Axitinib (Inlyta®)

A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a certain enzyme from working, this medication can slow the growth of cancer cells. Axitinib is a type of targeted therapy called a tyrosine kinase inhibitor that blocks VEGF. This means it works by targeting receptors present on the cancer cells. VEGF receptors are responsible for angiogenesis, or the development of new blood vessels by and for the tumor, so blocking these receptors attacks the tumor's source of nutrients.

How to Take Axitinib

Axitinib comes in a tablet form. The tablet should be swallowed whole with a glass of water, with or without food. Do not break, crush or chew the tablet. If you forget to take a dose or vomit after taking the dose, do not take another dose. Take your next dose at the usual time. If you are having trouble swallowing your medication contact your pharmacist or care team.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include: grapefruit, grapefruit juice, rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort, efavirenz, and nafcillin. Be sure to tell your healthcare provider about all medications and supplements you take.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Axitinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects

There are a number of things you can do to manage the side effects of axitinib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

High Blood Pressure

This medication can cause high blood pressure (hypertension). Patients should have their blood pressure checked regularly during therapy. Any hypertension should be treated appropriately. If hypertension cannot be controlled, the medication may be stopped. Report any headaches, vision changes or dizziness to your oncology care team.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (calcium, sodium, potassium, phosphate, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Decrease in Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Low White Blood Cell Count (Lymphocytopenia/Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care. Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Hoarseness

Some patients experienced changes in their voice, including hoarseness. Talk with your care team about management techniques.

Blood Sugar Changes (Hypoglycemia)

This medication can cause low blood sugar levels in patients with and without diabetes. Your healthcare team will monitor your blood sugar. If you develop shakiness, nervousness, anxiety, sweating, chills, clamminess, rapid/fast heartbeat, or headaches (symptoms of low blood sugar), tell your healthcare team. Diabetics should monitor their blood sugar closely and report elevations to the healthcare team.

Hand Foot Syndrome

Hand foot syndrome (HFS) is a skin reaction that appears on the palms of the hands and/or the soles of the feet, as a result of certain chemotherapy agents being absorbed by the skin cells. HFS can begin as a mild tingling, numbness, pins-and-needles feeling, redness or pain or swelling of the hands and/or feet. This can then progress to painful swelling, blistering or peeling skin that can interfere with your ability to do normal activities. Be sure to let your oncology team know right away if you notice these symptoms, as they may need to adjust the chemotherapy dose or take a break to allow the skin to heal. Some tips to help prevent HFS include:

• Keep hands and feet clean and dry.
• Avoid tight shoes or socks.
• Avoid activities that put pressure on the palms or soles for 1 week after treatment.
• Apply an alcohol-free moisturizer liberally and often. (Avoid moisturizers with perfumes or scents)
• Avoid very hot water for baths and showers.

Important but Less Common Side Effects

• Blood Clots: Axitinib can increase the risk of blood clots, which can cause stroke or heart attack. Symptoms can include: swelling, redness or pain in an extremity, chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, vision changes, headache, weakness on one side or trouble talking. If you experience any of these symptoms, go to an emergency room.
• Bleeding: Axitinib can cause bleeding. Contact your healthcare team immediately if you experience any of the following symptoms: unexpected bleeding or bleeding that lasts a long time, unusual bleeding from the gums, pink or brown urine, red or black stools, unusual bruising, coughing up blood, bloody vomit or vomit that looks like coffee grounds.
• Heart Problems: The medication can cause heart failure. Your healthcare team will monitor your cardiac function throughout treatment with axitinib. Contact you healthcare team or go to the emergency room if you have symptoms of increased fatigue, swelling in the abdomen, legs or ankles, shortness of breath or protruding neck veins.
• Tear in the Stomach or Intestinal Wall (perforation): This medication can cause a tear in the intestinal wall, also called a gastrointestinal perforation. Signs of this can include: new or worsening pain in the abdomen, new abdominal swelling, chills, fever, constipation, nausea or vomiting. If you experience any of these, contact your healthcare provider immediately or go to the emergency room.
• Wound Healing Complications: This medication can lead to slower or incomplete wound healing, such as a surgical wound not healing or staying closed. Be sure to inform the team performing the surgical procedure that you are taking axitinib. You should also inform your oncology team that a surgical procedure is planned. It is recommended that this medication be discontinued 24 hours prior to any surgery. In addition, any surgical incision should be fully healed prior to starting or restarting the medication. If you have a surgical wound that has not healed or begins to have signs of infection (redness, swelling, warmth), report this to your healthcare team.
• Thyroid Problems: This medication can cause hypothyroidism (under active thyroid) and hyperthyroidism (over active thyroid). Your doctor will perform blood tests to check the function of your thyroid and treat this side effect if it develops. Symptoms of thyroid problems include: tiredness, feeling hot or cold, change in your voice, weight gain or loss, hair loss and muscle cramps.
• Posterior Leukoencephalopathy Syndrome (PRES): This medication can cause a neurological disorder called posterior leukoencephalopathy syndrome (PRES). Symptoms of PRES include headache, seizure, lethargy, confusion, blindness and other visual and neurological disturbances. Report any of these symptoms to you healthcare team immediately.
• Proteinuria: This medication may cause proteinuria, the presence of protein in the urine. This can be a sign of kidney damage. Your oncology team will periodically check your urine for protein. Your kidney function will also be monitored throughout treatment.
• Liver Toxicity: This medication can cause liver toxicity, which your doctor may monitor for using blood tests called liver function tests. If you develop elevations in your liver function tests, your healthcare provider may need to lower your dose or stop the medication. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown or pain in your abdomen, as these can be signs of liver toxicity.

Sexual and Reproductive Concerns

This medication may affect your reproductive system, resulting in the menstrual cycle or sperm production becoming irregular or stopping permanently. Women may experience menopausal effects including hot flashes and vaginal dryness. In addition, your desire for sex may decrease during treatment. You may want to consider sperm banking or egg harvesting if you may wish to have a child in the future. Discuss these options with your oncology team.

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for one week after your last dose. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication or for 2 weeks after your last dose.