Resources for healthcare providers
Slide Kit
An Update in the Treatment of HER2+ Advanced or Metastatic Breast Cancer, a slide presentation containing the lastest information on HER2 inhibition. Call 1-866-4-TYKERB (1-866-489-5372) for additional information.
Multi-media
Mechanism of Action Video for TYKERB See how TYKERB directly inhibits tyrosine kinase phosphorylation.
Windows Media® Player required. If you do not have Windows Media® Player, you can download a free copy
Windows Media is a registered trademark of the Microsoft Corporation.
Print Materials
I Want More, a reference for healthcare professionals discussing the mechanism of action, clinical activity, adverse events, and dosing guidelines for TYKERB.
Dosing Card, a review of dosing guidelines for TYKERB.
Your Patients Want More. With the Tykerb® CARES Program They Get More, a guide to the benefits of the Tykerb® CARES Program.
Enrollment Form for Tykerb® CARES Complete this form for your patients to enable them to access program services.
Materials for Patients
Your Treatment With TYKERB, a booklet about what a patient can expect while taking TYKERB.
Tracking Your Treatment With TYKERB, an organizer to help patients understand and stick with their treatment plan. Also included:
- A treatment calendar to help patients keep track of their dosing schedule; and
- A side effect journal to track side effects and the steps to manage them.
Get more for your patient with
Tykerb® CARES, a support program sponsored by GlaxoSmithKline to help patients and the healthcare providers who treat them.
Learn more about HER2+ metastatic breast cancer and treatment with TYKERB.
Ask the Experts
Learn about advancements in breast cancer treatment and keep up with developments on www.TYKERB.com.
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.
BOXED WARNING and Additional Important Safety Information
Hepatotoxicity
TYKERB has been associated with hepatotoxicity. Hepatotoxicity (ALT or AST >3 times the upper limit of normal and total bilirubin >1.5 times the upper limit of normal) has been observed in clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with TYKERB should be discontinued and patients should not be retreated with TYKERB.
Decreased Left Ventricular Ejection Fraction
TYKERB has been reported to decrease 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. Confirm normal LVEF before starting TYKERB, and continue evaluations during treatment.
Patients with Severe Hepatic Impairment
If TYKERB is to be administered to patients with severe hepatic impairment, dose reduction should be considered.
Diarrhea
Diarrhea, including severe diarrhea, has been reported during treatment with TYKERB and was the most common adverse reaction resulting in discontinuation of TYKERB therapy. Proactive management of diarrhea with anti-diarrheal 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.
Interstitial Lung Disease/Pneumonitis
TYKERB has been associated with interstitial lung disease and pneumonitis. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease or pneumonitis and if symptoms are ≥ Grade 3 (NCI CTCAE), TYKERB should be discontinued.
QT Prolongation
TYKERB prolongs the QT interval in some patients. TYKERB should be administered with caution to patients who have or may develop prolongation of QTc. Hypokalemia or hypomagnesemia should be corrected prior to TYKERB administration. Baseline and on-treatment electrocardiograms with QT measurement should be considered.
Pregnancy
Pregnancy D
TYKERB can cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant when taking TYKERB. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Adverse Reactions
The most common adverse reactions (>20%) during therapy with TYKERB plus capecitabine compared to capecitabine alone were diarrhea (65%, 40%), nausea (44%, 43%), vomiting (26%, 21%), palmar-plantar erythrodysesthesia (53%, 51%), rash (28%, 14%), and fatigue (46%, 47%).
The most common grade 3 and 4 adverse reaction (NCI CTC v3) with TYKERB plus capecitabine compared to capecitabine alone were diarrhea (14%, 10%) and palmar-plantar erythrodysesthesia (12%, 14%).
Please see full US Prescribing Information, including BOXED WARNING for TYKERB.
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