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What is Stivarga and how does it work?
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 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 (HCC) in people who have been previously treated with sorafenib
It is not known if
Stivarga is safe and effective in children less than 18 years of age.
What are the side effects of Stivarga?
Stivarga can 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 also lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get:
- fever
- burning or pain when urinating
- severe cough with or without an increase in mucus
- unusual vaginal discharge or irritation (sputum) production
- redness, swelling or pain in any part of
- severe sore throat the body
- shortness of breath
- severe bleeding. Stivarga can cause bleeding which can be serious and sometimes lead to death. Tell your healthcare provider if you have any signs of bleeding during treatment with Stivarga including:
- vomiting blood or if your vomit looks like coffee-grounds
- unusual vaginal bleeding
- pink or brown urine
- nose bleeds that happen often
- red or black (looks like tar) stools
- bruising
- coughing up blood or blood clots
- 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. Tell your healthcare provider right away if you get:
- severe pain in your stomach-area (abdomen)
- nausea
- swelling of the abdomen
- vomiting
- fever
- dehydration
- 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.
- high blood pressure. Your blood pressure should be checked every week for the first 6 weeks of starting Stivarga. Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with Stivarga. Tell your healthcare provider if you have severe headaches, lightheadedness, or changes in your vision.
- decreased blood flow to the heart and heart attack. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, feel dizzy or feel like passing out.
- a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinking.
- risk of wound healing problems. Wounds may not heal properly during Stivarga treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with Stivarga.
- You should stop taking Stivarga at least 2 weeks before planned surgery.
- Your healthcare provider should tell you when you may start taking Stivarga again after surgery.
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
- infection mouth, throat, stomach and bowel (mucositis)
- weight loss
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Stivarga if you have certain side effects.
These are not all of the possible side effects of Stivarga.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WARNING
HEPATOTOXICITY
- Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
- Monitor hepatic function prior to and during treatment.
- Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
What is the dosage for 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.
- Swallow tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat.
- Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.
What drugs interact with Stivarga?
Effect Of Strong CYP3A4 Inducers On Regorafenib
- Co-administration of a strong CYP3A4 inducer with Stivarga decreased the plasma concentrations of regorafenib, increased the plasma concentrations of the active metabolite M-5, and resulted in no change in the plasma concentrations of the active metabolite M-2, and may lead to decreased efficacy.
- Avoid concomitant use of Stivarga with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).
Effect Of Strong CYP3A4 Inhibitors On Regorafenib
- Co-administration of a strong CYP3A4 inhibitor with Stivarga increased the plasma concentrations of regorafenib and decreased the plasma concentrations of the active metabolites M-2 and M-5, and may lead to increased toxicity. Avoid concomitant use of Stivarga with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole).
Effect Of Regorafenib On Breast Cancer Resistance Protein (BCRP) Substrates
- Co-administration of Stivarga with a BCRP substrate increased the plasma concentrations of the BCRP substrate. Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin).
- Consult the concomitant BCRP substrate product information when considering administration of such products together with Stivarga.
Is Stivarga safe to take when pregnant or breastfeeding?
- Based on animal studies and its mechanism of action, Stivarga can cause fetal harm when administered to a pregnant woman.
- There are no available data on Stivarga use in pregnant women.
- There are no data on the presence of regorafenib or its metabolites in human milk, the effects of regorafenib on the breastfed infant, or on milk production.
- Because of the potential for serious adverse reactions in breastfed infants from Stivarga, do not breastfeed during treatment with Stivarga and for 2 weeks after the final dose.