Description

Lenvaxen (Lenvatinib) is a targeted therapy that targets and binds to the tyrosine kinase receptors and inhibits vascular epidermal growth factor receptor (VEGFR), vascular endothelial growth factor (VEGF), and inhibits other kinase receptors that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors and platelet derived growth factor receptor alpha (PDGFRa), KIT and RET on the surface of the cell. By binding to these receptors Lenvatinib blocks important pathways that promote cell division.

 

Before taking Lenvaxen

To make sure Lenvatinib is safe for you, tell your doctor if you have ever had:

• Long QT syndrome (in you or a family member);
• Heart disease, high blood pressure;
• A heart attack, heart failure, stroke, or blood clot;
• Headaches or vision problems;
• Bleeding problems;
• A perforation (a hole or tear) in your stomach or intestines;
• A seizure disorder;
• Kidney disease; or
• Liver disease.

Lenvaxen may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

Lenvaxen may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

 

Uses Lenvaxen

Take lenvatinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take lenvatinib at the same time each day, with or without food.

To get a full dose, you may need to take a combination of capsules with different amounts (strengths) of lenvatinib in them. Follow your doctor’s dosing instructions very carefully.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, dissolve the capsules in water as follows:

• Measure 1 tablespoon of water or apple juice and pour the liquid into a small glass.
• Place only enough capsules for one dose into the liquid. Allow the capsules to dissolve for at least 10 minutes, then stir the mixture for at least 3 more minutes.
• Drink this mixture right away. Add a little more water or juice to the glass, swirl gently and drink right away.

Call your doctor if you are sick with vomiting or severe diarrhea. Prolonged illness can lead to dehydration and kidney failure.

Carefully follow your doctor’s instructions about when to start taking medicine to prevent diarrhea while you are using lenvatinib.

You will need frequent medical tests and blood pressure checks.

Pay special attention to your dental hygiene while taking lenvatinib. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using lenvatinib.

 

Miss a dose

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Avoid while taking

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

 

Lenvaxen side effects

Get emergency medical help if you have signs of an allergic reaction to Lenvatinib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking Lenvaxen have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Also call your doctor at once if you have:

• Severe diarrhea;
• Headache, confusion, change in mental status, vision loss, seizure (convulsions);
• Little or no urination;
• Unusual bleeding (nosebleeds, heavy menstrual bleeding), or any other bleeding that will not stop;
• Severe headache, blurred vision, pounding in your neck or ears;
• Jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• Signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• Heart problems – chest pain, pain in your jaw or shoulder, swelling, rapid weight gain, feeling short of breath;
• Signs of a blood clot – sudden numbness or weakness, problems with vision or speech;
• Liver problems – dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• Low calcium level – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Your cancer treatments may delay or permanently discontinued if you have certain side effects.

Common Lenvaxen side effects may include:

• Bleeding;
• Stomach pain, nausea, vomiting, diarrhea;
• Loss of appetite, weight loss;
• Abnormal thyroid function tests;
• Muscle or joint pain;
• Swelling in your arms and legs;
• Mouth sores;
• Redness, itching, or peeling skin on your hands or feet;
• Headache, tiredness; or
• Cough, trouble breathing, hoarse voice.

 

Dosing information

Thyroid Cancer: 24 mg orally once a day

Comment – Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)

 

Renal Cell Carcinoma: 18 mg orally once a day

Comments:

• This drug is given in combination with 5 mg everolimus.
• Refer to everolimus prescribing information for recommended dosing information.
• Treatment should be continued until disease progression or unacceptable toxicity.

Use: In combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy

Hepatocellular Carcinoma:

1. Weight less than 60 kg: 8 mg orally once a day
2. Weight 60 kg or greater: 12 mg orally once a day

Comment: Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

Endometrial Carcinoma: 20 mg orally once daily

Comments

• This drug is given in combination with pembrolizumab 200 mg IV over 30 minutes every 3 weeks.
• Refer to the pembrolizumab prescribing information for other dosing information.
• Treatment should be continued until disease progression or unacceptable toxicity.

Use: In combination with pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

 

Other drugs will affection

Lenvaxen can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV. Tell your doctor about all your other medicines, especially an osteoporosis medicine.

 

Warnings

Some people taking lenvatinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Get emergency medical help if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Call your doctor at once if you have signs of serious side effects, including: severe chest pain, shortness of breath, swelling in your ankles, numbness or weakness, confusion, severe headache, problems with speech or vision, seizure (convulsions), unusual bleeding, coughing up blood, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

 

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