Pronunciation:

frue-KWIN-ti-nib

Brand Names:

• Fruzaqla

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Fruquintinib is used to treat colorectal cancer (cancer of the colon or rectum) that has spread throughout the body in patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, and irinotecan) that did not work well.

Fruquintinib belongs to the group of medicines, called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fruquintinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fruquintinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Bosentan
• Carbamazepine
• Cenobamate
• Dabrafenib
• Dipyrone
• Efavirenz
• Elagolix
• Enzalutamide
• Etravirine
• Fosphenytoin
• Ivosidenib
• Lorlatinib
• Lumacaftor
• Mitotane
• Modafinil
• Nafcillin
• Phenobarbital
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• St John's Wort
• Telotristat Ethyl
• Thioridazine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including bronchial asthma) in patients with this condition.

• Bleeding problems or
• Blood clots, recent or
• Heart attack, recent or
• Hypertension (high blood pressure) or
• Infection or
• Kidney disease or
• Stroke, recent—Use with caution. May make these conditions worse.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole. Take the medicine at the same time each day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsule):
  • For treatment of colorectal cancer:
    • Adults—5 milligrams (mg) once a day for the first 21 days of each 28-day cycle. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

If you vomit after taking your medicine, do not take an extra dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may harm your unborn baby if either partner is using it during conception or pregnancy. 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 to keep from getting pregnant during treatment with this medicine and for at least 2 weeks after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 2 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat. Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home.

Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or trouble breathing. These may be symptoms of serious bleeding problems.

This medicine may increased risk of serious infections. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, body aches or pain, chest pain or tightness, chills, cough, difficult, burning, or painful urination, ear congestion, fever, frequent urge to urinate, headache, loss of voice, lower back or side pain, sneezing, sore throat, stuffy or runny nose, trouble breathing, or unusual tiredness or weakness.

This medicine can cause stomach or bowel perforation (tear or hole). Check with your doctor right away if you have severe stomach pain, constipation, fever, nausea, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause proteinuria (protein in the urine). Check with your doctor right away if you have cloudy urine or swelling of the face, hands, arms, legs, or feet.

This medicine may cause a serious skin problem called hand-foot syndrome or palmar-plantar erythrodysesthesia syndrome. Tell your doctor right away if you have a rash that does not go away or redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet.

This medicine may increase your chance of having a brain condition, called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are taking this medicine.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 2 weeks before and after major surgery, or until adequate wound healing before taking this medicine again.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, difficulty with breathing, loss of sensation, confusion, or problems with muscle control or speech.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums

blurred vision

cloudy urine

constipation

coughing up blood

depressed mood

dizziness

dry skin and hair

feeling cold

hair loss

headache

hoarseness or husky voice

increased menstrual flow or vaginal bleeding

muscle cramps and stiffness

nervousness

nosebleeds

paralysis

pounding in the ears

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

slow or fast heartbeat

tingling of the hands and feet

trouble breathing

ulceration of the skin

unusual tiredness or weakness

weight gain

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chest pain or tightness

cough

difficult, burning, or painful urination

ear congestion

fever or chills

frequent urge to urinate

heartburn

indigestion

lower back or side pain

loss of voice

severe stomach pain, cramping, or burning

sneezing

sore throat

stuffy or runny nose

vomiting of blood or material that looks like coffee grounds

Rare

Agitation

back pain

coma

confusion

drowsiness

hallucinations

irritability

mood or mental changes

seizures

stiff neck

sudden weakness in the arms or legs

Incidence not known

Dark urine

loss of appetite

nausea or vomiting

pains in the chest, groin, or legs, especially calves of the legs

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

difficulty in moving

joint pain

muscle or bone pain

swelling or inflammation of the mouth

throat pain

weight loss

Less common

Pain in the rectum

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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