CAPRELSA（Vandetanib tabs）
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授权形式： |
免费版 |
作者/开发商： |
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| 文件大小： |
36.57 Kb |
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| 软件语言： |
简体中文 |
更新时间： |
2013-04-17 |
| 版本号： |
1.0 |
软件平台： |
Win2000/WinXP/Win2003 |
| 软件类别： |
国产软件 |
演示地址： |
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| 评分等级： |
★★★★★ |
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| 发布人： |
admin |
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0（今日：0，本周：0，本月：0） |
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无插件 |
浏览次数： |
73 |
Manufacturer:
AstraZeneca Pharmaceuticals
Pharmacological Class:
Kinase inhibitor.
Active Ingredient(s):
Vandetanib 100mg, 300mg, tabs.
Indication(s):
Symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Pharmacology:
Vandetanib inhibits the activity of tyrosine kinases, including those associated with epidermal growth factor receptor, vascular endothelial cell growth factor receptor, and protein tyrosine kinase 6. It has been shown to inhibit endothelial cell migration, proliferation, survival, and angiogenesis in vitro, and it inhibits the phosphorylation of tyrosine kinase. Vandetanib reduces tumor cell-induced angiogenesis, tumor vessel permeability, and inhibits tumor growth and metastasis in vivo in murine models.
Clinical Trials:
A double-blind study involving 331 patients with unresectable locally advanced or medullary thyroid cancer was conducted to evaluate improvement in progression-free survival for vandetanib versus placebo. Overall survival and overall objective response rate were also examined. A statistically significant improvement in progression-free survival for patients randomized to vandetanib was demonstrated. At the time of primary analysis of progression-free survival, 15% of the patients had died, and there was no significant difference in overall survival between the two treatment groups. The overall objective response rate was 44% for those given vandetanib compared to 1% for placebo; all of the objective responses were partial responses.
Legal Classification:
Rx
Adults:
Do not crush tabs. May disperse tabs in 2 ounces noncarbonated water for oral or NGT administration; avoid contact of dispersion with skin, mucous membranes. 300mg once daily. Renal impairment (CrCl<50mL/min): initially 200mg once daily. Reduce dose if severe toxicity or QTc interval prolongation occurs (see literature). Do not take a missed dose within 12hrs of the next dose.
Children:
Not recommended.
Contraindication(s):
Congenital long QT syndrome.
Warnings/Precautions:
Hypocalcemia, hypokalemia, hypomagnesemia, QTcF interval >450msec, history of torsades de pointes, bradyarrhythmias, uncompensated heart failure, recent hemoptysis: not recommended. Ventricular arrhythmias. Recent MI. Monitor electrolytes (esp. K+, Ca++, Mg++), TSH, and ECG for QT prolongation at baseline, 2–4 weeks and 8–12 weeks after starting, then every 3 months, and after dose reductions or dose interruptions >2weeks; reduce dose as needed. Correct electrolyte disturbances before starting. Maintain serum K+ at least 4mEq/mL. Hepatic impairment (Child-Pugh B or C): not recommended. Suspend therapy and follow-up if dyspnea, cough, fever, QTcF >500msec, or posterior leukoencephalopathy symptoms (RPLS) occur. Avoid sun, UV light. Elderly. Pregnancy (Cat.D) (may cause fetal harm; use appropriate effective contraception during and for 4 months after stopping therapy), nursing mothers: not recommended.
Interaction(s):
Avoid strong CYP3A4 inducers (eg, carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampin, rifabutin, rifapentine, St.John’s Wort). Avoid other drugs that can prolong QT interval (eg, amiodarone, disopyramide, procainamide, sotalol, dofetilide, chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, pimozide, methadone, moxifloxacin).
Adverse Reaction(s):
Diarrhea (suspend if severe), rash, acne, nausea, hypertension, headache, fatigue, decreased appetite, abdominal pain, decreased calcium or glucose, increased ALT; QT prolongation, torsades de pointes, sudden death, severe skin reactions (eg, Stevens-Johnson syndrome; discontinue if occurs), interstitial lung disease, ischemic cerebrovascular events, hemorrhage, heart failure, hypothyroidism, hypertensive crisis, RPLS.
Notes:
Prescribers and pharmacies must enroll in the Caprelsa REMS program by calling (800) 236-9933 or visit www.caprelsarems.com.
How Supplied:
Tabs—30
Last Updated:
8/3/2011
http://www.drugs.com/pro/caprelsa.html
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