藥品名稱
drug name		公費 Engerix-B 10mcg/0.5mL/vial (Hepatits B vaccine) 安在時疫苗
藥檔狀態使用中
成　　份
Ingredient		Recombinant hepatitis B vaccines
單位含量10 mcg/0.5mL/vial
Dosage FormsInjection, suspension Engerix-B: 10mcg/0.5mL/vial
外觀描述 
Appearance 
廠商名稱
Manufacturer		裕利股份有限公司
製 造 商
Manufacturer		GLAXOSMITHKLINE BIOLOGICALS S.A.
字　　號
Product ID		衛署菌疫輸字第000301號
藥理分類
Pharmacologic Category		Vaccine; Vaccine, Inactivated (Viral); Vaccine, Recombinant
作用機轉
Mechanism of action		Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine, which confers active immunity via formation of antihepatitis B antibodies. The vaccine is derived from hepatitis B surface antigen (HBsAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HBsAg is cloned into yeast, which is then cultured to produce hepatitis B vaccine.
用途/適應症 
Use Hepatitis B disease prevention: Active immunization against infection caused by all known subtypes of hepatitis B virus (HBV).

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following (CDC/ACIP [Schillie 2018]):
— All neonates (regardless of weight) born to either hepatitis B surface antigen (HBsAg) positive mother or mother with unknown status (administer first dose within 12 hours of birth).
— All neonates weighing≧2 kg (eg, term) born to HBsAg negative mother (administer first dose within 24 hours of birth).
— All neonates weighing <2 kg (eg, preterm) born to HBsAg negative mother (administer first dose at 1 month of age or prior to hospital discharge).
— All unvaccinated infants, children, and adolescents <19 years of age.
— All unvaccinated adults requesting protection from HBV infection.
— All unvaccinated adults at risk for HBV infection such as those with:
— Behavioral risks: Sexually-active persons with >1 partner in a 6-month period; persons seeking evaluation or treatment for a sexually transmitted disease; men who have sex with men; injection drug users.
— Occupational risks: Health care personnel and public safety workers with reasonably anticipated risk for exposure to blood or blood contaminated body fluids.
— Medical risks: Persons with end-stage renal disease (including predialysis, hemodialysis, peritoneal dialysis, and home dialysis); persons with HIV infection; persons with chronic liver disease (eg, hepatitis C virus infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST level >2 times the upper limit of normal). Adults (19 through 59 years of age) with diabetes mellitus type 1 or type 2 should be vaccinated as soon as possible following diagnosis. Adults ≧60 years of age with diabetes mellitus may also be vaccinated at the discretion of their treating clinician based on the likelihood of acquiring HBV infection.
— Other risks: Household contacts or sex partners of persons who are HBsAg-positive; residents and staff of facilities for developmentally disabled persons; international travelers to regions with high or intermediate levels of endemic HBV infection; incarcerated persons.
— Pregnant patients at risk for infection or severe outcome from infection during pregnancy (ACIP [Freedman 2020]).

In addition, the ACIP recommends vaccination for any persons who are wounded in bombings or similar mass casualty events who have penetrating injuries or non-intact skin exposure, or who have contact with mucous membranes (exception - superficial contact with intact skin), and who cannot confirm receipt of a hepatitis B vaccination (CDC [Chapman 2008]).
衛福部核准適用症狀
MOHW approved indications		 預防Ｂ型肝炎
常用劑量
(藥品劑量會因人或病情增減，請依照醫師指示服用。)
Dose Adult
Primary immunization: IM: Note: Adult formulations of hepatitis B vaccine products differ by concentration (mcg/mL) but when dosed in terms of volume (mL), the dose of Engerix-B and Recombivax HB are the same (both 1 mL). Recombivax HB adult formulation contains 10 mcg/mL and Recombivax HB dialysis formulation contains 40 mcg/mL; See Dosing: Renal Impairment for dosing in adult patients with chronic kidney disease and/or dialysis.
Immunocompetent adults (non-dialysis): 1 mL/dose (adult formulation) for 3 total doses administered at 0, 1, and 6 months. Note: Refer to CDC guidelines (CDC/ACIP [Schillie 2018]) for other options. Manufacturer labeling may include alternate immunization schedules.
Adults with immunocompromising conditions (off-label use): Note: Some experts consider use of high-dose (40 mcg) hepatitis B vaccine for patients with immunocompromising conditions (eg, HIV infection, cirrhosis, transplantation, receipt of chemotherapy) despite limited data (AASLD [Terrault 2018]; CDC/ACIP [Schillie 2018]; HHS 2018; IDSA [Rubin 2014]).
Engerix-B 20 mcg/mL: Administer 2 mL per dose at 0, 1, 2, and 6 months
Recombivax HB 40 mcg/mL: Administer 1 mL per dose at 0, 1, and 6 months

