TWINRIX (hepatitis a and hepatitis b- recombinant vaccine injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ) (HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:5BFC8LZ6LQ), HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (UNII: 9GCJ1L5D1P) (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN - UNII:9GCJ1L5D1P)

Available from:

GlaxoSmithKline Biologicals SA

INN (International Name):

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN - UNII:5BFC8LZ6LQ)

Composition:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

TWINRIX is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing or hepatitis B-containing vaccine, or to any component of TWINRIX, including yeast and neomycin, is a contraindication to administration of TWINRIX [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 TWINRIX 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 TWINRIX within 28 days prior to conception or during pregnancy (see Data) . A developmental toxicity study was performed in female rats administered TWINRIX 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: A pregnancy exposure registry was maintained 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. In pre- and post-licensure clinical studies of TWINRIX, 45 pregnant women were inadvertently administered TWINRIX following their last menstrual period. Among such pregnancies, after excluding elective terminations (n = 1) and those lost to follow-up (n = 1), there were 43 pregnancies with known outcomes all with exposure in the first trimester. Miscarriage was reported in 16% of pregnancies (7/43) and major birth defects were reported in 2.6% of live births (1/38). 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 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 TWINRIX 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 TWINRIX and any potential adverse effects on the breastfed child from TWINRIX 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 pediatric patients younger than 18 years have not been established. Clinical studies of TWINRIX did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects [see Clinical Studies (14.1, 14.3)] .

Product summary:

TWINRIX is available in 1-mL single-dose prefilled disposable TIP‑LOK syringes (Luer Lock syringes) packaged without needles (Preservative-Free Formulation). 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. NDC 58160-815-43 Syringe in Package of 10: NDC 58160-815-52 Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TWINRIX- HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE INJECTION,
SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TWINRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TWINRIX.
TWINRIX [HEPATITIS A & HEPATITIS B (RECOMBINANT) VACCINE] INJECTABLE
SUSPENSION, FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.1) - Removed
4/2023
INDICATIONS AND USAGE
TWINRIX is a vaccine indicated for active immunization against disease
caused by hepatitis A virus and
infection by all known subtypes of hepatitis B virus. TWINRIX is
approved for use in persons 18 years of age
or older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Suspension for injection available in 1-mL prefilled syringes. (3, 11,
16)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any hepatitis A-containing or hepatitis
B-containing vaccine, or to any component of TWINRIX, including yeast
and neomycin. (4)
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Following any dose of TWINRIX, the most common (≥10%) solicited
injection site reactions were injection
site soreness (35% to 41%) and redness (8% to 11%); the most common
solicited systemic adverse
reactions were headache (13% to 22%) and fatigue (11% to 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 TWINRIX with any other vaccine or product in the same
syringe. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration
2.3 Recommended Dose and Schedule
3 DOSAGE FORMS AND STRENGTHS
TWINRIX is administered by intramuscular injection. (2.2)
Standard Dosing: A series of 3 doses (1-mL each) given on a 0-, 1