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Lapatinib 250mg 1 Tablet [Prescription Required]

Lapatinib 250mg 1 Tablet [Prescription Required]
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50028721
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Description

Indications:
Lapatinib (Tykerb®,), in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer, whose tumors overexpress HER2/neu (ErbB2) and who have progressed on prior trastuzumab therapy in the metastatic setting.
Lapatinib (Tykerb®,), in combination with trastuzumab, is indicated for the treatment of patients with hormone receptor-negative metastatic breast cancer whose tumors overexpress HER2/neu
(ErbB2) and who have progressed on prior trastuzumab therapy in combination with
chemotherapy in the metastatic setting.
Lapatinib (Tykerb®,), in combination with paclitaxel, is indicated for the first line treatment of patients with metastatic breast cancer whose tumors overexpress HER2/neu (ErbB2) and for whom trastuzumab is not appropriate.
Lapatinib (Tykerb®,), in combination with an aromatase inhibitor, is indicated for the treatment of postmenopausal women with hormone receptor-positive, HER2/neu (ErbB2) overexpressing advanced or metastatic breast cancer, and for whom endocrine therapy is indicated.
No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor or chemotherapy in this patient population.

Place of Origin

United Kingdom

Product Usage

Dosage and administration:
Adults: ♦Lapatinib in combination with capecitabine: 1250 mg once daily with capecitabine
2000 mg/m2/day in 2 doses 12 hours apart on days 1 to 14 in a 21 day cycle. ♦Lapatinib in
combination with trastuzumab: 1000 mg once daily, with trastuzumab 4 mg/kg as IV loading
dose, followed by 2 mg/kg IV weekly. ♦Lapatinib in combination with paclitaxel: 1500 mg
once daily, with paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day schedule or 175 mg/m2
IV every 21 days. ♦Lapatinib in combination with an aromatase inhibitor: 1500 mg once daily,
letrozole 2.5 mg once daily. ♦Take at least one hour before or one hour after food. ♦Management
of adverse reactions may require treatment interruption, dose reduction or treatment discontinuation.
Special populations: ♦Pediatric patients (aged below 18 years): Safety and efficacy not established. ♦Geriatric patients (>65 years): Limited data. No overall differences in the safety or efficacy on the basis of age were observed. ♦Renal impairment: No dose adjustment required. ♦Severe hepatic impairment: Caution and dose reduction.

Ingredients

Active Substance: Nilotinib Excipients
Microcrystalline cellulose
Povidone
Sodium starch glycolate
Magnesium stearate
Yellow tablet film-coat
Hypromellose
Titanium dioxide
Macrogol/PEG 400
Polysorbate 80
Iron oxide yellow
Iron oxide red
Pharmaceutical formulations may vary between countries.

Warnings

Contraindications: ♦Hypersensitivity to any of the ingredients.
Warnings and precautions: ♦Cardiac toxicity: Caution in patients with conditions that could impair left ventricular function. Baseline and on treatment monitoring of LVEF. LVEF within the institutionals normal limits prior to treatment initiation. Caution in patients who have or may develop prolongation of QTc. Correction of hypokalemia

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