Patient Medication Information: uses, side effects, how to take - Stivarga
Serious warnings and precautions box
What STIVARGA is used for:
STIVARGA is used in adults to treat:
- colon or rectal cancer that has spread to other parts of the body. STIVARGA is used in patients who already received other treatments (fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, anti-VEGF therapy, and anti-EGFR therapy).
- gastrointestinal stromal tumors that have spread to other parts of the body or cannot be removed by surgery. STIVARGA is used in patients who already received treatment with anticancer drugs imatinib and sunitinib.
- liver cancer in patients who have been previously treated with another anticancer medicine, sorafenib.
How STIVARGA works:
STIVARGA is a multikinase inhibitor. It works by:
This drug should be prescribed only by a healthcare professional experienced in anticancer drugs. You may experience the following serious side effects when taking STIVARGA:
- Liver problems which may cause death.
- Bleeding problems which may cause death.
- Chest pain or heart problems.
- Brain disorder that can cause headache, confusion, seizures and visual loss.
- Severe bowel problems (a tear developing in the stomach or a bowel) which may cause death.
- High blood pressure.
- Hand-Foot Skin Reaction that can cause redness, pain, swelling, or blisters on the palms of your hands and soles of your feet.
- Infections which may cause death.
- A brain disorder caused by high levels of ammonia in the blood, which may cause death.
- slowing down the growth and spread of cancer cells
- stopping/cutting off the development of new blood vessels that supply the tumors
The ingredients in STIVARGA are:
Medicinal ingredient: regorafenib
Non-medicinal ingredients: cellulose microcrystalline, croscarmellose sodium, iron oxide red, iron oxide yellow, lecithin (soy), macrogol, magnesium stearate, polyvinyl alcohol (partially hydrolyzed), povidone, silica colloidal anhydrous, talc and titanium dioxide
STIVARGA comes in the following dosage form:
Tablet (film-coated); 40 mg
Do not use STIVARGA if:
- you are allergic to regorafenib, sorafenib or any of the other ingredients of STIVARGA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take STIVARGA. Talk about any health conditions or problems you may have, including if you:
- have liver problems including Gilbert’s syndrome. Treatment with STIVARGA may lead to a higher risk of liver problems.
- have any bleeding problems or if you are taking warfarin or a medicine that thins the blood to prevent blood clots. Treatment with STIVARGA may lead to a higher risk of bleeding.
- have heart problems.
- have or have had high blood pressure and its complications, including separation of the layers of the arterial wall (artery dissection). If you develop seizures, noticeable decrease in energy, sleepiness or impaired consciousness, contact your healthcare professional immediately.
- have an upcoming surgery. STIVARGA might affect the way your wounds heal and treatment may need to be stopped until your wound heals.
Other warnings you should know about:
Check-ups and testing: Before starting treatment and periodically during your treatment, your healthcare professional will perform or check:
Blood tests for:
- electrolyte levels (including potassium, calcium, phosphorus and sodium)
- liver function
- thyroid stimulating hormone
- Digestive enzymes.
- How well your heart is working.
- Your blood pressure.
Pregnancy, contraception and breastfeeding:
- Avoid becoming pregnant while taking STIVARGA. It may harm your unborn baby.
- If you are pregnant, able to get pregnant, or think you are pregnant, there are specific risks you must discuss with your healthcare professional.
- Reliable birth control should be used by both males and females during treatment and for 8 weeks after the last dose of STIVARGA.
- It is not known if STIVARGA passes into breast milk. Do not breastfeed during treatment with STIVARGA.
Fertility: Treatment with STIVARGA may affect the ability in both men and women to have children.
Skin problems: STIVARGA can cause hand-foot skin reaction. Use shoe cushions and gloves to reduce the risk of developing this skin condition. To manage your symptoms, your healthcare professional may recommend the use of creams. If you experience this side effect, your healthcare professional may change your dose or temporarily stop your treatment until this skin condition improves.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
STIVARGA may affect the way other medicines work, and other medicines may affect how STIVARGA works. You may need to change the dosage or stop taking one of the medicines.
