Regorafenib was approved by the US Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancers. These are cancers which have spread to the colon or rectum. It is recommended for use after other medicines, such as Oxaliplatin, have failed.
The prescription drug is also used to treat locally, advanced gastrointestinal stromal tumors (GIST). These are rare cancers that have spread to the bowel, stomach or esophagus. It is especially indicated in GIST patients treated with other medicines, such as Imatinib and Sunitinib, that did not work.
In April of 2017, the FDA also approved this chemotherapy medication for treating hepatocellular carcinoma (HCC). This is the most common type of liver cancer but does not spread. It is especially indicated in patients with tumors that stopped responding to treatment with sorafenib, another cancer medicine.
The medicine was produced to block the growth and division of cancer cells by targeting proteins on those cells. If this is successful, it may stop the cancer from spreading further. Patients may feel ill when taking the drug but are encouraged to finish the treatment.
The drug is sold in the US under the brand name, Stivarga. Its use is limited in certain patients due to the risk of serious side effects, including abnormally high blood pressure, severe bleeding, and severe hepatotoxicity. Severe hepatotoxicity, a drug-induced liver injury, has been known to cause death in patients.
You should consider the potential benefits and risks of using Regorafenib. Your doctor may help you decide if it is safe for you and how to treat you. Routine tests may be done before, during and after your treatment to ensure the medicine is safe for you, and your body's response to it.
Liver function tests are necessary because severe, even fatal hepatotoxicity (drug-induced liver injury) has occurred in patients treated with this drug. Blood tests and screenings may also be done to determine whether you are at risk for other types of cancers or medical problems.
Tell your doctor if you are allergic to the medicine or have had an unusual reaction to it. Some patients may also be allergic to inactive ingredients in the medication. In discussing allergies, tell your doctor about any allergy to foods, preservatives, dyes or animals you may have.
Also tell your doctor if you are breastfeeding, or you (or your partner) are pregnant, may be pregnant or plan to become pregnant so you can be advised of the necessary precautions.
Certain medications or medical conditions may affect the way the tablet works. Tell your doctor if you have any other medical problems, and of all medications you are taking or plan to take. These include prescription and over-the-counter medicines (OTC's), vitamins, nutritional supplements, and herbal products.
Side effects are expected with the use of most, if not all, medicines. Some of them may be severe or serious and require urgent medical attention. Others may be mild and may go away on their own.
Severe hepatotoxicity, which can be fatal, is one of the most serious side effects that occurred in patients being treated with Regorafenib. Hemorrhage and gastrointestinal perforation (holes in the intestines) are other serious adverse effects which require emergency medical care.
When using Regorafenib, call your doctor immediately if you experience the following symptoms. They may be signs of a serious medical problem:
Tell your doctor immediately if any of the following other side effects occur:
Because the medication may increase the risk of bleeding and slow the healing of wounds, you should reduce the chance for cuts, bruises or other injuries to yourself. Take extra care to brush and floss gently to avoid bruising the gum.
The following side effects may not require medical attention if they occur. They tend to go away on their own. Talk to your doctor if they become bothersome, worse or do not go away.
Some patients may experience other side effects not listed in this guide. All of the listed side effects may not occur in one single patient. Tell your doctor if you notice other unusual symptoms. You can ask your doctor or healthcare professional what to do to reduce or prevent side effects. You may call the FDA at 1-800-FDA-1088 to report side effects.
Medicine dosage may vary from patient to patient. It may depend on age, weight, the condition being treated, the use of other medicines, and the presence of other medical problems.
When taking your dose, carefully follow all directions given to you on the prescription label and by your doctor or pharmacist. These directions may include the amount of your dose, the strength of it, how often you take it, the time between each dose, and the duration of your treatment.
The medication is supplied as a 40 milligrams (mg) oral tablet. You should take your dose with a glass of water (avoid grapefruit juice), right after a low-fat meal. The recommended dose is the same for adults with the following conditions:
Adults: After a low-fat meal, take 160 milligrams (mg) (four 40 mg tablets) once a day for 21 days of each 28-day cycle. Your doctor may adjust your dose if necessary.
Children: Not indicated in children. Treatment must be determined by a doctor.
If you miss a dose of this medicine, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and take the next dose as scheduled. Continue with your regular dosing schedule.
Call your local poison control center at 1-800-222-1222 if you overdose on this drug. If the patient collapses or is not breathing, call 911.
Using certain medications together with Regorafenib is not recommended, but may be required in some cases for the health of the patient. In such cases, your doctor may take the necessary precautions to ensure all your medicines are safely used.
The following medications were listed because they have the potential to cause significant interaction with Regorafenib. If any of them is prescribed together with your cancer treatment, your doctor may change the dose or how often you use all your medicines.
To avoid adverse interaction, your doctor, pharmacist or healthcare professional may tell you if you should avoid certain foods, alcohol or tobacco.
The following food is not recommended to be used with your medication. If it is necessary to use it, your doctor may give you directions on how or when to do so:
The existence of other medical conditions may affect the use of this chemotherapy drug. To avoid worsening their condition, the drug should be used with caution in patients who have the following medical problems:
The medicine should also be used with caution in patients with the following condition. The side effects of the drug may increase because the medicine takes a longer time to leave the body:
Store the medicine, in a closed container, at room temperature. Keep away from moisture, heat, and direct light.
Keep from freezing and out of the reach of children.
Throw away the medicine once it expires or is no longer needed. Throw it away if it has been unused for seven weeks after first opening the bottle.
You may ask your doctor, healthcare professional or local waste disposal company how to safely dispose of unused or expired medication.
Regorafenib (Stivarga) is a multi-kinase inhibitor medication that treats cancers that have spread to the colon or rectum, and gastrointestinal stromal tumors (GIST) which have spread to the stomach, esophagus, and bowel.
It has been so effective in treating these cancers that, in April 2017, the FDA approved it for the treatment of hepatocellular Carcinoma (HCC), a common type of liver cancer.
However, the use of this medication is more of an alternative treatment. It is recommended for treating these conditions only after other drugs have failed.
Regorafenib is not recommended for use in patients with certain medical conditions due to the risk of serious adverse effects. Severe hepatotoxicity, which can be fatal, is one of the most serious adverse effects that occurred in patients being treated with it.
It should also not be used in patients who are pregnant, may be pregnant or plan to become pregnant. Because of the risk of harm to an unborn baby, both male and female patients and their partners are encouraged to use contraceptives.
Although it is common for patients to feel ill when taking Regorafenib, they are encouraged to complete the course of treatment with the medicine.
A list of side effects may occur during treatment, and some are serious enough to require emergency medical attention. In addition, taking this chemotherapy drug with other medications can increase the risk of adverse interaction.
Doctor's caution is required when deciding use and dosage of all other medicines prescribed while taking Regorafenib. This is to ensure that treatment is carried out in a manner that protects the patient's health.