Lenvima

Approved Uses

Lenvima is used to treat specific types of cancer that are advanced, have spread, or cannot be removed by surgery. It is typically prescribed for the following conditions:

• Thyroid Cancer: It is used for differentiated thyroid cancer (DTC) that is locally recurrent or metastatic and can no longer be treated with radioactive iodine.
• Kidney Cancer (Renal Cell Carcinoma): Lenvima is used in two ways for advanced kidney cancer. It may be used in combination with everolimus after at least one other anti-angiogenic treatment has been tried. It is also used in combination with pembrolizumab as a first-line treatment for adults with advanced kidney cancer.
• Liver Cancer (Hepatocellular Carcinoma): It is used as a first-line treatment for liver cancer that cannot be removed by surgery.
• Endometrial Cancer: Lenvima is used in combination with pembrolizumab for advanced endometrial carcinoma (a type of uterine cancer) that has progressed following prior systemic therapy and is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

Mechanism of Action

Lenvima belongs to a class of drugs called kinase inhibitors. It works by targeting and blocking the activity of certain proteins, known as tyrosine kinases, which are found on the surface of both normal cells and cancer cells.

The medication specifically targets several receptors involved in tumor growth, including:

• Vascular endothelial growth factor (VEGF) receptors
• Fibroblast growth factor (FGF) receptors
• Platelet-derived growth factor (PDGF) receptor alpha
• KIT and RET proteins

By interfering with these proteins, Lenvima helps to treat cancer in two primary ways:

• Inhibiting Angiogenesis: It blocks the signals that tell the body to create new blood vessels. Without a dedicated blood supply, tumors cannot get the oxygen and nutrients they need to grow.
• Disrupting Cell Signaling: It interferes with the pathways that cancer cells use to communicate, grow, and divide. This helps slow down the progression and spread of the disease.

Common Side Effects

Many people taking Lenvima experience side effects. Common reactions include:

• Tiredness or weakness
• High blood pressure
• Diarrhea
• Joint or muscle pain
• Decreased appetite and weight loss
• Nausea and vomiting
• Mouth sores
• Hand-foot syndrome (redness, swelling, or pain on the palms of the hands or soles of the feet)
• Hoarseness
• Headache

Serious Side Effects

Lenvima can cause serious side effects that may require medical intervention. Seek immediate care for:

• Heart problems: Chest pain, shortness of breath, or swelling in the ankles.
• Blood clots: Sudden numbness, severe headache, or vision changes.
• Gastrointestinal issues: Severe stomach pain or persistent vomiting, which may indicate a tear in the stomach or intestinal wall.
• Liver or kidney problems: Yellowing of the skin or eyes, dark urine, or changes in urination.
• Bleeding: Unusual or heavy bleeding.
• Neurological issues: Seizures or extreme confusion.

Serious Cardiovascular Risks

Lenvima can cause severe high blood pressure, which is a common side effect. Blood pressure is typically checked before starting treatment and monitored regularly thereafter. There is also an increased risk of serious heart problems, such as heart failure or a heart attack. Additionally, blood clots may occur, which can lead to a stroke or other life-threatening complications.

Organ Damage and Internal Issues

This medication may cause significant damage to the liver or kidneys, sometimes leading to organ failure. It also carries a risk of gastrointestinal perforation (a hole in the stomach or intestine) or the formation of a fistula (an abnormal connection between body parts). Severe bleeding is another potential risk that can be fatal.

Neurological and Metabolic Concerns

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): This is a rare brain condition that can cause headaches, seizures, confusion, or vision changes.
• Thyroid Function: Lenvima can affect thyroid hormone levels, requiring regular blood tests.
• Electrolyte Imbalances: Low levels of calcium in the blood may occur during treatment.

Other Important Precautions

Lenvima can interfere with wound healing. It is generally recommended to stop the medication for a period of time before and after any planned surgery. The drug can also cause harm to an unborn baby; effective birth control is typically used during treatment and for a period after the final dose. Breastfeeding is generally not recommended while taking this medication.

Pregnancy

Lenvima can cause serious harm to a developing fetus, including birth defects or pregnancy loss. Healthcare providers typically require a pregnancy test before starting treatment to confirm the patient is not pregnant.

Individuals who can become pregnant should use effective contraception during treatment and for at least 30 days after the final dose. If pregnancy occurs while taking this medication, it is important to notify a healthcare provider immediately to discuss the potential risks.

Breastfeeding

It is not known whether lenvatinib passes into human breast milk. Due to the potential for serious side effects in a nursing infant, breastfeeding is not recommended during treatment with Lenvima and for at least one week following the last dose.

Available Forms

Lenvima is available as a capsule for oral administration. It is typically provided in blister packs that may contain capsules to make up the required daily dose.

The capsules should be swallowed whole. For patients who have difficulty swallowing, the capsules can be dissolved in water or apple juice without being crushed or broken.

FDA Approval History

Lenvima was first approved by the U.S. Food and Drug Administration (FDA) in February 2015. Since its initial approval, the FDA has expanded its use to include several different types of advanced or metastatic cancers.

Approved Indications

The FDA has approved Lenvima for the following uses:

• Differentiated Thyroid Cancer (DTC): For patients with local recurrence or metastatic disease that no longer responds to radioactive iodine treatment.
• Renal Cell Carcinoma (Kidney Cancer): Used in combination with everolimus for patients who have received one prior therapy, or in combination with pembrolizumab as a first-line treatment for advanced disease.
• Hepatocellular Carcinoma (Liver Cancer): As a first-line treatment for patients with liver cancer that cannot be removed by surgery.
• Endometrial Carcinoma (Uterine Cancer): Used in combination with pembrolizumab for certain types of advanced endometrial cancer that have progressed following prior systemic therapy and are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

Regulatory Status and Safety

Lenvima is a prescription-only medication. While it does not currently have a boxed warning, the FDA requires specific warnings regarding serious risks, including high blood pressure, heart problems, blood clots, liver damage, and kidney failure. It is also known to cause fetal harm, and the FDA advises that patients use effective contraception during treatment.

Factors Affecting Cost

Several factors determine the out-of-pocket cost for Lenvima, including:

• Insurance Coverage: Most private insurance plans and Medicare cover Lenvima, but the amount you pay depends on your specific plan's deductible, copayment, or coinsurance requirements.
• Specialty Pharmacy: Lenvima is typically dispensed through specialty pharmacies rather than standard retail pharmacies. These pharmacies specialize in handling and delivering complex medications.
• Dosage: The cost may vary depending on the daily dose and the number of capsules prescribed by your healthcare provider.

Financial Assistance

Because Lenvima is a high-cost medication, financial assistance may be available for eligible patients. This can include:

• Manufacturer Support: The drug manufacturer may offer co-pay cards or patient assistance programs to help reduce costs for those who qualify based on income or insurance status.
• Non-profit Organizations: Some independent foundations provide grants to help patients cover the costs of cancer treatments.

There is currently no generic version of Lenvima available. Brand-name medications typically cost more than generic alternatives because they are protected by patents that prevent other companies from making the drug for a certain period.