FREQUENTLY ASKED QUESTIONS
(FAQs) ABOUT TIBSOVO®
Frequently asked questions
TIBSOVO for bile duct cancer/cholangiocarcinoma (CCA)
What is TIBSOVO (ivosidenib)?
TIBSOVO is an oral prescription medicine used to treat advanced bile duct cancer/cholangiocarcinoma (CCA) in adult patients who have already received previous treatment(s) and whose cholangiocarcinoma has a certain type of abnormal isocitrate dehydrogenase-1 (IDH1) mutation. TIBSOVO is a targeted therapy that kills tumor cells with mutated IDH1.
Learn more about TIBSOVO and IDH1.
Download a free guide to IDH1-targeted treatment with TIBSOVO.
How does TIBSOVO work to treat bile duct cancer/cholangiocarcinoma (CCA)?
TIBSOVO specifically targets the mutated IDH1 protein, killing tumor cells with mutated IDH1. This can slow down the progression of advanced cholangiocarcinoma.
Learn more about TIBSOVO and IDH1.
Download a free guide to IDH1-targeted treatment with TIBSOVO.
How is TIBSOVO different from chemotherapy?
Traditional chemotherapy is cytotoxic, which means it kills both abnormal and healthy cells. Unlike chemotherapy, TIBSOVO only targets tumor cells with mutated IDH1.
Who can take TIBSOVO to treat bile duct cancer/cholangiocarcinoma (CCA)?
Adult patients with cholangiocarcinoma that has spread, who have already received previous treatment(s), and whose cholangiocarcinoma has a certain type of abnormal IDH1 mutation may be prescribed TIBSOVO.
Why did my doctor prescribe me TIBSOVO to treat bile duct cancer/cholangiocarcinoma (CCA)?
Your doctor may have prescribed you TIBSOVO because you have advanced cholangiocarcinoma with a certain type of abnormal IDH1 protein and you have already received at least one previous treatment.
How has treating bile duct cancer/cholangiocarcinoma (CCA) with TIBSOVO been studied?
TIBSOVO was studied in a large clinical trial of adult patients with CCA. This clinical trial was designed to determine if taking TIBSOVO once daily could reduce the risk of disease progression or death in patients with advanced cholangiocarcinoma with an IDH1 mutation whose disease had progressed after previous treatments.
The purpose of the trial was to determine how long patients lived without their cholangiocarcinoma getting worse.
Learn more about the TIBSOVO cholangiocarcinoma clinical trial.
How effective is TIBSOVO at treating bile duct cancer/cholangiocarcinoma (CCA)?
TIBSOVO has been shown to increase the length of time a person can live with cholangiocarcinoma without it getting worse.
Patients treated with TIBSOVO achieved longer progression-free survival (the length of time during and after cancer treatment that a patient lives with the disease, but it does not get worse) and better disease control (the percentage of patients whose disease shrinks or remains stable over the study period in a clinical trial) compared with patients who received placebo.
Patients taking TIBSOVO had a lower risk of disease progression over 6 to 12 months.
More than half (51%) of the patients who took TIBSOVO achieved stable disease (when a tumor neither increases nor decreases in size) vs 28% of patients who received placebo.
TIBSOVO safety and side effects
What serious side effects are possible with TIBSOVO in cholangiocarcinoma (CCA) patients?
TIBSOVO can cause 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 prickling sensation
- Difficulty breathing
Learn more about possible side effects with TIBSOVO for cholangiocarcinoma.
What are the most common possible side effects of TIBSOVO in cholangiocarcinoma (CCA) patients?
The most common side effects of TIBSOVO in adults with cholangiocarcinoma include:
- Fatigue
- Nausea
- Abdominal pain
- Diarrhea
- Cough
- Vomiting
- Hemoglobin decreased (anemia)
- Rash
- Changes in liver function tests
- Decreased appetite
- Fluid and swelling in your stomach area
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.
Learn more about possible side effects with TIBSOVO for cholangiocarcinoma.
What should I do if I have side effects while taking TIBSOVO?
Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint. These may be symptoms of QTc prolongation, which can cause irregular heartbeats and can be life-threatening.
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 prickling sensation
- Difficulty breathing
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.
Talk with your healthcare provider about ways that may help you manage any side effects you may experience with TIBSOVO. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Learn more about possible side effects with TIBSOVO for cholangiocarcinoma.
What should I tell my healthcare provider before I start taking 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.
Learn more about possible side effects with TIBSOVO for cholangiocarcinoma.
Taking and storing TIBSOVO
How do I 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. Swallow TIBSOVO tablets whole. Do not split, crush, or chew the tablets.
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 that is written for healthcare professionals.
