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Lenvatinib (Oral route)

Pronunciation:

len-VA-ti-nib

Brand Names:

  • Lenvima

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Lenvatinib 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. This medicine is used in combination with everolimus to treat advanced kidney cancer in patients who have received other treatments. 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.

Before Using This Medicine:

In deciding to use a medicine, 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenvatinib in the elderly.

Breast-feeding—

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.

Other medicines—

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.

Proper Use of This Medicine:

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, or you may dissolve the capsules in a small glass of liquid. Measure 1 tablespoon of water or apple juice and place the capsules into the liquid without breaking or crushing them. Allow the capsules to dissolve in the liquid for at least 10 minutes. Stir for at least 3 minutes and drink the mixture. Add an additional 1 tablespoon of apple juice or water to the glass and swallow it immediately.

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.
    • For the treatment of advanced kidney cancer (taken with everolimus):
      • Adults—18 milligrams (mg) (one 10 mg capsule and two 4 mg capsules) 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.

Precautions While Using This Medicine:

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, or 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, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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, or 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, or 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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
unusual 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.


Last Updated: 9/4/2017
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