Lenvima

The recommended adult dose of Lenvima (Lenvatinib) depends on the type of cancer being treated. Make sure you are clear on the correct number of capsules to take each day. Your doctor may adjust the dose based on side effects that you experience, until a balance between side effects and effectiveness is reached.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Lenvima (Lenvatinib) may be taken with food or on an empty stomach. Swallow the capsules whole, with water. Avoid contact with the powder inside the capsules. Do not open the capsules. Do not crush or chew the medication. If you have difficulty swallowing the capsules whole, you may dissolve the capsules (do not open them) in a small cup containing 1 tablespoon of water or apple juice. Let them sit for about 10 minutes, then stir the mixture for another 3 minutes. Swallow the mixture. Then rinse the cup with a small amount of water or apple juice and swallow the liquid to make sure you receive the full dose. It is important to take Lenvima (Lenvatinib) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is more than 12 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Lenvima (Lenvatinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

4 mg
Each hard hypromellose capsule with a yellowish-red body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 4 mg” on the body, contains Lenvima (Lenvatinib) mesylate equivalent to 4 mg of Lenvima (Lenvatinib). Nonmedicinal ingredients: calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc; capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172); printing ink: shellac, black iron oxide (E172), potassium hydroxide, and propylene glycol.

10 mg
Each hard hypromellose capsule with a yellow body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 10 mg” on the body, contains Lenvima (Lenvatinib) mesylate equivalent to 10 mg Lenvima (Lenvatinib). Nonmedicinal ingredients: calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc; capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172); printing ink: shellac, black iron oxide (E172), potassium hydroxide, and propylene glycol.

Do not take Lenvima (Lenvatinib) if you are allergic to Lenvima (Lenvatinib) or any ingredients of the medication.

There may be an interaction between Lenvima (Lenvatinib) and any of the following:

• Alfuzosin
• amantadine
• Amiodarone
• amphotericin B
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, sotalol)
• Buprenorphine
• chloral hydrate
• chloroquine
• Digoxin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Domperidone
• Donepezil
• Dronedarone
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• Famotidine
• Fingolimod
• Flecainide
• formoterol
• Galantamine
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Irinotecan
• laxatives
• Leuprolide
• lithium
• Loperamide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• Methadone
• Metoclopramide
• Metronidazole
• mifepristone
• Mirabegron
• Octreotide
• pentamidine
• Primaquine
• procainamide
• Propafenone
• Romidepsin
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• salmeterol
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Solifenacin
• sulfamethoxazole
• tacrolimus
• Tamoxifen
• Tetrabenazine
• Tolterodine
• Trazodone
• Trimethoprim
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• other tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, Nilotinib, Sunitinib)
• Vardenafil
• Venlafaxine
• vilanterol

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Lenvima (Lenvatinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Lenvima (Lenvatinib).

Abnormal heart rhythms: Lenvima (Lenvatinib) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with Lenvima (Lenvatinib). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden death due to heart attack or similar heart problems
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Lenvima (Lenvatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lenvima (Lenvatinib), and whether any special monitoring is needed.

Birth control: Effective birth control should be practiced while using Lenvima (Lenvatinib). Males taking Lenvima (Lenvatinib) should use a spermicide in addition to a barrier method of birth control (e.g., condoms). Women taking Lenvima (Lenvatinib) must also use reliable birth control while taking Lenvima (Lenvatinib) and for at least 1 month after stopping the medication. The effectiveness of hormonal contraceptives, such as birth control pills has not been determined. Barrier methods of birth control are recommended.

Bleeding: Lenvima (Lenvatinib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood clots: Lenvima (Lenvatinib) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack or stroke. Discuss with your doctor how Lenvima (Lenvatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lenvima (Lenvatinib), and whether any special monitoring is needed. The safety of using Lenvima (Lenvatinib) within 6 months of experiencing a blood clot has not been studied.

Gastrointestinal problems and fistula formation: Lenvima (Lenvatinib) can cause perforation of the stomach or intestines or fistula formation (an abnormal connection between two body parts), resulting in a collapsed lung. If you experience severe abdominal pain, fever, vomiting, or nausea, or sudden chest pain and/or difficulty breathing, contact your doctor immediately.

Heart function: Lenvima (Lenvatinib) may cause symptoms of heart failure. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

High blood pressure: Lenvima (Lenvatinib) can cause increased blood pressure. If you have high blood pressure, discuss with your doctor how Lenvima (Lenvatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lenvima (Lenvatinib), and whether any special monitoring is needed.

Kidney function/failure: Lenvima (Lenvatinib) can cause decreased kidney function or kidney failure. If you experience puffy hands, face, or feet, high blood pressure, unusual muscle cramping, or darkened urine, Lenvima (Lenvatinib) may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: Lenvima (Lenvatinib) is broken down by the liver. Liver disease or reduced liver function may cause Lenvima (Lenvatinib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Lenvima (Lenvatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lenvima (Lenvatinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Lenvima (Lenvatinib).

Lenvima (Lenvatinib) has been reported to cause a decrease in liver function, which has in rare cases caused liver failure. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like Lenvima (Lenvatinib). If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Surgery: Lenvima (Lenvatinib) causes changes to the blood and may slow down the healing process for wounds. Make sure anyone involved in your medical care knows you are taking Lenvima (Lenvatinib).

Thyroid function: Lenvima (Lenvatinib) can affect the way the body uses thyroid hormones. If you take thyroid replacement medication, your doctor may need to adjust the dose while you are taking Lenvima (Lenvatinib).

Pregnancy: Lenvima (Lenvatinib) is likely to harm the developing baby if it is taken by the mother while she is pregnant. Lenvima (Lenvatinib) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Lenvima (Lenvatinib), contact your doctor immediately.

Breast-feeding: It is not known if Lenvima (Lenvatinib) passes into breast milk. If you are a breast-feeding mother and are taking Lenvima (Lenvatinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Lenvima (Lenvatinib) have not been established for children.

Seniors: People over the age of 65 years may be more at risk of side effects from Lenvima (Lenvatinib).