Download a free dosing calendar to help remind you to take your medication.
Should I take TIBSOVO with food?
Take TIBSOVO with or without food. Do not take TIBSOVO with a high-fat meal (about 1000 calories and 58 grams of fat).
What should I do if I miss a dose of TIBSOVO?
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.
Download a free dosing calendar to help remind you to take your medication.
How should I store TIBSOVO?
Store TIBSOVO at room temperature between 68 °F to 77 °F (20 °C to 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.
About bile duct cancer/cholangiocarcinoma (CCA) and IDH1
What is bile duct cancer/cholangiocarcinoma (CCA)?
Cholangiocarcinoma, also called bile duct cancer, is a rare and aggressive cancer that forms in the bile ducts inside and around the liver. It accounts for about 3% of cancers in the gastrointestinal system.
Approximately 8000 people in the United States are diagnosed with cholangiocarcinoma each year, but because it is a difficult cancer to diagnose, the actual number of cases may be higher.
Signs and symptoms of cholangiocarcinoma are not specific, and many cases are not diagnosed until the disease has progressed when surgery may no longer be an option. The recommended treatment will depend on whether or not the tumor has advanced or metastasized. Once cholangiocarcinoma has advanced, TIBSOVO can be an approved treatment option.
What is advanced/metastatic bile duct cancer/cholangiocarcinoma (CCA)?
If there are several tumors in the bile ducts or if the cancer has spread to other parts of the body, it is called advanced or metastatic disease. If it has spread to other places in the body, such as a lung, it is still considered to be cholangiocarcinoma because of where the cancer started. TIBSOVO is a treatment option for this advanced cancer.
What is intrahepatic cholangiocarcinoma (CCA)? What is extrahepatic cholangiocarcinoma (CCA)?
Intrahepatic cholangiocarcinoma means the tumor originates in the bile ducts inside the liver.
Extrahepatic cholangiocarcinoma means the tumor originates in the bile ducts outside of the liver. There are two types of extrahepatic cholangiocarcinoma: perihilar and distal. In perihilar cholangiocarcinoma, the tumor originates in the hilum, just outside of the liver. In distal cholangiocarcinoma, the tumor originates farther down the bile duct system, farther away from the liver. Regardless of where the cholangiocarcinoma starts, TIBSOVO is a treatment option for advanced CCA.
What are the signs and symptoms of bile duct cancer/cholangiocarcinoma (CCA)?
Signs and symptoms of cholangiocarcinoma are not specific, and most patients do not have any symptoms in the early stages of the disease. For these reasons, many cases are not diagnosed until the disease has progressed when surgery may no longer be an option. The most common signs and symptoms of cholangiocarcinoma are jaundice, itchiness, unexplained weight loss, abdominal pain, dark urine, pale stools, and fever. Once cholangiocarcinoma has advanced, TIBSOVO is a treatment option that may help.
Learn more about cholangiocarcinoma progression and the role of TIBSOVO.
What are the stages of bile duct cancer/cholangiocarcinoma (CCA)?
There are many ways to classify and stage cholangiocarcinoma—based on where the tumor started growing, how far it has grown outside the bile duct system, what other places in the body it has spread to, and whether or not the tumor can be surgically removed (resected). Once the cholangiocarcinoma has progressed, TIBSOVO is a treatment option that may help.
What do the stages of bile duct cancer/cholangiocarcinoma (CCA) mean?
The stages of cholangiocarcinoma help doctors determine whether the tumor can be surgically removed (resected), what types of treatments are best for each patient, and the patient’s prognosis. At a certain point of disease progression, TIBSOVO becomes a treatment option in cholangiocarcinoma.
What is the prognosis for bile duct cancer/cholangiocarcinoma (CCA)?
The prognosis for every patient with cholangiocarcinoma is different. It depends on what type of cholangiocarcinoma they have, whether the tumor can be surgically removed (resected), whether the tumor has spread to other parts of the body, and many other factors that are unique for each individual patient. Once the cholangiocarcinoma has advanced, TIBSOVO is a treatment option that might help.
What causes bile duct cancer/cholangiocarcinoma (CCA)?
Although there are several risk factors associated with cholangiocarcinoma, most cases in the US and Europe cannot be linked to a specific cause. If a patient gets cholangiocarcinoma, TIBSOVO can help when the disease advances.
What are the risk factors for bile duct cancer/cholangiocarcinoma (CCA)?
