Precautions
Drug type: Stivarga ® is a targeted therapy. It is an oral receptor tyrosine kinase inhibitor - (For more detail, see "How this drug works," below.) What Stivarga Is Used For: For the treatment of colorectal cancer. For the treatment of hepatocellular …
What is Stivarga used to treat?
STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. STIVARGA is indicated for the treatment of patients with locally advanced, unresectable or metastatic …
What should I do if I want to stop taking Stivarga?
· Stivarga is a prescription medicine used to treat the symptoms of Colorectal Cancer, Gastrointestinal Stromal Tumors, and Hepatocellular Carcinoma. Stivarga may be used alone or with other medications. Stivarga belongs to a class of drugs called Antineoplastics, Tyrosine Kinase Inhibitor; Antineoplastics, Angiogenesis Inhibitor.
What is the duration of therapy for Stivarga in the US?
How effective is Stivarga in the treatment of ovarian cancer?
Is Stivarga a chemotherapy?
Stivarga® is the trade name for the generic chemotherapy drug regorafenib. In some cases, health care professionals may use the generic name regorafenib when referring to the trade name Stivarga®. Drug type: Stivarga® is a targeted therapy.
Is Stivarga an immunotherapy?
Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells. Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.
What class of drug is regorafenib?
Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply.
Is Stivarga a last resort?
The drug regorafenib (Stivarga®) was approved last year as third line treatment for patients with advanced Gastrointestinal Stromal Tumour (GIST). GIST is a rare type of cancer (a sarcoma) found in the digestive system, most often in the wall of the stomach.
How long does STIVARGA extend life?
Improvement in Overall Survival Patients taking STIVARGA (379) lived a median of 10.6 months compared to those taking placebo (194) who lived a median of 7.8 months.
How successful is STIVARGA?
Successful Treatment With STIVARGA Requires Flexible Approach. In clinical practice about 30%–40% of patients treated with STIVARGA have progression-free survival longer than 4 months.
Is regorafenib an immunotherapy?
Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Is regorafenib a chemotherapy?
Regorafenib is the generic name for the trade name chemotherapy drug Stivarga®. In some cases, health care professionals may use the trade name Stivarga® when referring to the generic drug name regorafenib.
Does STIVARGA shrink tumors?
Regorafenib may shrink the cancer or stop it growing for a time. You usually take regorafenib for as long as it is helping you and the side effects aren't too bad.
Does STIVARGA cause hair loss?
Stivarga comes in 40 mg tablets....Laboratory Test Abnormalities.Side effects reported in phase III trial of regorafenib vs. placeboRegorafenib (n=131)Any grade (all severities)Placebo (n=66)Any gradeAlopecia (hair loss)24%2%Rash, maculopapular18%3%Nausea16%9%10 more rows•Dec 14, 2012
Does STIVARGA cause pain?
People in the clinical trials experienced side effects when taking STIVARGA. Side effects with STIVARGA may occur early on in treatment....Most common side effects.stomach-area (abdomen) painvoice change or hoarsenesstiredness, weakness, fatigueincrease in certain liver function testsinfectionweight loss2 more rows
How long can you take regorafenib?
How long will I be taking STIVARGA? The recommended dose of STIVARGA is 160 mg (four 40-mg tablets) every day for 3 weeks, followed by a 1-week break. This is 1 cycle of treatment. Your doctor may stop your treatment or change the dose.
What is stivarga used for?
Stivarga is used to treat colorectal cancer and liver cancer.
How long does it take to take stivarga?
Your doctor may occasionally change your dose. Stivarga is usually taken daily for 3 weeks followed by 1 week off the medicine.
What is the best medicine for cancer?
Stivarga ( regorafenib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Stivarga is used to treat colorectal cancer and liver cancer. It is also used to treat a rare type of tumor that can affect the esophagus, stomach, or intestines.
Can stivarga cause liver problems?
Call your doctor at once if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes). You should not use Stivarga if past use has caused severe bleeding or severe liver problems.
Can stivarga cause jaundice?
Stivarga can cause serious or life-threatening liver problems. Call your doctor at once if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).
How long does stivarga last?
Stivarga is usually taken daily for 3 weeks followed by 1 week off the medicine. Your doctor will determine how many times you should repeat this treatment cycle. Stivarga works best if you take it after a low-fat, low-calorie meal. Swallow the tablet whole with a full glass of water.
What are the side effects of a syringe?
loss of appetite, weight loss; increased blood pressure; fever, infection; abnormal liver function tests; pain or redness in your mouth or throat, hoarse voice; or. feeling weak or tired. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
How Stivarga Is Given
Stivarga ® is a pill, taken by mouth, once daily. Take with a low-fat (less than 30% fat) breakfast. Examples of a low-fat breakfast include:
Precautions
Before starting Stivarga ® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take anything new without discussing with your provider first. This is very important as other medications, etc. may interact with Stivarga ®.
