Tibsovo
Tibsovo (ivosidenib) is a targeted therapy for cancer called an IDH1 inhibitor. It's used to treat adults with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or bile duct cancer (cholangiocarcinoma). This medication is FDA approved only for people who have the IDH1 mutation in their cancer. Tibsovo (ivosidenib) is a tablet that you take by mouth once a day. But it can cause side effects like nausea, diarrhea, and tiredness. It can also cause a serious reaction called differentiation syndrome in people with AML or MDS.
What is Tibsovo (ivosidenib)?
What is Tibsovo (ivosidenib) used for?
Acute myeloid leukemia (AML) with an IDH1 mutation
For newly-diagnosed adults who are 75 years or older or who can’t tolerate intensive treatment
For adults whose cancer has come back after previous treatment (relapsed or refractory AML)
Relapsed or refractory myelodysplastic syndrome (MDS) with an IDH1 mutation in adults
Advanced or metastatic cholangiocarcinoma with an IDH1 mutation in adults who’ve been previously treated
How Tibsovo (ivosidenib) works
Tibsovo (ivosidenib) is an IDH1 inhibitor. It blocks the mutated version of the IDH1 protein from working.
For IDH1-mutated AML and MDS: Stopping mutated IDH1 from working helps prevent the body from making too many abnormal and immature white blood cells. This helps treat AML and MDS.
For IDH1-mutated bile duct cancer (cholangiocarcinoma): Blocking mutated IDH1 stops the cancer cells from growing and spreading. This helps treat bile duct cancer.
Drug Facts
What are the side effects of Tibsovo (ivosidenib)?
Common Side Effects
- Lower hemoglobin levels (60%)
- Changes in electrolyte levels (up to 39%)
- Tiredness (39%)
- High white blood cell count (38%)
- Joint pain (36%)
- Diarrhea (34%)
- Trouble breathing (33%)
- Swelling (32%)
- Nausea (31%)
- Mouth sores (28%)
- Elevated liver enzyme levels (up to 27%)
- Changes in electrocardiogram (EKG) results (26%)
- Rash (26%)
- Fever (23%)
- Higher creatinine levels (23%)
- Cough (22%)
- Constipation (20%)
Other Side Effects
- Lower appetite
- Vomiting
- Chest pain
- Stomach pain
- Muscle pain
- Headache
- Numbness and tingling
- Low blood pressure
- Differentiation syndrome
Serious Side Effects
- Differentiation syndrome (for people with AML or MDS only): fever, sudden weight gain, trouble breathing, chest pain, swelling in legs
- Abnormal heart rhythm: irregular heartbeat, blurry vision, lightheadedness, fainting, loss of consciousness
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, cough, dizziness, feeling faint or lightheaded, shortness of breath, bone pain, sudden weight gain, swelling of the ankles, hands, or feet, which may be signs of differentiation syndrome
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- High white blood cell level—fever, fatigue, trouble breathing, night sweats, change in vision, weight loss
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Tibsovo (ivosidenib)
Pros
First-choice treatment for people with AML and an IDH1 mutation
Taken by mouth once a day
Works in a more targeted, specific way than traditional chemotherapy
Cons
Not a treatment option for people without an IDH1 mutation
Can cause a serious side effect called differentiation syndrome in people with AML or MDS
Interacts with several other medications, like hormonal birth control and certain antifungals
Pharmacist tips for Tibsovo (ivosidenib)
You can take Tibsovo (ivosidenib) with or without food. If you decide to take the medication with food, make sure it’s not with a high-fat meal. Taking Tibsovo (ivosidenib) with a high-fat meal can cause higher medication levels in your body and lead to worse side effects.
Swallow Tibsovo (ivosidenib) tablets whole with a glass of water. Don’t split, crush, or chew the tablets.
Take Tibsovo (ivosidenib) at about the same time every day. Choose a time that’s convenient and easy for you to remember. You can also use a reminder app on your phone to help you remember when to take your medication.
You might have some diarrhea while you’re taking Tibsovo (ivosidenib). Be sure to drink a lot of fluids to prevent dehydration. But avoid sugary sports drinks because they can make diarrhea worse. Speak with your oncology team for more recommendations for managing diarrhea, such as taking an over-the-counter medication like loperamide (Imodium A-D).
Your oncologist will recommend antiemetic medications that you can safely take to prevent and treat nausea since this is a common side effect of Tibsovo (ivosidenib). Avoid nausea medications like ondansetron (Zofran), though, because they can raise your risk for heart rhythm problems when they’re taken with Tibsovo (ivosidenib).
