SHINGRIX- zoster vaccine recombinant, adjuvanted kit

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (UNII: COB9FF6I46) (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN - UNII:COB9FF6I46)

Inapatikana kutoka:

A-S Medication Solutions

Matibabu dalili:

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. Limitations of Use : Do not administer SHINGRIX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women. A developmental toxicity study was performed in female rats administered SHINGRIX or the AS01B adjuvant alone prior to mating, during gestation, and during lactation. The total dose was 0.2 mL on each occasion (a single human dose of SHINGRIX is 0.5 mL). This study revealed no adverse effects on fetal or pre-weaning development due to SHINGRIX (see Data) . Data Animal Data: In a developmental toxicity study, female rats were administered SHINGRIX or the AS01B adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation Days 3, 8, 11, and 15, and on lactation Day 7. The total dose was 0.2 mL on each occasion (a single human dose of SHINGRIX is 0.5 mL). No adverse effects on pre-weaning development up to post-natal Day 25 were observed. There were no vaccine-related fetal malformations or variations. Risk Summary It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SHINGRIX and any potential adverse effects on the breastfed child from SHINGRIX or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Safety and effectiveness in individuals younger than 18 years have not been established. SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox). Adults Aged 60 Years and Older Of the total number of subjects who received at least 1 dose of SHINGRIX in Studies 1 and 2 (n = 14,645), 2,243 (15%) were aged 60 to 69 years, 6,837 (47%) were aged 70 to 79 years, and 1,921 (13%) were aged 80 years and older. There were no clinically meaningful differences in efficacy across the age groups. [See Clinical Studies (14.1, 14.2, 14.3).] The frequencies of solicited local and general adverse reactions in subjects aged 70 years and older were lower than in younger adults (aged 50 through 69 years). [See Adverse Reactions (6.1).] Immunocompromised Adults Aged 65 Years and Older Of the total number of subjects who received at least 1 dose of SHINGRIX in the auHSCT study (n = 922), 172 (18.7%) were aged 65 years and older [see Clinical Studies (14.5)] . There were no clinically meaningful differences in efficacy between these subjects and younger adults (aged 18 through 64 years). Of the total number of subjects who received at least 1 dose of SHINGRIX across the 6 studies in immunocompromised subjects (n = 1,587), 337 (21.2%) were aged 65 years and older. The frequencies of solicited local and general adverse reactions in subjects aged 65 years and older were generally similar to or lower than those reported by younger adults (aged 18 through 64 years).

Bidhaa muhtasari:

SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles). Presentation Carton NDC Number Components Adjuvant Suspension Component (liquid) Lyophilized gE Antigen Component (powder) An outer carton of 1 dose 58160-819-12 Vial 1 of 2 NDC 58160-829-01 Vial 2 of 2 NDC 58160-828-01 An outer carton of 10 doses 58160-823-11 10 vials NDC 58160-829-03 10 vials NDC 58160-828-03 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.

Idhini hali ya:

Biologic Licensing Application

Tabia za bidhaa

SHINGRIX- ZOSTER VACCINE RECOMBINANT, ADJUVANTED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SHINGRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SHINGRIX.
SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED), SUSPENSION FOR
INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ)
(shingles):
•
•
Limitations of Use (1):
•
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
Two doses (0.5 mL each) administered intramuscularly according to the
following schedules:
•
•
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied as a single-dose vial of lyophilized
varicella zoster virus glycoprotein E
(gE) antigen component to be reconstituted with the accompanying vial
of AS01 adjuvant suspension
component. After reconstitution, a single dose of SHINGRIX is 0.5 mL.
(3)
CONTRAINDICATIONS
History of severe allergic reaction (e.g., anaphylaxis) to any
component of the vaccine or after a previous
dose of SHINGRIX. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
in adults aged 50 years and older.
in adults aged 18 years and older who are or will be at increased risk
of HZ due to immunodeficiency
or immunosuppression caused by known disease or therapy.
SHINGRIX is not indicated for prevention of primary varicella
infection (chickenpox).
A first dose at Month 0 followed by a second dose administered 2 to 6
months later. (2.3)
For individuals who are or will be immunodeficient or immunosuppressed
and who would benefit from
a shorter vaccination schedule: A first dose at Month 0 followed by a
second dose administered 1 to
2 months later. (2.3)
B
In a postmarketing observational study, an increased risk of
Guillain-Barré syndrome was observed
during the 42 days following vaccination with SHINGRIX. (5.2,