Zoster vaccine, adjuvanted (Shingrix): Difference between revisions
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|clinicalStudies====== | |clinicalStudies= | ||
=====Efficacy in Subjects 50 Years and Older===== | |||
( | *Study 1 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified (8:5:3:1) by age: 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years. The study excluded, among others, subjects who were immunocompromised, had a history of previous HZ, were vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations. Subjects were followed for the development of HZ and postherpetic neuralgia (PHN) for a median of 3.1 years (range: 0 to 3.7 years). Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain (rated as 3 or greater on a 0- to 10-point scale by the study subject) occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ. | ||
*The primary efficacy analysis population (referred to as the modified Total Vaccinated Cohort [mTVC]) included 14,759 subjects aged 50 years and older who received 2 doses (0 and 2 months) of either SHINGRIX (n = 7,344) or placebo (n = 7,415) and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 61.2% were female; 72.3% were white, 18.9% were Asian, 1.7% were black, and 7.0% were of other racial/ethnic groups. The mean age of subjects was 62.3 years. | |||
===== | *Confirmed HZ cases were determined by either Polymerase Chain Reaction (PCR) (89.4%) or by a Clinical Evaluation Committee (10.6%). | ||
=====Efficacy against Herpes Zoster===== | |||
( | *Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 97.2% (95% CI: 93.7, 99.0) in subjects 50 years and older (Table 2). | ||
[[image:shingrixtrial1.png|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
===== | *In a descriptive analysis, vaccine efficacy against HZ in subjects aged 50 years and older was 93.1% (95% CI: 81.3, 98.2) in the fourth year post-vaccination. | ||
''Occurrence of PHN'' | |||
( | *Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group. | ||
=====Efficacy in Subjects 70 Years and Older===== | |||
*Study 2 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified (3:1) by age: 70 to 79 years and ≥80 years. With the exception of age, the study exclusion criteria were the same as for Study 1. Subjects were followed for the development of HZ and PHN for a median of 3.9 years (range: 0 to 4.5 years). Suspected HZ cases were followed prospectively for the development of PHN as for Study 1. | |||
*The primary efficacy analysis population (mTVC) included 13,163 subjects aged 70 years and older who received 2 doses (0 and 2 months) of either SHINGRIX (n = 6,541) or placebo (n = 6,622) and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 54.7% were female; 77.6% were white, 17.1% were Asian, 1.0% were black, and 4.2% were of other racial/ethnic groups. The mean age of subjects was 75.5 years. | |||
*Confirmed HZ cases were determined by either PCR (92.3%) or by a Clinical Evaluation Committee (7.7%). | |||
''Efficacy against Herpes Zoster'' | |||
*Vaccine efficacy results against HZ in subjects 70 years and older are shown in Table 3. | |||
[[image:shingrixtrial2.png|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
*In a descriptive analysis, vaccine efficacy against HZ in subjects 70 years and older was 85.1% (95% CI: 64.5, 94.8) in the fourth year after vaccination. | |||
''Efficacy against PHN'' | |||
*Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group. Vaccine efficacy against PHN was 85.5% (95% CI: [58.5; 96.3]). The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. | |||
''Reduction of Use of Pain Medication'' | |||
*Among subjects with confirmed HZ, the use of HZ-associated pain medications was reported for 10 of 23 subjects (43.5%) who received SHINGRIX and for 160 of 223 subjects (71.7%) who received placebo. | |||
=====Pooled Efficacy Analyses across Studies 1 and 2===== | |||
*The efficacy of SHINGRIX to prevent HZ and PHN in subjects 70 years and older was evaluated by combining the results from Studies 1 and 2 through a pre-specified pooled analysis in the mTVC. A total of 8,250 and 8,346 subjects who received SHINGRIX and placebo, respectively, were included in the pooled mTVC analysis. | |||
''Efficacy against Herpes Zoster'' | |||
*Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 91.3% (95% CI: 86.9, 94.5) in subjects 70 years and older (Table 4). | |||
[[image:shingrixtrial3.png|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
''Efficacy against PHN'' | |||
*Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies. | |||
[[image:shingrixtrial4.png|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
*The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated. | |||
=====Immunological Evaluation to Support Dosing Schedule===== | |||
*A measure of the immune response that confers protection against HZ is unknown. Anti-gE antibody levels were measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) and were used to support the dosing schedule. | |||
