Regorafenib Oral Tablet (REGORAFENIB - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

Take this medicine after a low-fat meal.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

Discard any unused medicine after 7 weeks.

Avoid grapefruit and grapefruit juice while on this medicine.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If you don't remember until the next day, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

To avoid a serious skin reaction, avoid heat and hot water. Also avoid pressure on elbows, knees, and feet. For example, avoid tight clothing, kneeling, or long walks.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 2 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 2 months after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• diarrhea
• dry mouth
• hair loss
• mouth sores or irritation
• changes in taste or unpleasant taste
• weight loss

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• chest or jaw pain
• confusion
• coughing
• coughing up blood or vomit that looks like coffee grounds
• fever or chills
• pain, redness, swelling or blistering on hands, feet or elbows
• numbness or tingling in hands and feet
• fast, irregular, or slow heartbeat
• high blood pressure
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• muscle pain
• red, burning, or itchy skin
• seizures
• shortness of breath
• red, peeling or blistering skin
• skin tingling, burning or prickly feeling
• sore throat
• bloody or dark, tarry stools
• urinating less often
• blood in urine
• blurring or changes of vision
• weight gain
• slow wound healing

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.