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Regorafenib

Pronunciation

Generic Name: regorafenib (RE-goe-RAF-e-nib)
Brand Name: Stivarga

Regorafenib may cause severe and sometimes fatal liver problems. Your doctor will monitor your liver function before and during treatment with regorafenib. 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).


Regorafenib 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.

Regorafenib is a kinase inhibitor. It works by helping to stop cancer cells from growing.

Do NOT use regorafenib if:

  • you are allergic to any ingredient in regorafenib
  • you have severe liver problems
  • you are taking carbamazepine, clarithromycin, itraconazole, ketoconazole, nefazodone, phenobarbital, phenytoin, posaconazole, rifampin, St. John's wort, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using regorafenib:

Some medical conditions may interact with regorafenib. 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 are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • 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 regorafenib. 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
  • Cobicistat, fluconazole, itraconazole , ketoconazole, macrolide antibiotics (eg, azithromycin, clarithromycin), mifepristone, nefazodone, posaconazole, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or voriconazole because they may increase the risk of regorafenib's side effects
  • Carbamazepine, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease regorafenib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if regorafenib 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 regorafenib:

Use regorafenib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with regorafenib. Talk to your pharmacist if you have questions about this information.
  • Take regorafenib by mouth with water after a low-fat meal. The low-fat meal must be less than 600 calories and less than 30% fat.
  • Take regorafenib at the same time each day.
  • Swallow regorafenib whole. Do not break, crush, or chew before swallowing.
  • Do not eat grapefruit or drink grapefruit juice while you use regorafenib.
  • Usually, regorafenib 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 regorafenib as directed by your doctor. Do not miss any doses.
  • If you miss a dose of regorafenib, 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 regorafenib.

Important safety information:

  • Do NOT change your dose or stop taking regorafenib without checking with your doctor.
  • Tell your doctor or dentist that you take regorafenib before you receive any medical or dental care, emergency care, or surgery. You will need to stop regorafenib 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 regorafenib. 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).
  • Regorafenib 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 regorafenib 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 regorafenib 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 regorafenib 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 regorafenib. 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 regorafenib. 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.
  • Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have happened with regorafenib. They can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Tell your doctor if you have a wound that does not heal.
  • Have your blood pressure checked as you have been told by your doctor.
  • Lab tests may be performed while you use regorafenib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Regorafenib may cause harm to the fetus. Avoid becoming pregnant while you are taking regorafenib 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 regorafenib while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking regorafenib.

Possible side effects of regorafenib:

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:

Decreased appetite; diarrhea; dry mouth; hair loss; headache; muscle stiffness; nausea; tiredness; voice changes; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or arm pain; confusion; 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; pink or brown urine; 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 bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of liver problems (eg, dark urine; persistent loss of appetite; pale stools; unusual nausea, vomiting, or tiredness; yellowing of the eyes or skin); very dry mouth or eyes; vision changes.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Proper storage of regorafenib:

Store regorafenib 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 7 weeks after opening the bottle. Keep regorafenib out of the reach of children and away from pets.

General information:

  • If you have any questions about regorafenib, please talk with your doctor, pharmacist, or other health care provider.
  • Regorafenib 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 regorafenib 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 regorafenib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to regorafenib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using regorafenib.

Issue Date: June 3, 2015
Database Edition 15.2.1.003
Copyright © 2015 Clinical Drug Information, LLC

Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.

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