*In an open-label clinical study, 238 subjects 50 years and older received SHINGRIX on either a 0- and 2-month or 0- and 6-month schedule. Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated. | |||
=====Concomitant Administration with Influenza Vaccine===== | |||
*In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and Fluarix Quadrivalent (QIV) at Month 0 and 1 dose of Shingrix at Month 2 (n = 413), or 1 dose of QIV at Month 0 and 1 dose of Shingrix at Months 2 and 4 (n = 415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine. | |||
|howSupplied= | |howSupplied= | ||
*SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (brown cap) and a single-dose vial of adjuvant suspension component (blue-green cap) (packaged without syringes or needles). | *SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (brown cap) and a single-dose vial of adjuvant suspension component (blue-green cap) (packaged without syringes or needles). | ||
Revision as of 19:29, 31 July 2018
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sonya Gelfand
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Black Box Warning
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Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Zoster vaccine, adjuvanted (Shingrix) is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Condition 3
- Dosing Information
- (Dosage)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Condition 3
- Dosing Information
- (Dosage)
Contraindications
CONTRAINDICATIONS
Warnings
|
Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
|
Conidition 1
(Description)
Conidition 2
(Description)
Conidition 3
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Condition 2
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zoster vaccine, adjuvanted (Shingrix) in women who are pregnant.
Labor and Delivery
(Description)
Nursing Mothers
(Description)g
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
There is limited information regarding the compatibility of Zoster vaccine, adjuvanted (Shingrix) and IV administrations.
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Zoster vaccine, adjuvanted (Shingrix)
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| Systematic (IUPAC) name | |
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| CAS number | ? |
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| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
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| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
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| Legal status | |
| Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Efficacy in Subjects 50 Years and Older
- Study 1 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified (8:5:3:1) by age: 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years. The study excluded, among others, subjects who were immunocompromised, had a history of previous HZ, were vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations. Subjects were followed for the development of HZ and postherpetic neuralgia (PHN) for a median of 3.1 years (range: 0 to 3.7 years). Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain (rated as 3 or greater on a 0- to 10-point scale by the study subject) occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.
- The primary efficacy analysis population (referred to as the modified Total Vaccinated Cohort [mTVC]) included 14,759 subjects aged 50 years and older who received 2 doses (0 and 2 months) of either SHINGRIX (n = 7,344) or placebo (n = 7,415) and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 61.2% were female; 72.3% were white, 18.9% were Asian, 1.7% were black, and 7.0% were of other racial/ethnic groups. The mean age of subjects was 62.3 years.
- Confirmed HZ cases were determined by either Polymerase Chain Reaction (PCR) (89.4%) or by a Clinical Evaluation Committee (10.6%).
Efficacy against Herpes Zoster
- Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 97.2% (95% CI: 93.7, 99.0) in subjects 50 years and older (Table 2).
- In a descriptive analysis, vaccine efficacy against HZ in subjects aged 50 years and older was 93.1% (95% CI: 81.3, 98.2) in the fourth year post-vaccination.
Occurrence of PHN
- Among all subjects aged 50 years or older in the mTVC, no cases of PHN were reported in the vaccine group compared with 18 cases reported in the placebo group.
Efficacy in Subjects 70 Years and Older
- Study 2 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified (3:1) by age: 70 to 79 years and ≥80 years. With the exception of age, the study exclusion criteria were the same as for Study 1. Subjects were followed for the development of HZ and PHN for a median of 3.9 years (range: 0 to 4.5 years). Suspected HZ cases were followed prospectively for the development of PHN as for Study 1.
