Managing treatment effects
Encourage your patients to communicate with you regularly regarding any side effects they may experience during treatment. In addition, your patients should call someone on the healthcare team if they experience any side effects that:
- Continue for an unreasonable amount of time
- Interfere with their daily life
- They consider to be serious
Diarrhea
Diarrhea is the most common side effect of TYKERB plus capecitabine. It is generally mild to moderate, but diarrhea was the most common side effect that caused patients in a clinical trial to withdraw from the study.1 If your patients experience mild to moderate diarrhea, it can usually be managed with over-the-counter medications.2 You may also suggest changes to your patient's diet to help reduce the effects of diarrhea.
- Drinking eight to ten glasses a day of sports drinks, broth, or other clear liquids to replace lost fluids and minerals
- Drinking plenty of water
- Try the BRAT (bananas, rice, applesauce, toast) diet to help lessen the number of bowel movements
- Eating low-fat, high-protein foods, such as lean meat and eggs, instead of fried, fatty, or spicy foods
- Eating cooked vegetables instead of raw ones and removing skins from fruits before eating them
- Avoiding herbal supplements. Some may cause diarrhea
- Avoid milk and milk products, including ice cream3
Patients should be instructed to call a member of the healthcare team if the diarrhea becomes severe or continues after treatment with over-the-counter medications.
See Resources and patient support for downloadable materials to help your patients manage treatment effects.
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.
Xeloda is a registered trademark of Roche Laboratories Inc.
Herceptin is a registered trademark of Genentech.
References:
- TYKERB [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2008.
- Diarrhea and Chemotherapy. Chemocare.com Web site. http://chemocare.com/managing/diarrhea_and_chemotherapy.asp. Accessed August 6, 2008.
- Gastrointestinal Complications (PDQ®). Diarrhea. National Cancer Institute Web site. http://www.cancer.gov/cancertopics/pdq/supportivecare/gastrointestinalcomplications/Patient/page6. Accessed August 6, 2008.