Lenvima (lenvatinib) Cost, Side Effects, Dosage, and Prescribing Information For Thyroid Cancer | Madeeha Baker, PharmD | RxEconsult
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Lenvima (lenvatinib) Cost, Side Effects, Dosage, and Prescribing Information For Treatment of Thyroid Cancer Category: Cancer by - March 2, 2015 | Views: 29339 | Likes: 0 | Comment: 0  

Review of Lenvima for thyroid cancer

Brand Name: Lenvima
Generic Name: lenvatinib

Medication Class: Tyrosine Kinase Inhibitor
Similar Drugs: Nexavar (sorafenib)
Manufacturer: Eisai

FDA Approval Date: February 13, 2015

What is Lenvima and its mechanism of action?

Lenvima is an oral medication used for treating thyroid cancer. It belongs to a class of medications known as receptor tyrosine kinase inhibitors (RTK). Kinase inhibitors like Lenvima work by blocking the action of proteins and receptors essential for growth of cancer cells. Examples of proteins and receptors inhibited by Lenvima include vascular endothelial growth factor receptors (VEGFR1, VEGFR2, VEGFR3), fibroblast growth factor (FGF) receptors (FGFR1, 2, 3, and 4), platelet derived growth factor receptor alpha (PDGFRα), and many others. These growth factors are involved in development of new blood vessels, growth of cancer cells, and cancer progression. For example, vascular endothelial growth factor (VEGF) are signaling proteins that promote the growth of new blood vessels. Lenvima interrupts progression of cancer by disrupting the activity of these proteins and receptors. 

What is Lenvima used to treat?

Lenvima is used for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. This means that Lenvima is used to treat thyroid cancer that has reoccurred in one or more areas of the body, is growing, and has not responded to radioactive iodine treatment.  

In 2012, there were an estimated 601,789 people living with thyroid cancer in the United States and 1.1% of men and women will develop thyroid cancer during their lifetime. Thyroid cancer is commonly diagnosed at a younger age than most other adult cancers. Nearly 2 out of 3 cases are found in people younger than 55 years of age. Treatment options for thyroid cancer include the following:

  • Surgery
  • Radioactive Iodine Treatment
  • Thyroid Hormone Therapy
  • External Beam Radiation Therapy
  • Chemotherapy
  • Targeted Therapy

How effective is Lenvima?

The FDA approved Lenvima was based on a study of 392 patients with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within 12 months prior to the study. Patients received Lenvima 24 mg once daily or placebo (dummy pill) until disease progression. Study results showed Lenvima-treated subjects lived a median of 18.3 months without their disease progressing (progression-free survival) compared to a median of 3.6 months for patients who received placebo. Additionally, 65% of people treated with Lenvima saw a reduction in tumor size compared to 2% of subjects who received a placebo.

What are some interesting facts about Lenvima?

  • Lenvima was released two months earlier than expected because it was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that provide significant improvement in safety or effectiveness in the treatment of a serious condition
  • Median survival  was 18.3 months compared to 3.6 months for patients treated with placebo.
  • Lenvima is the second medication (Nexavar is the first) approved for radioactive iodine refractory differentiated thyroid cancer.
  • Based on results of studies used to approve Lenvima and Nexavar, Lenvima may be more effective than Nexavar. The two drugs have not been directly compared in a clinical trials.

What are the side effects of Lenvima?

Common side effects include:

  • High blood pressure
  • Fatigue
  • Diarrhea
  • Joint pain
  • Muscle pain
  • Loss of appetite
  • Nausea
  • Inflammation of the mouth's lining
  • Headache
  • Vomiting 
  • Excess protein in urine.

More serious side effects include:

  • Heart failure
  • Clot formation
  • Liver damage
  • Kidney damage

Dosage of Lenvima

Lenvima is supplied as 4 mg and 10 mg capsules. The recommended daily dose of Lenvima is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily with or without food. For severe renal or hepatic impairment the dose is 14 mg daily.

Lenvima is continued until disease progression or until unacceptable toxicity occurs. 

Lenvima should be taken every day at the same time. The dose should be skipped and the next dose should be taken at the usual time of administration if a dose is missed and cannot be taken within 12 hours

Which drugs interact with Lenvima

Currently Lenvima has no known drug-drug interactions 

What are warnings and precautions for Lenvima?

Patients should contact their health care provider immediately if the following symptoms occur while taking Lenvima:

  • Uncontrolled hypertension 9high blood pressure)
  • New onset of chest pain or symptoms consistent with a heart attack.
  • Stroke symptoms such as numbness in certain parts of the body, loss of vision, dizziness or loss of consciousness.  
  • Yellowing of skin, increased right lower abdominal pain, severe nausea or vomiting, and dark urine due to liver damage (hepatotoxicity).
  • Proteinuria (protein in urine),  decreased urine output due to kidney failure.
  • Unexplained bleeding such as black tarry stools and bloody nose.
  • Prolonged QT interval resulting in abnormal heart beats.
  • Numbness in hands, feet and around the mouth due to hypocalcemia (low blood calcium).

Lenvima also causes reversible posterior leukoencephalopathy syndrome (RPLS). Lenvima should be withheld if RPLS occurs. Gastrointestinal perforation and fistulas also occurred during clinical trials. 

Can pregnant or nursing women take Lenvima?

Based on its mechanism of action and data from animal reproduction studies, Lenvima can cause fetal harm when administered to a pregnant woman. Therefore, females should use effective contraception while using Lenvima and for up to 2 weeks after completion of therapy. In animal reproduction studies, oral administration of Lenvima at doses below the recommended human dose resulted in harm to baby rats and rabbits. . 

It is not known whether Lenvima is present in human milk; however, Lenvima and its metabolites are excreted in rat milk at concentrations higher than in maternal plasma. Because of the potential for serious adverse reactions in nursing infants from women taking Lenvima, they should discontinue breastfeeding during treatment.

What is the cost of Lenvima?

Lenvima is packaged as a month supply for patients taking 14 mg a day or 24 mg a day. The cost for a month’s supply  of 14 mg doses is  $12,000. For patients taking the 24 mg dose of Lenvima, it is $15,176 for a month’s supply.

Where to find cost assistance for Lenvima

Patients taking Lenvima can receive a discount card through Lenvima Assistance Program.

References

Lenvima Prescribing Information

Thyroid Cancer

National Cancer Institute Seers Stat Fact Sheet: Thyroid Cancer

 

 



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