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Overview: Fruzaqla is used to treat certain people with colorectal cancer. It comes as a capsule that is taken by mouth. Common side effects may include hoarseness, stomach pain, diarrhea, and feeling very tired or weak. Fruzaqla can also cause serious side effects, such as high blood pressure, severe bleeding, infections, blood clots, and liver or kidney problems. Keep all appointments with your health care provider, including for blood tests, urine checks, and blood pressure checks. Call your health care provider right away or get emergency help if you have any new or unusual symptoms, such as easy bleeding or bruising, lightheadedness, headache, vision changes, confusion, or chest pain.

Uses

What is Fruzaqla used for?

Fruzaqla (fruquintinib) is commonly used to treat certain people with colorectal cancer.

Fruzaqla may also be used for other conditions as determined by your health care provider.

How does Fruzaqla work (mechanism of action)?

Fruzaqla is known as a kinase inhibitor. It works by binding to and blocking the activity of three vascular endothelial growth factor (VEGF) receptors. These receptors send signals that help tumors form new blood vessels, grow, and spread. By blocking these signals, Fruzaqla can help slow tumor survival, growth, and spread.

How is Fruzaqla supplied (dosage forms)?

Brands and other names

  • Fruzaqla

Dosage forms and strengths

  • 1 mg oral capsules
  • 5 mg oral capsules

How should I store Fruzaqla?

Fruzaqla should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place, and protect from moisture. If you have any unused or expired Fruzaqla, ask your pharmacist or other health care provider how to throw it away properly.

Side Effects

What are the most common side effects of Fruzaqla?

The most common side effects of Fruzaqla are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Increased blood pressure (see below)
  • Hand-foot syndrome (see below)
  • Protein in the urine (see below)
  • Hoarseness
  • Stomach pain
  • Diarrhea
  • Feeling unusually weak or tired

There may be other side effects of Fruzaqla that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Fruzaqla?

While less common, the most serious side effects of Fruzaqla are described below, along with what to do if they happen.

Severe Allergic Reactions. Fruzaqla may cause allergic reactions, which can be serious. Stop taking Fruzaqla and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Increased Blood Pressure (Hypertension). Fruzaqla may increase your blood pressure or make it worse if you have a history of high blood pressure. Check your blood pressure as recommended by your health care provider, and call your health care provider if your blood pressure increases while taking this medicine. Your health care provider may need to lower your dose of Fruzaqla or stop the medicine based on your blood pressure readings.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness, lightheadedness, or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Severe Bleeding. Fruzaqla can increase your risk of bleeding, including severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have unusual bleeding or bruising or any of the following signs of severe bleeding while taking Fruzaqla.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Heavy menstrual periods or unexpected vaginal bleeding
  • Nosebleeds
  • Lightheadedness
  • Bleeding that does not stop or is severe

Infections. Fruzaqla can increase your risk of infections, including serious infections that may be life-threatening. In people taking Fruzaqla, the most common infections were bladder or kidney infections (urinary tract infections), infections in the nose or throat (upper respiratory tract infections), and pneumonia. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Coughing or coughing up blood or mucus
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath or trouble breathing
  • Diarrhea or stomach pain
  • Severe sore throat
  • Weight loss
  • Redness, pain, or swelling in any part of your body

Stomach or Gut Tear. Fruzaqla can increase your risk of tears (perforation) in your stomach or gut, which can lead to death. Get emergency help if you have any of the following symptoms.

  • Vomiting or vomiting blood
  • Black or tarry poop
  • Stomach pain that does not go away
  • Severe stomach pain 
  • Feel faint
  • Fever or chills
  • Nausea

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Fruzaqla. Keep all appointments for blood tests before starting and while taking this medicine. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish (also called jaundice)
  • Easy bleeding or bruising

Protein in the Urine (Pee). Fruzaqla may cause you to have a high amount of protein in your pee, also called proteinuria. This can be a sign of kidney problems. Keep all appointments to check your pee while taking this medicine. Call your health care provider right away if you have any of the following symptoms of proteinuria.

  • Peeing more often than usual
  • Pee that is bubbly or foamy
  • Swelling in your hands, arms, legs, feet, belly, or face
  • Tiredness
  • Loss of appetite, nausea, or vomiting
  • Muscle cramps at night

Hand-Foot Syndrome. Fruzaqla can cause “hand-foot syndrome,” also called palmar-plantar erythrodysesthesia. Call your health care provider right away if you have any of the following symptoms.

