaced 2-6 months apart, for full efficacy.

The interactions of Shingrix with other medications, vitamins, or food have not been established.

Shingrix was equally effective in people who had previously received Zostavax, a different Herpes Zoster vaccine. Let your doctor know if you have already received Zostavax.

Each dose of Shingrix contains 5 mcg of Varicella Zoster Virus glycoprotein E.

The Shingrix vaccine should be refrigerated. It should be stored in the original packaging in order to protect it from light.

Shingrix is manufactured by GlaxoSmithKline Inc. (GSK).

There is no generic version of Shingrix at this time.

Shingrix is given in 2 separate doses. It is not known if booster doses are required at this time.

The safety of Shingrix has not been studied in pregnant women. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

The safety of administering Shingrix to breastfeeding people has not been studied. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.