"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"...
Inform patients of the following:
Advise patients to contact a healthcare provider for new onset fever, or symptoms of infection [see WARNINGS AND PRECAUTIONS]
- Constipation and bowel obstruction
Advise patients to follow a diet rich in fibers, drink fluids to stay well hydrated and use stool softeners to avoid constipation. Contact a health care provider for severe constipation, new onset abdominal pain, nausea and vomiting [see WARNINGS AND PRECAUTIONS]
- Neurologic toxicity
Advise patients to contact a health care provider for new onset or worsening of numbness, tingling, decrease sensation or muscle weakness [see WARNINGS AND PRECAUTIONS]
- Pulmonary Toxicity
Advise patients to contact a healthcare provider for new onset or worsening of shortness of breath, cough, wheezing or other new pulmonary symptoms [see WARNINGS AND PRECAUTIONS]
- Females and Males of Reproductive Potential
- NAVELBINE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use highly effective contraception during treatment with NAVELBINE, and to contact their healthcare provider if they become pregnant, or if pregnancy is suspected [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- NAVELBINE may damage sperm. Advise males to use highly effective contraception during and for 3 months after therapy [see Use in Specific Population and Nonclinical Toxicology].
- NAVELBINE, may cause decreased fertility in males [see Nonclinical Toxicology].
Last reviewed on RxList: 4/7/2014
This monograph has been modified to include the generic and brand name in many instances.
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