INDICATIONS
LONSURF is a prescription medicine used:
- alone or in combination with the medicine bevacizumab to treat adults with colorectal cancer:
- that has spread to other parts of the body, and
- who have been previously treated with certain chemotherapy medicines
- alone to treat adults with a kind of stomach cancer called gastric cancer including adenocarcinoma of the gastroesophageal junction:
- that has spread to other parts of the body, and
- who have been previously treated with at least 2 types of treatment which included certain medicines
It is not known if LONSURF is safe and effective in children.
IMPORTANT SAFETY INFORMATION
LONSURF may cause serious side effects, including:
- Low blood counts. Low blood counts are common with LONSURF and can sometimes be severe and life-threatening. LONSURF can cause a decrease in your white blood cells, red blood cells, and platelets. Low white blood cells can make you more likely to get serious infections that could lead to death. Your healthcare provider should do blood tests before you receive LONSURF, at day 15 during treatment with LONSURF, and as needed to check your blood cell counts. Your healthcare provider may lower your dose of LONSURF or stop LONSURF if you have low white blood cell or platelet counts
Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with LONSURF: fever, chills, or body aches.
Before taking LONSURF, tell your healthcare provider about all of your medical conditions, including if you:
- Have kidney or liver problems
- Are pregnant or plan to become pregnant. LONSURF can harm your unborn baby
- Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with LONSURF. You should use effective birth control during and 6 months after the last dose of treatment with LONSURF. Tell your healthcare provider immediately if you become pregnant
- Males, while on treatment and for 3 months after your last dose of LONSURF, you should use a condom during sex with female partners who are able to become pregnant. Tell your healthcare provider right away if your partner becomes pregnant while you are taking LONSURF
- Are breastfeeding or plan to breastfeed. It is not known if LONSURF passes into your breast milk. Do not breastfeed during treatment with LONSURF and for 1 day after your last dose of LONSURF
Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take.
The most common side effects of LONSURF when used alone include low blood counts, tiredness and weakness, nausea, decreased appetite, diarrhea, vomiting, stomach-area (abdominal) pain, and fever.
The most common side effects of LONSURF when used in combination with bevacizumab include low blood counts, tiredness and weakness, nausea, certain abnormal liver function blood tests, decreased salt (sodium) in your blood, diarrhea, stomach-area (abdominal) pain, and decreased appetite.
Tell your healthcare provider if you have nausea, vomiting, or diarrhea that is severe or that does not go away.
These are not all of the possible side effects of LONSURF. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see accompanying full Prescribing Information.
