fruquintinib 1 mg capsule

Generic name:
Fruquintinib - oral

Brand name(s)
Fruzaqla

This medication is used to treat cancer of the colon and rectum. Fruquintinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking fruquintinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily for 21 days, followed by 7 days off treatment. Repeat this treatment cycle for as long as directed by your doctor. Swallow the capsules whole. The dosage is based on your medical condition and response to treatment.

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

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Diarrhea, hoarseness, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• swelling hands/feet/legs
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine)
• slow wound healing

Get medical help right away if you have any very serious side effects, including:

• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• pink/bloody urine

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough, burning/frequent/painful/urgent urination).

This medication can also cause serious (possibly fatal) bleeding, such as bleeding from the stomach/intestines. You should not receive this medication if you have any serious bleeding problems. In addition, this medication can rarely cause a tear in the stomach/intestines (gastrointestinal perforation). Get medical help right away if you have any signs of these serious side effects, including stomach/abdominal pain that is severe or doesn't go away, bloody or black/tarry stools, vomit that is bloody or looks like coffee grounds, coughing up blood, dizziness/fainting.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot skin reaction (palmar-plantar erythrodysesthesia). Tell your doctor right away if you experience swelling, pain, redness, peeling, blisters, or tingling/burning of the hands/feet. Depending on how severe your hand-foot reaction is, your doctor may lower your dose or delay your treatment.

Rarely, fruquintinib may cause a condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking fruquintinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine or sunset yellow), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• heart problems (such as heart failure, heart attack)
• current infection
• stroke/transient ischemic attack- TIA
• high blood pressure
• kidney problems
• liver problems

Fruquintinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using fruquintinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to not take fruquintinib for at least 2 weeks before and after surgery. This medication may cause wounds to heal more slowly. Follow all instructions about when to stop or restart this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using fruquintinib. Fruquintinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 2 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of fruquintinib from your body, which may affect how fruquintinib works. Examples include rifamycins (such as rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), St. John's wort, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function, urine protein, skin exam, heart function) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.