Revaccination (CDC/ACIP [Schillie 2018]): IM:
Healthcare professionals (HCP): For HCPs completely vaccinated and with anti-HBs levels <10 milliunits/mL, administer an additional hepatitis B dose; perform anti-HBs testing 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, complete the vaccine series; perform anti-HBs testing 1 to 2 months later. Alternatively, HCPs with anti-HBs levels <10 milliunits/mL may receive a second, complete 3-dose vaccination series followed by a reassessment of anti-HBs levels 1 to 2 months after the final dose.

Bombings or similar mass-casualty events: IM: In persons without a reliable history of vaccination against HepB and who have no known contraindications to the vaccine, vaccination should begin within 24 hours (but no later than 7 days) following the event (CDC [Chapman 2008]).

Postexposure management of health care personnel (HCP) (CDC/ACIP [Schillie 2018]): IM:
Documented vaccine responder: If the HCP has prior documentation of ≧3 doses of a hepatitis B vaccine and a postvaccination anti-HBs ≧10 milliunits/mL, then additional hepatitis B vaccine is not needed, regardless of the patient`s HBsAg status. HCP is considered seroprotected.
Unvaccinated or incompletely vaccinated: Test source patient for HBsAg as soon as possible after exposure. Administer a complete hepatitis B vaccine series to the HCP; if source patient positive or unknown status for HBsAg, begin vaccination series as soon as possible (with a dose of HBIG). Follow up with anti-HBs testing 1 to 2 months after the final vaccine dose. If anti-HBs levels are <10 milliunits/mL, then the HCP should receive a second, complete vaccine series followed by anti-HBs testing 1 to 2 months after the final vaccine dose.
Vaccinated with 3 doses of hepatitis B vaccine but postvaccination anti-HBs status is unknown: Test HCP for anti-HBs.
If anti-HBs ≧10 milliunits/mL, no additional hepatitis B vaccine is needed.
If anti-HBs <10 milliunits/mL and the source patient status is HBsAg positive or unknown, revaccinate the HCP with a complete 3-dose vaccination series and administer 1 dose of HBIG as soon as possible. Anti-HBs testing should be performed 1 to 2 months after the final vaccine dose.
If anti-HBs <10 milliunits/mL and the source patient is HBsAg negative, the HCP should receive a single vaccine dose followed by anti-HBs testing 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, then 2 additional vaccine doses should be administered and anti-HBs testing performed 1 to 2 months after the final vaccine dose.
Vaccinated with 6 doses of hepatitis B vaccine (2 complete series) but documented as a nonresponder to the vaccine: No postexposure vaccination is recommended. If the source patient status is HBsAg positive or unknown, administer 2 doses of HBIG separated by 1 month.

Postexposure management in nonoccupational settings (CDC/ACIP [Schillie 2018]): IM:
Documented vaccine recipient without post-vaccination anti-HBs testing: If exposure was to an HBsAg-positive source, administer a single dose of hepatitis B vaccine. If exposure was to an HBsAg-unknown source, then no additional treatment required.
Vaccination in process: Complete the vaccination series. If exposure was to an HBsAg-positive source, also administer a dose of HBIG.
Unvaccinated: If exposure was to an HBsAg-positive source, administer both hepatitis B vaccine and HBIG as soon as possible (preferably within 24 hours after exposure [<7 days for percutaneous exposure or <14 days for sexual exposure]); complete the vaccination series. If exposure was to an HBsAg-unknown source, administer complete vaccination series.

