Fruquintinib Capsules

What is this medication?

FRUQUINTINIB (frue KWIN ti nib) treats colorectal cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Fruzaqla

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Having or recent surgery
• Heart disease
• High blood pressure
• History of blood clots
• History of heart attack
• History of stroke
• History of a tear in your stomach or intestines
• Infection
• Kidney disease
• Liver disease
• Protein in your urine
• An unusual or allergic reaction to fruquintinib, FD and C Yellow No. 5 (tartrazine), FD and C Yellow No. 6 (sunset yellow FCF), other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication is taken in cycles. There will be days you do not take it. Talk to your care team if you have questions about when to take your medication. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Talk to your care team about use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

If you vomit after taking your dose, do not take another dose. Take your next dose at your usual time the next day.

What may interact with this medication?

• Certain medications that prevent or treat blood clots

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while you are taking this medication.

Before having surgery, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound. You will need to stop this medication for 2 weeks before surgery. After surgery, wait at least 2 weeks before restarting this medication. Make sure the surgical site or wound is healed enough before restarting this medication. Talk to your care team if you have questions.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 2 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 weeks after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 2 weeks after the last dose.

Do not breastfeed while taking this medication and for 2 weeks after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, swelling, and blistering of the skin over hands and feet
• Stomach pain that is severe, does not go away, or gets worse
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in voice, hoarseness
• Diarrhea
• Unusual weakness or fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.