英文药名: Immucyst(Bacillus Calmette-Guérin)

中文药名: 巴斯德BCG免疫治疗剂, 膀胱癌治疗用卡介苗

药品介绍

商品名: BCG IMMUNOTHERAPEUTIC
中文名: 巴斯德 BCG 免疫治疗剂
学名: BCG vaccine
类别: INT 剂量
结构式: 每瓶含有81mg(乾重) BCG和5% Monosodium glutamate。
BCG桿菌经重新调配后可存活，每剂含6.6-19.2 X 108菌落形成单位(CFC)。

药理作用
BCG免疫治疗剂促进膀胱处其有组织细胞及白血球细胞渗透的局部发炎。局部发炎作用因膀胱表面癌损伤之明显去除或减少而引起。其真正之机转未明。

适应症
本品(BCG免疫治疗剂)适用於膀胱内使用，治疗膀胱之初级復发性原位癌(CIS)，以降低肿瘤再发之频率。其适用於治疗伴有或未伴有乳头状肿瘤之原位癌。但不适用於治疗单独发生之乳头状瘤。本品亦用作膀胱对其他原位癌(CIS)治疗疗程无法反应后之补救疗法。
治疗及预防膀胱原发或復发性原位癌或经尿道切除后之表浅性乳头瘤（ＴＡ及Ｔ１）。

用法用量
膀胱内治疗及预防膀胱原位癌(CIS)应於切片检查或经尿道切除手术后7至14天开始。一次剂量3小瓶，本品(BCG免疫治疗剂)由膀胱内投举每週一次歷时6週(诱导疗法)。各次剂量(3瓶调製好小瓶)再用50毫升减菌，无防腐剂之食盐水稀释，总量为53毫升。尿道导管在无菌状况下插入膀胱内，引导膀胱内容物，然后藉重力缓慢将50毫升本品悬浮液灌入，之后取出导管。灌注后之第一小时内，患者应採俯卧、平躺及左右两侧躺15分鐘，然后患者可站立但再保持悬浮液60分鐘，总计达2小时，应教导其若需要以较少时间排尿。2小时终了时，为安全理由，所有患者以坐姿排尿。应教导患者保持足够之水份。达到最理想反应所需灌注之真正次数仍未知。大多数有反应之患者用6至12次灌注时达到。

不良反应
1. 大多数局部不良反应发生於第三次膀胱内灌注后，最常见者如下，排尿困难、频尿、血尿、膀胱炎、急迫、尿路感染、尿失禁及痉挛/疼痛、症状通常开始於灌注后2至4小时，持续24至72小时。
2. 每一次灌注后全身性反应一般持续1～3天，最常见者如下，身体不适、发热(>38℃)、发冷、贫血、噁心/呕吐、厌食、肌肉痛/关节痛/关节炎、腹泻、白血球过少、肾毒性及生殖器疼痛、颗粒肉牙肿性前列腺炎、副睪炎、睪丸炎以及肾肿疡已有报告已有报告挫伤性插管后或尿道感染之状况使用本品造成死亡。
3. 因使用本品所引起的刺激性小水泡副作用，可用phenazopyridinehy-drochlorid(Pyridium), probanthelia Bromide(ProBanthine)及 acetaminophen处理。
4. 全身性副作用(如身体不适，发烧及发冷)代表过敏反应，可用diphenhydraminhydrochloride治疗、用膀胱内本品偶而会发生因BCG菌种分佈所引起全身性感染、此种状况之处理於预防措施处提供。

禁忌
1. 正使用免疫抑制治疗的患者或免疫系统受损之患者不应接受ImmucCysTM(BCG免疫治疗剂)因有无法抵抗分枝桿菌而可能会造成全身性之败血症。
2. 骨髓抑制剂及/或免疫抑制剂及/或放射物之药物互相组合可能会损害本品之反应，而增加骨髓炎或散佈性BCG感染之危险性。
3. 除非发烧之原因已被测定且评估过，否则本品不应投药给发烧之患者、若发生之原因为感染，则应停用本品，直至烧退。
4. 尿路感染之患者不应接受本品治疗，因其会有造成散佈性BCG感染之危险性或增加膀胱刺激之危险性。

