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Regorafenib

Brand name: Stivarga
Dosage form:Oral tablet, 40 mg
Drug classes: multikinase inhibitors, VEGF/VEGFR inhibitors

What is Regorafenib?

Regorafenib can be used to treat colon cancer and cancer of the liver. The drug is used for a type of rare tumor that can occur in the stomach, intestines, and esophagus.Regorafenib can be prescribed after other chemotherapy drugs have failed.This medication guide does not list all possible uses of Regorafenib.

Side effects of Regorafenib

You may experience severe allergic reactions, such as hives, difficulty breathing, swelling of the face or throat, or skin irritations (fever, itching, or burning eyes or your skin). If you have a skin condition (such as rashes, blisters, redness, and/or purple skin), it is important to seek immediate medical care.

Regorafenib may cause life-threatening or serious liver problems. Contact your doctor immediately if you experience nausea or vomiting.

Call your doctor immediately if:

  • Confusion and headache;
  • Vision changes
  • A seizure;
  • Pain, blisters, or bleeding in your palms or soles
  • Heart problems: chest pain; feeling as if you could pass out.
    Increased blood pressure—severe head pain, blurred or distorted vision, and a pounding sensation in the neck, ears, or shoulders;
  • Perforation in the stomach or intestines: fever, chills, and severe pain, swelling, or nausea
  • Severe bleeding includes nosebleeds or heavy periods, blood in the urine, bloody or black stools, bloody coughs, or bleeding that won't stop.
  • Signs of infection include fever, a sore throat, and feeling short of breath. Cough without or with mucus.

If you experience certain side effects, your cancer treatment may be delayed.

Side effects common to regorafenib include:

  • Nausea and stomach pain.
  • Loss of appetite weight loss
  • Increased blood pressure
  • Fever, infection;
  • Abnormal liver function tests
  • Pain or redness of the mouth or throat; hoarseness
  • Feeling weak or tired?

There may be other side effects.Call your doctor for medical advice about side effects. Call the FDA to report side effects at 1-800-FDA-1088.

Similar/related drugs

Keytruda, Avastin, Fluorouracil, Capecitabine, Pembrolizumab, Xeloda, and Imatinib

Warnings

Do not become pregnant for 2 months following the cessation of regorafenib.Regorafenib may cause life-threatening or serious liver problems. Contact your doctor immediately if you experience nausea, vomiting, or sleep disturbances, as well as dark urine or jaundice.

Before you take this drug

If you've ever:

  • Liver disease
  • High blood pressure
  • A bleeding disorder or clotting problem;
  • Heart disease, chest pain
  • If you have recently undergone surgery or are planning to undergo surgery,

Regorafenib is harmful to an unborn child if either the father or mother uses this medication.Continue to use birth control at least two months after you have taken your last dose. If you become pregnant while using Regorafenib, either as a mother or father, tell your doctor immediately.You should not breastfeed for 2 weeks following your last dose of this medication.

How to take Regorafenib?

Follow the instructions in the guide or instruction manual that comes with the medication. Your doctor may change your dose. Take the medicine exactly as directed.Regorafenib can be taken every day for three weeks, followed by a week without the medication. The number of times this cycle should be repeated will depend on your doctor.Regorafenib is most effective when taken after eating a meal low in fat and calories. Take the whole tablet with plenty of water.Do not take the medication at different times each day.You will also need to check your liver function. You will need to check your liver function as well.Tell your doctor if you are planning surgery that you use Regorafenib.Regorafenib may cause issues with the healing of wounds, even surgical incisions. Stop taking the medicine two weeks prior to surgery. Follow your doctor's advice about how to take regorafenib.Keep away from heat and moisture. The tablets should be stored in the original packaging with the moisture-absorbing preservation packet or canister. Regorafenib should not be put into daily pill boxes.Regorafenib tablets not consumed within seven weeks of opening the container should be thrown away.

Details on dosage

Adult dose for colorectal cancer:

Oral administration of 160 mg once daily for the 21st day in each cycle (28 days) until progression of disease or unacceptable toxicities
Uses:
Metastatic colorectal carcinoma (CRC), previously treated with oxaliplatin, irinotecan, anti-VEGF treatment, or anti-EGFR therapy if the RAS is wild type
GIST that is locally advanced, metastatic, or unresectable and has been previously treated with Imatinib Mesylate as well as Sunitinib Malate
Hepatocellular carcinoma previously treated with Sorafenib

Adult dose for gastrointestinal stromal tumors:

Oral administration of 160 mg once daily for the 21st day in each cycle (28 days) until progression of disease or unacceptable toxicities
Uses:
-Metastatic cancer of the colorectal (CRC), previously treated with fluoropyrimidine, oxaliplatin, or irinotecan, as well as an anti-VEGF and anti-EGFR treatment if RAS is wild type
-GIST that is locally advanced, metastatic, or unresectable and has been previously treated with sunitinib esylate (Imatinib)
Hepatocellular cancer previously treated with Sorafenib

Adult dose for hepatocellular carcinoma:

Oral administration of 160 mg once daily for the 21st day in each cycle (28 days) until progression of disease or unacceptable toxicities
Uses:
-Colorectal metastatic cancer (CRC), previously treated with oxaliplatin, fluoropyrimidine, or irinotecan, as well as an anti-VEGF and anti-EGFR treatment if the RAS is wild type
-GIST that is locally advanced, metastatic, or unresectable and has been previously treated with sunitinib esylate (Imatinib)
Hepatocellular cancer (HCC), previously treated with Sorafenib

What happens if I miss the dose?

If you are almost due for the next dose, skip the missed one. Never take more than one dose at a time.

What happens if I overdose?

For poison assistance, call 1-800-222-1222 or get immediate medical help.

What should be avoided?

Regorafenib can interact with grapefruit and juice. This could lead to dangerous side effects. Regorafenib should not be taken with grapefruit or any other products containing the fruit.St. John’s wort is an herbal product that should not be taken.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking.Regorafenib can be affected by many drugs. These include prescription drugs, over-the-counter medications, vitamins, and herbal products. This list does not include all interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.