LONSURF Side Effects

Potential Side Effects

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 may lower your dose of LONSURF or stop LONSURF if you have low white blood cell or platelet counts.

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.

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.

What are the most common side effects?

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
  • Decreased appetite

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
  • Fever

Tell your healthcare provider if you have nausea, vomiting, or diarrhea that gets worse or does not go away. These are not all of the possible side effects of LONSURF.

A thermometer is available within the Treatment Kit to remind you to check your temperature. It also includes a treatment calendar that has a place for you to record your temperature and side effects. Discuss any changes in temperature and side effects with your healthcare provider at your next appointment. A digital version of the calendar is also available here.

You can also call the Taiho Oncology 24/7 hotline with questions about, or to report, side effects with LONSURF at 1‑844‑US‑TAIHO (1‑844‑878‑2446). You may report side effects to the FDA at 1‑800‑FDA‑1088 (1‑800‑332‑1088).

How to manage LONSURF side effects

Your healthcare provider may have ways to help manage some of the side effects of treatment. This could include adjusting your treatment plan by changing your dosage of LONSURF or stopping treatment. After discussing any side effects, your healthcare provider may prescribe medications or recommend certain lifestyle changes or non-prescription medications that can help.

The following information may also be helpful to you in managing some of these side effects that may occur with LONSURF alone or in combination with bevacizumab while under the care of your healthcare provider.

This information is not meant to replace your healthcare provider's advice. Always discuss any side effects with your healthcare provider.

  • Exercise regularly*
  • Try to eat plenty of foods that are high in fiber such as fruits and vegetables
  • Avoid foods that produce gas
  • Try deep breathing, yoga, or other ways to relax. This can help with muscle tension, anxiety, and pain
  • Try to eat soup if you do not feel like eating solid foods, or drink milkshakes, smoothies, and juice
  • Choose foods that are high in calories and/or protein
  • Being active may help you feel hungrier. Try going for a 15-minute walk, stretching, swimming, or riding a bike*
  • Try to eat or drink foods high in sodium and potassium, like bananas, oranges, peach and apricot nectar, and boiled or mashed potatoes
  • Try to eat or drink low-fiber foods including tender meats, tofu, eggs, fish, white bread, white rice, and fruit and vegetable juices
  • Drink 8 to 12 cups of clear, room temperature liquids slowly each day
  • Try to avoid foods that are greasy, fried, sweet, or spicy if they've made you feel sick after eating them
  • Try to eat 5 or 6 small meals a day, instead of 3 big ones (this does not change your dosing schedule)
  • Have food and drinks that are warm or cool instead of hot or cold
  • Try sucking on ice cubes or taking small bites of ice pops or fruit ices (stop if the cold temperature bothers you)
  • Do the things that are most important first each day. Don't overdo it
  • Try to be active each day. Go for a 15-minute walk, practice yoga, or ride an exercise bike*
  • Ask family members and friends for help with chores, driving to your appointments, shopping, and cooking
  • Take time to rest and take short naps throughout the day
  • Try adding bathing, reading, listening to music, or meditation to your bedtime routine to help you feel more relaxed

Abdominal Pain

  • Exercise regularly*
  • Try to eat plenty of foods that are high in fiber such as fruits and vegetables
  • Avoid foods that produce gas
  • Try deep breathing, yoga, or other ways to relax. This can help with muscle tension, anxiety, and pain

Decreased Appetite

  • Try to eat soup if you do not feel like eating solid foods, or drink milkshakes, smoothies, and juice
  • Choose foods that are high in calories and/or protein
  • Being active may help you feel hungrier. Try going for a 15-minute walk, stretching, swimming, or riding a bike*

Diarrhea

  • Try to eat or drink foods high in sodium and potassium, like bananas, oranges, peach and apricot nectar, and boiled or mashed potatoes
  • Try to eat or drink low-fiber foods including tender meats, tofu, eggs, fish, white bread, white rice, and fruit and vegetable juices
  • Drink 8 to 12 cups of clear, room temperature liquids slowly each day

Nausea and Vomiting

  • Try to avoid foods that are greasy, fried, sweet, or spicy if they've made you feel sick after eating them
  • Try to eat 5 or 6 small meals a day, instead of 3 big ones (this does not change your dosing schedule)
  • Have food and drinks that are warm or cool instead of hot or cold
  • Try sucking on ice cubes or taking small bites of ice pops or fruit ices (stop if the cold temperature bothers you)

Tiredness (fatigue/weakness)

  • Do the things that are most important first each day. Don't overdo it
  • Try to be active each day. Go for a 15-minute walk, practice yoga, or ride an exercise bike*
  • Ask family members and friends for help with chores, driving to your appointments, shopping, and cooking
  • Take time to rest and take short naps throughout the day
  • Try adding bathing, reading, listening to music, or meditation to your bedtime routine to help you feel more relaxed

*You should check with your doctor before beginning any exercise program.

INDICATIONS

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.

Indications and Important Safety Information

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.