Pediatric
Although hepatitis B vaccine products differ by concentration (mcg/mL), when dosed in terms of volume (mL), the equivalent dose is the same between products (ie, 0.5 mL of Recombivax-HB is equivalent to 0.5 mL of Engerix-B). Combination vaccines may be used to complete the immunization series after the infant is 6 weeks of age. Please see combination vaccine monographs for dose and schedule details. Vaccines from different manufacturers are interchangeable during an immunization series with the exception of an adolescent (11 to 15 years) 2-dose Recombivax-HB regimen (CDC/ACIP [Schillie 2018]).

Primary immunization:
CDC (ACIP) recommendations (CDC/ACIP [Schillie 2018]): Infants: Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation): IM: 0.5 mL per dose for a total of 3 doses given as follows: Ideally first dose is administered at birth, the second dose at 1 to 2 months of age, and a final third dose at 6 months up to 18 months of age; minimum age for the final (third) dose is 24 weeks
Infants born to HBsAg-negative mothers:
First dose: 0.5 mL within 24 hours of birth
Second dose: 0.5 mL at 1 to 2 months of age
Third dose: 0.5 mL at 6 to 18 months of age. The final dose should be given ≧8 weeks after the second dose and ≧16 weeks after the first dose, but no sooner than 24 weeks of age. For populations with current or historically elevated rates of childhood HBV infection, the final dose should be administered between 6 and 12 months of age.
Note: Former premature neonates <2 kg should have the initial dose deferred up to 30 days of chronological age or at hospital discharge.

Infants born to HBsAg- positive mothers:
Former term neonates and infants should receive the usual 3-dose series; preterm neonates should receive a 4-dose series due to potential decreased immunogenicity.
First dose: 0.5 mL within first 12 hours of life, even if premature and regardless of birth weight; HBIG should also be administered at the same time at a different anatomical site
Second dose: 0.5 mL, timing of dose dependent on birthweight:
Birthweight <2 kg (eg, preterm): At 1 month of age
Birthweight ≧2 kg (eg, term): At 1 to 2 months of age
Third dose: 0.5 mL, timing of dose dependent on birthweight:
Birthweight <2 kg (eg, preterm): At 2 to 3 months of age
Birthweight ≧2 kg (eg, term): Final dose: At 6 months of age. This dose should be given ≧8 weeks after the second dose and ≧16 weeks after the first dose, but no sooner than 24 weeks of age.
Fourth dose: Birthweight <2 kg (eg, preterm): Final dose: At least 6 months of age (24 weeks)
Follow-up serologic testing after completion of vaccine series: Anti-HBs and HBsAg levels should be checked at 9 to 12 months of age (ie, next well-child visit after series completion). If level ≧10 milliunits/mL, no further action needed. If HBsAg negative and anti-HBs levels <10 milliunits/mL, revaccinate with a single vaccine dose and reassess 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, administer 2 additional vaccine doses to complete the second vaccination series and reassess anti-HBs levels 1 to 2 months after the final dose. Alternatively, HBsAg-negative infants with anti-HBs levels <10 milliunits/mL may receive a second, complete 3-dose vaccination series followed by a reassessment of anti-HBs and HBsAg levels 1 to 2 months after the final dose.

Infants born to mothers whose HBsAg status is unknown at birth:
Birthweight <2 kg (eg, preterm): Manage as if born to HBsAg-positive mother (ie, birth dose of vaccine not counted in series); once maternal status determined, follow applicable schedule.
Birthweight ≧2 kg (eg, term): Manage as if born to HBsAg-positive mother; once maternal status determined, follow applicable schedule.

Canadian labeling: 0.5 mL/dose (pediatric/adolescent formulation) for 3 total doses administered at 0, 1, and 6 months. For accelerated protection, a 4-dose series can be administered at 0, 1, and 2 months plus a booster at 12 months.

