Patient Medication Information: uses, side effects, how to take - Fruzaqla
What is FRUZAQLA used for?
FRUZAQLA is used to treat adult patients with colorectal cancer (CRC) that has spread to other parts of the body (metastatic). It is used when other treatments have not worked or when other treatments are not suitable for you.
How does FRUZAQLA work?
FRUZAQLA stops tumors from making new blood vessels and therefore slows down the growth of cancer. Blood vessels would usually provide the tumor with nutrients and oxygen.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, please ask your healthcare professional.
What are the ingredients in FRUZAQLA?
Medicinal ingredients: fruquintinib
Non-medicinal ingredients: corn starch, FD&C Blue No. 1 (brilliant blue FCF) (5 mg), FD&C Red No. 40 (allura red AC) (5 mg), FD&C Yellow No. 5 (tartrazine) (1 mg), FD&C Yellow No. 6 (sunset yellow FCF) (1 mg), gelatin, microcrystalline cellulose, pharmaceutical grade printing ink, talc, titanium dioxide.
FRUZAQLA comes in the following dosage forms:
Capsule: 1 mg and 5 mg
Do not use FRUZAQLA if:
- You are allergic to fruquintinib, any of the other ingredients in this medicine or any parts of the container (see What are the ingredients in FRUZAQLA?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FRUZAQLA. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure. Your healthcare professional should make sure that your blood pressure is under control before starting and while taking FRUZAQLA.
have any bleeding problems. Tell your healthcare professional if you:
- had or have bleeding problems
- are taking medicines to thin the blood and prevent blood clots (like warfarin and acenocoumarol).
- have severe stomach and bowel problems. If you get severe stomach and bowel problems, talk to your healthcare professional immediately.
- have kidney problems.
- have any skin problems, which may include redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
- had severe and persistent headache, visual disturbances, seizures or altered mental status (such as confusion, memory loss or loss of orientation). If you notice any of these changes, talk to your healthcare professional immediately.
- had or are going to have surgery or have an unhealed wound. FRUZAQLA may affect the way your wounds heal.
- had problems with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism (blockage in your blood vessels), or thrombosis (blood clot forming in your blood vessels).
- have liver problems.
- have or have had infections.
Other warnings you should know about:
Pregnancy
FRUZAQLA has not been studied in pregnant women. FRUZAQLA should not be used during pregnancy. FRUZAQLA may harm your unborn child.
If you are pregnant, think you may be pregnant or are planning to become pregnant, talk to your healthcare professional for advice before taking this medicine. Your healthcare professional will discuss with you the potential risks of taking this medicine during pregnancy.
Breastfeeding
Tell your healthcare professional if you are breastfeeding or planning to breast-feed. It is unknown if FRUZAQLA passes into breast milk, and may harm the baby.
You should not breast-feed during treatment with this medicine and for at least 2 weeks following the last dose of FRUZAQLA. Talk to your healthcare professional about the best way to feed your baby during treatment with FRUZAQLA.
Fertility
The effects of FRUZAQLA on your ability to have children has not been studied.
Contraception – for men and women
Women who are able to become pregnant and male patients with female partners who are able to become pregnant should use highly effective birth control methods during treatment, and for at least 2 weeks following the last dose of FRUZAQLA.
Driving and Using Machines:
It is not known if FRUZAQLA changes your ability to drive or use machines. Do NOT drive or use any tools or machines if you experience tiredness, drowsiness, dizziness, lightheadedness, or any other symptoms that may affect your ability to concentrate and react.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with FRUZAQLA:
- Medicines used to treat seizures such as carbamazepine, phenobarbital, and phenytoin.
- Medicines used to treat tuberculosis such as rifampin.
- Medicines used to treat certain infections such as rifabutin.
- Herbs such as St. John’s Wort.
- Medicines used to treat HIV-1 infection such as efavirenz and etravirine.
- Medicines used to treat high blood pressure such as bosentan.
- Medicines used to treat certain sleep disorders such as modafinil.
- Antibiotics used to treat bacterial infections such as nafcillin.
How to take FRUZAQLA:
- Take exactly as prescribed for you by your healthcare professional. Continue to take FRUZAQLA unless your healthcare professional tells you to stop.
Take with or without food.
- Swallow whole. Do not open or dissolve the capsules.
- If you vomit after taking a dose, you should not take another dose on the same day. Take the dose as prescribed by your healthcare professional on the next day.
