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Inform patients of the following: Decreased Left Ventricular Ejection Fraction (LVEF): TYKERB has been reported to decrease left ventricular ejection fraction which may result in shortness of breath, palpitations, and/or fatigue [see Decreased Left Ventricular Ejection Fraction under Precautions]. Advise patients to inform their healthcare provider if they develop these symptoms while taking TYKERB.
Hepatotoxicity and Hepatic Impairment: Periodic laboratory testing will be performed while taking TYKERB. Advise patients to report signs and symptoms of liver dysfunction to their healthcare provider right away [see Hepatotoxicity under Precautions].
Diarrhea: TYKERB often causes diarrhea which may be severe in some cases [see Diarrhea under Precautions]. Instruct patients on how to manage and/or prevent diarrhea and to inform their healthcare provider immediately if there is any change in bowel patterns or severe diarrhea occurs during treatment with TYKERB.
Interstitial Lung Disease/Pneumonitis: Advise patients to report pulmonary signs or symptoms indicative of ILD or pneumonitis [see Interstitial Lung Disease/Pneumonitis under Precautions].
Severe Cutaneous Reactions: Advise patients to report severe cutaneous reactions to their healthcare provider if they develop these symptoms while taking TYKERB [see Severe Cutaneous Reactions under Precautions].
Drug and Food Interactions: TYKERB may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products [see Interactions].
TYKERB may interact with grapefruit. Advise patients not to take TYKERB with grapefruit products [see Dose Modification Guidelines under Dosage & Administration and Drugs That Inhibit or Induce Cytochrome P450 3A4 Enzymes under Interactions].
Dosing Administration: TYKERB should be taken at least one hour before or one hour after a meal, in contrast to capecitabine which should be taken with food or within 30 minutes after food. The dose of TYKERB should be taken once daily. Dividing the daily dose is not recommended [see Recommended Dosing under Dosage & Administration].
Embryo-Fetal Toxicity: Inform female patients of the risk to a fetus and potential loss of the pregnancy. Advise females to inform their healthcare provider if they are pregnant or become pregnant [see Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment with TYKERB and for 1 week after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose [see Embryo-Fetal Toxicity under Precautions and Use in Pregnancy & Lactation].
Lactation: Advise patients not to breastfeed during treatment and for 1 week after the last dose of TYKERB [see Use in Pregnancy & Lactation].
