Generic Name: regorafenib (RE-goe-RAF-e-nib)
Brand Name: Stivarga
Stivarga may cause severe and sometimes fatal liver problems. Your doctor will monitor your liver function before and during treatment with Stivarga. Be sure to keep all doctor and lab appointments. Tell your doctor right away if you have symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; severe stomach pain; unusual nausea, vomiting, or tiredness; yellowing of the eyes or skin).
Stivarga is used for:
Treating certain patients with colorectal cancer that has spread to other parts of the body. It is also used to treat patients with a type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumors (GIST). It may also be used for other conditions as determined by your doctor.
Stivarga is a kinase inhibitor. It works by helping to stop cancer cells from growing.
Do NOT use Stivarga if:
- you are allergic to any ingredient in Stivarga
- you have severe liver problems
- you are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), carbamazepine, cobicistat, enzalutamide, hydantoins (eg, phenytoin), certain macrolide antibiotics (eg, clarithromycin), mifepristone, nefazodone, phenobarbital, primidone, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), St. John's wort, or telithromycin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Stivarga:
Some medical conditions may interact with Stivarga. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you have allergies to medicines, foods, or other substances
- if you have high blood pressure, kidney or liver problems, bleeding problems, thyroid problems, heart problems, chest pain, or a wound that has not fully healed
- if you have a history of stomach or bowel problems (eg, ulcer, tearing, fistula, bleeding), or you are at risk of developing these problems
- if you have a history of angina attacks or heart attack, or you are at risk of developing these problems
- if you are or will be having surgery, or you have recently had surgery
Some MEDICINES MAY INTERACT with Stivarga. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Azole antifungals (eg, fluconazole, ketoconazole), cobicistat, macrolide antibiotics (eg, azithromycin, clarithromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Stivarga's side effects
- Carbamazepine, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Stivarga's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Stivarga may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Stivarga:
Use Stivarga as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Stivarga. Talk to your pharmacist if you have questions about this information.
- Take Stivarga by mouth at the same time each day with a low-fat breakfast.
- An example of a low-fat breakfast include 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk. Another example is 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jelly, apple juice, and 1 cup of coffee or tea. Check with your doctor if you have questions about what would be considered a low-fat breakfast.
- Swallow Stivarga whole. Do not break, crush, or chew before swallowing.
- Do not eat grapefruit or drink grapefruit juice while you use Stivarga.
- Usually, Stivarga is taken by mouth daily for 21 days and then stopped for 7 days as directed by your doctor. This is called a cycle. Continue to take Stivarga as directed by your doctor. Do not miss any doses.
- If you miss a dose of Stivarga, take it as soon as possible on the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.
Ask your health care provider any questions you may have about how to use Stivarga.
Important safety information:
- Do NOT change your dose or stop taking Stivarga without checking with your doctor.
- Tell your doctor or dentist that you take Stivarga before you receive any medical or dental care, emergency care, or surgery. You will need to stop Stivarga at least 2 weeks before planned surgery as directed by your doctor. Your doctor will decide when you should start to take it again.
- High blood pressure has been reported in patients who take Stivarga. If this occurs, it is usually seen during the first cycle of treatment. However, it may occur at any time during treatment. Contact your doctor if you develop symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes).
- Stivarga may rarely cause a serious brain problem called reversible posterior leukoencephalopathy syndrome (RPLS). Contact your doctor right away if you experience severe headache, seizures, sluggishness, confusion, problems thinking, or vision changes (eg, loss of vision).
- Women who may become pregnant should use effective birth control while they are taking Stivarga and for 2 months after they stop taking it. Check with your doctor if you have questions about effective birth control.
- Men who may father a child should use effective birth control while taking Stivarga and for 2 months after you stop taking it. Check with your doctor if you have questions about effective birth control. If your partner becomes pregnant while taking Stivarga or within 2 months after you stop taking it, contact your doctor right away.
- Severe and sometimes fatal bleeding has been reported in patients taking Stivarga. Contact your doctor right away if you develop blood in the urine, coughing or spitting up blood, menstrual bleeding that is heavier than normal, nosebleeds that happen often, pink or brown urine, unusual vaginal bleeding, or other unusual bruising or bleeding.
- Severe and sometimes fatal stomach or bowel problems (eg, tearing, fistula) have rarely occurred in patients taking Stivarga. Contact your doctor right away if you develop severe or persistent stomach pain, black tarry or bloody stools, or vomiting blood or a substance that looks like coffee grounds.
- Tell your doctor if you have a wound that does not heal.
- Lab tests, including liver function, thyroid function, and blood pressure, may be performed while you use Stivarga. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Stivarga should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Stivarga may cause harm to the fetus. Avoid becoming pregnant while you are taking Stivarga and for 2 months after you stop taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Stivarga while you are pregnant. It is not known if Stivarga is found in breast milk. Do not breast-feed while taking Stivarga.
Possible side effects of Stivarga:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Decreased appetite; diarrhea; dry mouth; hair loss; headache; muscle stiffness; nausea; tiredness; voice changes; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blood in the urine; chest, jaw, or arm pain; confusion; coughing or spitting up blood; fainting; fever, chills, or persistent cough or sore throat; irregular heartbeat; menstrual bleeding that is heavier than normal; mental or mood changes; muscle pain, weakness, or cramping; nosebleeds that happen often; pink or brown urine; red, swollen, blistered, or peeling skin; redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet; seizures; severe or persistent headache, dizziness, or light-headedness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; sluggishness; stomach swelling; sudden unusual sweating; swelling, sores, pain, or redness in the mouth or throat; symptoms of liver problems (eg, dark urine; persistent loss of appetite; pale stools; unusual nausea, vomiting, or tiredness; yellowing of the eyes or skin); unusual bruising or bleeding; unusual vaginal bleeding; very dry mouth or eyes; vision changes; vomiting blood or a substance that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased appetite; diarrhea; dry mouth; rash; redness, pain, swelling, blisters, or bleeding on the palms of your hands or soles of your feet; severe or persistent headache or dizziness; swelling, sores, pain, or redness in the mouth or throat; tiredness; voice changes.Proper storage of Stivarga:
Store Stivarga at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original bottle, away from heat, moisture, and light. Tightly close the bottle after each time you open it. Do not store in the bathroom. Keep the desiccant in the bottle to help keep your medicine dry. Safely discard any unused tablets 28 days after opening the bottle. Keep Stivarga out of the reach of children and away from pets.
- If you have any questions about Stivarga, please talk with your doctor, pharmacist, or other health care provider.
- Stivarga is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Stivarga or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Stivarga. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Stivarga. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Stivarga.