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regorafenib oral

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
regorafenib oral Warnings

Regorafenib has rarely caused very serious (possibly fatal) liver disease. Your doctor will monitor your liver function before and during treatment with this medication. Tell your doctor right away if you develop symptoms of liver disease, including persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

regorafenib oral Uses

Regorafenib is used to treat cancer of the colon and rectum which has spread to other parts of the body. It is also used to treat a certain cancer of the digestive system (gastrointestinal stromal tumor). It works by slowing or stopping the growth of cancer cells.

How to use regorafenib oral

Read the Patient Information Leaflet if available from your pharmacist before you start taking regorafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a low-fat breakfast as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor. Swallow the medication whole. Do not crush, chew, or split the tablets.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day that you are scheduled to take it.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

regorafenib oral Side Effects

See also Warning section.

Diarrhea, pain/sores in the mouth/throat, changes in taste, dry mouth, loss of appetite, hair loss, voice changes, weight loss, or muscle stiffness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot skin reaction (palmar-plantar erythrodysesthesia). Tell your doctor right away if you experience swelling, pain, redness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (for example, hot dishwater, long hot baths). Use a sunscreen and wear protective clothing when outdoors. Avoid pressure on elbows, knees, and soles of feet (such as leaning on elbows, kneeling, taking long walks). Wear loose clothing and comfortable shoes. Depending on how severe your hand-foot reaction is, your doctor may give you an additional medication to reduce the symptoms, or stop or delay your regorafenib treatment.

Regorafenib may increase blood pressure. Your blood pressure should be checked regularly while you are taking this medication.

Tell your doctor right away if you have any serious side effects, including: slow wound healing, signs of dehydration (such as extreme thirst, dizziness, decreased urination), signs of mineral imbalance (such as muscle cramps/weakness, irregular heartbeat, mental/mood changes), signs of infection (such as fever, chills, persistent sore throat), signs of underactive thyroid (weight gain, cold intolerance, unusual tiredness, slow heartbeat).

This medication can cause serious bleeding. Tell your doctor right away if you have any signs of serious bleeding, including: easy bleeding/bruising, severe stomach/abdominal pain, vomit that is bloody or looks like coffee grounds, black/tarry stool, unusual vaginal bleeding, pink/bloody urine, coughing up blood.

Get medical help right away if you have any very serious side effects, including: signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), seizure, severe headache, confusion, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Regorafenib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

regorafenib oral Precautions

Before taking regorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high blood pressure, heart disease (such as heart attack, chest pain), bleeding problems (such as bleeding of the stomach/intestines), recent major surgery/injury.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Wash your hands well to prevent the spread of infections.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. To prevent pregnancy, both males and females using regorafenib must use reliable form(s) of birth control during treatment and for at least 2 months after the end of treatment. Consult your doctor for more details. If you or your partner becomes pregnant or may be pregnant, tell your doctor right away.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

regorafenib oral Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of regorafenib from your body, which may affect how regorafenib works. Examples include boceprevir, nefazodone, telaprevir, telithromycin, azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, nelfinavir), rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

regorafenib oral Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function, complete blood count, blood mineral levels, blood pressure, urine protein test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

If you miss a dose and remember on the same day, take it as soon as you remember. If you remember on the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Store at room temperature away from light and moisture. Keep the medication in the original bottle with the desiccant to protect against moisture. Do not store in the bathroom. Discard any remaining tablets 28 days after opening the bottle. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.

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