Lenvata®(Lenvatinib)

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capsule 4-10 mg

Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors.

INDICATIONS

• in combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy.

• for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

• In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

It is not known if Lenvatinib is safe and effective in children.

DOSAGE AND ADMINISTRATION

Lenvatinib is a kinase inhibitor that is indicated:

• For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

• in combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) .

Single agent therapy:

• DTC: The recommended dosage is 24 mg orally once daily.
• HCC: The recommended dosage is based on actual body weight: 12 mg orally once daily for patients greater than or equal to 60 kg or 8 mg orally once daily for patients less than 60 kg.

Combination therapy:
• EC: The recommended dosage is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
• RCC: The recommended dosage is:
o 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
o 18 mg orally once daily with everolimus 5 mg orally once daily.

Modify the recommended daily dose for certain patients with renal or hepatic impairment.

WARNINGS AND PRECAUTIONS

• High blood pressure (hypertension).

• Heart problems.

• Problem with blood clots in your blood vessels (arteries).

• Liver problems.

• Kidney problems.

• Increased protein in your urine (proteinuria).

• Diarrhea.

• An opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula).

• Changes in the electrical activity of your heart called QT prolongation.

• Low levels of blood calcium (hypocalcemia).

• A condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS).

• Bleeding.

• Change in thyroid hormone levels.

• Wound healing problems.

• Severe jaw bone problems (osteonecrosis).

DRUG INTERACTIONS

Lenvatinib has been reported to prolong the QT/QTc interval. Avoid coadministration of Lenvatinib with medicinal products with a known potential to prolong the QT/QTc interval.

Brochure

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	Lenvatinib En -02.10.16-Final.pdf	679.74 KB