Lenvima

Lenvima

Lenvima

What is Lenvima?

Lenvima is used to treat thyroid cancer. It is usually given after radioactive iodine has been tried unsuccessfully.

Lenvima is used with everolimus (Afinitor) to treat advanced kidney cancer in patients who have received a course of treatment with another cancer drug.

Lenvima is used with pembrolizumab (Keytruda) to treat advanced kidney cancer that has spread to other parts of the body (metastasized) or cannot be removed with surgery.

Lenvima is also used with Keytruda to treat a certain type of endometrial cancer (a type of uterine cancer) that is advanced and cannot be removed with surgery or radiation.

Lenvima is also used to treat liver cancer that cannot be removed with surgery.

Warnings

Some patients taking Lenvima have experienced a perforation (a hole or tear) or a fistula (an abnormal passage) in the stomach or intestines.Get medical help right away if you have severe stomach pain or feel like you are choking and choking when eating or drinking.

Call your doctor immediately if you notice any signs of serious side effects, including:severe chest pain, shortness of breath, swelling in the ankles, numbness or weakness, confusion, severe headache, problems with speech or vision, seizures, unusual bleeding, coughing up blood, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before you take this medicine

To make sure you can take Lenvima safely, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a heart attack, heart failure, stroke or blood clot;

• headache or vision problems;

• bleeding problems;

• a perforation (a hole or tear) in your stomach or intestines;

• a fistula (an abnormal passage between parts of the body);

• a seizure disorder;

• a recent operation or if you are planning an operation or dental procedure;

• kidney disease; or

• Liver disease.

Lenvima can cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people being treated with steroids, chemotherapy or radiation. Ask your doctor about your own risk.

Lenvatinib can harm an unborn baby.You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medication and for at least 30 days after your last dose.

The risk of pregnancy may be lower while the mother or father is using Lenvima. Women should continue to use contraception to prevent pregnancy as lenvatinib may harm the unborn child.

Lenvatinib can affect fertility in men and women. Pregnancy may be more difficult to achieve if one parent is taking this medicine.

Do not breast-feed while using Lenvima.and for at least 1 week after your last dose.

How should I take Lenvima?

Take Lenvima exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use.

Take Lenvima at the same time every day with or without food.

Your doctor will carry out tests to make sure Lenvima is the right treatment for you.

To get a full dose, you may need to take a combination of capsules with different amounts (strengths) of lenvatinib. Follow your doctor's dosage instructions very carefully.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, dissolve the capsules in water as follows:

• Measure 1 tablespoon of water or apple juice and pour the liquid into a small glass.

• Only add enough capsules to the liquid for one dose. Allow the capsules to dissolve for at least 10 minutes and then stir the mixture for at least 3 more minutes.

• Drink this mixture immediately. Add a little more water or juice to the glass, swirl gently and drink immediately.

Lenvima can also be given through a feeding tube.Carefully read and follow all instructions for use that come with your medicine.Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if you experience vomiting or severe diarrhea. Prolonged illness can lead to dehydration and kidney failure.

Drink plenty of fluids if you have diarrhea.

Carefully follow your doctor's instructions about when to start taking medicine to prevent diarrhea while using Lenvima.

You need frequent medical examinations and blood pressure checks.

Pay particular attention to your dental hygiene while taking Lenvima. Brush and floss your teeth regularly.

If you are planning to have surgery or a dental procedure, tell the surgeon or dentist that you are currently using Lenvima. You may need to stop taking the medication at least a week before a scheduled surgery or dental procedure.

Store at room temperature, protected from moisture and heat.

Store the mixed medicine in the refrigerator and use within 24 hours. Throw away any medicines that you have not taken within this time.

Dosage information

Usual Adult Lenvima Dose for Thyroid Cancer:

24 mg orally once daily

Comment:
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)

Usual Adult Lenvima Dose for Renal Cell Carcinoma:

Initial treatment of patients with advanced renal cell carcinoma:
20 mg orally once daily in combination with 200 mg pembrolizumab IV. over 30 minutes every 3 weeks

Previously treated renal cell carcinoma:
18 mg orally once daily in combination with 5 mg everolimus orally once daily

Comments:
– For recommended dosage, see the everolimus prescribing information.
– For recommended dosage, see the pembrolizumab prescribing information
-Everolimus treatment should be continued until disease progression or unacceptable toxicity.
-Pembrolizumab treatment should be continued until disease progression or unacceptable toxicity or up to 2 years.
-After 2 years of combination with pembrolizumab, this drug may be administered as a single agent until disease progression or unacceptable toxicity occurs.

Used:
-In combination with everolimus for the treatment of patients with advanced renal cell carcinoma after prior antiangiogenic therapy
-In combination with pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma

Usual Adult Lenvima Dose for Hepatocellular Carcinoma:

-Weight less than 60 kg: 8 mg orally once daily
-Weight 60 kg or more: 12 mg orally once daily

Comment:
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For initial treatment of patients with unresectable hepatocellular carcinoma (HCC)

Usual Adult Lenvima Dose for Endometrial Cancer:

20 mg orally once daily in combination with pembrolizumab 200 mg IV. over 30 minutes every 3 weeks

Comments:
-For additional dosage information, see the pembrolizumab prescribing information.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: In combination with pembrolizumab for the treatment of patients with advanced microsatellite unstable (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer whose disease has progressed after prior systemic therapy and who are not candidates for curative surgery or radiation

What happens if I miss a dose?

Use the medicine as soon as possible, but skip the missed dose if you are more than 12 hours late. Do not use two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking Lenvima?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

Lenvima side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Lenvima:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Some patients taking Lenvima have experienced a perforation (a hole or tear) or a fistula (an abnormal passage) in the stomach or intestines.Call your doctor if you have severe stomach pain or if you feel like you are choking and choking when eating or drinking.

Also call your doctor immediately if you have:

• severe diarrhea;

• headache, confusion, weakness, loss of vision, seizures;

• pain or burning when urinating, less urination;

• increased protein levels in the urine (proteinuria);

• irregular heartbeat;

• unusual bleeding (nosebleeds, heavy menstrual bleeding) or other bleeding that doesn't stop;

• severe headache, blurred vision, throbbing in the neck or ears;

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental procedures;

• Signs of stomach bleeding- bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;

• Heart problems– Chest pain, jaw or shoulder pain, swelling of the lower legs, shortness of breath;

• Signs of a blood clot- sudden numbness or weakness, pain in the arms or back, problems with vision or speech;

• Liver problems- dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low calcium levels– Muscle spasms or contractions, numbness or tingling (around your mouth or in your fingers and toes).

If you experience certain side effects, your cancer treatments may be delayed or permanently stopped.

Common side effects of Lenvima may include:

• bleeding;

• stomach pain, nausea, vomiting, diarrhea, constipation;

• loss of appetite, weight loss;

• abnormal urine tests or thyroid function tests, increased blood pressure;

• muscle or joint pain;

• pain and burning when urinating;

• swelling in arms and legs;

• mouth sores;

• rash;

• redness, itching, or peeling skin on the hands or feet;

• headache, fatigue; or

• Cough, difficulty breathing, hoarse voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lenvima?

Lenvatinib can cause serious heart problems.Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria or HIV.

Tell your doctor about all other medicines, especially an osteoporosis medicine.

Other medications may interact with lenvatinib, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use Lenvima for the prescribed indication.