Capecitabine USP
Composition: Lanib-10: Each capsule contains Lenvatinib 10mg as Lenvatinib Mesylate INN.
Indications: Differentiated Thyroid Cancer: Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Renal Cell Carcinoma: Lenvatinib is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Hepatocellular Carcinoma: Lenvatinib is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Endometrial Carcinoma: Lenvatinib, in combination with Pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Dosage and administration: Recommended Dosage for Differentiated Thyroid Cancer (DTC): The recommended dosage of Lenvatinib is 24 mg orally once daily until disease progression or until unacceptable toxicity. Recommended Dosage for Renal Cell Carcinoma (RCC): The recommended dosage of Lenvatinib is 18 mg in combination with 5 mg Everolimus orally once daily until disease progression or until unacceptable toxicity. Refer to Everolimus prescribing information for recommended Everolimus dosing information. Recommended Dosage for Hepatocellular Carcinoma (HCC): The recommended dosage of Lenvatinib is based on actual body weight: i) 12 mg for patients greater than or equal to 60 kg or ii) 8 mg for patients less than 60 kg. Lenvatinib should be taken orally once daily until disease progression or until unacceptable toxicity. Recommended Dosage for Endometrial Carcinoma: The recommended dosage of Lenvatinib is 20 mg orally once daily, in combination with Pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression. Refer to the Pembrolizumab prescribing information for recommended Pembrolizumab dosing information. Or, as directed by the registered physicians.
Use in Pregnancy and Lactation: Based on the mechanism of action, Lenvatinib can cause embryo-fetal harm when administered to a pregnant female. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Lenvatinib and for at least 30 days after the last dose. It is not known whether Lenvatinib is present in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should be advised to discontinue breastfeeding during treatment with Lenvatinib and for at least 1 week after the last dose.
Packing: Lanib-10: Each
container contains 30 capsules in a box.
