(EYE voe SID e nib)
Trade Name: Tibsovo®
Ivosidenib is the generic name for the trade name drug Tibsovo®. In some cases, health care professional may use the trade name, Tibsovo®, when referring to the generic drug name, ivosidenib.
Drug Type: Ivosidenib is a targeted therapy. This medication is classified as an “antineoplastic agent and IDH1 inhibitor” (for more detail, see “How Ivosidenib Works” below).
What is the use of Ivosidenib ?
- Ivosidenib is used for newly-diagnosed, refractory or relapsed acute myeloid leukemia (AML) with isocitrate dehydrogenase-1 (IDH-1) mutation
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Ivosidenib Is Given
- Ivosidenib is a tablet which may be taken with or without food.
- Do not take with a high fat meal.
- Do not crush, chew, or dissolve tablets.
- Avoid grapefruit and grapefruit juice.
- Take at the same time every day.
- Take ivosidenib as prescribed.
- Do not change or stop taking ivosidenib unless told to do so by your health care provider.
- If you miss a dose of ivosidenib, take the missed dose as soon as possible or at least 12 hours before your next dose. And if it is less than 12 hours before your next dose, skip the missed dose.
- If you vomit after taking a dose, do not take another dose. Wait until the next scheduled dose.
- Do not take extra ivosidenib the following day to make up for the missed dose.
- Call your health care provider and go to the emergency room if you have taken more than one dose of ivosidenib.
- Store at room temperature (68° F to 77° F). Keep medication in original bottle.
- Keep out of reach from children and pets.
- Safely throw away any ivosidenib that is out of date or unused (ask your provider or pharmacist for directions on how to discard the medication).
The amount of ivosidenib that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of ivosidenib:
- Most people will not experience all of the ivosidenib side effects listed.
- Ivosidenib side effects are often predictable in terms of their onset, duration, and severity.
- The side effects will improve after therapy is complete.
- Ivosidenib side effects may be quite manageable. There are many options to minimize or prevent the side effects of ivosidenib.
The following side effects are common (occurring in greater than 30%) for patients taking ivosidenib:
- Edema (swelling)
- Hyponatremia (low sodium)
- Hyperuricemia (high uric acid)
- Hypokalemia (low potassium)
- Anemia (decreased hemoglobin
- Leukocytosis (high white blood cell count)
Less Common Side Effects
These are less common side effects (occurring in 10-29%) for patients receiving ivosidenib:
- Abnormal EKG (OTc prolongatoin)
- Chest pain
- Hypotension (low blood pressure
- Neuropathy (numbness)
- Skin rash
- Hypophosphatemia (low phosphorus levels)
- Loss of appetite
- Abdominal pain
- Liver dysfunction
- Myalgia (muscle pain)
- Differentiation Syndrome
- Tumor Lysis Syndrome
- Guillain-Barre Syndrome
A rare but serious side effect of Ivosidenib is differentiation syndrome. This is a condition that affects you blood cells which may be a life threatening or lead to death if not treated. This can occur in as early as 10 days and during the first 5 months of treatment. Call your doctor to go to the nearest emergency room if you develop any of the following symptoms:
- Shortness of breath
- Swelling of the arms and legs
- Swelling around neck, groin, or underarm area
- Fast weight gain (greater than 10 pounds within a week)
- Bone pain
Tumor lysis syndrome
Tumor lysis syndrome may occur as a result of leukemia treatment. This syndrome occurs when large amounts of cancerous cells are rapidly killed by the therapy. These cells release uric acid, potassium and phosphorus into the blood stream. Tumor lysis syndrome can lead to kidney failure. Tumor lysis syndrome usually occurs within 24 – 48 hours of therapy. Proper care to prevent the tumor lysis syndrome is important. Your health care provider will prescribe plenty of fluids to keep you hydrated. You may be given a drug called allopurinol that blocks uric acid production. In some cases, your health care provider may prescribe other measures to lower your white blood count before therapy. Let your health care provider know immediately if you are unable to urinate. Your health care provider will monitor your progress carefully during therapy.
Guillain-Barre Syndrome (GBS)
A rare, but serious, side effect of ivosidenib is Guillain-Barre Syndrome (GBS). GBS is known as an autoimmune disease, where your immune system attacks your own body. GBS affects the nervous system. If this occurs, ivosidenib will need to be discontinued. Contact your doctor as soon as possible if you experience any of the following:
- Weakness on one or both sides of the body
- Changes in senses (vision, touch, hearing, or taste)
- Difficulty breathing
- Numbness, especially if it starts in lower body
Not all side effects are listed above. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
- Change in senses like change in vision, touch, hearing, or taste.
- Chest pain.
- Fever of 100.4°F (38°C) or higher, chills (possible signs of infection).
- Signs of Tumor Lysis Syndrome – fast heartbeat, passing out, difficulty urinating, muscle weakness or cramps, upset stomach, throwing up, diarrhea, not able to eat, or feel sluggish
- Signs of Differentiation Syndrome – bone pain, cough, fever, shortness of breath, sudden weight gain, swelling in arms or legs, swollen glands, difficulty urinating, blood in urine, signs of liver problems (dark urine, stomach pain, light-colored stools, or yellow skin and eyes), or low blood pressure (passing out or dizziness).
The following symptoms require medical attention but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
- Yellowing of the skin or eyes.
- Swelling of the feet or ankles.
- Sudden weight gain.
Always inform your health care provider if you experience any unusual symptoms.
- Before starting ivosidenib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Some drugs can increase the amount of ivosidenib in your body. Talk to your physician or pharmacist before starting new medication.
- Ivosidenib may alter the efficacy of hormonal birth control. Use back-up methods while on ivosidenib.
- Do not receive any kind of immunization or vaccination without your doctor’s approval while taking ivosidenib.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. There is not enough data to predict fetal risk. Animal reproduction studies produced adverse effects. The use of ivosidenib during pregnancy could cause fetal harm.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking ivosidenib. Barrier methods of contraception, such as condoms, are important.
- Do not breast feed while taking ivosidenib for at least 1 month after the last dose.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding
- Avoid contact sports or activities that could cause injury
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea (see managing side effects – diarrhea).
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be completely cut off. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition
- Remain active as you are able. Gentle exercise is important such as a daily walk.
- You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness .
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Ivosidenib
You will be checked regularly by your doctor while you are taking ivosidenib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor. Your doctor will also monitor heart function with an electrocardiogram (ECG) throughout the course of treatment.
How Ivosidenib Works
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently, but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
Different Types of Targeted Therapies
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Ivosidenib is a targeted therapy that inhibits mutant IDH1 enzyme. Blocking this enzyme leads to reduced blasts counts and increased percentages of mature myeloid cells.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational but is not a substitute for medical advice.