Fruquintinib (frue-KWIN-ti-nib)

Treats colorectal cancer.

Brand Name(s):

Fruzaqla

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Take the medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is within 12 hours, take it as soon as possible. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• If you vomit after taking your medicine, do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how fruquintinib works. Tell your doctor if you are using efavirenz or rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 2 weeks after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 2 weeks after the last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, high blood pressure, an infection, or a recent blood clots, heart attack, or stroke.
• This medicine may cause the following problems:
  • Hypertension (high blood pressure)
  • Serious bleeding problems
  • Increased risk of infections
  • Stomach or bowel perforation (tear or hole)
  • Liver problems
  • Proteinuria (protein in the urine)
  • Palmar-plantar erythrodysesthesia (hand-foot skin reaction), a condition that can cause pain and blisters on your hands or feet
  • Posterior reversible encephalopathy syndrome (PRES), a brain condition
  • Increased risk of blood clots
• Tell any doctor who treats you that you are using this medicine. This medicine may affect the way your body heals from cuts and wounds. You may need to stop using it for at least 2 weeks before and after major surgery, or until adequate wound healing before taking this medicine again.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including bronchial asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody, black, or tarry stools, vomiting of material that looks like coffee grounds
• Blurred vision, fast heartbeat, nervousness, pounding in the ears
• Chest pain, coughing up blood, trouble breathing
• Cloudy urine, swelling of the face, hands, arms, legs, or feet
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Seizures, unusual drowsiness, confusion
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Lack or loss of strength

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088