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TYKERB

 
 
Package(a):
FILM COATED TABLETS: 10.
Dosage(a):
Treatment should only be initiated by a physician experienced in the administration of anti-cancer agents.
Lapatinib is taken in combination with capecitabine.
The recommended dose is 1,250 mg (i.e. five tablets) once daily continuously. Should be taken at least one hour before, or at least one hour after food. Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose. 
The recommended dose of capecitabine is 2,000 mg/m²/day taken in 2 doses 12 hours apart on days 1-14 in a 21 day cycle. Capecitabine should be taken with food or within 30 minutes after food.
Hepatic impairment/change in function: Lapatinib should be discontinued if changes in liver function are severe and patients should not be retreated.
Administration of lapatinib to patients with moderate to severe hepatic impairment should be undertaken with caution. 
Children: Safety and efficacy has not been established. See prescribing information for full details.
Prescribing Restrictions:    

Package(b):
FILM COATED TABLETS: 70.
Dosage(b):
Treatment should only be initiated by a physician experienced in the administration of anti-cancer agents.
Lapatinib is taken in combination with capecitabine.
The recommended dose is 1,250 mg (i.e. five tablets) once daily continuously. Should be taken at least one hour before, or at least one hour after food. Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose. 
The recommended dose of capecitabine is 2,000 mg/m²/day taken in 2 doses 12 hours apart on days 1-14 in a 21 day cycle. Capecitabine should be taken with food or within 30 minutes after food.
Hepatic impairment/change in function: Lapatinib should be discontinued if changes in liver function are severe and patients should not be retreated.
Administration of lapatinib to patients with moderate to severe hepatic impairment should be undertaken with caution. 
Children: Safety and efficacy has not been established. See prescribing information for full details.
Prescribing Restrictions:     


Indications:
In combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress ErbB₂ (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
In combination with 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.
Contra-Indications:
There are no known contraindications associated with lapatinib. Please refer to the capecitabine prescribing information for relevant contraindications and safety information when administering lapatinib in combination with capecitabine.
Special Precautions:
Caution should be taken if lapatinib is to be administered to patients with conditions that could impair left ventricular function. LVEF should be evaluated in all patients prior to initiation of treatment with lapatinib. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease/pneumonitis. Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before initiation of treatment and monthly thereafter, or as clinically indicated. Lapatinib dosing should be discontinued if changes in liver function are severe and patients should not be retreated. Hepatotoxicity has also been reported with other tyrosine kinase inhibitors. Caution is warranted if lapatinib is prescribed to patients with moderate or severe hepatic impairment. Proactive management of diarrhea with anti-diarrheal agents is important. See prescribing information for full details. 
Pregnancy and lactation: Should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment. Breast feeding must be discontinued in women who are receiving therapy.
Side Effects:
Very common: Anorexia, diarrhea (which may lead to dehydration), nausea vomiting, rash (including dermatitis acneform), fatigue, Stomatitis, constipation, abdominal pain, palmar-plantar erythrodysesthesia, mucosal inflammation, pain in extremity, back pain, insomnia, dyspepsia, dry skin. Common: Headache, decreased left ventricular ejection fraction.
Drug Interactions:
CYP3A4 inhibitors (ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, and grapefruit juice); CYP3A4 inducers (rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John? wort]). 
Pgp and BCRP inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, erythromycin) and inducers (rifampin, St John? Wort). Substances that increase gastric pH.