产品介绍

阿帕鲁胺（apalutamide，又译为：阿帕他胺）是第二代因非甾体雄激素受体（AR）抑制剂，能有效防止雄激素与受体结合，阻止AR向肿瘤细胞的细胞核中转移，起到抑制雄激素促进肿瘤细胞生长的作用。

阿帕鲁胺由美国加利福尼亚大学首先研制，2009年授权美国Aragon公司独家开发。2017年12月23日杨森药业公司向美国食品药品管理局（FDA）提交新药上市申请，获得FDA优先审评资格。2018年2月14日，阿帕鲁胺获FDA批准上市，是FDA首个依据无转移生存期(MFS)的临床终点批准上市的抗肿瘤新药。

2020年8月14日，阿帕鲁胺在中国获得批准用于治疗转移性激素敏感性前列腺癌(mHSPC)成年患者。

根据美国癌症学会期刊发表的《2018年全球癌症统计数据》，前列腺癌（7.1%）已成为全球男性第二常见癌症。而随着前列腺癌病情的发展，非转移性去势抵抗性前列腺癌（nm-CRPC）及转移性去势敏感性的前列腺癌（mCSPC）更是泌尿肿瘤科医师面对的一大挑战。

相比阿比特龙等第一代雄激素受体拮抗剂，阿帕鲁胺等第二代已得到明显改善，新的二代雄激素受体拮抗剂对受体的亲和力比第一代高5-10倍。阿帕鲁胺更是改写历史，成为首款用于治疗非转移性去势抵抗性前列腺癌（nm-CRPC）及转移性去势敏感性的前列腺癌（mCSPC）的药物。

阿帕鲁胺和恩杂鲁胺的区别

阿帕鲁胺和恩杂鲁胺（Enzalutamide，又译为：恩扎卢胺）都是基于AR突变体和比卡鲁胺的晶体结构设计出来的，它们的作用机制是相同的：1、高亲和力；2、防止核进入；3、防止脱氧核糖核酸结合不能结合PSA增强子，不能结合TMPRSS2增强子，不能启动AR转录。

阿帕鲁胺和恩杂鲁胺疗效相当，但恩扎鲁胺在一个非常特殊的副作用——癫痫的发生率远高于阿帕鲁胺。临床实验证明，服药后，进入血脑屏障的阿帕鲁胺的浓度远低于恩杂鲁胺的浓度，在正常用药的情况下，癫痫一般不会发生。因此，在使用恩杂鲁胺时，应该更加注意药物的浓度，必须更加注意防止遗漏和多服。

碧康制药生产的Apalunix是阿帕鲁胺在全球的首仿药，也是迄今为止唯一获得政府监管机构批准合法生产的仿制药。

碧康制药由欧洲财团参与投资，是南亚地区唯一执行欧盟技术规范，并且在孟加拉两大证券交易所主板上市的大型制药企业，产品符合欧洲药典和美国药典标准。

相比其他来源不清晰的所谓同一种仿制药，即使其主要成份含量与碧康产品相接近，但由于不具备严格规范的GMP标准生产场所和政府部门的严格监管，其产品中影响药物吸收率的溶出度和生物利用度也与碧康产品具有很大差异。

为保证用药安全，敬请谨慎选择！

适应症:

适用于治疗有高危转移风险的非转移性去势抵抗性前列腺癌（NM-CRPC）、转移性去势敏感性前列腺癌（mCSPC）、转移性激素敏感性前列腺癌(mHSPC)和去势敏感性前列腺癌(CSPC)的成年患者。

用法与用量:

