Lenvatinib

What is Lenvatinib?

• Lenvatinib (Lenvima) is a kinase inhibitor used to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).

What are the uses of this medicine?

This medicine is used to treat:

• 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 to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC):
• along with the medicine pembrolizumab as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
• along with the medicine everolimus after one course of treatment with another anti-cancer 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 endometrial carcinoma, a type of uterine cancer:

• when your tumor is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
• you have received anti-cancer treatment, and it is no longer working, and
• your cancer cannot be cured by surgery or radiation (advanced endometrial carcinoma)

How does this medicine work?

• Lenvatinib (len va' ti nib) is an orally available, small molecule, multi-kinase inhibitor with activity against vascular endothelial growth factor receptor (VEGFR) 1, 2 and 3 as well as fibroblast growth factor (FGF) 1, 2, 3 and 4, platelet derived growth factor receptor (PDGFR) alpha, cKit and the RET proto-oncogene.
• Several of these receptors are overexpressed in cancer cells and can cause unregulated cell growth.
• Lenvatinib has been evaluated as therapy of several forms of advanced and metastatic carcinomas and has shown efficacy in thyroid and renal cell carcinoma.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: Recommended Dosage for Differentiated Thyroid Cancer (DTC)ː

• 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)ː

• 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 disease progression or until unacceptable toxicity or up to 2 years.
• The recommended dosage of Lenvima is 18 mg in combination with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity.

Recommended Dosage for Hepatocellular Carcinoma (HCC)ː

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 (EC)ː

• 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.

Administration

• Take Lenvima exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Lenvima to take and when to take it. Your healthcare provider may change your dose during treatment, stop treatment for some time, or completely stop treatment with Lenvima if you have side effects.
• Take Lenvima 1 time each day at the same time, with or without food.
• If you miss a dose of Lenvima, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.
• If you cannot swallow Lenvima capsules whole:
• Use a medicine cup to measure about one tablespoon of water or apple juice and place into a small glass.
• Place the Lenvima capsules into the small glass without breaking or crushing them.
• Leave the capsules in the liquid for at least 10 minutes.
• Stir the contents of the glass for at least 3 minutes.
• Drink the mixture. After drinking, rinse the glass with a small amount of additional water or apple juice and swallow the liquid.
• If you take too much Lenvima, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 4 mg and 10 mg.

This medicine is available in fallowing brand namesː

• Lenvima

What side effects can this medication cause?

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 when given with everolimus 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 include:

• decrease in thyroid hormone levels
• increased blood pressure
• tiredness
• diarrhea
• joint and muscle pain
• nausea
• decreased appetite
• vomiting
• mouth sores
• weight loss
• stomach-area (abdomen) pain
• urinary tract infection
• protein in your urine
• constipation
• headache
• bleeding
• rash, redness, itching, or peeling of your skin on your hands and feet
• hoarseness
• rash

Lenvima may cause serious side effects, including:

• 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)

What special precautions should I follow?

• Hypertension may occur with Lenvima. Control blood pressure prior to treatment and monitor during treatment. Withhold for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for Grade 4 hypertension.
• Cardiac dysfunction may occur. Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold or discontinue for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction.
• Arterial thromboembolic events may occur with Lenvima . Discontinue following an arterial thromboembolic event.
• Hepatotoxicity may occur with Lenvima. Monitor liver function prior to treatment and periodically during treatment. Withhold or discontinue for Grade 3 or 4 hepatotoxicity. Discontinue for hepatic failure.
• Renal failure or impairment may occur with Lenvima. Withhold or discontinue for Grade 3 or 4 renal failure or impairment.
• Proteinuria may occur with Lenvima. Monitor for proteinuria prior to treatment and periodically during treatment. Withhold for 2 or more grams of proteinuria per 24 hours. Discontinue for nephrotic syndrome.
• Diarrhea may occur with Lenvima. May be severe and recurrent. Promptly initiate management for severe diarrhea. Withhold or discontinue based on severity.
• Fistula formation and gastrointestinal perforation may occur with Lenvima. Discontinue in patients who develop Grade 3 or 4 fistula or any Grade gastrointestinal perforation.
• Lenvima may cause QT interval prolongation. Monitor and correct electrolyte abnormalities. Withhold for QT interval greater than 500 ms or for 60 ms or greater increase in baseline QT interval.
• Hypocalcemia may occur with Lenvima. Monitor blood calcium levels at least monthly and replace calcium as necessary. Withhold or discontinue based on severity.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS) may occur with Lenvima Withhold for RPLS until fully resolved or discontinue.
• Hemorrhagic Events may occur with Lenvima. Withhold or discontinue based on severity.
• Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction may occur with Lenvima. Monitor thyroid function prior to treatment and monthly during treatment.
• Impaired Wound Healing may occur with Lenvima. Withhold Lenvima for at least 1 week before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Lenvima after resolution of wound healing complications has not been established.
• Osteonecrosis of the Jaw may occur with Lenvima. Consider preventive dentistry prior to treatment with Lenvima. Avoid invasive dental procedures, if possible, particularly in patients at higher risk.
• Lenvima Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

Death due to multiorgan dysfunction occurred in a patient who received a single dose of Lenvima 120 mg orally.

Management for overdosage:

• Due to the high plasma protein binding, lenvatinib is not expected to be dialyzable.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and data from animal reproduction studies, Lenvima can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Lenvima in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lenvatinib
• Inactive ingredients: calcium carbonate, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, mannitol, microcrystalline cellulose, and talc.

The capsule shell contains: hypromellose, titanium dioxide, ferric oxide yellow, and ferric oxide red. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

Who manufactures and distributes this medicine?

• Distributed by: Eisai Inc., Woodcliff Lake

What should I know about storage and disposal of this medication?

• Store Lenvima at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep Lenvima and all medicines out of the reach of children.

• Dailymed label info on Lenvatinib
• FDA Lenvatinib

Lenvatinib Resources
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