Generic Name: ivosidenib
Trade Name: Tibsovo®
For which conditions is Tibsovo approved for? Tibsovo is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Tibsovo is also approved for adult patients over 75 years of age with newly-diagnosed AML with an IDH1 mutation who are ineligible for intensive induction chemotherapy. The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and/or life-threatening side effects of differentiation syndrome which affects your blood cells.
What is the mechanism of action? Tibsovo is an oral, targeted inhibitor of the IDH1 enzyme, and is the first and only FDA-approved therapy for patients with AML and an IDH1 mutation which is present in approximately 6-10% of AML patients. Tibsovo works by decreasing the body’s abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG) which will eventually restore the ability of cancerous cells to differentiate.
How is Tibsovo typically given (administered)? Tibsovo is taken orally, once per day at the same time each day. Tibsovo should be swallowed whole (do not chew or split) with or without food; avoid high-fat meals with Tibsovo. If you miss a dose or vomit immediately after you have taken Tibsovo, take the dose of Tibsovo as soon as possible on the same day and take your next dose the next day at your regularly scheduled time; do not take two doses within 12 hours. However, do not take two doses at the same time to make up for a missed dose.
How are patients typically monitored? During treatment with Tibsovo, at a minimum your healthcare provider will do blood tests to check your blood counts before you start treatment and at least every two weeks for the first 3 months during treatment to check for side effects. Tibsovo may harm an unborn baby. Do not breastfeed during treatment with Tibsovo and for at least 1 month after the last dose of Tibsovo.
What are the common (occur in 20% or more of patients) side effects of treatment with Tibsovo?
- Joint pain
- Changes in blood cell counts
- Swelling of arms or legs
- Shortness of breath
- Mouth sores
- Irregular heart rhythm or heartbeat
- Decreased appetite
- Muscle pain
- Decrease in hemoglobin
- Decrease levels of electrolytes in the blood
- Changes in liver or kidney function tests
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tibsovo and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions. Tibsovo may cause serious side effects.
When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your doctor right away if you feel dizzy, lightheaded, faint or experience weakness or tingling in your extremeities, numbness, sensory changes or difficulty breathing.
TIBSOVO may cause severe or life-threatening side effects from differentiation syndrome and it is important that you call your healthcare provider or seek care from the nearest emergency room right away if you experience any of the following symptoms:
· Shortness of breath
· Swelling of arms and legs
· Swelling around neck, grown or underarm area
· Fast weight gain (more than 10 pounds in a week)
· Bone Pain
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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