라파티닙 디토실레이트

® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase …

is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. ( 4 )

Decreases in left ventricular ejection fraction (LVEF) have been reported. Confirm normal LVEF before starting TYKERB and continue evaluations during treatment. ( 5.1 ) TYKERB has been associated with hepatotoxicity. Monitor liver function tests before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. Discontinue and do not restart TYKERB if patients experience severe changes in liver function tests. ( 5.2 ) Dose reduction in patients with severe hepatic impairment should be considered. ( 2.2 , 5.3 , 8.7 ) Diarrhea, including severe diarrhea, has been reported during treatment. Manage with antidiarrheal agents, and replace fluids and electrolytes if severe. ( 5.4 ) TYKERB has been associated with interstitial lung disease (ILD) and pneumonitis. Discontinue TYKERB if patients experience severe pulmonary symptoms. ( 5.5 ) TYKERB may prolong the QT interval in some patients. Consider electrocardiogram (ECG) and electrolyte monitoring. ( 5.6 , 12.2 ) Severe cutaneous reactions have been reported. Discontinue TYKERB if life-threatening reactions are suspected. ( 5.7 ) TYKERB can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Decreased Left Ventricular Ejection Fraction TYKERB has been reported to decrease LVEF [see Adverse Reactions (6.1)] . In clinical trials, the majority (greater than 57%) of LVEF decreases occurred within the first 12 weeks of treatment; …

8.1 Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, TYKERB can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available human data to inform of the drug-associated risks. In an animal reproduction study, administration of lapatinib to pregnant rats during organogenesis and through lactation led to death of offspring within the first 4 days after birth at maternal exposures that were ≥ 3.3 times the human clinical exposure based on AUC following 1,250 mg dose of lapatinib plus capecitabine. When administered to pregnant animals during the period of organogenesis, lapatinib caused fetal anomalies …