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Lenvatinib (Oral) (Capsule)

Lenvatinib (By mouth)
Lenvatinib (len-VA-ti-nib)Treats cancer of the thyroid and kidneys.
Lenvima

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to lenvatinib, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Capsule

  • Your doctor will tell you how much medicine to use. Do not use more than directed.
  • Take this medicine the same way every day. This means take it at the same time and always take it with or without food.
  • 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.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose: Take a dose as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and take the next dose at the regular time. Do not take extra medicine to make up for a missed dose.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some foods and medicines can affect how lenvatinib works. Tell your doctor if you are using any of the following:
    • Medicine to treat heart rhythm problems
    • Thyroid medicines

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use birth control during treatment and for at least 2 weeks after you stop using this medicine.
  • Tell your doctor if you have kidney problems, liver disease, bleeding problems, heart disease, heart rhythm problems, stomach problems, high blood pressure, or a history of heart attack, blood clots, or stroke.
  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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.
  • This medicine may cause the following problems:
    • High blood pressure or changes in heart rhythm
    • Increased risk for heart problems, heart attack, stroke, blood clots, or bleeding problems
    • Liver problems
    • Kidney damage
    • Gastrointestinal perforation (hole in your digestive system)
    • Reversible posterior leukoencephalopathy syndrome (RPLS)
  • This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also check your blood pressure on a regular basis.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain that may spread, trouble breathing, nausea, unusual sweating, fainting
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Decrease in how much or how often you urinate, cloudy urine
  • Fast, slow, pounding, or uneven heartbeat
  • Muscle cramps, numbness and tingling around the mouth, fingertips, or feet
  • Red or dark brown urine, bloody or black stools, unexplained nosebleeds, vomit that looks like coffee grounds
  • Severe diarrhea or stomach pain
  • Sudden or severe headache, confusion, seizures, problems with vision, speech, or walking
  • Swelling in your hands, ankles, or feet
  • Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

  • Constipation, mild diarrhea, nausea or vomiting
  • Joint or muscle pain, tiredness
  • Rash, redness, pain, or skin peeling on the palms of your hands or soles of your feet
  • Sores or white patches on your lips or in your mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088