TAKING TIBSOVO® &
POSSIBLE SIDE EFFECTS
IN CCA
Taking TIBSOVO FOR CHOLANGIOCARCINOMA (CCA)
Before you take TIBSOVO
Tell your healthcare provider about all of your medical conditions, including if you:
- Have any heart problems, including a condition called long QT syndrome
- Have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
- Have nervous system problems
- Have problems with your kidneys or are on dialysis
- Have any liver disorders, including cirrhosis
- Are pregnant or plan to become pregnant. TIBSOVO may cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
- Are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work well.
How to take TIBSOVO
TIBSOVO is an oral medication you can take at home. Take TIBSOVO exactly as your healthcare provider tells you to.
Take 2 tablets orally, once a day. Taking TIBSOVO at the same time
as another daily activity, like when you brush your teeth, can help you remember.
Take TIBSOVO with or without food. Do not take TIBSOVO with a
high-fat meal (about 1000 calories and 58 grams of fat).
Swallow TIBSOVO tablets whole. Do not split, crush, or chew
the tablets.
If you miss a dose of TIBSOVO or did not take it at the
usual time, take your dose as soon as possible and at least 12 hours before your next dose. Return to your
normal schedule the following day. Do not take 2 doses of TIBSOVO within 12 hours. Do not change your dose or stop taking TIBSOVO without talking to your healthcare provider.
If you vomit after taking a dose of TIBSOVO, do not take
an
additional dose. Take your next dose at your usual time.
It's important to keep talking with your healthcare provider about your treatment plan and follow his or her instructions about treatment schedule and dose.
Information about the safe use of TIBSOVO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take TIBSOVO for conditions for which it was not prescribed. Do not give TIBSOVO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TIBSOVO this is written for healthcare professionals.
How you should store TIBSOVO
- Store TIBSOVO at room temperature between 68 to 77 °F (20-25 °C)
- Keep TIBSOVO in the original container
- Keep the container tightly closed with the desiccant canister (drying agent) inside to protect the tablets from moisture
- Keep TIBSOVO and all medicines out of reach of children
Possible side effects of TIBSOVO for cca
TIBSOVO may cause serious side effects, including:
- Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats and can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
- Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will
permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of
Guillain-Barré syndrome, including
- Weakness or tingling feeling in your legs, arms, or upper body
- Numbness and pain on one side or both sides of your body
- Any changes in your ability to see, touch, hear, or taste
- Burning or pricking sensation
- Difficulty breathing
The most common side effects of TIBSOVO in adults with cholangiocarcinoma include:
-
Fatigue -
Nausea -
Abdominal pain -
Diarrhea -
Cough -
Hemoglobin
decreased
(anemia) -
Decreased
appetite -
Fluid and
swelling in your
stomach area -
Vomiting -
Changes in liver
function tests -
Rash -
Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if
you develop certain side effects. TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What to do if you experience side effects
Always tell your healthcare provider about any side effects you experience. They may be able
to
prescribe
medicines to help you manage them. However, there are some things you can do on your own that may help as
well.If you experience nausea
- If nausea only happens between meals, eat frequent small meals and have a snack at bedtime
- Drink clear liquids served cold and sipped slowly
- Eat bland foods (dry toast and crackers)
- Eat food cold or at room temperature
- Avoid fatty, fried, spicy, or very sweet foods
- Rest quietly while sitting upright for at least an hour after each meal
- Distract yourself with music, TV, or company
If you experience diarrhea
- Eat small meals often
- Avoid acidic drinks (tomato or citrus juices, fizzy soft drinks); hot, spicy, or greasy foods; bran; raw fruits and vegetables; pastries; candies; rich desserts; jellies; preserves; and nuts
- Avoid caffeine, alcohol, and tobacco
- Avoid milk and milk products if they make diarrhea worse
- Try a clear liquid diet as soon as diarrhea starts or when you feel it’s going to start
- When diarrhea starts to improve, try eating small amounts of foods that are easy to digest (rice, bananas, applesauce, yogurt, mashed potatoes, low-fat cottage cheese, dry toast). If diarrhea continues to improve after a day or two, start to eat small, regular meals
If you experience a rash
- Avoid the sun (especially between 10 am and 4 pm),
wear a broad-brimmed hat, and use sunscreen with an SPF of
15 or higher
- If the sunscreen stings or burns, try one with zinc oxide or titanium dioxide
- Shower with lukewarm (not hot) water and use a mild soap
- Apply a cream-based moisturizer to all skin within 5 minutes of showering or bathing
- Use a hypoallergenic moisturizer that does not have perfumes or preservatives
- Avoid skin products containing alcohol or retinoids, which can dry out your skin
Talk with your healthcare provider about ways that may help you manage any side effects you may experience with TIBSOVO.