- The primary efficacy analysis population (mTVC) included 13,163 subjects aged 70 years and older who received 2 doses (0 and 2 months) of either SHINGRIX (n = 6,541) or placebo (n = 6,622) and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 54.7% were female; 77.6% were white, 17.1% were Asian, 1.0% were black, and 4.2% were of other racial/ethnic groups. The mean age of subjects was 75.5 years.
- Confirmed HZ cases were determined by either PCR (92.3%) or by a Clinical Evaluation Committee (7.7%).
Efficacy against Herpes Zoster
- Vaccine efficacy results against HZ in subjects 70 years and older are shown in Table 3.
- In a descriptive analysis, vaccine efficacy against HZ in subjects 70 years and older was 85.1% (95% CI: 64.5, 94.8) in the fourth year after vaccination.
Efficacy against PHN
- Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group. Vaccine efficacy against PHN was 85.5% (95% CI: [58.5; 96.3]). The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.
Reduction of Use of Pain Medication
- Among subjects with confirmed HZ, the use of HZ-associated pain medications was reported for 10 of 23 subjects (43.5%) who received SHINGRIX and for 160 of 223 subjects (71.7%) who received placebo.
Pooled Efficacy Analyses across Studies 1 and 2
- The efficacy of SHINGRIX to prevent HZ and PHN in subjects 70 years and older was evaluated by combining the results from Studies 1 and 2 through a pre-specified pooled analysis in the mTVC. A total of 8,250 and 8,346 subjects who received SHINGRIX and placebo, respectively, were included in the pooled mTVC analysis.
Efficacy against Herpes Zoster
- Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 91.3% (95% CI: 86.9, 94.5) in subjects 70 years and older (Table 4).
Efficacy against PHN
- Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.
- The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.
Immunological Evaluation to Support Dosing Schedule
- A measure of the immune response that confers protection against HZ is unknown. Anti-gE antibody levels were measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) and were used to support the dosing schedule.
- In an open-label clinical study, 238 subjects 50 years and older received SHINGRIX on either a 0- and 2-month or 0- and 6-month schedule. Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated.
Concomitant Administration with Influenza Vaccine
- In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and Fluarix Quadrivalent (QIV) at Month 0 and 1 dose of Shingrix at Month 2 (n = 413), or 1 dose of QIV at Month 0 and 1 dose of Shingrix at Months 2 and 4 (n = 415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.
How Supplied
- SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (brown cap) and a single-dose vial of adjuvant suspension component (blue-green cap) (packaged without syringes or needles).
- An outer package of 1 dose (NDC 58160-819-12) contains:
- Adjuvant Suspension Component (Vial 1 of 2) NDC 58160-829-01
- Lyophilized gE Antigen Component (Vial 2 of 2) NDC 58160-828-01
- An outer package of 10 doses (NDC 58160-823-11) contains:
- Adjuvant Suspension Component (10 vials) NDC 58160-829-03
- Lyophilized gE Antigen Component (10 vials) NDC 58160-828-03
Storage
Storage before Reconstitution
- Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the adjuvant suspension has been frozen.
- Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the antigen component has been frozen.
Storage after Reconstitution
- After reconstitution, administer SHINGRIX 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. Do not freeze. Discard if the vaccine has been frozen.
Images
Drug Images
{{#ask: Page Name::Zoster vaccine, adjuvanted (Shingrix) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Zoster vaccine, adjuvanted (Shingrix) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
- Inform patients of the potential benefits and risks of immunization with SHINGRIX and of the importance of completing the 2-dose immunization series according to the schedule.
- Inform patients about the potential for adverse reactions that have been temporally associated with administration of SHINGRIX.
Precautions with Alcohol
Alcohol-Zoster vaccine, adjuvanted (Shingrix) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
- Shingrix
Look-Alike Drug Names
There is limited information regarding Zoster vaccine, adjuvanted (Shingrix) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.