Fruquintinib is used to treat a certain type of colorectal cancer (cancer that begins in the large intestine) that has spread to other parts of the body in adults who have already been treated with other chemotherapy medications and have not improved or worsened. Fruquintinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Fruquintinib comes as a capsule to take by mouth. It is usually taken with or without food once daily for the first 21 days of a 28-day cycle. The cycle may be repeated as recommended by your doctor. Take fruquintinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fruquintinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

If you vomit after taking fruquintinib, do not take another dose. Continue your regular dosing schedule the next day.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking fruquintinib,

• tell your doctor and pharmacist if you are allergic to fruquintinib, aspirin, any other medications, tartrazine (a yellow dye in some processed foods and medications) or other yellow dyes, or any of the ingredients in fruquintinib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with fruquintinib: St. John’s Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking fruquintinib. Do not start any of this medication while taking fruquintinib without discussing with your healthcare provider.
• tell your doctor if you have an infection or an unhealed wound. Also, tell your doctor if you have or have ever had a bleeding problem, a blood clot, a heart attack, a stroke, high blood pressure, high blood cholesterol or high triglycerides (a fatty substance in the blood), proteinuria (increased protein in urine) or any other kidney problem, or thyroid or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking fruquintinib. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment and for 2 weeks after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with fruquintinib and for 2 weeks after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking fruquintinib, call your doctor. Fruquintinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking fruquintinib and for 2 weeks after your final dose.
• you should know that fruquintinib may slow the healing of wounds, such as cuts made by a doctor during surgery. Tell your doctor if you have recently had surgery or if you plan to have surgery, including dental surgery. Your doctor will probably tell you that should not take fruquintinib injection until at least 2 weeks after your surgery and until the area has completely healed. If you are scheduled to have surgery, your doctor will stop your treatment with fruquintinib at least 2 weeks before the surgery or procedure.
• you should know that fruquintinib may cause high blood pressure. Your doctor will check your blood pressure before starting treatment, once a week for the first month of treatment, and then at least once a month thereafter, while you are taking fruquintinib.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is less than 12 hours before you are scheduled to take your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fruquintinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• voice changes
• hoarseness
• diarrhea
• stomach pain
• mouth sores
• weight loss
• tiredness or lack of energy
• weakness
• muscle, joint, or bone pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• nosebleeds and other unusual bruising or bleeding
• bloody or black and tarry stools
• pink, red, or dark-brown urine
• vomiting or coughing up blood
• unusual vaginal bleeding or heavy menstrual bleeding
• severe or persistent stomach pain
• fever or chills
• cough, sore throat, pain or burning while urinating, or other signs of an infection
• sudden weakness, tingling, or numbness in your face, arm, or leg, especially on one side of your body; sudden confusion; difficulty speaking or understanding; sudden difficulty seeing in one or both eyes; sudden difficulty walking; dizziness; loss of balance or coordination; or sudden severe headache
• chest pain or discomfort in the arms, shoulders, neck, jaw, stomach, or upper back
• shortness of breath or trouble breathing
• excessive sweating
• seizures, headaches, vision changes, or confusion
• wound that is red, oozing pus, or slow to heal
• increased urination
• swelling of your face, hands, legs, ankles, or feet
• yellow eyes or skin, dark urine, loss of appetite, fatigue, nausea, vomiting, or pain or discomfort in right upper stomach area
• redness, pain, swelling or blisters on the palms of the hands or soles of the feet
• rash
• hives

Fruquintinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests, such as blood tests and urine tests before and during your treatment with fruquintinib to check your body’s response to the medication.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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