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For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with lenvatinib in combination with pembrolizumab based on MSI or MMR status in tumor specimens.
Reduce the dose for certain patients with renal or hepatic impairment.
Take lenvatinib once daily, with or without food, at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.
The recommended dosage of lenvatinib is 24 mg orally once daily until disease progression or until unacceptable toxicity.
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 disease progression or until unacceptable toxicity or up to 2 years. After completing 2 years of combination therapy, lenvatinib may be administered as a single agent until disease progression or until unacceptable toxicity.
The recommended dosage of lenvatinib is 18 mg in combination with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity.
The recommended dosage of lenvatinib is based on actual body weight: 12 mg for patients greater than or equal to 60 kg or 8 mg for patients less than 60 kg.
Take lenvatinib orally once daily until disease progression or until unacceptable toxicity.
The recommended dosage of lenvatinib is 20 mg orally once daily, in combination with pembrolizumab 200mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression.
Recommendations for lenvatinib dose interruption, reduction and discontinuation for adverse reactions are listed in Table 1. Table 2 lists the recommended dosage reductions of lenvatinib for adverse reactions.
When administering lenvatinib in combination with pembrolizumab, modify the dosage of one or both drugs as appropriate. Withhold, dose reduce, or discontinue lenvatinib as shown in Table 1. Refer to pembrolizumab prescribing information for additional dose modification information.
When administering lenvatinib in combination with everolimus, withhold or reduce the lenvatinib dose first and then the everolimus dose for adverse reactions of both lenvatinib and everolimus. Refer to the everolimus prescribing information for additional dose modification information.
The recommended dosage of lenvatinib for patients with DTC, RCC, or endometrial carcinoma and severe renal impairment (creatinine clearance less than 30 mL/min calculated by Cockcroft-Gault equation using actual body weight) is:
Differentiated thyroid cancer: 14 mg orally once daily
Renal cell carcinoma: 10 mg orally once daily
Endometrial carcinoma: 10 mg orally once daily
The recommended dosage of lenvatinib for patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment (Child-Pugh C) is:
Differentiated thyroid cancer: 14 mg taken orally once daily
Renal cell carcinoma: 10 mg taken orally once daily
Endometrial carcinoma: 10 mg orally once daily
Oral: Capsule or Suspension
Capsule
Swallow lenvatinib capsules whole at the same time each day with or without food. Do not crush or chew the lenvatinib capsules.
Suspension
Prepare oral suspension with water or apple juice and administer at the same time each day with or without food.
Suspension
Prepare suspension for feeding tube administration with water and administer at the same time each day with or without food.
Place the required number of capsules, up to a maximum of 5, in a small container (approximately 20 mL capacity) or syringe (20 mL). Do not break or crush capsules.
Add 3 mL of liquid to the container or syringe. Wait 10 minutes for the capsule shell (outer surface) to disintegrate, then stir or shake the mixture for 3 minutes until capsules are fully disintegrated and administer the entire contents.
Next, add an additional 2mL of liquid to the container or syringe using a second syringe or dropper, swirl or shake and administer. Repeat this step at least once and until there is no visible residue to ensure all of the medication is taken.
If 6 capsules are required for a dose, follow these instructions using 3 capsules at a time. If lenvatinib suspension is not used at the time of preparation, lenvatinib suspension may be stored in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC) for a maximum of 24 hours in a covered container. If not administered within 24 hours, the suspension should be discarded.
Note: Compatibility has been confirmed for polypropylene syringes and for feeding tubes of at least 5 French diameter (polyvinyl chloride or polyurethane tube) and at least 6 French diameter (silicone tube).
from FDA，2024.06
