Lenvatinib (len-VA-ti-nib)

Treats cancer of the liver, thyroid, uterus, and kidneys.

Brand Name(s):

Lenvima

When This Medicine Should Not Be Used:

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. Do not crush or chew it.
• If you cannot swallow the capsule whole:
  • Place the required number of capsules (up to 5 capsules) into a small container or oral syringe.
  • Add 3 milliliters (mL) of liquid (including water or apple juice) into the container or syringe. Wait 10 minutes for the capsule shell to dissolve. Stir or shake the mixture for 3 minutes until capsules are fully dissolved. Do not break or crush the capsules.
  • Drink the mixture or use an oral syringe to take directly by mouth.
  • Use a second syringe and add another 2 mL of liquid into the same container or syringe, then swirl or shake and drink the mixture. Repeat this step at least once until no mixture is left to make sure all of the medicine is taken.
  • If 6 capsules are required, use 3 capsules at a time.
• If medicine is given through a feeding tube:
  • Place the required number of capsules (up to 5 capsules) into a syringe.
  • Add 3 milliliters (mL) of water into the syringe. Wait 10 minutes for the capsule shell to dissolve. Stir or shake the mixture for 3 minutes until capsules are fully dissolved. Do not break or crush the capsules.
  • Give the mixture through a feeding tube.
  • Cap the syringe and remove the plunger. Use a second syringe and add another 2 mL of water into the syringe. Swirl or shake and give the mixture in the feeding tube. Repeat this step at least once until no mixture is left to make sure all of the medicine is taken.
  • If 6 capsules are required, use 3 capsules at a time.
• 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. You may store the mixture in the refrigerator for up to 24 hours. Throw away mixture after 24 hours.

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 medicines can affect how lenvatinib works. Tell your doctor if you are using any of the following:
  • Medicine to treat bone problems (including denosumab)
  • Medicine which may cause 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. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 30 days after your last dose.
• Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, heart disease, heart rhythm problems, stomach or bowel problems, dental 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
  • Increased risk for heart problems, heart failure, heart attack, stroke, blood clots, or bleeding problems
  • Liver problems
  • Kidney problems
  • Stomach or bowel perforation (tear or hole)
  • Heart rhythm problems, including QT prolongation
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
• Tell your doctor or dentist that you are using this medicine. This medicine may cause slow wound healing or a serious jaw bone problem (osteonecrosis). You may need to stop using it for at least 1 week before surgery or dental work or at least 2 weeks after having major surgery.
• 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.
• 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, 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
• Heavy feeling of the jaw, loosening of a tooth, pain, swelling, or numbness in the mouth or jaw
• Muscle cramps, numbness and tingling around the mouth, fingertips, or feet
• Red or dark brown urine, bloody or black stools, unexplained nosebleed, vomit that looks like coffee grounds
• Severe diarrhea or stomach pain
• Slow wound healing
• 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
• 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, mouth, or throat
• Thickening of the skin
• Trouble sleeping

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