Catch-up immunization: Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.
Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation): Infants ≧4 months, Children, and Adolescents: IM: 0.5 mL per dose for 3 total doses; refer to annual immunization and CDC guideline (CDC/ACIP [Schillie 2018]) for timing options.
Recombivax HB (Adult formulation): Adolescents 11 to 15 years: IM: 1 mL per dose for 2 doses; first dose given on the elected date, second dose given 4 to 6 months later if patient still ≧15 years. Note: Refer to most recent CDC guideline for other options. Manufacturer`s labeling may include alternate immunization schedules.

Bombings or similar mass casualty events: IM: In persons without a reliable history of vaccination against hepatitis B and who have no known contraindications to the vaccine, vaccination should begin within 24 hours (but no later than 7 days) following the event (CDC [Chapman 2008])

Geriatric
Refer to adult dosing.

Renal impairment
Adult
≧20 years:
Chronic kidney disease: Recombivax HB 40 mcg/mL: IM: Administer 1 mL per dose at 0, 1, and 6 months
Dialysis patients: IM:
Engerix-B 20 mcg/mL: Administer 2 mL per dose at 0, 1, 2, and 6 months
Recombivax HB 40 mcg/mL: Administer 1 mL per dose at 0, 1, and 6 months
Note: Serologic testing is recommended 1 to 2 months after the final dose of the primary vaccine series and annually to determine the need for booster doses. Persons with anti-HBs concentrations of <10 milliunits/mL should receive a booster dose (CDC/ACIP [Schillie 2018]).

Pediatric
Hemodialysis patients often respond poorly to hepatitis B vaccination; higher vaccine doses or increased number of doses may be required. The anti-HBs (antibody to hepatitis B surface antigen) response of such persons should be tested after they are vaccinated, and those who have not responded should be revaccinated with 1 to 3 additional doses. Patients with chronic renal disease should be vaccinated as early as possible, ideally before they require hemodialysis.
Chronic renal impairment: Infants, Children, and Adolescents: IM: Administer a 3-dose series with subsequent doses at 1 to 2 and 4 to 6 months after the initial dose; repeat dose depending upon annual assessment of anti-HBs level; if anti-HBs <10 milliunits/mL administer an additional dose (CDC/ACIP [Mast 2005]; Rangel 2000)
Dialysis and predialysis patients (CrCl <60 mL/minute/1.73 m2): Infants, Children, and Adolescents: IM: There are no specific ACIP recommendations regarding dosing in dialysis patients; however, some experts suggest that pediatric patients follow standard pediatric schedule; higher doses or additional doses may be required (CDC 2012; CDC/ACIP [Mast 2005]; Neu 2012; Rangel 2000)
Recombivax HB (40 mcg/mL dialysis formulation): Limited data available: Children and Adolescents: IM: 0.5 mL/dose (20 mcg) for 3-dose series with subsequent doses at 1 month and 6 months after the first dose. Dosing based on a multicenter trial of 78 pediatric patients (age: 1 to 18 years) using Recombivax-HB (Dialysis formulation) and showed protective levels of antibody occurring in 75% to 97% of pediatric hemodialysis patients using higher dose (Watkins 2002)

Hepatic impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
懷孕分級
Pregnancy Risk Factor		 依文獻內容判定系統稽核懷孕分級建置為：CM

