Nibalap (Lapatinib) tablet contains 250 mg of Lapatinib which is a tyrosine kinase inhibitor.
Lapatinib is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors. Lapatinib inhibits ErbB-driven tumour cell growth. Lapatinib is indicated for the treatment of breast cancer whose tumors overexpress HER2.
Each film coated tablet contains Lapatinib Ditosylate Monohydrate INN 405 mg equivalent to Lapatinib 250 mg.
Nibalap is indicated in combination with:
Lapatinib in combination with an aromatase inhibitor has not been compared to a Trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
Nibalap should be taken once daily, do not divide the daily doses. Nibalap should be taken at least one hour before or one hour after a meal. However, Capecitabine should be taken with food or within 30 minutes after a meal.
Lapatinib is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product.
Pregnancy: Pregnancy category D. Lapatinib can cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant when taking Lapatinib. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Nursing mothers: It is not known whether Lapatinib is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Lapatinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric use: The safety and effectiveness of Lapatinib in pediatric patients have not been established. Geriatric use: No overall differences in safety or effectiveness has been observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Cardiovascular: Confirm normal left ventricular ejection fraction before starting Lapatinib and continue evaluations during treatment.
Hepatic: Monitor liver function tests before initiation of treatment, every 4 to 6 weeks during treatment. Discontinue and do not restart Lapatinib if patients experience severe changes in liver function tests. Dose reduction in patients with severe hepatic impairment should be considered.
Diarrhea: Can be severe. Manage with anti-diarrheal agents, and replace fluids and electrolytes if severe.
Pulmonary: Lapatinib has been associated with interstitial lung disease and pneumonitis. Discontinue Lapatinib if patients experience severe pulmonary symptoms.
Common (>20%) adverse reactions during treatment with Lapatinib plus Capecitabine are diarrhea, palmar-plantar erythrodysesthesia, nausea, rash, vomiting, and fatigue. The most common (≥20%) adverse reactions during treatment with Lapatinib plus Letrozole are diarrhea, rash, nausea and fatigue.
Lapatinib is likely to increase exposure to concomitantly administered drugs which are metabolized by CYP3A4 or CYP2C8 (Lapatinib can increase 24-hour systemic exposure (AUC) of Paclitaxel by 23%). Avoid strong CYP3A4 inhibitors; if unavoidable, consider dose reduction of Lapatinib in patients co-administered a strong CYP3A4 inhibitor (Ketoconazole, a CYP3A4 inhibitor, at 200 mg twice daily dose for 7 days increased AUC of Lapatinib by 3.6-fold and half-life by 1.7-fold of control). Avoid strong CYP3A4 inducers; if unavoidable, consider gradual dose increase of Lapatinib in patients co-administered a strong CYP3A4 inducer (Carbamazepine, at 100 mg twice daily dose for 3 days and 200 mg twice daily dose for 17 days, decreased AUC of Lapatinib by 72%).
Store below 30°C. Keep in a dry place away from light.
Each box contains 12 Nibalap tablets in Alu-Alu blister pack.
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