Lenvima (lenvatinib) Cancer Medication: Side Effects & Dosage

What is Lenvima, and how does it work?

Lenvima is a prescription medicine that is used to treat certain kinds of cancer.

Lenvima is used by itself to treat differentiated
thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing.
Lenvima is used along with another medicine called everolimus to treat
advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anticancer medicine.
Lenvima is used by itself as the first treatment for a type of
liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery.
Lenvima is used along with another medicine called pembrolizumab to treat advanced endometrial carcinoma, a type of uterine cancer:
- that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
- that has progressed after treatment with anti-cancer medicine, and
- that cannot be treated with surgery or radiation.

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

What are the side effects of Lenvima?

Lenvima may cause serious side effects, including:

high blood pressure (hypertension). High blood pressure is a common side effect of Lenvima and can be serious. Your blood pressure should be well controlled before you start taking Lenvima. Your healthcare provider should check your blood pressure regularly during treatment with Lenvima. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure.
heart problems. Lenvima can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.
problem with blood clots in your blood vessels (arteries). Get emergency medical help right away if you get any of the following symptoms:
- severe chest pain or pressure
- pain in your arms, back, neck or jaw
- shortness of breath
- numbness or weakness on one side of your body
- trouble talking
- sudden severe headache
- sudden vision changes
liver problems. Lenvima may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with Lenvima. Tell your healthcare provider right away if you have any of the following symptoms:
- your skin or the white part of your eyes turns yellow (jaundice)
- dark “tea colored” urine
- light-colored bowel movements (stools)
- feeling drowsy, confused or loss of consciousness
kidney problems. Kidney failure, which can lead to death, has happened with Lenvima treatment. Your healthcare provider should do regular blood tests to check your kidneys.
increased protein in your urine (proteinuria). Proteinuria is a common side effect of Lenvima and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with Lenvima.
diarrhea. Diarrhea is a common side effect of Lenvima and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room, if you are unable to drink enough liquids and your diarrhea is not able to be controlled.
an opening in the wall of your stomach or intestines (perforation) or an abnormalconnection between two or more body parts (fistula). Get emergency medical help right away if you have severe stomach (abdomen) pain.
changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with Lenvima to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an ECG.
low levels of blood calcium (hypocalcemia). Your healthcare provider will check your blood calcium levels during treatment with Lenvima and may tell you to take a calcium supplement if your calcium levels are low.
a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Call your healthcare provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision.
bleeding. Lenvima may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment with Lenvima, including:
- severe and persistent nose bleeds
- vomiting blood
- red or black (looks like tar) stools
- blood in your urine
- coughing up blood or blood clots
- heavy or new onset vaginal bleeding
change in thyroid hormone levels. Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with Lenvima.
wound healing problems. Wound healing problems have happened in some people who take Lenvima. Tell your healthcare provider if you plan to have any surgery before or during treatment with Lenvima.
- You should stop taking Lenvima at least 1 week before planned surgery.
- Your healthcare provider should tell you when you may start taking Lenvima again after surgery.

The most common side effects of Lenvima in people treated for thyroid cancer include:

tiredness
joint and muscle pain
decreased appetite
weight loss
nausea
mouth sores
headache
vomiting
rash, redness, itching, or peeling of your skin on your hands and feet
stomach (abdomen) pain
hoarseness

The most common side effects of Lenvima in people treated for kidney cancer include:

tiredness
joint and muscle pain
decreased appetite
vomiting
nausea
mouth sores
swelling in your arms and legs
cough
stomach (abdomen) pain
trouble breathing
rash
weight loss
bleeding

The most common side effects of Lenvima in people treated for liver cancer include:

tiredness
decreased appetite
joint and muscle pain
weight loss
stomach (abdomen) pain
rash, redness, itching, or peeling of your skin on your hands and feet
hoarseness
bleeding
change in thyroid hormone levels
nausea

The most common side effects of Lenvima when given with pembrolizumab in peopletreated for uterine cancer include:

tiredness
joint and muscle pain
decreased appetite
change in thyroid hormone levels
nausea
mouth sores
vomiting
weight loss
stomach (abdomen) pain
headache
constipation
urinary tract infection
hoarseness
bleeding
low magnesium level
rash, redness, itching, or peeling of your skin on your hands and feet
trouble breathing
cough
rash

Lenvima may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Lenvima.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.

What is the dosage for Lenvima?

Important Dosage Information

Reduce the dose for certain
patients with renal or hepatic impairment.
Take Lenvima 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.

Recommended Dosage For Differentiated Thyroid Cancer (DTC)

The recommended dosage of Lenvima is 24 mg orally once daily until disease progression or until unacceptable toxicity.