  • Redness, swelling, blisters, bleeding, or pain on the palms of your hands or soles of your feet
  • Severe rash

Posterior Reversible Encephalopathy Syndrome (PRES). Fruzaqla may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision 
  • Sudden severe headache
  • Seizures

Wound Healing Problems. Fruzaqla can make it hard for your body to heal wounds. Tell your health care provider if you have any planned or emergency surgeries or if you have any injuries while taking Fruzaqla.

Blood Clots. Fruzaqla may cause a blood clot in your arteries, which could lead to a stroke, heart attack, or death. Get emergency help if you have any of the following signs of a blood clot in your arteries. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing or shortness of breath
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden numbness or weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Feeling lightheaded, dizzy, or faint
  • Confusion or trouble walking 
  • Vision loss, double vision, or other vision changes

Warnings & Precautions

Who should not use Fruzaqla?

Allergies to Ingredients. People who are allergic to any of the following should not take Fruzaqla.

  • Fruquintinib
  • Fruzaqla
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Fruzaqla.

What should I know about Fruzaqla before using it?

Do not take Fruzaqla unless it has been prescribed to you by a health care provider. Take it as prescribed. Try to take Fruzaqla at the same time every day. Consider using a timer or other device to help you remember.

Swallow Fruzaqla whole. 

Do not share Fruzaqla with other people, even if they have the same condition as you. It may harm them.

Keep Fruzaqla out of the reach of children.

Keep all appointments with your health care provider, including for blood tests, urine checks, and blood pressure checks. This will help your health care provider make sure it is safe for you to keep taking this medicine. Your health care provider may adjust your dose or pause or stop the medicine if you have certain side effects.

If you throw up (vomit) after taking Fruzaqla, do not take another dose. Take your next dose at the regularly scheduled time.

If you can get your partner pregnant, you should use effective birth control while taking Fruzaqla and for two weeks after your last dose. Tell your health care provider right away if your partner becomes pregnant while you are taking Fruzaqla. See the Pregnancy section for more details.

If you can get pregnant, Fruzaqla may make it hard for you to have children. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Fruzaqla?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Fruzaqla is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • High blood pressure
  • Heart disease, heart attack, or stroke
  • Blood clots
  • Bleeding problems
  • An infection
  • Liver problems
  • Kidney problems

Surgeries or Procedures. Tell all of your health care providers that you take this medicine before any surgeries or procedures, including dental work. Before starting Fruzaqla, tell your health care providers if you have had any surgeries or procedures recently, especially if you have a wound that is still healing. You may need to stop Fruzaqla for at least two weeks before and after certain surgeries because it may affect how quickly your wounds heal. Follow all instructions from your health care provider.

Allergies to Dyes or Medicines. Tell your health care provider if you have any allergies, including to dyes. Fruzaqla may contain the dyes FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (sunset yellow FCF), which some people are allergic to. Also tell your health care provider if you have an allergy to aspirin, since people who are allergic to aspirin may be more likely to have an allergy to Yellow 5 dye.

Other Medicines and Supplements. Fruzaqla may interact with other medicines and supplements. Before taking Fruzaqla, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Fruzaqla can cause harm to a fetus. Your health care provider will likely make sure you are not pregnant before starting Fruzaqla. If you can get pregnant, you should use effective birth control while taking Fruzaqla and for two weeks after your last dose. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while you are taking Fruzaqla and for two weeks after your last dose. It is not known if Fruzaqla passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Fruzaqla?

For more information about Fruzaqla, you can visit the drugmaker’s website at www.fruzaqla.com or call them at 844-217-6468.

Interactions

Does Fruzaqla interact with foods or drinks?

There are no known interactions between Fruzaqla and foods or drinks.

It is unknown if drinking alcohol will affect Fruzaqla, but both Fruzaqla and alcohol can increase your risk of bleeding. Heavy drinking can slow your immune response and make it harder for your body to fight cancer. It is best to limit the amount of alcohol you drink.

Does Fruzaqla interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Fruzaqla.

  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Efavirenz, which is a medicine commonly used to treat HIV

Many other medicines may alter the blood levels of Fruzaqla. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Fruzaqla. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Fruzaqla?

If you or someone else has used too much Fruzaqla, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Fruzaqla?

If you miss a dose and it is less than 12 hours since you missed the dose on the same day, take it as soon as you remember. If it has been 12 hours or more since you missed your dose, skip the missed dose and only take the next dose at the usual time. Do not take double or extra doses.