"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...
Neumega Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, flushing, headache, severe weakness, sudden/unexplained weight gain, swelling of the hands/ankles/feet, shortness of breath, muscle/bone pain, fast/pounding/irregular heartbeat, white patches in the mouth, unusual tiredness, change in the amount of urine, vision changes (e.g., blurred vision, loss of vision).
Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, confusion, weakness on one side of the body, slurred speech, chest pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing/swallowing/talking.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Neumega (oprelvekin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using oprelvekin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart/blood vessel disease (e.g., congestive heart failure, irregular heartbeat, stroke), unusual fluid retention (e.g., swelling of the ankles/feet, ascites, pleural effusion), eye problems (e.g., papilledema), brain/spinal cord tumors, high blood pressure (hypertension).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Children may be at greater risk for eye/heart problems and bone changes while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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