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Lapatinib tablets
TYKERB™ |
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FDA Approval: |
March 2007 |
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Indication: |
Advanced or metastatic breast cancer with HER2 overexpression;
previously-treated patients |
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Pharmacology: |
Kinase inhibitor |
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Usual Dose: |
1250 mg orally once daily, 1 hour before or after a meal, in 21-day
cycles (in combination with capecitabine) |
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Contraindications: |
None |
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Warnings: |
May cause decreased left ventricular ejection fraction; LVEF should
be monitored
Dose adjustments should be considered in severe liver impairment
May cause severe diarrhea, which should be managed appropriately
ECGs should be performed at baseline and periodically; caution in
patients with congenital long QT syndrome, or on concomitant drugs
that cause QT prolongation
Lactation: Either breast-feeding or the drug should be discontinued
Safety and efficacy not established in pediatric patients |
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Pregnancy Category: |
D |
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Side Effects: |
Diarrhea, nausea, vomiting, stomatitis, dyspepsia Palmar-plantar
erythrodysesthesia, rash, dry skin
Mucosal inflammation
Extremity and back pain, fatigue
Dyspnea
Insomnia |
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Drug Interactions: |
CYP450 3A4 inhibitors and inducers CYP450 3A4 and 2C8 substrates |
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