Recommended Dosage For Renal Cell Carcinoma (RCC)

The recommended dosage of Lenvima 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
Lenvima 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
Lenvima orally once daily until disease progression or until unacceptable toxicity.

Recommended Dosage For Endometrial Carcinoma

The recommended dosage of Lenvima 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.

Dosage Modifications For Adverse Reactions

Recommendations for
Lenvima dose interruption, reduction and discontinuation for adverse reactions are listed in Table 1. Table 2 lists the recommended dosage reductions of
Lenvima for adverse reactions.

Table 1: Recommended Dosage Modifications for
Lenvima for Adverse Reactions

Adverse ReactionSeverity ^a
Dosage Modifications for LenvimaHypertensionGrade 3

Withhold for Grade 3 that persists despite optimal antihypertensive therapy.
Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.

Grade 4

Permanently discontinue.

Cardiac Dysfunction Grade 3

Withhold until improves to Grade 0 to 1 or baseline.
Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.

Grade 4

Permanently discontinue.

Arterial Thromboembolic EventAny Grade

Permanently discontinue.

HepatotoxicityGrade 3 or 4

Withhold until improves to Grade 0 to 1 or baseline.
Either resume at a reduced dose or discontinue depending on severity and persistence of hepatotoxicity.
Permanently discontinue for hepatic failure.

Renal Failure or ImpairmentGrade 3 or 4

Withhold until improves to Grade 0 to 1 or baseline.
Resume at a reduced dose or discontinue depending on severity and persistence of renal impairment.

Proteinuria2 g or greater proteinuria in 24 hours

Withhold until less than or equal to 2 grams of proteinuria per 24 hours.
Resume at a reduced dose.
Permanently discontinue for nephrotic syndrome.

Gastrointestinal PerforationAny Grade

Permanently discontinue.

Fistula Formation Grade 3 or 4

Permanently discontinue.

QT ProlongationGreater than 500 ms or greater than 60 ms increase from baseline

Withhold until improves to less than or equal to 480 ms or baseline.
Resume at a reduced dose.

Reversible Posterior Leukoencephalopathy SyndromeAny Grade

Withhold until fully resolved.
Resume at a reduced dose or discontinue depending on severity and persistence of neurologic symptoms.

Other Adverse ReactionsPersistent or intolerable Grade 2 or 3 adverse reaction Grade 4 laboratory abnormality

Withhold until improves to Grade 0 to 1 or baseline.
Resume at reduced dose.

Grade 4 adverse reaction

Permanently discontinue.

^a National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Table 2: Recommended Dosage Reductions of
Lenvima for Adverse Reactions

IndicationFirst Dosage Reduction ToSecond Dosage Reduction ToThird Dosage Reduction ToDTC20 mg once daily14 mg once daily10 mg once dailyRCC14 mg once daily10 mg once daily8 mg once dailyEndometrial Carcinoma14 mg once daily10 mg once daily8 mg once dailyHCC

Actual weight 60 kg or greater

8 mg once daily4 mg once daily4 mg every other day

Actual weight less than 60 kg

4 mg once daily4 mg every other dayDiscontinue

When administering
Lenvima in combination with everolimus for the treatment of renal cell carcinoma, reduce the
Lenvima dose first and then the everolimus dose for adverse reactions of both
Lenvima and everolimus. Refer to the everolimus prescribing information for additional dose modification information.

When administering
Lenvima in combination with pembrolizumab for the treatment of endometrial carcinoma, interrupt one or both drugs or dose reduce
Lenvima as appropriate. No dose reductions are recommended for pembrolizumab. Withhold or discontinue pembrolizumab in accordance with the instructions in the pembrolizumab prescribing information.

Dosage Modifications For Severe Renal Impairment

The recommended dosage of Lenvima 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

Dosage Modifications For Severe Hepatic Impairment

The recommended dosage of Lenvima 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

Preparation And Administration

Lenvima capsules can be swallowed whole or dissolved in a small glass of liquid.
To dissolve in liquid, put capsules into 1 tablespoon of water or apple juice without breaking or crushing the capsules.
Leave the capsules in the water or apple juice for at least 10 minutes. Stir for at least 3 minutes.
After drinking the mixture, add 1 tablespoon of water or apple juice to the glass, swirl the contents a few times and swallow the water or apple juice.

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What drugs interact with Lenvima?

Drugs That Prolong The QT Interval

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

Is Lenvima safe to use while pregnant or breastfeeding?

Based on its mechanism of action and data from animal reproduction studies,
Lenvima can cause fetal harm when administered to a pregnant woman.
It is not known whether Lenvima is present in human milk; however, lenvatinib and its metabolites are excreted in rat milk at concentrations higher than those in maternal plasma.
Because of the potential for serious adverse reactions in breastfed infants, advise women to discontinue breastfeeding during treatment with
Lenvima and for at least 1 week after the last dose.