Description
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.
Lenvatinib is also used in combination with pembrolizumab injection as first-line treatment of advanced renal cell carcinoma (RCC), a kind of kidney cancer, in patients whose cancer has spread or cannot be removed by surgery. This medicine is also used in combination with everolimus to treat advanced kidney cancer in patients who have previously received one course of treatment with another cancer medicine.
Lenvatinib is also used to treat hepatocellular carcinoma, a type of liver cancer, that cannot be removed by surgery.
Lenvatinib is also used in combination with pembrolizumab injection to treat advanced endometrial cancer (cancer of the lining of the uterus or womb) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), in patients who have received other cancer medicines but did not work well and cannot be removed by surgery or radiation.
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.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- 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.
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Disopyramide
- Dofetilide
- Dolasetron
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
- Dental disease or
- Electrolyte imbalance or
- Heart rhythm problems (eg, congenital long QT syndrome, slow heartbeat)
- Poor oral hygiene—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.
Take this medicine the same way everyday. This means take it at the same time and take it consistently, either 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.
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 (used 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 advanced kidney cancer (used with pembrolizumab):
- Adults—20 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.
- Adults—Dose is based on body weight and 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.
- For the treatment of advanced endometrial cancer (used with pembrolizumab):
- Adults—20 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 advanced kidney cancer (used with everolimus):
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
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may store the mixture in the refrigerator for up to 24 hours. Throw away mixture after 24 hours.
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. If you are a woman who can bear children, your doctor may give you a pregnancy test before starting treatment to make sure you are not pregnant. 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, trouble breathing, sweating, or vomiting.
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, including QT prolongation.
This medicine may cause hypocalcemia (low calcium levels in the blood). Check with your doctor right away if you have stomach cramps, confusion, seizures, difficulty in breathing, irregular heartbeat, mood or mental changes, muscle cramps, numbness and tingling around the mouth, fingertips, or feet, or tremors.
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.
Make sure any doctor or dentist who treats you knows that you are using this medicine. Lenvatinib may cause slow wound healing and a serious jaw bone problem (osteonecrosis), especially if you have a dental problem, if you are taking a medicine to treat bone problems (eg, bisphosphonates, denosumab), or if you are having an invasive dental procedure. You may need to stop using this medicine for at least 1 week before surgery (including dental work) or at least 2 weeks after major surgery.
Check with your doctor right away if you have a heavy jaw feeling, loosening of a tooth, or pain, swelling, or numbness in the mouth or jaw.
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
- Bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision or other change in vision
- chest pain or discomfort
- chills
- cloudy urine
- confusion
- constipation
- cough
- coughing up blood
- decreased frequency or amount of urine
- depressed mood
- diarrhea
- difficulty with breathing or swallowing
- dilated neck veins
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- dry skin and hair
- feeling cold
- fever
- hair loss
- heavy jaw feeling
- hoarseness or husky voice
- increase in heart rate
- increased menstrual flow or vaginal bleeding
- loosening of a tooth
- lower back or side pain
- muscle cramps in the hands, arms, feet, legs, or face
- muscle stiffness
- nervousness
- nosebleeds
- numbness and tingling around the mouth, fingertips, or feet
- pain, swelling, or numbness in the mouth, or jaw
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- pounding in the ears
- prolonged bleeding from cuts
- rapid or irregular breathing
- rapid weight gain
- red or black, tarry stools
- red or dark brown urine
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- severe headache
- slow or fast heartbeat
- sore throat
- stomach pain and bloating
- swelling of the face, fingers, feet, or lower legs
- tingling of the hands or feet
- tremor
- ulceration of the skin
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- wrinkled skin
Less common
- Clay-colored stools
- difficulty with speaking
- heartburn or indigestion
- inability to move the arms, legs, or facial muscles
- pain or discomfort in the arms, jaw, back, or neck
- severe stomach pain, cramping, or burning
- stomach tenderness
- vomiting of material that looks like coffee grounds
- yellow eyes or skin
Incidence not known
- Abnormal small opening
- loss of appetite
- severe nausea or vomiting
- slow wound healing
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 weight
- dry mouth
- hair loss or thinning of the hair
- itching, skin rash
- muscle or joint pain
- 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.
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