Fruquintinib (Fruzaqla™)

Fruquintinib is a tyrosine kinase inhibitor. A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. Fruquintinib is a type of targeted therapy that blocks a protein called “vascular endothelial growth factor receptor” (VEGFR). This medication stops or slows cancer from growing and spreading by blocking new blood vessels from forming.

How to Take Fruquintinib (Fruzaqla™)

Fruquintinib is taken as a capsule by mouth with or without food. Swallow the capsule whole. Do not crush, chew, or cut the capsule. Your dose and schedule will be decided by your healthcare team. Take a missed dose of fruquintinib if less than 12 hours have passed since the missed scheduled dose. Do not take two doses on the same day to make up for a missed dose. If you vomit after taking this medication, do not take another. Continue with the next scheduled dose.

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. 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?

Fruquintinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for the 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 of Fruquintinib

There are a number of things you can do to manage the side effects of fruquintinib. 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). You should have your blood pressure checked regularly during therapy and treated appropriately. If you develop headaches, light headedness, or dizziness, notify your healthcare team.

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.

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 have 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.

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.

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.

Proteinuria

This medication can cause an increase in the amount of protein in your urine. Your healthcare team will monitor your kidney function and protein in your urine throughout treatment with this medication.

Dysphonia

This medication can cause changes to your voice, including hoarseness.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Tell your healthcare provider if you notice yellowing of the skin or eyes, if your urine looks dark or brown, or if you have pain in your abdomen (belly), as these can be signs of liver toxicity.

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.

Muscle or Joint Pain/Aches and Abdominal Pain

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Hemorrhage (Bleeding)

Serious bleeding has also occurred in patients treated with this medication. If you take aspirin, non-steroidal anti-inflammatory medications (such as Motrin, ibuprofen, naproxen) or other medications that interfere with blood clotting, let your healthcare provider know. Signs of bleeding can include: nose bleeds, blood in the stool or dark, tarry stools, coughing up or vomiting blood, or vomit that looks like coffee grounds. While some bleeding, such as a nosebleed, may not seem like much of a concern, you should notify your healthcare team right away if you develop bleeding of any sort.

High Cholesterol/Triglyceride Level

This medication can cause high levels of cholesterol and/or triglycerides. You may be monitored for this using blood tests. There are no immediate symptoms of high cholesterol ortriglycerides but when not treated, they can lead to heart attack and stroke.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (calcium, potassium, magnesium, sodium, 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.

Mouth Ulcers (Mucositis)

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. Notify your oncology care team if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages and citrus juices.

Infection and Low White Blood Cell Count (Lymphocytopenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts.
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 care team 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.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Increased Clotting Time

This medication can cause your blood to take longer to clot, which can increase the risk of serious bleeding. Your healthcare provider may monitor your INR and aPTT (blood tests to measure clotting time) frequently. Be sure to report any bleeding to your provider.

Thyroid Problems

This medication can cause hypothyroidism (under-active thyroid). Your healthcare provider 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 cold, change in your voice, weight gain, hair loss and muscle cramps. Report any of these symptoms to your oncology care team.

Important but Less Common Side Effects

• 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 an emergency room.
• Posterior Reversible Encephalopathy Syndrome (PRES): In rare cases, this medication has caused a neurological disorder called posterior reversible encephalopathy syndrome (PRES), also called reversible posterior leukoencephalopathy (RPLS). Symptoms of PRES/RPLS include headache, seizure, lethargy, confusion, blindness, and other visual and neurological disturbances. Report any of these symptoms to your healthcare team immediately.
• Wound Healing: This medication can lead to slower or incomplete wound healing, such as a surgical wound not healing or staying closed. Therefore, it is recommended that the medication be discontinued 2 weeks prior to any surgery. The medication should not be restarted for at least 2 weeks after surgery or until any surgical incision is fully healed. 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. You should inform the team performing the procedure and your oncology team of the upcoming procedure in advance of scheduling your procedure.
• Blood Clots: This medication can increase the risk of blood clots. These clots can occur anywhere in the body. Symptoms of blood clots can include severe headache, swelling in the arm or leg, chest pain or shortness of breath, among others. If you experience any unusual symptoms, you should contact your healthcare provider immediately or go to an emergency room.
• Allergic Reactions: In some cases, patients can have an allergic reaction to this medication, especially if you are allergic to Aspirin (acetylsalicylic acid or ASA), FD&C Yellow No. 5 (tartrazine), or FD&C Yellow No. 6 (sunset yellow FCF). Signs of a reaction can include: shortness of breath or difficulty breathing, chest pain, rash, flushing or itching or a decrease in blood pressure. If you notice any changes in how you feel during the infusion, let your nurse know right away. The infusion will be slowed or stopped if this occurs. Depending on the severity of your reaction, you may still be able to receive the medication with a pre-medication to prevent a reaction, or if the medication is given at a slower rate.

Reproductive Concerns

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 at least 2 weeks 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 receiving this medication and for at least 2 weeks after the last dose.