Usual dose:
The recommended dose is 5 mg once daily at around the same time each day for 21 days (3 weeks), followed by 7 days (1 week) of no treatment (rest period). This is 1 cycle of treatment.
Overdose:
| If you think you, or a person you are caring for, have taken too much FRUZAQLA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss a dose and you are less than 12 hours late, take the missed dose as soon as you remember. Take the next dose at your regular time.
If you are more than 12 hours late, do NOT take the missed dose. Wait until the regular time for your next dose.
Do not take two doses to make up for a missed dose.
What are possible side effects from using FRUZAQLA?
These are not all the possible side effects you may have when taking FRUZAQLA. If you experience any side effects not listed here, tell your healthcare professional.
- reduced number of blood platelets (cells that help blood to clot) may show in your blood tests (thrombocytopenia) – can cause easy bruising or bleeding.
- reduced number of white blood cells may show in your blood tests (leukopenia).
- reduced number of neutrophils (type of white blood cell) may show in your blood tests (neutropenia).
- reduced activity of the thyroid gland (hypothyroidism).
- weight loss and loss of appetite (anorexia).
- voice changes or hoarseness (dysphonia).
- diarrhea.
- painful or dry mouth, mouth sores or ulcers (stomatitis).
- bone, muscle, chest, or neck pain.
- joint pain (arthralgia).
- weakness, lack of strength and energy, excessive tiredness and unusual sleepiness (asthenia/fatigue).
- low levels of potassium in blood (hypokalaemia).
- throat pain.
- increased pancreatic enzymes.
- toothache, gum, or lip pain (oral pain).
- rash.
- mouth sores (mucosal inflammation).
- inflammation of the pancreas (pancreatitis).
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| High blood pressure: very high blood pressure, severe headache, severe chest pain | ✓ | ||
| Bleeding: blood in stools, black stools, blood in urine, stomach pain, coughing or vomiting up blood, nosebleed, bleeding in the digestive system such as stomach, rectum or intestine (gastrointestinal haemorrhage) | ✓ | ||
| Infections: fever, sever cough with or without an increase in mucus | ✓ | ||
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| production, severe sore throat, trouble breathing, burning or pain when you urinate, redness, swelling or pain in the body, infection of the lungs (pneumonia), nose and throat infection | |||
| Liver problems: yellowing of your skin or the white parts of your eyes, dark coloured (tea coloured) urine, pain in your right upper stomach-area (abdomen), loss of appetite, nausea, vomiting, bleeding, bruising, increased levels of liver enzymes in blood tests, (including aspartate aminotransferase and alanine aminotransferase), abnormal liver function test (increased amounts of bilirubin in blood) | ✓ | ||
| Palmar-plantar erythrodysaesthesia syndrome: redness, pain, blisters and swelling of the palms of the hands or soles of the feet (palmar-plantar erythrodysaesthesia syndrome) | ✓ | ||
| Kidney problems: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma), protein in your urine | ✓ | ||
| COMMON | |||
| Severe stomach and bowel problems: coughing or vomiting up blood, severe stomach or abdominal pain that doesn’t go away, vomiting blood, red or black stools | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Reversible swelling of the brain (posterior reversible encephalopathy syndrome): headache, confusion, seizure (fits), changes in vision with or without high blood pressure | ✓ | ||
| Impaired wound healing: wounds heal slower | ✓ | ||
| Arterial thromboembolic events: chest pain, shortness of breath, dizziness, face drooping on one side, weakness in one arm, slurred speech, limbs may become painful, skin on limb may be pale or blue in colour and cold | ✓ | ||
| UNKNOWN | |||
| Arterial Dissection (tear along the inside of an artery): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||
Storage:
Store at 15°C to 30°C. Store in the original container to protect from moisture. Keep the bottle tightly closed. Do not remove desiccant from the bottle.
Do not use this medicine after the expiry date (EXP) shown on the pack.
Keep out of reach and sight of children.
If you want more information about FRUZAQLA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://takeda.info/ca-medicines, or by calling 1-800-268-2772.
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto, Ontario M5H 4E3
Last Revised: SEP 10, 2024
FRUZAQLA and the FRUZAQLA Logo are trademarks of HUTCHMED Group Enterprises Limited, used under license.
TAKEDA and the TAKEDA Logo are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.