If you’re taking Tibsovo (ivosidenib) for AML or MDS, get medical help right away if you have fever, trouble breathing, cough, weight gain, chest pain, or very low blood pressure. These can be symptoms of differentiation syndrome, which is a serious immune reaction to the medication. You’ll need to get treated as soon as possible.
If you vomit after you take Tibsovo (ivosidenib), don’t take another dose to replace it. Just wait until the next day to take the medication at the usual dose and usual time.
If you forget to take Tibsovo (ivosidenib) at your usual time, take the medication as soon as you remember (as long as there’s at least 12 hours until your next dose). You can go back to your usual routine the next day. Don’t double up on your dose to make up for any missed doses.
If you’re able to become pregnant, be sure to talk to your oncologist about the risk of harm to an unborn baby while you're taking Tibsovo (ivosidenib). You might want to use nonhormonal birth control (such as condoms) during treatment if you're sexually active to prevent an unplanned pregnancy. This medication might make hormonal birth control work less well.
Tell your oncology team before you start any new medications while you’re taking Tibsovo (ivosidenib). They can check for drug interactions to keep you safe. Some medications might affect the level of Tibsovo (ivosidenib) in your body, which can affect how well the cancer medication works or raise your risk for side effects.
Frequently asked questions about Tibsovo (ivosidenib)
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What are the risks and warnings for Tibsovo (ivosidenib)?
Tibsovo (ivosidenib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Differentiation syndrome in people with AML or MDS
During clinical studies, some people with AML MDS who took Tibsovo (ivosidenib) had a serious reaction called differentiation syndrome. Differentiation syndrome is an immune reaction that happens when proteins in the body called cytokines become active. This causes too much inflammation in the body, which can lead to possibly life-threatening problems. In studies, this reaction happened as early as a few days and up to a few months after people started taking Tibsovo (ivosidenib).
Get medical help right away if you have any symptoms of differentiation syndrome, including fever, trouble breathing, cough, weight gain, swelling of the arms or legs, or low blood pressure. Differentiation syndrome is a medical emergency and must be treated as soon as possible. Most people can restart Tibsovo (ivosidenib) once they get treated for differentiation syndrome and once their symptoms get better.
Changes in heart rhythm
Risk factors: Personal or family history of long QT syndrome | Heart failure | Abnormal electrolyte levels | Taking medications that can cause abnormal heart rhythm
Tibsovo (ivosidenib) can make the heart take longer to recharge after each beat. This effect is known as QT prolongation and it can cause abnormal heart rhythm.
Let your oncology team know if you have any heart rhythm problems (e.g., long QT syndrome). Also tell them if you take other medications that can affect heart rhythm. This helps them check for your risk for QT prolongation.
You’ll also need to get an electrocardiogram (EKG) before you start Tibsovo (ivosidenib) and also occasionally during treatment. You’ll need EKGs more often if you’re at higher risk for QT prolongation. If the EKG shows that you have changes in your heart rhythm, your oncologist might pause or stop your treatment with Tibsovo (ivosidenib).
Get medical help right away if you have any symptoms of an abnormal heart rhythm, such as irregular heartbeat, dizziness, or passing out.
Guillain-Barré syndrome
Rarely, people who took Tibsovo (ivosidenib) developed a condition that affects the nervous system called Guillain-Barré syndrome (GBS). It can cause weakness that starts in the legs, arms, or face and then progresses to other parts of the body. Symptoms can also include numbness and tingling, difficulty moving or walking, or trouble breathing.
Seek medical help right away if you have symptoms of GBS. You’ll need to stop taking Tibsovo (ivosidenib) permanently if you're diagnosed with GBS.
Tibsovo (ivosidenib) dosage forms
Typical dosing for Tibsovo (ivosidenib)
The typical dose is 500 mg by mouth once a day.
What are alternatives to Tibsovo (ivosidenib)?
Acute myeloid leukemia (AML) with an IDH1 mutation
For newly-diagnosed adults who are 75 years or older or who can’t tolerate intensive treatment
For adults whose cancer has come back after previous treatment (relapsed or refractory AML)
Relapsed or refractory myelodysplastic syndrome (MDS) with an IDH1 mutation in adults
Advanced or metastatic cholangiocarcinoma with an IDH1 mutation in adults who’ve been previously treated
Treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with an IDH1 mutation
What is the latest news about Tibsovo (ivosidenib)?
Tibsovo (ivosidenib) images
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