The most common risk factors for cholangiocarcinoma include:
- Certain liver diseases, including primary sclerosing cholangitis (PSC), where inflammation in the bile ducts leads to the formation of scar tissue
- Liver cirrhosis, or damage to the liver caused by scar tissue. This can be caused by overuse of alcohol or diseases like hepatitis
- Bile duct stones, which can cause inflammation
- Infections from certain viruses and parasites, including liver flukes, hepatitis B and C viruses
- Inflammatory disorders, including inflammatory bowel disease and chronic pancreatitis
- Exposure to toxins, such as alcohol and tobacco
- Metabolic conditions such as diabetes, obesity, and nonalcoholic fatty liver disease
TIBSOVO helps treat cholangiocarcinoma after it progresses.
Types of treatment for cholangiocarcinoma (CCA)
What are the types of treatment for bile duct cancer/cholangiocarcinoma (CCA)?
Surgery can cure cholangiocarcinoma in some cases, but because many patients may not be diagnosed until the disease is advanced or has spread to other parts of the body, surgery is not always an option. For these patients, the main treatments for cholangiocarcinoma are chemotherapy or targeted therapy, like TIBSOVO.
What is chemotherapy?
Chemotherapy is a drug treatment that uses chemicals to kill cells that divide quickly, including cancer cells and cells in healthy tissue. Chemotherapy is also typically given by infusion, which usually takes place in an infusion center, but this depends on the specific treatment. Unlike chemotherapy, TIBSOVO is a targeted treatment that helps treat the cancer, cholangiocarcinoma, once it has advanced.
What is a targeted therapy?
Targeted therapy is a type of treatment that can block the action of certain molecules involved in the growth and spread of cancer cells with less harm to normal cells. TIBSOVO is a targeted therapy that only targets tumor cells with mutated IDH1 to treat advanced cholangiocarcinoma.
About IDH1 mutations
What is IDH1?
IDH1 stands for isocitrate dehydrogenase-1. In healthy cells, the IDH1 gene makes the IDH1 protein, which plays a role in normal chemical reactions within cells. When the IDH1 gene is altered due to a genetic mutation, cells make an abnormal (mutated) version of the IDH1 protein. This mutated IDH1 protein may promote the development of certain types of cancers, including cholangiocarcinoma. TIBSOVO is a targeted therapy that kills tumor cells with mutated IDH1 in advanced cholangiocarcinoma.
What is a mutation? What does it mean when IDH1 is mutated?
Mutations are changes in the DNA sequences of cells. Mutations may be caused by mistakes during cell division, or they may be caused by exposure to DNA-damaging agents in the environment. Certain mutations may lead to cancer or other diseases. When the IDH1 gene is altered due to a genetic mutation, cells make an abnormal (mutated) version of the IDH1 protein. This mutated IDH1 protein may promote the development of certain types of cancers, including cholangiocarcinoma. TIBSOVO is a targeted treatment that kills tumor cells with mutated IDH1 in advanced cholangiocarcinoma.
What does mutated IDH1 mean in bile duct cancer/cholangiocarcinoma (CCA)?
Nearly 20% of patients with intrahepatic cholangiocarcinoma may have a mutated version of IDH1. Mutated IDH1 has not been found to affect the prognosis of intrahepatic cholangiocarcinoma, but having mutated IDH1 can make patients eligible for targeted therapies like TIBSOVO.
How is mutated IDH1 identified in bile duct cancer/cholangiocarcinoma (CCA)? What is biomarker testing?
Biomarker testing involves a piece of tumor (from biopsy or surgery) being sent to the laboratory for analysis to check for certain genes, proteins, or other molecules that may be a sign of a disease or condition, such as cancer.
Your doctor may recommend biomarker testing to look for specific changes in the DNA of the cancer cells, including mutated IDH1. It may take a few weeks to get results, but the results will enable your doctor to personalize the best approach to treating your type of cancer. TIBSOVO is a treatment that your doctor may prescribe after giving you an FDA-approved test for IDH1 and it targets the IDH1 mutation in cholangiocarcinoma.
Additional support
Where can I go for additional support? What is ServierONE?
ServierONE Patient Support Services will work with you, your caregiver, and your healthcare provider(s) to help you get treatment after you’ve been prescribed TIBSOVO.
Financial assistance may be available, no matter your insurance type or status.a
Your healthcare provider or ServierONE Patient Support Services can help figure out which financial assistance program is right for you when you’re prescribed TIBSOVO.
Independent foundations may also provide support to patients. Your ServierONE care manager team can provide more information about TIBSOVO.
For more information, please visit ServierONE.com or call 1-800-813-5905.
aIf you are waiting for coverage, you may be eligible for a free product program. Contact ServierONE for more information.
Are there other organizations that can help me understand cholangiocarcinoma?
There are several organizations that can provide additional advocacy, support, and assistance for cholangiocarcinoma patients.
