Description
Regorafenib is used to colorectal cancer (cancer of the colon or rectum) that has spread throughout the body in patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, and irinotecan) that did not work well.
Regorafenib is also used to treat a certain type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST) that cannot be treated by surgery of that has spread to other parts of the body (metastatic) in patients who have received other medicines (eg, imatinib, sunitinib) that did not work well. This medicine is used to treat a type of liver cancer called hepatocellular cancer (HCC) in patients who have already been treated with sorafenib.
Regorafenib belongs to the group of medicines, called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of regorafenib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of regorafenib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alpelisib
- Amiodarone
- Boceprevir
- Carbamazepine
- Celecoxib
- Ceritinib
- Cholera Vaccine
- Cilostazol
- Clarithromycin
- Cobicistat
- Conivaptan
- Dasabuvir
- Ebola Zaire Vaccine, Live
- Enzalutamide
- Fosphenytoin
- Idelalisib
- Indinavir
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
- Lopinavir
- Lumacaftor
- Meloxicam
- Methadone
- Mitotane
- Nefazodone
- Nelfinavir
- Ospemifene
- Phenytoin
- Piperaquine
- Posaconazole
- Rifampin
- Rifapentine
- Ritonavir
- Rosuvastatin
- Rotavirus Vaccine, Live
- Saquinavir
- Seladelpar
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems or
- Heart disease (eg, heart attack) or
- Hypertension (high blood pressure)—Use with caution. May make these conditions worse.
- Infection—May decrease the body's ability to fight infection.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Swallow the tablet whole with water. Do not crush, break, or chew it.
Take this medicine at the same time each day with a low-fat meal (less than 30% fat).
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit products may increase the amount of medicine in your body.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For colorectal cancer, hepatocellular cancer (HCC), and gastrointestinal stromal tumor (GIST):
- Adults—160 milligrams (mg) (four 40 mg tablets) once a day for 21 days of each 28-day cycle. Your doctor may adjust the dose if needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For colorectal cancer, hepatocellular cancer (HCC), and gastrointestinal stromal tumor (GIST):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in its original container. Do not remove the drying agent (desiccant). Do not place the tablets in daily or weekly pill boxes.
Throw away any unused tablets 7 weeks after opening the bottle for the first time.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 months after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 2 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat. Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow skin or eyes. These could be symptoms of a serious liver problem (eg, drug-induced liver injury).
Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, low body temperature, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools. These may be symptoms of serious bleeding problems.
This medicine may cause a serious skin problem called hand-foot syndrome or palmar-plantar erythrodysesthesia syndrome. Tell your doctor right away if you have a rash that does not go away or redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet.
This medicine may cause serious heart problems. Check with your doctor right away if you are having chest pain or discomfort, nausea, pain or discomfort in your arms, jaw, back, or neck, shortness of breath, sweating, or vomiting.
Check with your doctor right away if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).
This medicine can cause stomach or bowel perforation (tear or hole). Check with your doctor right away if you have severe stomach pain, constipation, fever, nausea, or vomiting.
This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 2 weeks before and after major surgery, or until adequate wound healing before taking this medicine again.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding gums
- bloody or cloudy urine
- blurred vision
- cough or hoarseness
- coughing up blood
- difficult, burning, or painful urination
- difficulty with breathing or swallowing
- dizziness
- fever or chills
- frequent urge to urinate
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nervousness
- nosebleeds
- painful or difficult urination
- pounding in the ears
- prolonged bleeding from cuts
- rash
- red or black, tarry stools
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- slow or fast heartbeats
- tingling of the hands and feet
- ulcers on the skin
Less common
- Chest pain or discomfort
- dark-colored urine
- general feeling of tiredness or weakness
- light-colored stools
- nausea or vomiting
- pain or discomfort in the arms, jaw, back, or neck
- shakiness in the legs, arms, hands, or feet
- stomach pain that continues
- sweating
- yellow eyes or skin
Rare
- Blistering, peeling, or loosening of the skin
- bloody, black, or tarry stools
- chills
- confusion
- diarrhea
- heartburn
- indigestion
- itching
- joint or muscle pain
- red skin lesions, often with a purple center
- severe stomach pain, cramping, or burning
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- trouble breathing
- unusual tiredness or weakness
- vomiting of material that looks like coffee grounds, severe and continuing
Incidence not known
- Changes in mental status
- low body temperature
- mental depression or anxiety
- nightmares or unusually vivid dreams
- unusual drowsiness, dullness, or feelings of sluggishness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bad, unusual, or unpleasant taste
- hair loss or thinning of the hair
- lack or loss of strength
- muscle or joint stiffness
- weight loss
Less common
- Constipation
- dry skin and hair
- feeling cold
- muscle cramps
- weight gain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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