"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"...
CeeNU Consumer (continued)
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
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. (See also Warning section.)
Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, swelling of lower legs/feet, vision changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: coughing up blood, persistent nausea/vomiting, stomach/abdominal pain, black tarry stools, unusual tiredness, change in the amount of urine, dark or pink urine, yellow eyes/skin.
A severe (sometimes fatal) lung problem (pulmonary fibrosis) has occurred in patients using this drug. This condition can occur months to years after you start taking this medication. Tell your doctor immediately if you experience any of these serious side effects: cough, chest pain, difficult/painful breathing.
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.
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 CeeNU (lomustine capsules) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking lomustine, 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current infection.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorder (e.g., anemia, clotting problem), kidney disease, liver disease, lung disease.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. To prevent the spread of infections, wash your hands well, and avoid touching your eyes or the inside of your nose without first washing your hands.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Limit alcoholic beverages as drinking alcohol may increase your chances of bleeding in your stomach or intestines.
During pregnancy, lomustine should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of childbearing age should use 2 forms of birth control while using this medication. Discuss the use of birth control, the risks and benefits of this medication, and any other concerns about using this medication with your doctor.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional CeeNU Information
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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