Zuellig Pharma
Concise Prescribing Info
Lapatinib ditosylate monohydrate
In combination w/ capecitabine for the treatment of patients w/ advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2/neu) & progressed after treatment w/ trastuzumab. In combination w/ trastuzumab for the treatment of patients w/ metastatic breast cancer whose tumours overexpress ErbB2 (HER2/neu) & progressed after treatment of trastuzumab therapy. In combination w/ paclitaxel for the treatment of patients w/ metastatic breast cancer whose tumours overexpress ErbB2 (HER2/neu). In combination w/ an aromatase inhibitor for the treatment of postmenopausal woman w/ hormone receptor-positive, ErbB2 (HER2/neu) overexpressing advanced & metastatic breast cancer.
Dosage/Direction for Use
In combination w/ capecitabine 1,250 mg once daily continuously & capecitabine 2,000 mg/m2/day in 2 doses 12 hr apart on days 1-14 in a 21-day cycle. In combination w/ trastuzumab 1,000 mg once daily continuously & trastuzumab 4 mg/kg IV loading dose, followed by 2 mg/kg IV wkly. In combination w/ paclitaxel 1,500 mg once daily continuously & paclitaxel 80 mg/m2 on days 1, 8 and 15 in a 28-day schedule, alternatively, paclitaxel may be given at a dose of 175 mg/m2 every 21 days. In combination w/ an aromatase inhibitor 1,500 mg once daily continuously & letrozole 2.5 mg once daily.
Should be taken on an empty stomach: Take at least 1 hr before or after a meal. Do not eat/drink grapefruit products.
Special Precautions
Conditions that could impair left ventricular function. Evaluate left ventricular ejection fraction (LVEF) prior to treatment. Monitor liver function & pulmonary symptoms indicative of interstitial lung disease/pneumonitis. Moderate or severe hepatic impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Monotherapy: Anorexia, diarrhoea, nausea, vomiting, rash, fatigue; decreased LVEF, nail disorders including paronychia. Combination therapy w/ capecitabine: Dyspepsia, dry skin, stomatitis, constipation, abdominal pain, palmar-plantar erythrodysaesthesia, mucosal inflammation, pain in extremity, back pain, headache, insomnia. W/ paclitaxel: Neutropenia, leukopenia, anaemia, peripheral neuropathy, myalgia. W/ letrozole: Epistaxis, alopecia.
Drug Interactions
Increased conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole or grapefruit juice), midazolam, irinotecan & digoxin. Decreased conc w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin) & proton-pump inhibitors (eg, esomeprazole). Altered pharmacokinetics w/ P-glycoprotein, breast cancer resistance protein (BCRP) inhibitors & inducers, topotecan & rosuvastatin. Increased incidence & severity of adverse events w/ paclitaxel & docetaxel. CYP3A4 or CYP2C8 substrates.
ATC Classification
L01EH01 - lapatinib ; Belongs to the class of human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors. Used in the treatment of cancer.
Tykerb FC tab 250 mg
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