注意事项
1. 本品因含活的减毒分枝桿菌，以传染物处理。
2. 所有用以灌注本品进入膀胱的装置及材料(例如：针筒、导管)在使用后应立即置入胶袋内，袋上标有\"感染性废弃物\"并依据生物危险废弃物丢弃。
3. 使用本品(BCG免疫治疗剂)治疗膀胱原位癌时必须小心，不要引污染入尿道造成不当地伤害尿路粘膜。
4. 建议经尿道切除后一週内不可投用膀胱内本品，因为外伤性插管后使用本品已有死亡之报告。
5. 若医师相信膀胱插管已造成外伤(例如：引起出血或可能之歧道)，则不应使用本品，治疗至少须延后一过。接下去应用完所有本品剂量，即使曾暂时性停止投药亦是。
6. 若於治疗期间患者有发烧或严重的身体不适，应投用isoniazid，每天300mg，直至症状缓解止。若症状持续，则应停止BCG免疫法。以后任何重新灌注BCG前应开始Isoniazid预防性治疗。
7. 若有怀疑全身性BCG感染(即患者若发热超过39℃或发热高过 38℃时持续2天或严重身体不适)应开始用isoniazid每天300 mg Rifampicin 600mg/天，及ethambutol 120mg/天作快速作用抗结核病疗法。停止BCG疗法，且应请询传染病专家。应加 cycloserine 250～500mg 以对致命性感染作紧急治疗。应该知道假定性BCG全身感染仅少见地由阳性培养确定。
8. 怀孕时使用：尚未使用本品进行动物生殖研究。亦未知本品投用到怀孕妇女是否造成胎儿伤害，或是否会影响生育能力。只有清楚明确地需要本品方能给予怀孕妇女使用。
9. 哺乳母亲：全身性BCG感染之母亲会传染其餵乳之婴儿。未知本品是否排出在人类乳汁中。因此当投用本品至哺乳母亲时应小心。儿童使用：对儿童CIS之安全性及效力尚未确立。

孕妇用药分级
C 级：
在对照的动物研究试验中显示该药学物对胚胎有不良反应（致畸胎性或杀胚胎性或其他），但未进行人体怀孕妇女研究；或者尚无对照的人体怀孕妇女或动物研究试验。只有在可能的利益大於潜在的危险，才可使用此药物。

药品保存方式
药品应置於摄氏 2 ~ 8 度冰箱内(勿冷冻)；如发生变质或过期，不可再使用。

Bacillus Calmette-Guerin Live, BCG

What is Bacillus Calmette-Guerin Live, BCG?

BACILLUS CALMETTE-GUERIN LIVE, BCG (TICE® BCG, TheraCys®) is a bacteria. It is used to stimulate your body's immune system against certain types of bladder cancer. Generic BCG Live intravesical solutions are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• tuberculosis or a positive skin test for tuberculosis (PPD)
• aneurysm
• blood in the urine
• bladder biopsy within 2 weeks
• diabetes mellitus
• fever or infection
• immune deficiency (natural or due to cancer chemotherapy, radiation, or steroid therapy)
• infection with the human immunodeficiency virus (HIV) or AIDS
• leukemia or lymphoma
• myasthenia gravis
• prosthetic device such as prosthetic heart valves
• renal failure
• an unusual reaction to Bacillus Calmette-Guerin Live, BCG, other medicines, latex, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

BCG intravesical solution is put in the bladder through a catheter. It is usually given by a trained health care professional in a hospital, clinic, or prescriber's office. Do not drink any liquids 4 hours before you receive BCG intravesical solution. Empty your bladder just before the treatment is given. If you can, you will need to hold this solution in your bladder for at least 2 hours. Treatments are usually given once a week for 6 weeks.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss a dose. Let your prescriber or health care professional know if you are unable to keep an appointment.

What drug(s) may interact with Bacillus Calmette-Guerin Live, BCG?

• antibiotics
• medicines that suppress your immune system such as chemotherapy agents, radiation, or corticosteroids
• medicine to treat tuberculosis

Because BCG intravesical solution is given into your bladder, there is very little absorption into the rest of your body.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Bacillus Calmette-Guerin Live, BCG?

Visit your prescriber or health care professional for regular checks on your progress.

BCG Live intravesical solution contains live bacteria. If you have an immune deficiency or have lesions in your bladder that have not healed, you may be at increased risk of an infection due to this bacteria. If you develop a cough, have a fever more than 103 degrees F, a fever that lasts longer than 3 days, or bladder symptoms that do not go away, call your prescriber or health care professional. You may have developed an infection that needs treatment with certain antibiotics.

For 24 hours after receiving BCG Live intravesical solution, urinate by sitting down on the toilet. Sitting down helps to reduce urine from splashing. For the first 6 hours after treatment, add 2 cups of chlorine bleach to the toilet bowl after you urinate. Let stand for at least 15 minutes before flushing. Repeat this process each time you urinate for the first 6 hours after each treatment. Wash your hands and genital area thoroughly after you urinate.

Drink several glasses of water a day after taking BCG intravesical solution to wash out your bladder.

Side effects after BCG intravesical may not be bothersome until after the third treatment. Side effects may gradually get worse after each administration.

Men and women of childbearing age should use effective birth control methods during BCG intravesical treatment. Women should not become pregnant while being treated with BCG intravesical solution.

What side effects may I notice from receiving Bacillus Calmette-Guerin Live, BCG?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• blood in urine
• severe burning or pain when urinating
• difficulty urinating
• fever, chills, or other signs of infection
• joint or muscle pain
• increased or new cough
• nausea or vomiting
• skin rash

Side effects that usually do not require immediate medical attention (report these side effects to your prescriber or health care professional if they continue or are bothersome):
• bladder spasm
• bladder pain
• burning when urinating
• flu-like symptoms such as tiredness
• having to urinate often
• unable to control urination
• waking up at night to urinate
Most side effects occur after placing BCG intravesical solution in your bladder and may last up to 7 days.

Where can I keep my medicine?

This medicine is given into your bladder at a clinic or hospital. You will not be given doses to store at home.