Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Lenvima

Descriptions


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 also used in combination with everolimus to treat advanced kidney cancer in patients who have received other treatments.

Lenvatinib is also used to treat hepatocellular carcinoma, a type of liver cancer, that cannot be removed by surgery.

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

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

This product is available in the following dosage forms:

  • Capsule

Before Using

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.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Buprenorphine
  • Buserelin
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lumefantrine
  • Macimorelin
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Osimertinib
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Triclabendazole
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

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 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 or bowel problems (eg, fistula or perforation), 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

Medicines used to treat cancer are very strong and can have many side effects. Before using 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. You may also 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 advanced kidney cancer (taken with everolimus):
      • Adults—18 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For the treatment of liver cancer:
      • Adults—Dose is based on body weight and must be determined by your doctor.
        • Weighs 60 kilograms (kg) or more—12 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
        • Weighs less than 60 kg—8 mg once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For the treatment of thyroid cancer:
      • Adults—24 milligrams (mg) once a day. Your doctor may adjust your dose as 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.

If you miss a dose, and it is 12 hours or less from your regular schedule, take the dose as soon as you can. If you miss a dose, and it is more than 12 hours, skip the missed dose then go back to your regular dosing schedule.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. 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 with this medicine and for at least 30 days after your last dose. 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 for at least 6 days 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 a serious kidney problem.

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 risk 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

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

  1. Bladder pain
  2. bleeding gums
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. blood in the urine or stools
  5. blurred vision or other change in vision
  6. chest pain or discomfort
  7. chills
  8. cloudy urine
  9. confusion
  10. constipation
  11. cough
  12. coughing up blood
  13. decreased frequency or amount of urine
  14. depressed mood
  15. diarrhea
  16. difficulty with breathing or swallowing
  17. dilated neck veins
  18. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  19. dry skin and hair
  20. extreme tiredness or weakness
  21. fainting
  22. feeling cold
  23. fever
  24. hair loss
  25. hoarseness or husky voice
  26. increase in heart rate
  27. increased menstrual flow or vaginal bleeding
  28. lower back or side pain
  29. muscle cramps in the hands, arms, feet, legs, or face
  30. muscle stiffness
  31. nervousness
  32. nosebleeds
  33. numbness and tingling around the mouth, fingertips, or feet
  34. painful or difficult urination
  35. pale skin
  36. paralysis
  37. pinpoint red spots on the skin
  38. pounding in the ears
  39. prolonged bleeding from cuts
  40. rapid or irregular breathing
  41. rapid weight gain
  42. red or black, tarry stools
  43. red or dark brown urine
  44. redness, swelling, or pain of the skin
  45. scaling of the skin on the hands and feet
  46. severe headache
  47. slow or fast heartbeat
  48. sore throat
  49. stomach pain and bloating
  50. swelling of the face, fingers, feet, or lower legs
  51. tingling of the hands or feet
  52. tremor
  53. ulceration of the skin
  54. ulcers, sores, or white spots in the mouth
  55. unusual bleeding or bruising
  56. unusual tiredness or weakness
  57. unusual weight gain or loss
  58. vomiting
  59. wrinkled skin

Less common

  1. Clay-colored stools
  2. difficulty with speaking
  3. heartburn or indigestion
  4. inability to move the arms, legs, or facial muscles
  5. pain or discomfort in the arms, jaw, back, or neck
  6. severe abdominal or stomach pain, cramping, or burning
  7. stomach pain or tenderness
  8. troubled breathing with exertion
  9. vomiting of material that looks like coffee grounds
  10. yellow eyes or skin

Incidence not known

  1. Abnormal small opening
  2. impaired wound healing
  3. loss of appetite
  4. severe nausea or vomiting

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

  1. Belching
  2. change or loss of taste
  3. decreased weight
  4. dry mouth
  5. hair loss or thinning of the hair
  6. itching or skin rash
  7. muscle or joint pain
  8. swelling or inflammation of the mouth
  9. trouble sleeping
  10. 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.