Available data do not suggest an increased risk of major birth defects or miscarriage following maternal use of hepatitis B vaccine.
The ACIP recommends HBsAg testing for all pregnant females. Pregnancy itself is not a contraindication to vaccination; vaccination is recommended for those identified as being at risk for HBV infection (CDC/ACIP [Schillie 2018]). Refer to current immunization schedule for vaccinating pregnant females.
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[FDA(美國食品及藥物管理局)懷孕分級說明:
A：對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B：動物試驗無法證實對胎兒有害，但缺乏人類對照試驗；或動物試驗有副作用報告，但無法證實對懷孕初期及後期之胎兒有害。
C：動物實驗中對胎兒有害但缺乏孕婦對照實驗；或無動物及孕婦試驗。
D：證實對胎兒有害，但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X：證實對胎兒有害，且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
禁忌症 Engerix-B不應用於以知對此疫苗中任何成分過敏者，或先前曾於接種Engerix-B後產生過敏病徵者。
Contraindications Severe allergic or hypersensitivity reaction to yeast, hepatitis B vaccine, or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Known hypersensitivity to any component of the formulation; severe febrile illness.
常見副作用 
Common adverse drug reactions 
Adverse Reactions The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined. The most common adverse effects reported with both products included injection site reactions (>10%).
— Cardiovascular：Flushing, hypotension
— Central nervous system：Body pain, chills, dizziness, drowsiness, fatigue, headache, insomnia, irritability, malaise, paresthesia, tingling sensation, vertigo
— Dermatologic：Diaphoresis, pruritus, skin rash, urticaria
— Gastrointestinal：Abdominal pain, anorexia, decreased appetite, diarrhea, dyspepsia, nausea, stomach cramps, vomiting
— Genitourinary：Dysuria
— Hematologic & oncologic：Lymphadenopathy
— Hypersensitivity：Angioedema
— Infection：Influenza
— Local：Bruising at injection site, erythema at injection site, induration at injection site, injection site nodule, itching at injection site, local soreness/soreness at injection site, pain at injection site, swelling at injection site, tenderness at injection site, warm sensation at injection site
— Neuromuscular & skeletal：Arthralgia, back pain, myalgia, neck pain, neck stiffness, shoulder pain, weakness
— Otic：Otalgia
— Respiratory：Cough, pharyngitis, rhinitis, upper respiratory tract infection
— Miscellaneous：Fever (≧37.5°C/100°F)

Postmarketing and/or case reports: Abnormal hepatic function tests, acute exacerbations of multiple sclerosis, agitation, alopecia, anaphylactoid reaction, anaphylaxis, apnea, arthritis, Bell`s palsy, brain disease, bronchospasm, conjunctivitis, constipation, convulsions, eczema, encephalitis, erythema nodosum, erythema multiforme, febrile seizures, Guillain-Barre syndrome, herpes zoster, hypersensitivity reaction, hypoesthesia, increased erythrocyte sedimentation rate, increased liver enzymes, keratitis, lichen planus, limb pain, lupus-like syndrome, meningitis, migraine, multiple sclerosis, myasthenia, myelitis, neuritis, neuropathy, optic neuritis, palpitations, paralysis, paresis, periarteritis nodosa, peripheral neuropathy, petechiae, purpura, radiculopathy, seizure, serum sickness-like reaction (may be delayed days to weeks), Stevens-Johnson syndrome, syncope, systemic lupus erythematosus, tachycardia, thrombocytopenia, tinnitus, transverse myelitis, uveitis, vasculitis, visual disturbance
★高警訊藥品
監測建議
監測
Monitoring		 Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2021]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. In preterm infants, consider respiratory monitoring for 48 to 72 hours after administration.
警語與注意事項 
Warnings & precautions 
針劑溶解條件
針劑稀釋條件
針劑不相容性 Engerix-B不應與其它疫苗混合使用。(1100601仿單資料)
針劑施打條件 Engerix-B應以肌肉注射方式注射於成人或兒童的手臂三角肌部位，或新生兒、嬰兒及幼童的大腿前外側。血小板減少症或出血性疾病患者則例外，應以皮下注射方式投與此疫苗。
Engerix-B不可採臀部注射或皮內注射方式投與，因為這種投予方式所產生的免疫反應較低。任何情況下都不可採血管內注射方式投予Engerix-B。(1100601仿單資料)
針劑保存安定性 避光貯存於2℃-8℃。切勿冷凍。(1100601仿單資料)

離開冰箱保存條件與時效：
8-25度C可存放168小時(7天)
26-37度C可存放72小時(3天)
若離開冰箱在室溫再度回冰，則以離開冰箱的溫度時效開始計算7天或3天。
(GSK提供之藥品安定性資料)
最近修改日期時間
Updated		6/1/2021 11:51:38 AM
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