Tibsovo (Ivosidenib)

Tibsovo is an anti-cancer prescription medication also known by the generic name ivosidenib. It is indicated for the treatment of acute myeloid leukemia (AML) and cholangiocarcinoma, which is bile duct cancer. 

Acute myeloid leukemia is the most common type of leukemia (blood and bone marrow cancer) in adults. Tibsovo can be used for the treatment of newly diagnosed AML in adults 75 years or older and for the treatment of relapsed/refractory AML.

Before starting this medication, make sure to tell your healthcare provider if you have any of the following conditions:

• Any known medication or food allergy 
• A history of seizures
• An HIV diagnosis 
• Pregnant or breastfeeding or planning to become pregnant
• A history of heart problems
• Kidney disease
• Cirrhosis or liver disease
• Nerve problems
• An electrolyte imbalance (low levels of sodium, potassium, or magnesium in the blood).

What Is Tibsovo Used For?

Components of blood such as red blood cells, white blood cells, and platelets are produced in the bone marrow. Patients with AML are not able to form a substantial type of white blood cells called myeloblasts which are essential to fight infections and protect the body. When myeloblasts do not properly form and grow and there are not enough healthy cells in the blood, AML complications become visible. 

Acute myeloid leukemia can also be linked to genetic mutations in the body such as a mutation called IDH1. IDH1 mutation prevents myeloblasts from growing and becoming mature. It is found that one in 10 people with AML has IDH1 mutation. Tibsovo is a targeted therapy and works by blocking IDH1 mutation and helping myeloblasts to grow.   

How Long Does It Take for Tibsovo To Work?

Therapy management and treatment duration depend on patient factors and adherence. 

Side Effects

Some patients might experience one or more of the following side effects while on treatment with Tibsovo: 

• Stomach upset 
• Fatigue 
• Muscle or joint pain
• Mouth irritation or mouth sores
• Loss of appetite and weight loss
• Headache
• Acne
• Constipation
• Diarrhea
• Nausea and vomiting 

Tibsovo Strength

Oral tablet 250 mg

Dosing

• 500 mg tablets taken once daily for a minimum of 6 months if tolerated
• It is best to take this medication at the same time each day
• Tablets should be swallowed whole
• Do not split, crush, or chew the tablets
• If a dose is missed it can be taken as soon as it is remembered and at least 12 hours before the next dose. Do not take two doses on the same day.

How Long Can You Take Tibsovo?

Tibsovo is continued for a minimum of 6 months if therapy is tolerated and there is no disease progression. 

When To Discontinue Tibsovo?

• Tibsovo can cause differentiation syndrome which can be fatal. Symptoms include fever, dyspnea, hypoxia, rapid weight gain, edema, and low blood pressure. If a patient experiences any of these symptoms, therapy should be stopped immediately and the patient should seek medical attention.
• If a patient develops an allergic reaction such as a change in balance, hives, swelling, chest pain, or abnormal heartbeat, medical attention should be sought immediately. 
• Therapy is also discontinued if the patient experiences toxicity or disease progression. 

Tibsovo Interactions – Food And Drugs To Avoid

Tibsovo should NOT be taken with a high-fat meal because drug concentration can be increased. 

Tibsovo can increase the risk of QT prolongation (heart rhythm disorder). Please inform your provider if you have any cardiovascular issues or are taking antiarrhythmic medications such as flecainide. 

Tibsovo may also interact with antibiotics. Please inform your provider and pharmacist regarding any antibiotic medication you are taking. 

Tibsovo can reduce the efficacy of hormonal contraceptives. Patients should discuss their concerns with their provider at the initial visit. 

There are many other drug interactions with Tibsovo. Please make sure to have your provider and pharmacist check for these interactions before starting Tibsovo.  

Pregnancy or Planning Pregnancy

Tibsovo can cause fertility issues in males and females. Please inform your provider if you are pregnant or planning on becoming pregnant. Breastfeeding is NOT recommended while on this medication. 

Is Tibsovo Chemotherapy?

Tibsovo is not a chemotherapy drug. It is a targeted therapy anti-cancer prescription medication.

The difference between targeted therapy and chemotherapy is that targeted therapy works on specific molecular targets associated with cancer while chemotherapy works on all rapidly dividing cancerous and normal cells.

Tibsovo is an oral targeted therapy drug that inhibits the IDH1 enzyme.

Is Tibsovo FDA approved?

Ivosidenib is the first IDH1-inhibitor approved by the FDA (Food And Drug Administration) in  May 2022 for its use in the treatment of acute myeloid leukemia and advanced or metastatic cholangiocarcinoma. 

Conclusion

Ivosidenib, sold under the brand name Tibsovo, is a targeted anti-cancer prescription medicine that inhibits the mutant IDH1 enzyme. Inhibition of the enzyme promotes the production of healthy myeloid cells (blood cells). It is used to treat advanced bile duct cancer and acute myeloid leukemia (AML). 

This medication is safe to use but it does have side effects such as stomach upset, fatigue, muscle or joint pain, mouth irritation or mouth sores, loss of appetite and weight loss, headache, acne, and constipation/diarrhea.

These side effects become tolerable as medication is used as scheduled. 

If side effects persist or you encounter severe adverse effects like heart problems, irregular heart palpitations, symptoms of QTC interval prolongation, fainting, or uncontrollable breathing problems, please seek medical attention immediately and inform your provider.

Do not stop this medication without your doctor’s recommendation. Inform your pharmacist and doctor about your medical conditions and drug history before starting Tibsovo.