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伯舒替尼,BOSULIF/BOSUTINIB MONOHYDRATE,原研参比制剂，一次性进口和代购
伯舒替尼,BOSULIF/BOSUTINIB MONOHYDRATE,原研参比制剂，一次性进口，代购
产品名称：伯舒替尼片
英文名称：Bosulif/Bosutinib
原研厂家：Pfizer Pharma GmbH
上市地区：德国/美国/日本
药品规格：100mg
BOSULIF® (bosutinib)简介
博舒替尼(Bosutinib)-2012年9月4日FDA批准的抗癌药。主要用于治疗慢性髓细胞白血病(chronic myelogenous leukemia, CML)，是一种酪氨酸激酶抑制剂，同类的药物还有伊马替尼(imatinib)，大沙替尼(dasatinib)，尼洛替尼(nilotinib)。商品名Bosulif，开发商Wyeth。
国外上市情况
欧盟：片剂（2013.3.27）；Pfizer Ltd公司持有；商品名Bosulif
美国：片剂100mg、500mg（2012.9.4）；PF PRISM CV公司持有；商品名BOSULIF
日本：片剂100mg（2014.12）；ファイザー株式会社（日本辉瑞）公司持有；商品名ボシュリフ錠
完整说明书附件：以便使用者防问；
1）：https://www.medicines.org.uk/emc/product/3147/smpc
2）：http://www.info.pmda.go.jp/go/pack/4291036F1028_1_07/
3）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adc84ad5-a04d-4fee-9ba8-91f7abd928e3
BOSULIF(bosutinib) Tablets.
BOSULIF Rx
Generic Name and Formulations:
Bosutinib 100mg, 500mg; tabs.
Company:
Pfizer Inc.
Indications for BOSULIF:
Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
Adult Dose for BOSULIF:
500mg once daily with food. Continue until disease progression or patient intolerance. Consider dose escalation to 600mg once daily in patients who do not reach complete hematological response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week 12, who did not have Grade 3 or higher adverse reactions. Adjust dose for hematologic and non-hematologic toxicity: see literature. Hepatic impairment: 200mg daily.
Children's Dose for BOSULIF:
<18yrs: not established.
Pharmacological Class:
Tyrosine kinase inhibitor.
Warnings/Precautions:
Monitor and manage GI toxicity, fluid retention; withhold, reduce dose, or discontinue as necessary. Perform CBC weekly for first month, then monthly; hepatic enzyme tests monthly for first three months (more frequently if transaminase elevations occur); withhold, reduce dose, or discontinue as necessary. Pregnancy (Cat.D), nursing mothers: not recommended.
Interactions:
Potentiated by concomitant strong or moderate CYP3A and/or P-gp inhibitors (eg, ritonavir, indinavir, nelfinavir, saquinavir, ketoconazole, boceprevir, telaprevir, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, conivaptan, fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprenavir, crizotinib, imatinib, verapamil, grapefruit products, ciprofloxacin); avoid. Antagonized by concomitant strong or moderate CYP3A inducers (eg, rifampin, phenytoin, carbamazepine, St. John’s Wort, rifabutin, phenobarbital, bosentan, nafcillin, efavirenz, modafinil etravirine); avoid. Antagonized by proton pump inhibitors (eg, lansoprazole); consider short-acting antacids or H2 blockers instead; separate dosing by more than 2hrs. May potentiate drugs that are P-gp substrates (eg, digoxin).
Adverse Reactions:
Diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, fatigue; fluid retention (monitor), hepatic toxicity.
Metabolism:
Hepatic (CYP3A4); 94% protein bound.
Elimination:
Fecal (primary), renal.
Generic Availability:
NO
How Supplied:
Tabs 100mg—120; 500mg—30 |
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