Lapatinib Ditosylate Monohydrate

Indications & Dose:

Treatment of advanced or metastatic breast cancer in patients with tumours that overexpress human epidermal growth factor receptor-2 (HER2) with hormone-receptornegative disease who have had previous treatment with trastuzumab in combination with chemotherapy (in combination with trastuzumab) l

• BY MOUTH

Adult: 1 g once daily

Treatment of advanced or metastatic breast cancer in patients with tumours that overexpress human epidermal growth factor receptor-2 (HER2), for patients who have had previous treatment with an anthracycline, a taxane, and trastuzumab (in combination with capecitabine) l

• BY MOUTH

Adult: 1.25 g once daily

Treatment of advanced or metastatic breast cancer with tumours that overexpress human epidermal growth factor receptor-2 (HER2), for postmenopausal women with hormonereceptor-positive disease (in combination with an aromatase inhibitor) l

• BY MOUTH

Adult: 1.5 g once daily

Contraindications:

Hypersensitivity to any of the ingredients 

Side Effects:

Cautions:

Precautions:

NOTE: lapatinib ditosylate treatment should only be initiated by a physician experienced in the administration of anti-cancer agents. Prior to the initiation of treatment, left ventricular ejection fraction (LVEF) must be evaluated to ensure that baseline LVEF is within the institutional limits of normal . LVEF must continue to be monitored during treatment with lapatinib ditosylate to ensure that LVEF does not decline below the institutional lower limit of normal.

• RENAL IMPAIRMENT: Patients with renal impairment are unlikely to require dose modification of lapatinib ditosylate given that less than 2% of an administered dose (lapatinib and metabolites) is eliminated by the kidneys

• HEPATIC IMPAIRMENT:Lapatinib is metabolised in the liver. Moderate and severe hepatic impairment have been associated, respectively, with 56% and 85% increases in systemic exposure, respectively. 

PATIENTS W ITH SEVERE HEPATIC IMPAIRMENT

(Child-Pugh Class C) should have their dose of lapatinib ditosylate reduced. A dose reduction to from 1250 mg to 750 mg/day or from 1500 mg/day to 1000 mg/day in patients with severe hepatic impairment is predicted to adjust the area under the curve (AUC) to the normal range.

Children: The safety and efficacy of lapatinib ditosylate in paediatric patients has not been established.

Dose delay and dose reduction

Interaction:

Warnings:

Adverse Effects:

Lactations:

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Counselling:

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Patient And Carer Advice: