WARNING

Tibsovo (ivosidenib) is a medication used to treat certain types of acute myeloid leukemia (AML) in adults with specific genetic mutations. Like any medication, Tibsovo carries certain risks and potential side effects. Some common risks associated with Tibsovo include:

• Differentiation Syndrome: This is a potentially life-threatening condition where there’s an influx of white blood cells into the bloodstream, leading to symptoms such as fever, breathing difficulties, swelling, and rapid weight gain.
• QT Prolongation: Tibsovo can cause a heart rhythm problem known as QT prolongation, which may lead to irregular heartbeat and fainting.
• Liver Toxicity: Some patients may experience liver problems while taking Tibsovo, resulting in symptoms like yellowing of the skin or eyes, dark urine, abdominal pain, or nausea.
• Guillain-Barré Syndrome: Although rare, there have been reports of Guillain-Barré Syndrome, a condition affecting the nerves, in patients taking Tibsovo.
• Risk of Infections: Tibsovo can suppress the immune system, increasing the risk of infections. Patients should promptly report any signs of infection, such as fever or persistent sore throat, to their healthcare provider.
• Other Side Effects: Additional side effects may include nausea, vomiting, diarrhea, fatigue, decreased appetite, and muscle pain.

It’s crucial for patients to discuss their medical history and any potential risks with their healthcare provider before starting Tibsovo. Regular monitoring and communication with healthcare professionals can help manage these risks effectively.

Why is this medication prescribed?

Tibsovo (ivosidenib) is prescribed for the treatment of acute myeloid leukemia (AML) in adult patients who have a specific genetic mutation known as IDH1. AML is a type of cancer that affects the bone marrow and blood cells. IDH1 mutations are found in a subset of AML patients, and Tibsovo works by inhibiting the mutated IDH1 enzyme, which plays a role in the growth and proliferation of cancer cells. By targeting this mutation, Tibsovo helps to slow down or stop the growth of cancer cells, thus providing a treatment option for patients with IDH1-mutated AML.

How should this medicine be used?

Tibsovo (ivosidenib) is typically taken orally, in the form of tablets. The dosage and administration schedule may vary based on individual patient factors and the recommendations of the prescribing healthcare provider. However, the general guidelines for the use of Tibsovo are as follows:

• Dosage: The recommended dosage of Tibsovo is usually determined by the healthcare provider based on factors such as the patient’s weight, overall health, and specific treatment plan. It’s important to follow the prescribed dosage carefully and not to adjust it without consulting the healthcare provider.
• Administration: Tibsovo tablets should be taken by mouth with or without food, as directed by the healthcare provider. The tablets should be swallowed whole and not crushed, split, or chewed.
• Timing: It’s important to take Tibsovo consistently and at the same time each day, as instructed by the healthcare provider. Missing doses or taking doses at irregular intervals may affect the effectiveness of the medication.
• Duration of Treatment: Treatment with Tibsovo may continue for as long as it is providing benefit to the patient and as recommended by the healthcare provider. It’s essential to follow up with the healthcare provider regularly to monitor the response to treatment and adjust the treatment plan as needed.
• Special Instructions: Patients should follow any additional instructions provided by their healthcare provider, such as precautions or potential side effects to watch for during treatment.
• Genetic Testing: Tibsovo is specifically indicated for AML patients with IDH1 mutations. Before initiating treatment with Tibsovo, patients will typically undergo genetic testing to confirm the presence of this mutation.

As with any medication, it’s crucial for patients to adhere to the prescribed dosage and administration schedule and to communicate regularly with their healthcare provider regarding any concerns or questions about their treatment.

Other uses for this medicine

Tibsovo (ivosidenib) is primarily used to treat a specific type of acute myeloid leukemia (AML) in adults with an IDH1 mutation. However, it’s essential to note that Tibsovo should only be used for its approved indication, as prescribed by a healthcare provider. Off-label use of Tibsovo for other conditions or purposes is not recommended and can be potentially harmful.

What special precautions should I follow?

As for special precautions to follow when taking Tibsovo, here are some important considerations:

• Genetic Testing: Tibsovo is specifically indicated for AML patients with an IDH1 mutation. Before starting Tibsovo treatment, patients should undergo genetic testing to confirm their mutation status. This ensures that the medication is prescribed appropriately.
• Liver Function Monitoring: Tibsovo can cause liver toxicity in some patients. Healthcare providers typically monitor liver function tests before starting Tibsovo and regularly during treatment to detect any signs of liver problems. Patients should promptly report any symptoms of liver issues, such as yellowing of the skin or eyes, dark urine, abdominal pain, or nausea.
• Heart Rhythm Monitoring: Tibsovo has the potential to cause QT prolongation, which is a heart rhythm disorder. Healthcare providers may conduct electrocardiograms (ECGs) before starting Tibsovo and periodically during treatment to monitor the patient’s heart rhythm. Patients should report any symptoms of irregular heartbeat, fainting, or dizziness to their healthcare provider.
• Differentiation Syndrome: There is a risk of differentiation syndrome, a potentially life-threatening condition associated with Tibsovo treatment. Patients should be monitored for symptoms such as fever, cough, difficulty breathing, rapid weight gain, or swelling. Prompt medical attention is necessary if these symptoms occur.
• Infections: Tibsovo can suppress the immune system, increasing the risk of infections. Patients should take precautions to avoid exposure to infections and promptly report any signs of infection to their healthcare provider, such as fever or persistent sore throat.
• Drug Interactions: Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting Tibsovo, as it may interact with certain drugs.
• Pregnancy and Breastfeeding: Tibsovo may harm an unborn baby, so it should not be used during pregnancy unless clearly necessary. Women of childbearing potential should use effective contraception during Tibsovo treatment and for some time after the last dose. It’s not known whether Tibsovo passes into breast milk, so breastfeeding is not recommended during treatment.

Patients should discuss any concerns or questions about Tibsovo treatment with their healthcare provider and adhere to their prescribed treatment plan closely.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Tibsovo. You can generally take Tibsovo with or without food. However, it’s essential to follow any dietary recommendations provided by your healthcare provider to support overall health and manage any side effects or complications related to your condition.

What should I do if I forget a dose?

If you miss a dose of Tibsovo, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you’re unsure about what to do, contact your healthcare provider or pharmacist for advice. It’s essential to maintain consistent dosing to maximize the effectiveness of Tibsovo.

What side effects can this medication cause?

Tibsovo (ivosidenib) can cause a range of side effects, some of which can be serious. It’s important to discuss potential side effects with your healthcare provider before starting Tibsovo and to promptly report any new or worsening symptoms during treatment. Common side effects of Tibsovo may include:

• Nausea: Feeling sick to your stomach or the urge to vomit.
• Vomiting: The act of forcibly expelling stomach contents through the mouth.
• Diarrhea: Frequent, loose, or watery bowel movements.
• Fatigue: Feeling unusually tired or lacking energy.
• Decreased appetite: Reduced desire to eat.
• Abdominal pain: Discomfort or cramping in the stomach or abdomen.
• Fever: An elevated body temperature, often accompanied by sweating or chills.
• Cough: A sudden, forceful expulsion of air from the lungs, often accompanied by a distinctive sound.
• Difficulty breathing: Shortness of breath or feeling like you can’t get enough air.
• Rash: A change in the skin’s appearance, such as redness, bumps, or irritation.
• Swelling: An abnormal enlargement or puffiness, often in the hands, feet, or face.
• Muscle pain: Aching or discomfort in the muscles.

In addition to these common side effects, Tibsovo may also cause more serious adverse reactions. These can include:

• Differentiation syndrome: A potentially life-threatening condition characterized by fever, cough, difficulty breathing, rapid weight gain, or swelling.
• Liver problems: Tibsovo may cause liver toxicity, leading to symptoms such as yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or nausea.
• Heart rhythm problems: Tibsovo can cause QT prolongation, a heart rhythm disorder that may lead to irregular heartbeat and fainting.
• Infections: Tibsovo can suppress the immune system, increasing the risk of infections. Symptoms of infection may include fever, chills, sore throat, or difficulty swallowing.

It’s crucial to communicate openly with your healthcare provider about any side effects you experience while taking Tibsovo. They can offer guidance on managing side effects and adjust your treatment plan if necessary. Additionally, seek medical attention promptly if you experience any signs of a severe allergic reaction or other serious side effects while taking Tibsovo.

What should I know about storage and disposal of this medication?

Storage and disposal:

Storage:

• Store Tibsovo tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the medication in its original container, tightly closed, and away from moisture and heat.
• Keep Tibsovo out of reach of children and pets.

Disposal:

• Dispose of unused or expired Tibsovo tablets according to local regulations or guidelines provided by your healthcare provider or pharmacist.
• Do not flush Tibsovo down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist.
• If you have questions about how to properly dispose of Tibsovo, consult your healthcare provider or pharmacist for guidance.

In case of emergency/overdose

• In case of an emergency or suspected overdose with Tibsovo, immediately call your local emergency services or go to the nearest emergency room.
• Be prepared to provide information about the medication you have taken, including the name (Tibsovo), dosage, and time of ingestion.
• If possible, bring the Tibsovo medication container with you to the emergency room.
• Do not attempt to treat a Tibsovo overdose on your own. Prompt medical attention is essential.

What other information should I know?

• Inform all healthcare providers involved in your care that you are taking Tibsovo.
• Attend all scheduled appointments for monitoring and follow-up with your healthcare provider.
• Keep a list of all medications, supplements, and herbal products you are taking and share it with your healthcare provider.
• Do not change the dosage or stop taking Tibsovo without consulting your healthcare provider.
• Report any new or worsening symptoms to your healthcare provider promptly.

It’s important to follow these guidelines for storage, disposal, and emergency procedures to ensure safe and appropriate use of Tibsovo. If you have any questions or concerns about Tibsovo or its use, consult your healthcare provider or pharmacist for guidance.