A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Stivarga 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. Stivarga is usually given after other cancer medications have been tried without success.
Take Stivarga exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. 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. Take the medicine at the same time each day. Your blood pressure will need to be checked often. Your liver function will also need to be checked. If you need surgery, tell your surgeon you currently use this medicine. Stivarga can cause problems with wounds healing, including surgical incisions. You should stop taking this medicine at least 2 weeks before you have surgery. Carefully follow your doctor's instructions about when to stop and start taking Stivarga. Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Do not put Stivarga tablets into a daily pill box. Throw away any Stivarga tablets not used within 7 weeks after opening the bottle.
The active ingredient in Stivarga is regorafenib.
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). You should not use Stivarga if past use has caused severe bleeding or severe liver problems. Use birth control to prevent pregnancy, whether you are a man or a woman. Avoid pregnancy for at least 2 months after you stop using this medicine.
Get emergency medical help if you have signs of an allergic reaction to Stivarga (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). 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). Also call your doctor at once if you have: • headache, confusion, change in mental status; • vision changes; • a seizure; • pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet; • heart problems - chest pain, shortness of breath, feeling like you might pass out; • increased blood pressure - severe headache, blurred vision, pounding in your neck or ears; • perforation (a hole or tear) in your stomach or intestines - fever, chills, severe stomach pain or swelling, nausea, vomiting, increased thirst, decreased urination; • severe bleeding - bruising, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, or any bleeding that will not stop; or • signs of infection - fever, sore throat, feeling short of breath, cough with or without mucus, vaginal itching or discharge, pain or burning when you urinate, or redness and swelling anywhere in your body. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Common Stivarga side effects may include: • diarrhea, nausea, stomach pain; • 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. You may report side effects to FDA at 1-800-FDA-1088.