Indications
Nibalap Tablet is used for:
Breast cancer
Adult Dose
Oral
Breast Cancer
HER2-overexpressing metastatic breast cancer
Indicated in combination with capecitabine for treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab
1250 mg PO qDay on Days 1-21 continuously in combination with capecitabine (2000 mg/m²/day PO divided q12hr) on Days 1-14 in a repeating 21-day cycle
Hormone-positive & HER2-positive advanced breast cancer
Indicated in combination therapy with letrozole for treatment of postmenopausal women with hormone receptor-positive and HER2-positive breast cancer for whom hormonal therapy is indicated
1500 mg PO qDay administered continuously in combination with letrozole 2.5 mg PO qDay
Hepatic Impairment
Severe (Child-Pugh Class C)
HER2 positive metastatic breast cancer: Reduce dose from 1250 mg/day to 750 mg/day
Hormone receptor positive, HER2 positive breast cancer: Reduce dose from 1500 mg/day to 1000 mg/day
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Should be taken on an empty stomach. Take at least 1 hr before or 1 hr after a meal. Do not eat/drink grapefruit products.
Contra Indications
Hypersensitivity to lapatinib ditosylate
Precautions
Evaluate left ventricular ejection fraction (LVEF) prior to treatment. Moderate or severe hepatic impairment. Patients who have or may develop QTc prolongation, including those w/ hypokalaemia or hypomagnesemia. Monitor liver function & pulmonary symptoms indicative of interstitial lung disease/pneumonitis. Pregnancy & lactation.
Lactation: Do not nurse
Pregnancy-Lactation
Pregnancy Category: D
Lactation: Do not nurse
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 & rosuvastation. Increased incidence & severity of adverse events w/ paclitaxel & docetaxel. CYP3A4 or CYP2C8 substrates.
Side Effects
Side effects of Lapatinib :
>10% (lapatinib+capecitabine)
Diarrhea (65%), Anemia (56%), Hand-foot synd (53%), Increased LFTs (37-49%), Nausea (44%), Rash (28%), Vomiting (26%), Pain (23%), Neutropenia (22%), Thrombocytopenia (18%), Mucositis (15%), Stomatitis (14%), Dyspnea (12%), Dyspepsia (11%), Insomnia (10%)
1-10%
Insomnia
Mode of Action
Kinase inhibitor, blocks EGF-receptor HER2 kinase; tyrosing kinase inhibition possibly blocks angiogenesis and cellular proliferation.
Note
Nibalap 250mg Tablet generic name is Lapatinib. Nibalap 250mg Tablet is manufactured by Aristopharma LimitedNibalap is availble in all over Bangladesh.
Mes BD drug index information on Nibalap Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.