Taking STIVARGA^® (regorafenib)

STIVARGA® (regorafenib) pill bottle. Visit STIVARGA-US.com to see full Safety and Prescribing Information, including Boxed Warning.

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How does taking STIVARGA fit into my daily routine?

STIVARGA is a once-daily oral therapy that can be stored at room temperature between 68° F to 77° F.

STIVARGA should be swallowed whole with water and after a low-fat meal. This is a meal that contains less than 600 calories and less than 30% fat.

You can decide what time you want to take STIVARGA each day. You may prefer to take it with breakfast, dinner, or a midday meal. The important thing is to be consistent and take STIVARGA at the same time each day.

What to Avoid

You should avoid consuming grapefruit juice and St. John's Wort during treatment with STIVARGA, as these may affect the way the medicine works.

Tips for Meal-planning

Explore some examples of good, low-fat meal choices below:

Breakfast

1% low-fat cottage cheese (4 ounces)
English muffin (1)
Fat-free butter (1 tablespoon)
Jam or preserves (1 tablespoon)
Apple juice (8 ounces)

Total calories: 379 | Total fat: 5.9%

Lunch

Turkey breast lunch meat (2 slices)
Toasted white bread (2 slices)
Real mayonnaise (1 tablespoon)
Lettuce and tomato (1 leaf/slice)
1 large apple (3 & 1/4")
Cranberry juice (8 ounces)

Total calories: 496 | Total fat: 23.6%

Dinner

Spaghetti cooked without added salt (1 cup)
Spaghetti marinara (meatless) sauce (1/2 cup)
Salad, vegetables (1 & 1/2 cups)
Salad dressing (oil and vinegar) (1 tablespoon)

Total calories: 435 | Total fat: 26.5%

How long will I be taking STIVARGA?

The recommended dose of STIVARGA is 160 mg (four 40-mg tablets) every day for 3 weeks, followed by a 1-week break. This is 1 cycle of treatment. Your doctor may stop your treatment or change the dose. Be sure to take the dose based on the schedule that your doctor prescribes for you. Continue taking STIVARGA until your healthcare provider tells you to stop.

Tips When Starting STIVARGA

Contact your doctor’s office as soon as you first receive STIVARGA to schedule your first appointment within the week.

If you experience side effects, it's important to let your doctor or another member of your treatment team know right away, even if you feel it is minor.

Here is an example of what a daily dosing schedule could look like:

Daily Dosing Schedule

Be sure you understand the daily dose (number of tablets each day) that your doctor has prescribed for you and follow the directions for treatment.

If you miss a dose, take it as soon as you remember on that day
If you forget to take STIVARGA until the next day, NEVER try to “catch up”—don’t take 2 doses on the same day to make up for a missed dose
Call your healthcare provider or go to the nearest emergency room right away if you take more than your prescribed dose by mistake

Before starting
STIVARGA

What should I tell my doctor or nurse before taking STIVARGA?

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems in addition to liver cancer
have bleeding problems
have high blood pressure
have heart problems or chest pain
plan to have surgery or have had a recent surgery. You should stop taking STIVARGA at least 2 weeks before planned surgery

are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males with female partners who can become pregnant should use effective birth control during treatment with STIVARGA and for 2 months after their last dose of STIVARGA. Tell your healthcare provider right away if you or your partner becomes pregnant either while taking STIVARGA or within 2 months after your last dose of STIVARGA
are breastfeeding or plan to breastfeed. It is not known if STIVARGA passes into your breast milk. Do not breastfeed during treatment with STIVARGA and for 2 weeks after your final dose of STIVARGA

Tell your doctor or nurse about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. STIVARGA may affect the way other medicines work, and other medicines may affect how STIVARGA works.

Know Your Medicines

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider when you get a new medicine.

Storage of
STIVARGA

STIVARGA can be kept at room temperature between 68° F to 77° F.

Here are some “dos” and “don'ts” for proper storage of STIVARGA:

Do:

Always keep STIVARGA tightly closed in its original bottle as it contains a special drying agent (called a desiccant) to keep your medicine dry
Remove the drying agent to get tablets from the bottle. Always put it back in the bottle after getting your medicine
Always keep the bottle of STIVARGA tightly closed and store at room temperature (68°-77° F) in cases where the weather can fluctuate above or below the range
Only open 1 bottle of STIVARGA at a time
Keep STIVARGA and all medicines out of the reach of children

Don't:

Use STIVARGA tablets after the bottle has been opened for 7 weeks or more. These tablets should be safely thrown away
Put the tablets in a pillbox; keep STIVARGA in the original bottle with the drying agent

Prepare for treatment

Know the possible side effects of STIVARGA

Get support

Connect with financial resources and treatment counseling

INDICATIONS

STIVARGA (regorafenib) is a prescription medicine used to treat people with:

colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines
a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines
a type of liver cancer called hepatocellular carcinoma (HCC) in people who have been previously treated with sorafenib

It is not known if STIVARGA is safe and effective in children less than 18 years of age.

IMPORTANT SAFETY INFORMATION

STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or change in your sleep pattern.

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems in addition to liver cancer
have bleeding problems
have high blood pressure
have heart problems or chest pain
plan to have surgery or have had a recent surgery. You should stop taking STIVARGA at least 2 weeks before planned surgery
are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males should use effective birth control during treatment with STIVARGA and for 2 months after their last dose of STIVARGA. Tell your healthcare provider right away if you or your partner becomes pregnant either while taking STIVARGA or within 2 months after your last dose of STIVARGA
are breast-feeding or plan to breast-feed. It is not known if STIVARGA passes into your breast milk. Do not breastfeed during treatment with STIVARGA and for 2 weeks after your final dose of STIVARGA

Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Avoid drinking grapefruit juice and taking St. John’s Wort while taking STIVARGA.

STIVARGA may cause serious side effects, including:

Infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get 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 or pain in any part of the body
severe bleeding. STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your healthcare provider if you have any signs of bleeding while taking STIVARGA, including: vomiting blood or if your vomit looks like coffee grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, nose bleeds that happen often, bruising, and lightheadedness
a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or intestinal wall that can be serious and sometimes lead to death. Contact your healthcare provider immediately if you notice severe pains or swelling in your stomach area (abdomen), fever, chills, nausea, vomiting, or dehydration
a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands and soles of your feet, or a severe rash
high blood pressure. Your blood pressure should be checked every week for the first 6 weeks of starting STIVARGA. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are receiving STIVARGA. Tell your healthcare provider if you have severe headaches, light-headedness, or changes in your vision
decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, have shortness of breath, feel dizzy, or feel like passing out
a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinking
risk of wound healing problems. Wounds may not heal properly during STIVARGA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with STIVARGA.
- You should stop taking STIVARGA at least 2 weeks before planned surgery.
- Your healthcare provider should tell you when you may start taking STIVARGA again after surgery.

The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss.

For important risk and use information about STIVARGA, please see the full Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

*Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Access Services by Bayer^™ program at any time, including but not limited to this commercial co-pay assistance program.

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Last updated on March 2024

Taking STIVARGA® (regorafenib)