BOOSTRIX- tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: I05O535NV6) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:I05O535NV6)

から入手可能:

GlaxoSmithKline Biologicals SA

INN（国際名）:

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

構図:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [iU] in 0.5 mL

投与経路:

INTRAMUSCULAR

適応症:

BOOSTRIX is indicated for:     •    active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,     •    immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. Do not administer BOOSTRIX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of BOOSTRIX or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine [see Description (11)] . Encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BOOSTRIX during pregnancy. Healthcare providers are encouraged to register women by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html. 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. In a randomized, controlled clinical study (NCT02377349), in which the non-U.S. formulation of BOOSTRIX was administered during the third trimester of pregnancy, there were no identified vaccine-related adverse effects on pregnancy or on the fetus/newborn child (see Data) . Available data from the pregnancy registry and from spontaneous and postmarketing reports suggest that the rates of major birth defects and miscarriage in women who received BOOSTRIX within 28 days prior to conception or during pregnancy are consistent with estimated background rates (see Data) . A developmental toxicity study was performed in female rats administered INFANRIX prior to mating and BOOSTRIX during gestation, 0.1 mL at each occasion (a single human dose is 0.5 mL). In a second study, female rats were administered 0.2 mL of BOOSTRIX prior to mating and during the gestation and lactation period. In a third study, female New Zealand White rabbits were given 0.5 mL (full human dose) of BOOSTRIX (non-U.S. formulation) prior to mating and during gestation. These studies revealed no evidence of harm to the fetus due to BOOSTRIX (see Data). Data Human Data: Safety data from a randomized (1:1), controlled clinical study (NCT02377349) (341 non-U.S. formulation of BOOSTRIX, 346 placebo pregnancy outcomes) in which the non-U.S. formulation of BOOSTRIX was administered to pregnant women during the third trimester did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child. Safety data from prospective clinical studies on the use of BOOSTRIX during the first and second trimester of pregnancy are not available. An assessment of data from the U.S. pregnancy exposure registry over approximately 17 years (2005-2022) included 1,523 prospective reports of exposure to BOOSTRIX within 28 days prior to conception or during pregnancy. Among the 256 reports with known pregnancy outcomes, 19 women were exposed to BOOSTRIX in the first trimester with no major birth defects reported and 3 spontaneous abortions with no apparent birth defect; 28 women were exposed to BOOSTRIX in the second trimester, and 199 women were exposed to BOOSTRIX in the third trimester with no major birth defects reported; 10 women were exposed to BOOSTRIX at an unknown timing in pregnancy with no major birth defects reported. An assessment of U.S. spontaneous reports and postmarketing data included 810 prospective reports of exposure to BOOSTRIX during pregnancy since May 2005 through 31 August 2022. Among the 138 reports with known pregnancy outcomes, 17 women were exposed to BOOSTRIX in the first trimester with no major birth defects reported and 2 spontaneous abortions with no apparent birth defect; 26 women were exposed to BOOSTRIX in the second trimester, and 92 women were exposed to BOOSTRIX in the third trimester with no major birth defects reported; 3 women were exposed to BOOSTRIX at an unknown timing in pregnancy with no major birth defects reported. Animal Data: Developmental toxicity studies were performed in female rats and New Zealand White rabbits. In one study, female rats were administered 0.1 mL of INFANRIX (a single human dose is 0.5 mL) by intramuscular injection 30 days prior to mating and 0.1 mL of BOOSTRIX (a single human dose is 0.5 mL) by intramuscular injection on Gestation Days 6, 8, 11, and 15. The antigens in INFANRIX are the same as those in BOOSTRIX, but INFANRIX is formulated with higher quantities of these antigens. In a second study, female rats were administered 0.2 mL of BOOSTRIX by intramuscular injection 28 days and 14 days prior to mating, on Gestation Days 3, 8, 11, and 15, and on Lactation Day 7. In these studies, no adverse effects on embryo-fetal or pre-weaning development up to Postnatal Day 25 were observed; there were no fetal malformations or variations observed. In a third study, female New Zealand White rabbits were administered 0.5 mL (full human dose) of BOOSTRIX (non-U.S. formulation) by intramuscular injection on Premating Days -28 and -14 and on Gestation Days 3, 8, 11, 15, and 24. In this study, no adverse effects on embryo-fetal development related to BOOSTRIX were observed; postnatal development was not evaluated. Risk Summary It is not known whether the vaccine components of BOOSTRIX are excreted in human milk. Data are not available to assess the effect of administration of BOOSTRIX on breastfed infants or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BOOSTRIX and any potential adverse effects on the breastfed child from BOOSTRIX or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. BOOSTRIX is not indicated for use in children aged younger than 10 years. Safety and effectiveness of BOOSTRIX in this age group have not been established. In the initial-dose clinical trials, 1,104 subjects aged 65 years and older received BOOSTRIX; of these subjects, 299 were aged 75 years and older. Adverse events following BOOSTRIX were similar in frequency to those reported with the comparator Td vaccine [see Adverse Reactions (6.1)] . A revaccination study of BOOSTRIX in adults aged 28 to 73 years [see Clinical Studies (14.4)] did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

製品概要:

BOOSTRIX is available in 0.5-mL single-dose vials and single-dose, disposable, prefilled TIP‑LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11 NDC 58160-842-43 Syringe in Package of 10: NDC 58160-842-52 Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

認証ステータス:

Biologic Licensing Application

製品の特徴

BOOSTRIX- TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR
PERTUSSIS
VACCINE, ADSORBED SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOOSTRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BOOSTRIX.
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR
PERTUSSIS VACCINE,
ADSORBED) INJECTABLE SUSPENSION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
10/2023
INDICATIONS AND USAGE
BOOSTRIX is a vaccine indicated for:
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DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY.
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DOSAGE FORMS AND STRENGTHS
Single-dose vials and single-dose prefilled syringes containing a
0.5-mL suspension for injection. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions, Latex (5.2) - Removed
active booster immunization against tetanus, diphtheria, and pertussis
in individuals aged 10 years
and older, (1)
immunization during the third trimester of pregnancy to prevent
pertussis in infants younger than 2
months of age. (1)
Each dose of BOOSTRIX is administered as a 0.5-mL injection. (2.2)
An initial dose of BOOSTRIX is administered 5 years or more after the
last dose of the Diphtheria and
Tetanus Toxoids and Acellular Pertussis (DTaP) series or 5 years or
more after a dose of Tetanus and
Diphtheria Toxoids Adsorbed (Td). BOOSTRIX may be administered as an
additional dose 9 years or
more after the initial dose of Tetanus Toxoid, Reduced Diphtheria
Toxoid and Acellular Pertussis
Vaccine Adsorbed (Tdap). (2.2)
BOOSTRIX may be administered for tetanus prophylaxis for wound
management. For management of
a tetanus-prone wound, a dose of BOOSTRIX may be administered if at
least 5 years have elapsed
since previous receipt of a tetanus toxoid-containing vaccine. (2.2)
To provide protection against pertussis in infants younger than 2
months of age, administer
BOOSTRIX during the third trimester of pregnancy. (2.2)
Severe al