SHINGRIX

Shingrix Generic Name & Formulations

Legal Class

General Description

Varicella zoster vaccine recombinant, adjuvanted; susp for IM inj after reconstitution (contains 50mcg of recombinant glycoprotein E antigen, 50mcg of monophosphoryl lipid A, and 50mcg of QS-21); per 0.5mL; preservative-free.

Pharmacological Class

Shingles vaccine.

How Supplied

Single-dose vials—1, 10 (antigen + adjuvant components)

Storage

Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F); protect from light.

Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F).

After reconstitution, administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) and use within 6 hours; discard reconstituted vaccine if not used within 6 hours.

Discard if adjuvant suspension, antigen component, or reconstituted vaccine has been frozen.

Manufacturer

GlaxoSmithKline

Generic Availability

Mechanism of Action

Shingrix was shown to boost varicella zoster virus-specific immune response, which is thought to be the mechanism by which it protects against zoster disease.

Shingrix Indications

Indications

Prevention of herpes zoster (shingles): in adults ≥50yrs of age; or in adults ≥18yrs of age at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.

Limitations of Use

Not for preventing primary varicella infection (chickenpox).

Shingrix Dosage and Administration

Adult

Give by IM inj in deltoid region of upper arm. ≥50yrs: one 0.5mL dose at Month 0 followed by second dose given between 2–6 months later. Immunocompromised (≥18yrs): one 0.5mL dose at Month 0 followed by second dose given between 1–2 months later.

Children

<18yrs: not established.

Administration

Shingrix is supplied in 2 vials that must be combined before administration.

The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid.

After reconstitution, administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) and use within 6 hours; discard reconstituted vaccine if not used within 6 hours.

The preferred site for intramuscular injection is the deltoid region of the upper arm.

Shingrix Contraindications

Contraindications

Allergies to any previous Shingrix vaccination.

Shingrix Boxed Warnings

Not Applicable

Shingrix Warnings/Precautions

Warnings/Precautions

Review immunization history prior to administration. Have appropriate medical treatment and supervision available to manage allergic reactions. Increased risk of Guillain-Barré syndrome observed during the 42 days after vaccination. Syncope. Pregnancy. Nursing mothers.

Pregnancy Considerations

Data insufficient to determine if there is a vaccine-associated risk in pregnant women.

Nursing Mother Considerations

It is not known whether Shingrix is excreted in human milk, what effect it has on a breastfed infant or on milk production. Consider the mother’s need for Shingrix vs the possibility of adverse effects on the breastfed child.

Pediatric Considerations

Safety and effectiveness have not been established in individuals younger than 18 years old.

Geriatric Considerations

No clinically meaningful differences in efficacy across age groups.

Immunocompromised adults aged 65 years and older: No clinically meaningful differences in efficacy between these patients and younger adults.

Shingrix Pharmacokinetics

See Literature

Shingrix Interactions

Shingrix Adverse Reactions

Adverse Reactions

Local reactions (eg, pain, redness, swelling), myalgia, fatigue, headache, shivering, fever, GI symptoms; Guillain-Barre syndrome, transient neurological effects.

Shingrix Clinical Trials

Clinical Trials

The FDA approval of Shingrix was supported by data from the phase 3 clinical trial program that assessed its safety, efficacy, and immunogenicity in over 38,000 individuals aged 50 years and older.

Findings from a pooled analysis showed >90% efficacy against shingles for all age groups and sustained efficacy over a 4-year follow-up. The use of Shingrix also decreased the overall incidence of postherpetic neuralgia.

Study 1: Vaccine Efficacy Results by Age Group

50-59 years (n=3492): 96.6% (95% CI, 89.6-99.3)
60-69 years (n=2141): 97.4% (95% CI, 90.1-99.7)
≥70 year (n=1711): 97.9% (95% CI, 87.9-100)

Study 2: Vaccine Efficacy Results by Age Group

70-79 years (n=5114): 90% (95% CI, 83.5-94.3)
≥80 years (n=1427): 89.1% (95% CI, 74.7-96.2)

Efficacy in Immunocompromised Individuals 18 Years of Age and Older

The approval was based on data from clinical studies that assessed the efficacy and safety of Shingrix in adults 18 years of age and older who previously had an autologous hematopoietic stem cell transplant (auHSCT; N=1721) and in those undergoing treatment for hematologic malignancies (N=515; post-hoc analysis).

Shingrix was found to be 68.2% (95% CI, 55.5-77.6) effective against the development of herpes zoster in immunocompromised adults who received an auHSCT 50 to 70 days prior to the first dose and who were expected to receive prophylactic antiviral therapy for at most 6 months post-transplant. In the hematologic malignancy study, post hoc analysis showed Shingrix was 87.2% (95% CI, 44.2-98.6) effective against herpes zoster development.

The approval was further supported by safety and immunogenicity data in adults who were, or were anticipated to be immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.

Concomitant Administration With Influenza Vaccine

Immunogenicity and safety were assessed in an open-label, multicenter phase 3 trial of 828 adults aged ≥50 years who received either Fluarix Quadrivalent and Shingrix at month 0 and Shingrix at month 2 (n=413), or Fluarix Quadrivalent at month 0 and Shingrix at month 2 and 4 (n=415).

Results showed that there was no evidence of interference in antibody responses (haemagglutination inhibition [HI] antibodies and anti-gE antibodies) to Fluarix Quadrivalent or Shingrix.

Shingrix Note

Notes

To report adverse events, contact VAERS at (800) 822-7967.

Shingrix Patient Counseling

Patient Counseling

It is important to complete the Shingrix 2-dose immunization series according to the schedule.

Report any adverse reactions following administration of Shingrix.

Shingrix

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