Self-Care Tips
Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
Monitoring and Testing
You will be checked regularly by your health care professional while you are taking Stivarga ®. Testing may include: electrolytes, complete blood counts, liver function test, and blood pressure to monitor side effects and check your response to therapy. If you are on warfarin (Coumadin) your blood INR may be monitored more frequently.
How Stivarga Works
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly.
Does stivarga cause infections?
STIVARGA may cause serious side effects, including: Infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may lead to a higher risk of fungal infections of the mucous membrane, skin or the body.
Can you die from taking stivarga?
STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems.
What is the best medicine for colon cancer?
STIVARGA (regorafenib) is a prescription medicine used to treat people with: 1 colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines 2 a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines 3 a type of liver cancer called hepatocellular carcinoma (HCC) in people who have been previously treated with sorafenib
What is a rare stomach cancer?
A rare stomach, bowel, or esophagus cancer that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines.
What is the name of the cancer that has spread to other parts of the body?
STIVARGA (regorafenib) is a prescription medicine used to treat people with: colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines. a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated ...
What is stivarga used for?
Stivarga is a prescription medicine used to treat people with: colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines. a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumors) that cannot be treated with surgery or ...
How long does it take to take stivarga?
The recommended dose is 160 mg Stivarga (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity. Take Stivarga at the same time each day.
What is the rarest cancer in the stomach?
a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumors) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines. a type of liver cancer called hepatocellular carcinoma ...
What does it mean when you have a tear in your stomach?
lightheadedness. menstrual bleeding that is heavier than normal. a tear in your stomach or intestinal wall (bowel perforation). Stivarga may cause a tear in your stomach or intestinal wall (bowel perforation) that can be serious and sometimes lead to death.
What is it called when you have a rash on your feet?
chills. a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet, or a severe rash.
Indications
STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
Important Safety Information
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
References
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed January 29, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.
What are the side effects of stivarga?
The most common side effects of STIVARGA include: pain, including stomach-area (abdomen) voice changes or hoarseness. tiredness, weakness, fatigue. increase in certain liver function test. frequent or loose bowel movements (diarrhea) fever. decreased appetite. swelling, pain and redness of the lining in your.
What is regorafenib used for?
Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl and CSF1R at concentrations of regorafenib that have been achieved clinically. In in vivo models, regorafenib demonstrated antiangiogenic activity in a rat tumor model and inhibition of tumor growth in several mouse xenograft models including some for human colorectal carcinoma, gastrointestinal stromal and hepatocellular carcinoma. Regorafenib also demonstrated anti-metastatic activity in a mouse xenograft model and two mouse orthotopic models of human colorectal carcinoma.
What is the HFSR in regorafenib?
In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients in the regorafenib arm and in 25.5% of patients in the placebo arm, including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES), and severe rash requiring dose modification.
Is regorafenib carcinogenic?
Studies examining the carcinogenic potential of regorafenib have not been conducted. Regorafenib itself did not demonstrate genotoxicity in in vitro or in vivo assays; however, a major human active metabolite of regorafenib, (M-2), was positive for clastogenicity, causing chromosome aberration in Chinese hamster V79 cells.
Can you adjust regorafenib dose?
No dose adjustment is recommended for patients with renal impairment. The pharmacokinetics of regorafenib have not been studied in patients who are on dialysis and there is no recommended dose for this patient population [see CLINICAL PHARMACOLOGY ].
How long does regorafenib stay in your system?
Following a single 160 mg oral dose of STIVARGA, the geometric mean (minimum to maximum) elimination half-lives for regorafenib and the M-2 metabolite in plasma are 28 hours (14 to 58 hours) and 25 hours (14 to 32 hours), respectively.
What does it mean when you have a tear in your stomach?
menstrual bleeding that is heavier than normal. a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or intestinal wall (bowel perforation) that can be serious and sometimes lead to death.
How does regorafenib work?
Regorafenib is a type of targeted cancer drug called a cancer growth blocker. It works in two ways. It stops: signals that tell cancer cells to grow. cancer cells forming new blood vessels, which they need to be able to grow. Find out more about cancer growth blockers.
How to control sickness?
Feeling or being sick is usually well controlled with anti sickness medicines. Avoiding fatty or fried foods, eating small meals and snacks, drinking plenty of water, and relaxation techniques can all help.
Can cancer drugs interact with other drugs?
Cancer drugs can interact with some other medicines and herbal products. Tell your doctor or pharmacist about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies.
What do they check before and during a chemo treatment?
You have blood tests before and during your treatment. They check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.
What are the symptoms of an infection?
Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is.
How do you know if you have an infection?
Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is. Infections can sometimes be life threatening. You should contact your advice line urgently if you think you have an infection.
What happens if you stop taking a med?
a drop in thyroid hormone levels which can make you feel tired, unable to cope with the cold and you might get muscle cramps. shaking or tremors. loss of hair – this usually starts to grow back after you have stopped taking the drug.