The following may interact with STIVARGA:
- Medicines to treat fungal infections (e.g. ketoconazole)
- Medicines to treat bacterial infections (e.g. rifampin)
- Medicines to treat epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
- Methotrexate, a medicine used to treat cancer
- Medicines used to treat high cholesterol (e.g. rosuvastatin, fluvastatin, atorvastatin)
- St. John’s wort
How to take STIVARGA:
- Take exactly as your healthcare professional has told you. Speak with your doctor or pharmacist if you are not sure.
- Swallow tablets whole with water.
- STIVARGA is taken in a four week cycle. You take STIVARGA for three weeks followed by one week off. Your doctor may change, reduce, interrupt or stop your treatment if necessary.
- STIVARGA should be taken at the same time each day after a light (low fat) meal. An example of a low-fat, low-calorie meal is two slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly and 8 ounces of skim milk (approximately 319 calories and 8.2 grams of fat).
Usual dose:
Take 4 tablets (160 mg of regorafenib) once a day for three weeks. Do NOT take any pills in week four.
Overdose:
If you think you, or a person you are caring for, have taken too much STIVARGA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss a dose, take it as soon as you remember on that day. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day. Tell your healthcare professional about any missed dose.
Possible side effects from using STIVARGA:
These are not all the possible side effects you may have when taking STIVARGA. If you experience any side effects not listed here, tell your healthcare professional.
- pain
- rash, itching or peeling of your skin
- tiredness, fatigue
- diarrhea (frequent or loose bowel movements)
- loss of appetite
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Bleeding problems: blood in the stools or black stools, blood in the urine, stomach pain, coughing / vomiting up blood, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, frequent nose bleeds | |||
| High blood pressure: severe and persistent headache, visual disturbances | |||
| Hand-foot skin reaction: redness, pain, swelling, or blisters on the palms of your hands or sole of your feet | |||
| Infection: high fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning or pain when | |||
| urinating, unusual vaginal discharge or irritation, redness, swelling and/or pain in any part of the body | |||
| Wound healing problems | |||
| Rare | |||
| Serious liver problems: yellowish discoloration of the skin and the whites of the eyes (jaundice), dark urine, confusion and/or disorientation, nausea or vomiting | |||
| Decreased blood flow to the heart and heart attack: chest discomfort or pain which may spread beyond your chest to your shoulders, arms, back, neck, teeth, jaw or stomach and may come and go, shortness of breath, sudden outbreak into a sweat with cold, clammy skin, feeling dizzy or fainting | |||
| Severe stomach and bowel problems: severe stomach (abdominal) pain or stomach pain that does not go away, vomiting blood, red or black stools | |||
| Severe drug allergic reaction: skin eruption, fever, shortness of breath, liver problems | |||
| Very rare | |||
| Artery Dissection (a tear forms in a wall of an artery): sudden severe pain in the back, chest or abdomen | |||
| Artery Aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart and brain): symptoms will differ by the site. They can be cough, coughing up blood. Strong pain high in your neck or in your back when you didn’t hurt yourself. Problems swallowing. Hoarse voice. Unusual pulsing in your chest or abdomen | |||
| Unknown | |||
| Hyperammonemic encephalopathy (a brain disorder caused by high levels of ammonia in the blood): noticeable decrease in energy, confusion, sleepiness, trembling, impaired consciousness | |||
| Thrombotic Microangiopathies (blood clots in small blood vessels): bleeding, bruising, weakness, confusion, fever, chills, nausea, vomiting, diarrhea, low or no urine output | |||
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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store STIVARGA at 15- 30°C in the original package to protect it from moisture.
Keep the bottle tightly closed after first opening and keep the desiccant in the bottle.
Once the bottle is opened the medicine is to be discarded after 7 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If you want more information about STIVARGA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.bayer.ca or by calling Bayer Medical Information at 1-800-265-7382 or emailing canada.medinfo@bayer.com.
Bayer Inc.
2920 Matheson Blvd East
Mississauga, Ontario
L4W 5R6
Canada
Date of Authorization: 2025-11-12
© 2025, Bayer Inc.
® TM see www.bayer.ca/tm-mc