ENGERIX-B (hepatitis b vaccine- recombinant injection, suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (UNII: 9GCJ1L5D1P) (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN - UNII:9GCJ1L5D1P)

Tersedia dari:

GlaxoSmithKline Biologicals SA

INN (Nama Internasional):

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

Komposisi:

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 0.5 mL

Rute administrasi :

INTRAMUSCULAR

Indikasi Terapi:

ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B [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. There are no adequate and well-controlled studies of ENGERIX-B in pregnant women in the U.S. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received ENGERIX-B during pregnancy (see Data) . There are no animal studies with ENGERIX-B to inform use during pregnancy. A developmental toxicity study was performed in female rats administered a vaccine with the same hepatitis B surface antigen component and quantity as ENGERIX-B prior to mating and during gestation (0.2 mL at each occasion). This study revealed no adverse effects on fetal or pre-weaning development (see Data ). Data Human Data: In an evaluation of pre- and post-licensure clinical trials of ENGERIX-B, 58 pregnant women were inadvertently administered ENGERIX-B following their last menstrual period. After excluding elective terminations (n = 6), those with an unknown outcome (n = 3), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 22), there were 26 pregnancies with known outcomes with exposure in the first or second trimester. Miscarriage was reported in 11.5% of pregnancies with exposure prior to 20 weeks of gestation (3/26) and major birth defects were reported in 0% (0/23) of live births born to women with exposure during the first or second trimester. The rates of miscarriage and major birth defects were consistent with estimated background rates. No pregnancy registry for ENGERIX-B was conducted. TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the same hepatitis B surface antigen component and quantity as used in ENGERIX-B. Therefore, clinical data accrued with TWINRIX are relevant to ENGERIX-B. A pregnancy exposure registry was maintained for TWINRIX from 2001 to 2015. The registry prospectively enrolled 245 women who received a dose of TWINRIX during pregnancy or within 28 days prior to conception. After excluding induced abortions (n = 6, including one of a fetus with congenital anomalies), those lost to follow-up (n = 142), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 9), there were 87 pregnancies with known outcomes with exposure within 28 days prior to conception, or in the first or second trimesters. Miscarriage was reported for 9.6% of pregnancies with exposure to TWINRIX prior to 20 weeks gestation (8/83). Major birth defects were reported for 3.8% of live born infants whose mothers were exposed within 28 days prior to conception or during the first or second trimester (3/80). The rates of miscarriage and major birth defects were consistent with estimated background rates. Animal Data: In a developmental toxicity study, female rats were administered TWINRIX, which contains the same hepatitis B surface antigen component and quantity as ENGERIX-B, by intramuscular injection on Day 30 prior to mating and on gestation Days 6, 8, 11, and 15. The total dose was 0.2 mL (divided) at each occasion (a single human dose is 1 mL). No adverse effects on pre-weaning development up to post-natal Day 25 were observed. There were no fetal malformations or variations. Risk Summary There is no information regarding the presence of ENGERIX-B in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENGERIX-B and any potential adverse effects on the breastfed child from ENGERIX-B or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Safety and effectiveness of ENGERIX-B have been established in all pediatric age-groups. Maternally transferred antibodies do not interfere with the active immune response to the vaccine. [See Adverse Reactions (6), Clinical Studies (14.1, 14.3, 14.4).] The timing of the first dose in infants weighing less than 2,000 g at birth depends on the HBsAg status of the mother. [See Warnings and Precautions ( 5.2).] Clinical studies of ENGERIX-B used for licensure did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years.5 [See Clinical Studies (14.2).]

Ringkasan produk:

ENGERIX‑B (preservative-free formulation) is available in prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (pediatric/adolescent and adult doses) and single-dose vials (adult dose only). 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. 10 mcg/0.5 mL Pediatric/Adolescent Dose NDC 58160-820-43 Syringe in Package of 10: NDC 58160-820-52 20 mcg/mL Adult Dose NDC 58160-821-01 Vial in Package of 10: NDC 58160-821-11 NDC 58160-821-43 Syringe in Package of 10: NDC 58160-821-52 Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen. Do not dilute to administer.

Status otorisasi:

Biologic Licensing Application

Karakteristik produk

ENGERIX-B- HEPATITIS B VACCINE (RECOMBINANT) INJECTION, SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENGERIX-B SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENGERIX-B.
ENGERIX-B [HEPATITIS B VACCINE (RECOMBINANT)] INJECTABLE SUSPENSION,
FOR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ENGERIX-B is a vaccine indicated for immunization against infection
caused by all known subtypes of
hepatitis B virus. (1)
DOSAGE AND ADMINISTRATION
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•
•
DOSAGE FORMS AND STRENGTHS
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•
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any hepatitis B-containing vaccine, or
to any component of ENGERIX-B, including yeast. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common solicited adverse reactions were injection-site
soreness (22%) and fatigue (14%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
DRUG INTERACTIONS
Do not mix ENGERIX-B with any other vaccine or product in the same
syringe or vial. (7.1)
USE IN SPECIFIC POPULATIONS
Warnings and Precautions, Latex (5.1) - Removed
10/2023
FOR INTRAMUSCULAR ADMINISTRATION. (2, 2.2)
Persons from birth through 19 years of age: A series of 3 doses (0.5
mL each) on a 0-, 1-, 6-month
schedule. (2.3)
Persons 20 years of age and older: A series of 3 doses (1 mL each) on
a 0-, 1-, 6-month schedule.
(2.3)
Adults on hemodialysis: A series of 4 doses (2 mL each) as a single
2-mL dose or as two 1-mL doses
on a 0-, 1-, 2-, 6-month schedule. (2.3)
ENGERIX-B is a sterile suspension available in the following
presentations:
0.5-mL (10 mcg) prefilled syringes (3)
1-mL (20 mcg) single-dose vials and prefilled syringes (3)
Syncope (fainting) can occur in association with administration of
injectable vaccines, including
ENGERIX-B. Procedures should be in place to avoid falling inj