藥品名稱
drug name
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant 0.5mL/syringe), 嘉喜九價人類乳突病毒基因重組疫苗
藥檔狀態使用中
成  份
Ingredient
Human Papillomavirus Vaccine,9-valent
單位含量0.5 mL/Syringe
Dosage FormsSuspension Prefilled Syringe, Intramuscular [preservative free]: 0.5 mL [contains polysorbate 80, yeast extract]
外觀描述 
Appearance 
廠商名稱
Manufacturer
美商默沙東藥廠股份有限公司台灣分公司
製 造 商
Manufacturer
Merck Sharp & Dohme Corp.
字  號
Product ID
衛部菌疫字第001001號
藥理分類
Pharmacologic Category
Vaccine;Vaccine, Inactivated (Viral)
作用機轉
Mechanism of action
Contains inactive human papillomavirus (HPV) proteins (types 6 L1,11 L1, 16 L1, 18 L1, 31 L1, 33 L1, 45 L1, 52 L1, and 58 L1) which produce neutralizing antibodies to prevent cervical, vulvar, vaginal, and anal cancers, cervical adenocarcinoma, cervical, vaginal, vulvar, and anal neoplasia, and genital warts caused by HPV. Efficacy of HPV 9-valent vaccine against anogenital diseases related to the vaccine HPV types in humans is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.
用途/適應症 
Use Prevention of human papillomavirus infection:
Females 9 to 45 years of age:
For the prevention of the following diseases:
Cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58
Genital warts (condyloma acuminata) caused by HPV types 6 and 11
For the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3
Cervical adenocarcinoma in situ (AIS)
Vulvar intraepithelial neoplasia (VIN) grades 2 and 3
Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Males 9 through 45 years of age:
For the prevention of the following diseases:
Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Genital warts (condyloma acuminata) caused by HPV types 6 and 11
For the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
AIN grades 1, 2, and 3.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for females and males 11 to 12 years of age; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age. Catch-up vaccination is recommended for all persons through 26 years of age. Shared clinical decision-making regarding catch-up HPV vaccination is recommended for some adults 27 to 45 years of age (CDC/ACIP [Meites 2019]). The American Academy of Pediatrics and the American Cancer Society (ACS) recommend routine vaccination for individuals 9 to 12 years of age (ACS [Saslow 2020]; Red Book [AAP 2018]). ACS recommends catch-up vaccination only for individuals through 26 years of age (ACS [Saslow 2020]).
衛福部核准適用症狀
MOHW approved indications
GARDASIL 9適用於9至45歲的人施打,使其產生主動免疫反應,以預防下列由人類乳突病毒(HPV)所引起的病變: ‧ 由第6, 11, 16, 18, 31, 33, 45, 52及58型 HPV所引起的子宮頸、外陰、陰道及肛門部位的癌前病變與癌症。 ‧ 由第6及11型 HPV所引起的生殖器疣(尖形濕疣)。
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】
Immunization: IM:
Manufacturer`s labeling: Adults ≦45 years of age: 3-dose series: 0.5 mL at 0, 2, and 6 months

CDC/ACIP recommended immunization schedule: Adults≦26 years of age: Catch-up vaccination is recommended in all persons≦26 years of age if not previously vaccinated or have not completed the 3-dose series (typically administer first dose at age 11 to 12 years). Second and third doses may be given after age 26 years to complete a previously initiated series (CDC/ACIP [Markowitz 2014]; CDC/ACIP [Meites 2016]; CDC/ACIP [Meites 2019]). Note: Shared clinical decision-making regarding catch-up human papillomavirus vaccination is recommended for some adults 27 to 45 years of age (CDC/ACIP [Meites 2019]). The American Cancer Society does not endorse vaccination in adults 27 to 45 years of age (ACS [Saslow 2020]).

Have not received any doses: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months. There should be a 4-week minimum interval between the first and second dose; a 12-week minimum interval between the second and third dose; a 5-month minimum interval between the first and third dose.
Partially vaccinated, first dose before 15 years of age:
If 2 doses administered at least 5 months apart: no more doses needed
If only a single dose or if doses <5 months apart: IM: Administer one additional 0.5 mL dose
Partially vaccinated, first dose at 15 years of age or later: Complete 3-dose series: IM: There should be a 4-week minimum interval between the first and second dose; a 12-week minimum interval between the second and third dose; a 5-month minimum interval between the first and third dose.

【Pediatric】
Primary immunization: Children≧9 years and Adolescents: IM: 0.5 mL per dose for 2 or 3 doses; see the following recommendations for number and timing of doses (CDC/ACIP [Meites 2016]; CDC/ACIP [Petrosky 2015]).
CDC/ACIP recommended immunization schedule: Routine vaccination at 11 to 12 years of age for all persons; may start as early as 9 years of age. AAP and ACS recommend routine vaccination between 9 and 12 years of age (ACS [Saslow 2020]; Red Book [AAP 2018]).
- In a 2-dose schedule, minimum interval between first and second doses is 5 months.
- In a 3-dose schedule, minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 5 months (CDC/ACIP [Meites 2016]).
- Non-immunocompromised patients and certain specified medical conditions: Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system, anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:
* Children≧9 years and Adolescents <15 years: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. Administer first dose at age 11 to 12 years. For patients with any history of sexual abuse or assault, vaccination should be started at 9 years.
* Adolescents≧15 years: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months.
-Immunocompromised patients: Including those with conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy:
* Children≧9 years and Adolescents: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months.