推荐剂量是 240 mg（4 片 60 mg 片剂），每日一次，口服给药。

需整片吞下，可以单独服用或与食物同服。

如果错过了 1 次用药，应尽快在当天补服药物，次日仍按正常计划服药。请勿额外服用本品以弥补漏服剂量。

剂量调整：

如果患者出现≥3 级毒性或无法耐受的不良反应，应暂停给药，直至症状改善至≤1 级或原有级别，如果有必要，再恢复相同剂量或减量（180 mg 或 120 mg）。

特殊人群用药

儿童：尚未确定本品在儿童患者中的安全性和有效性。

老年人：老年患者无需调整剂量。

肾功能损害：轻度至中度肾损害患者无需调整剂量。

不建议重度肝损害患者使用本品，因为尚无此患者人群的相关数据，且本品主要经肝脏代谢。

副作用和不良反应

在临床试验中，患者使用阿帕鲁胺片最常见的副作用和不良反应有：

疲乏、关节痛、皮疹、食欲下降、外周水肿、跌倒、骨折、体重降低、高血压、潮热、腹泻、呕吐。

发生率≥2%的其他显著不良反应包括：甲状腺功能减退、瘙痒、缺血性心脏病、心脏衰竭。

在临床试验中，患者使用阿帕他胺片最常见的实验室检查异常有：

贫血、白细胞减少、淋巴细胞减少、高胆固醇血症、高血糖症、高甘油三酯血症、高钾血症。

贮存和处置

贮存在20°C至25°C(68°F至77°F)；外出允许至15°C至30°C(59°F至86°F)。

贮存在原始包装，不要遗弃干燥剂。避光和潮湿保护。

APCALIS SX TABLETS – PRODUCT INFORMATION :

Apcalis Sx Tablet belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.

APCALIS SX TABLETS USES

Apcalis is a globally acclaimed and highly acknowledged medicinal brand which has been offering all medically approved medicines. Its effective range of Apcalis SX Oral Jelly 20mg Tablets are known for curing Erectile Dysfunction which further contains Tadalafil 20mg. The jelly has been proven effective in terms of treating impotence. This medicine represents whole new class of medications which is known as PDE-5 inhibitors.
Ajanta Pharma Tadalafil is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

APCALIS SX TABLETS SIDE EFFECTS  :

    headache;
    diarrhea;
    sinus pain, sore throat; or
    muscle pain.

Call your doctor right away if you have:

    ringing in your ears, or sudden hearing loss;
    irregular heartbeat;
    swelling in your hands, ankles, or feet;
    shortness of breath;
    seizure (convulsions); or
    a light-headed feeling, like you, might pass out.

WARNINGS AND PRECAUTIONS WHEN USING AJANTA PHARMA APCALIS SX TABLETS :

·        
Before taking
Tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you
have any other allergies. This product may contain inactive ingredients, which
can cause allergic reactions or other problems. Talk to your pharmacist for
more details.

·        
Before using this
medication, tell your doctor or pharmacist your medical history, especially of:
heart problems stroke in the past 6 months, kidney disease, liver disease, high
or low blood pressure, a severe loss of body water penis conditions story of
painful/prolonged erection conditions that may increase the risk of priapism bleeding
disorders, active stomach ulcers.

·        
 This drug
may make you dizzy. Do not drive, use machinery, or do any activity that
requires alertness until you are sure you can perform such activities safely.
Limit alcoholic beverages.

·        
Before having
surgery, tell your doctor or dentist about all the products you use (including
prescription drugs, nonprescription drugs, and herbal products).

·        
 It is
unknown if this medication passes into breast milk. Consult your doctor before
breast-feeding.

This is not a complete list. Ask your health care provider for more information.

APCALIS SX TABLETS – STORAGE :

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

DRUG INTERACTIONS :

Tell your doctor about all your current medicines and any you start or stop using, especially:

    an antibiotic or antifungal medicine;
    antiviral medicine to treat hepatitis C or HIV/AIDS;
    drugs to treat high blood pressure or a prostate disorder; or
    seizure medicine.

This document does not contain all possible interactions. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Apremilast Tablet Generic Otezla:

Aprezo Tablet is used in the treatment of moderate to severe plaque psoriasis which is a type of skin condition. This medicine is used when other conventional treatments cannot be used or if the patient is not responsive or intolerant to any of these treatments.

通用阿普司特片剂的用途:

阿普斯特片，一种磷酸二酯酶-4(PDE-4)的抑制剂，是适用于为治疗有活动性银屑病关节炎的成年患者。

Benefits of Indian Apremilast Tablets:

In Plaque psoriasis

Plaque psoriasis is the most common form of psoriasis, a condition where the skin cells in the body grow too quickly and form scales and dry patches. They can grow anywhere, but most appear on the scalp, elbows, knees, and lower back. Aprezo Tablet reduces the scaly, itchy patches which may develop on the different parts of the body. It may take several months to become fully effective. You should avoid drinking alcohol while having this treatment and drink plenty of water to stay hydrated.

Side-Effects of Aprazo Tablets:

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them:

Diarrhea.

Vomiting.

Nausea.

Weight loss.

Back pain

How to Glenmark Apremilast Tablet Work?

Aprezo Tablet is a phosphodiesterase 4 (PDE4) inhibitor. It works by blocking the action of certain chemical messengers that are responsible for inflammation associated with psoriatic arthritis and psoriasis, and thereby reduces the signs and symptoms of these conditions.

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