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Prescribing Information  |  Important Safety Information  |  For Patients and Caregivers

The first and only approved small-molecule intracellular HER2 inhibitor1

TYKERB plus Xeloda® (capecitabine) is a targeted therapy for HER2+ advanced or metastatic breast cancer patients that received prior treatment with an anthracycline, a taxane, and Herceptin® (trastuzumab). When given in combination with Xeloda, TYKERB offers these patients greater median time to progression than capecitabine alone.1

TYKERB is a breast cancer treatment specifically designed to work intracellularly to slow or stop the processes that cause tumor growth and disease progression.1

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Indication

TYKERB® is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

Dose Modification Guidelines

For dose modification guidelines, please see complete Prescribing Information.

Important Safety Information

As with other therapies for HER2 overexpression, TYKERB has been associated with reports of decreases in left ventricular ejection fraction (LVEF). Caution should be taken if TYKERB is to be administered to patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. LVEF should be evaluated in all patients prior to and during treatment with TYKERB.

A dose reduction should be considered for patients with severe hepatic impairment.

Diarrhea was the most common adverse event resulting in discontinuation of study medication. Proactive management of diarrhea with antidiarrheal agents is important, and severe cases of diarrhea may require administration of oral or intravenous electrolytes and fluids and interruption or discontinuation of therapy with TYKERB.

TYKERB has been associated with interstitial lung disease and pneumonitis. Discontinue TYKERB if patients experience severe pulmonary symptoms.

TYKERB prolongs the QT interval in some patients. Consider ECG and electrolyte monitoring.

Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking TYKERB.

The most common adverse events (>20%) during treatment with TYKERB plus capecitabine were diarrhea, vomiting, nausea, fatigue, palmar-plantar erythrodysesthesia, and rash.

Please see complete US Prescribing Information for additional safety information on TYKERB.

 

Xeloda is a registered trademark of Roche Laboratories Inc.
Herceptin is a registered trademark of Genentech.

Reference:

  1. TYKERB [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2007.