Manufacturing labeling: May not reflect current practice:
- Children≧9 years and Adolescents <15 years:
* 2-dose series: IM: 0.5 mL per dose; administer the second dose at 6 to 12 months after initial dose. If the second dose is inadvertently administered earlier than 5 months after the first dose, then patient should be converted to a 3-dose series.
* 3-dose series: IM: 0.5 mL per dose; administer the second and third doses at 2 and 6 months after initial dose.
-Adolescents≧15 years: IM: 0.5 mL per dose for a total of 3 doses; administer the second and third doses at 2 and 6 months after initial dose.


Catch-up immunization: CDC/ACIP recommendations (Meites 2016; Meites 2019): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number. Children≧9 years and Adolescents: IM: 0.5 mL per dose for a total of 2 to 3 doses (See CDC/ACIP recommendations in Primary Immunization for 2-dose vs 3-dose schedule criteria):
- First dose given on the elected date.
- Second dose given at least 4 weeks after the first dose (for a 3-dose schedule) or 5 months after the first dose (for a 2-dose schedule).
- Third dose (for a 3-dose schedule) given at least 12 weeks after the second dose and at least 5 months after the first dose.

【Renal Impairment】
There are no dosage adjustments provided in the manufacturer`s labeling.

【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:B

Based on available data, an increased risk of adverse pregnancy outcomes has not been observed following inadvertent use in pregnant women. Administration of the vaccine in pregnancy is not recommended. The vaccine series (or completion of the series) should be delayed until pregnancy is completed (CDC/ACIP [Petrosky 2015]).

仿單:
目前並無任何適當且控制良好的、對孕婦施打GARDASIL 9的研究。現有的人類試驗資料並未顯示在懷孕期間施打GARDASIL 9會使發生重大出生缺陷與流產的風險因使用疫苗而升高。
-----------------------------------------------------------
[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 過敏反應,包括對酵母菌(疫苗組成之一)嚴重過敏反應,或先前曾於接種一劑Gardasil 9或Gardasil之後出現過敏反應。
Contraindications Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of this vaccine or human papillomavirus (types 6, 11, 16, 18) vaccine (recombinant).
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.
Reported incidences are for females 9 to 45 years of age and males 9 to 26 years of age.

>10%:
Local: Erythema at injection site (7% to 42%; increased with successive doses), pain at injection site (63% to 90%), swelling at injection site (13% to 49%; increased with successive doses)
Nervous system: Headache (7% to 20%)

1% to 10%:
Dermatologic: Injection site pruritus (1% to 8%)
Gastrointestinal: Diarrhea (≦1%), nausea (1% to 4%), upper abdominal pain (≦2%)
Immunologic: Autoimmune disease (2%)
Local: Bleeding at injection site (1%), bruising at injection site (2%), hematoma at injection site ( ≦5%), hypersensitivity reaction at injection site (1%), induration at injection site (≦2%), injection site nodule (1%), injection site reaction (≦1%)
Nervous system: Dizziness (≦3%), fatigue (1% to 3%)
Neuromuscular & skeletal: Myalgia (≦1%)
Respiratory: Oropharyngeal pain (1% to 3%)
Miscellaneous: Fever (2% to 10%)

<1%:
Local: Warm sensation at injection site
Respiratory: Upper respiratory tract infection

Frequency not defined:
Hypersensitivity: Hypersensitivity reaction
Respiratory: Status asthmaticus

Postmarketing:
Cardiovascular: Syncope
Dermatologic: Urticaria
Gastrointestinal: Vomiting
★高警訊藥品
監測建議

監測
Monitoring
Screening for HPV is not required prior to vaccination. Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. Continue recommended anal cancer screening.

Females: Gynecologic screening exam, papillomavirus test; screening for cervical cancer should continue per current guidelines following vaccination
警語與注意事項 
Warnings & precautions 
針劑溶解條件
針劑稀釋條件 不可稀釋使用。(1100325仿單資料)
針劑不相容性 不可與其他疫苗混合使用。(1100325仿單資料)
針劑施打條件 僅供肌肉注射使用。施打於上臂的三角肌區域,或大腿前外側區域較高的部位。(1100325仿單資料)
針劑保存安定性 冷藏儲存於2-8℃的環境,切勿冷凍,避光儲存。
離開冷藏環境(8-25℃的溫度下)的總時間(多次短程運送的累計時間)不超過72小時的情況下仍可使用。也允許在0-2℃的條件下多次短程運送,只要總時間不超過72小時。(1100325仿單資料)
最近修改日期時間
Updated
3/25/2021 11:40:28 AM
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