Lenvima - Lenvatinib Capsules

What is this medication?

LENVATINIB (len VA ti nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): LENVIMA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Dental or gum disease
• Having or recent surgery
• Heart attack
• Heart disease
• Headaches
• High blood pressure
• High thyroid levels
• History of a connection between 2 or more body parts that do not usually connect (fistula)
• History of a tear in your stomach or intestines
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low thyroid levels
• Protein in your urine
• Seizures
• Stroke
• Vision problems
• An unusual or allergic reaction to lenvatinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. If you are unable to swallow the capsules whole, you can mix them with water or apple juice. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

When using capsules to make a suspension: Place the number of capsules for your dose in a small container or syringe. If your dose is more than 5 capsules, follow these directions with 3 capsules at a time. Add 3 mL of water or apple juice to the container or syringe. If you will be giving in a feeding tube, only mix with water. After 10 minutes, shake or stir until it is completely dissolved. Do not break or crush the capsules. Drink the mixture or give it through the feeding tube right away. Repeat adding another 2 mL of water or apple juice, shaking or stirring, and drinking the mixture or giving through the feeding tube right away. Repeat this at least 1 more time until you cannot see any more of the mixture left in the container or syringe.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

Visit your care team for regular checks on your progress. Check your blood pressure as directed. Know what your blood pressure should be and when to contact your care team.

Do not treat yourself for coughs, colds, or pain while you are using this medication without talking to your care team for advice. Some medications may increase your blood pressure.

Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication.

Before having surgery or dental work, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound. You will need to stop this medication for at least 1 week before surgery. After surgery, wait at least 2 weeks before restarting this medication. Make sure the surgical site or wound is healed enough before restarting this medication. Talk to your care team if questions.

Tell your dentist or dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

Some people who take this medication have severe bone, joint, or muscle pain. This medication may also increase your risk for jaw problems. Tell your care team right away if you have severe pain in your jaw. Tell your care team if you have any pain that does not go away or gets worse.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 30 days after stopping it. Do not breast-feed while taking this medication and for 1 week after stopping it.

This medication may cause infertility. Talk with your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Diarrhea
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Redness, swelling, and blistering of the skin over hands and feet
• Stomach pain that is severe, does not go away, or gets worse
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Joint pain
• Loss of appetite with weight loss
• Muscle pain
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). If you make a mixture with water or apple juice, store it in a covered container in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F) for up to 24 hours. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return a medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.