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Regorafenib (Oral route)

Pronunciation:

re-goe-RAF-e-nib

Brand Names:

  • Stivarga

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Severe and sometimes fatal hepatotoxicity has been observed with regorafenib therapy. Monitor hepatic function prior to and during therapy. Adjust, interrupt, or discontinue dose if hepatoxicity occurs .

Uses of This Medicine:

Regorafenib is used to treat metastatic cancer (cancer that has spread) of the colon and rectum. It is used in patients who have already been treated with other cancer medicines that did not work well. Regorafenib prevents the growth of tumors.

Regorafenib is also used to treat metastatic gastrointestinal stromal tumors (GIST) in patients who have already received other medicines that did not work well. GIST is a rare cancer that affects the stomach, bowel, or esophagus.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of regorafenib in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

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.

Other medicines—

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.

  • Eletriptan

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.

  • Amiodarone
  • Aprepitant
  • Atazanavir
  • Boceprevir
  • Bupropion
  • Carbamazepine
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Fentanyl
  • Fosaprepitant
  • Fosphenytoin
  • Hydrocodone
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Ospemifene
  • Phenytoin
  • Piperaquine
  • Posaconazole
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

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:

  • Angina (severe chest pain) or
  • Bleeding problems or
  • Heart disease or
  • Hypertension (high blood pressure) or
  • Liver disease or
  • Skin rash, severe or
  • Stomach fistula or perforation (a hole from the inside)—Use with caution. May make these conditions worse.
  • Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

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 insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the tablet whole. Do not crush, break, or chew it.

Take this medicine at the same time each day with a low-fat breakfast. Examples 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; or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea.

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 metastatic cancer of the colon or rectum:
      • 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.
      • Children—Use and dose must be determined by your doctor.
    • For metastatic gastrointestinal stromal tumors (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.
      • Children—Use and dose must be determined by your doctor.

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 place the tablets in daily or weekly pill boxes.

Throw away any unused tablets 28 days after opening the bottle for the first time.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during therapy and for up to 2 months after treatment. If you think you have become pregnant while using this medicine or within 2 months after the last dose, tell your doctor right away.

Your doctor will check your blood pressure on a regular basis while you are taking this medicine. You may also need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

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.

This medicine may increase your chance of bleeding and cause wounds or injuries to heal more slowly. To help with this problem, stay away from rough sports or situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious skin reactions or a severe rash. Call your doctor right away if you have skin redness, pain, blisters, bleeding, or swelling of the palms of your hands and 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).

Check with your doctor right away if you have severe burning, cramps, or pain in the stomach area, a high fever, chills, nausea, vomiting, or severe diarrhea. These could be symptoms of a serious bowel problem.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop the medicine several days before having surgery.

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.

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 of This Medicine:

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
blurred vision
cough or hoarseness
coughing up blood
difficulty with breathing or swallowing
dizziness
fever or chills
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
Confusion
heartburn
indigestion
severe stomach pain, cramping, or burning
vomiting of material that looks like coffee grounds

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
depressed mood
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.


Last Updated: 4/4/2014

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