Lenvima

Lenvima is used to treat progressive, differentiated thyroid cancer that can no longer be treated with radioactive iodine and has already spread to different parts of the body.

It interferes with the growth of cancer cells, which are eventually destroyed by the body. Lenvatinib is an antineoplastic (cancer) medicine.

This medicine is available only with your doctor's prescription.

In deciding to use a Lenvima, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lenvatinib in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenvatinib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems or Blood clots (eg, heart attack, stroke) or Heart disease (eg, heart failure) or Heart rhythm problems (eg, QT prolongation) or Hypertension (high blood pressure) or Hypocalcemia (low calcium levels in the blood) or Proteinuria (protein in the urine) or Stomach fistula or perforation (a hole from the inside), or history of: Use with caution.

May make these conditions worse. Congestive heart failure or Electrolyte imbalance or Heart rhythm problems (eg, congenital long QT syndrome, slow heartbeat): Use with caution.

May increase risk for more serious side effects. Kidney disease, severe or Liver disease, severe: Use with caution.

The effects may be increased because of slower removal of the medicine from the body.

To use Lenvima properly, you must follow all instructions given by your doctor.

Medicines used to treat cancer are very strong and can have many side effects. Before taking this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. This medicine comes with a patient information insert. Read and follow the instructions carefully.

Ask your doctor if you have any questions. Swallow the capsule whole. Do not crush, break, chew, or open the capsule. Take this medicine the same way every day. This means take it at the same time and take it consistently, either with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):

For the treatment of thyroid cancer:

• Adults: 24 milligrams (mg) (two 10 mg capsules and one 4 mg capsule) per day as a single dose. Your doctor may adjust your dose if needed.
• Children" Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not take this medicine if it has been more than 12 hours since you missed your last dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Before using Lenvima, there are some precautions you must take.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 2 weeks after you stop taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Your doctor will check your blood pressure on a regular basis while you are taking this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision. This medicine may increase your risk of having blood clots, heart attack, or stroke.

Check with your doctor right away if you have

• chest pain or discomfort,
• nausea,
• numbness or weakness in your arm or leg, or on one side of your body,
• pain or discomfort in your arms, jaw, back, or neck,
• shortness of breath,
• sweating,
• vomiting.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before having surgery.

Check with your doctor right away if you have:

• pain or tenderness in the upper stomach,
• pale stools,
• dark urine,
• loss of appetite,
• nausea,
• vomiting,
• yellow eyes or skin.

These could be symptoms of a serious liver problem.

Check with your doctor right away if you have:

• decreased frequency or amount of urine,
• bloody urine,
• increased thirst,
• swelling of the face, fingers, or lower legs,
• trouble breathing,
• weight gain.

These could be symptoms of serious kidney problems.

Check with your doctor right away if you have severe stomach pain, or gagging, coughing or choking when you eat or drink. These could be symptoms of a perforation (tear) or fistula (hole) in the bowel.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor right away if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may increase your chance of bleeding.

Tell your doctor right away if you:

• cough up blood or have bleeding gums,
• difficulty with breathing or swallowing,
• dizziness,
• increased menstrual flow or vaginal bleeding,
• nosebleeds,
• prolonged bleeding from cuts,
• red or dark brown urine,
• red or black, tarry stools.

Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Talk with your doctor before using this medicine if you plan to have children.

Some men and women who use this medicine have become infertile (unable to have children). Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Lenvima.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• changes in vision
• chest pain or discomfort
• confusion
• coughing up blood
• decreased frequency or amount of urine
• difficulty with breathing or swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extreme fatigue
• fainting
• increase in heart rate
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• nervousness nosebleeds
• numbness and tingling around the mouth, fingertips, or feet paralysis
• rapid or irregular breathing
• rapid weight gain
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• severe headache
• slow or fast heartbeat
• swelling of the face, fingers, feet, or lower legs
• tingling of the hands or feet
• tremor
• ulceration of the skin
• nusual tiredness or weakness
• unusual bleeding or bruising
• vomiting
• wrinkled skin

Less common

• Abdominal or stomach pain or tenderness
• clay colored stools
• dark urine
• difficulty with speaking
• fever
• heartburn or indigestion
• inability to move the arms, legs, or facial muscles
• pain or discomfort in the arms, jaw, back, or neck
• severe abdominal or stomach pain, cramping, or burning
• vomiting of material that looks like coffee grounds
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• Belching change or loss of taste
• decreased appetite
• dry mouth
• hair loss or thinning of the hair
• headache
• hoarseness
• itching or skin
• rash
• muscle pain or stiffness
• nausea
• pain in the joints
• sore throat
• swelling or inflammation of the mouth
• trouble sleeping
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.