英文药名：AFINITOR DISPERZ(everolimus tablets for oral suspension) 中文名称：依维莫司口服混悬液片 生产厂家：诺华制药 药品介绍 抗癌药AFINITOR DISPERZ(EVEROLIMUS)TABLET FOR SUSPENSION ORAL获FDA批准用于儿童罕见脑肿瘤治疗 2012年8月30日，抗癌药物Afinitor Disperz获FDA批准，用于1岁及以上儿童一种罕见形式脑瘤的治疗。 FDA称，已批准这种新的儿科剂型Afinitor用于治疗一种被称为室管膜下巨细胞星形细胞瘤（SEGA）的罕见类型脑部肿瘤。根据FDA，Afinitor Disperz是首个获批用于儿科肿瘤治疗的专门配方药物。这种新形式的Afinitor具有适用于儿童的低剂量，同时也易于溶解于水，供那些无法吞服药片的儿童患者使用。 具体而言，Afinitor Disperz已被批准用于1岁及以上儿童结节性硬化症（tuberous sclerosis complex）的治疗，这是一种罕见的遗传性疾病，导致肿瘤在大脑及其他重要器官中生长，被诊断患有SEGA的患者不能开展手术治疗。 Afinitor最初于2009年获批用于肾细胞癌的治疗，这是一种药片，能够阻断一种名为mTOR蛋白的失控活动，该蛋白在某些类型肿瘤的形成及生长中发挥着关键作用。Afinitor也被批准用于成人某些类型的乳腺癌、胰腺癌及脑肿瘤的治疗。 包装规格 2毫克/片*28片/盒（7片 4吸塑卡） 3毫克/片*28片/盒（7片 4吸塑卡） 5毫克/片*28片/盒（7片 4吸塑卡） AFINITOR DISPERZ(everolimus tablets for oral suspension) AFINITOR DISPERZ CNS cancers  Only 4 drugs may be compared at once Remove Selected Compare Selected Generic Name and Formulations: Everolimus 2mg, 3mg, 5mg; tabs for oral susp. Company: Novartis Pharmaceuticals Corp Select therapeutic use: CNS cancers Indications for AFINITOR DISPERZ: In adults and children with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. Adults and Children: <1yr: not recommended. Swallow tabs whole with water or use Disperz tabs administered as a suspension only. Take at the same time each day either consistently with or without food. Prepare suspension using 5mL of water in an oral syringe or 25mL of water in a drinking glass; max 10mg dose per syringe or glass. ≥1yrs: initially 4.5mg/m2 once daily. Do not combine the 2 dosage forms to achieve the desired total dose. Use therapeutic drug monitoring to guide subsequent dosing. Adjust dose at 2 week intervals as needed to achieve and maintain trough concentrations of 5–15ng/mL (see full labeling). Severe hepatic impairment: initiate at 2.5mg/m2 once daily. Concomitant strong CYP3A4/PgP inhibitors: avoid; moderate CYP3A4/PgP inhibitors: initiate at 2.5mg/m2 once daily, if CYP3A4/PgP inhibitor discontinued, after 2–3 days, return to dose used prior to initiating moderate inhibitor. Concomitant strong CYP3A4 inducers: avoid, if required, then initiate at 9mg/m2 once daily; if discontinued, then return to dose used prior to initiating strong inducer. Continue therapy until disease progression or unacceptable toxicity occurs. Dose modifications for adverse reactions, or others: see full labeling. Contraindications: Allergy to other rapamycin derivatives. Warnings/Precautions: Monitor for new or worsening respiratory symptoms. Increased risk of infections; some may be severe or fatal; monitor and treat promptly if occur. Pre-existing invasive fungal infections: treat before starting. Monitor for signs of wound-related complications. Peri-surgical period. Hepatic impairment (see Adult dose). Monitor CBCs, renal function, lipids, and blood glucose prior to starting and periodically thereafter. Avoid close contact with those who have received live vaccines. Pediatrics: complete childhood vaccination series according to ACIP guidelines prior to initiation. Elderly. Females of reproductive potential must use effective contraception during therapy and for 8 weeks after treatment. Pregnancy (Cat.D), nursing mothers: not recommended. Interactions: Avoid live vaccines. Potentiated by strong CYP3A4/PgP inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole), grapefruit or grapefruit juice; avoid. Caution with moderate CYP3A4/PgP inhibitors (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem); reduce everolimus dose if used. Antagonized by strong CYP3A4/PgP inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital), St. John's Wort; avoid. See Also: AFINITOR Pharmacological Class: mTOR kinase inhibitor. Adverse Reactions: Pneumonitis (interrupt, reduce dose and/or manage with corticosteroids; if severe, discontinue; may reintroduce daily dose at approx. 50% lower than previously administered), infections (discontinue if invasive systemic fungal infection develops), stomatitis (treat with non-alcoholic, non-peroxide mouthwash), diarrhea, nausea, abdominal pain, rash, fatigue, edema, fever, asthenia, cough, headache, decreased appetite; increased serum creatinine, blood glucose, lipids; decreased hemoglobin, platelets, neutrophils, serum phosphate; proteinuria, renal failure, others (see full labeling). Metabolism: Hepatic (CYP3A4, 2D6), PgP. Elimination: Fecal, renal (minor). Generic Availability: NO How Supplied: Tabs, Disperz—28 (4 blister cards x 7 tabs) https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=87801