WARNING

Ivosidenib is a medication that belongs to a class of drugs called isocitrate dehydrogenase 1 (IDH1) inhibitors. It is used to treat a specific type of acute myeloid leukemia (AML) in patients who have a specific genetic mutation.

While Ivosidenib can be effective in treating AML, like any medication, it carries certain risks. Here are some of the potential risks and side effects associated with taking Ivosidenib:

• Differentiation syndrome: This is a potentially life-threatening condition that can occur when cells in the bone marrow mature into specific types of blood cells too quickly. Symptoms may include fever, cough, difficulty breathing, rapid weight gain, and swelling.
• QT prolongation: Ivosidenib can cause an abnormal heart rhythm called QT prolongation, which can be serious or even fatal. It is important to inform your doctor if you have a history of heart problems or are taking other medications that can affect heart rhythm.
• Liver problems: Ivosidenib may cause liver damage, including an increase in liver enzymes and a condition called differentiation syndrome. Regular monitoring of liver function is essential during treatment.
• Other side effects: Common side effects of Ivosidenib include fatigue, joint pain, nausea, diarrhea, increased white blood cell count, decreased appetite, and shortness of breath. These side effects may vary in severity and can be managed with medical guidance.

It is crucial to consult with your healthcare provider before starting Ivosidenib treatment to discuss the potential risks, benefits, and any specific concerns related to your medical history or current health condition. They can provide you with detailed information and guidance tailored to your individual circumstances.

Why is this medication prescribed?

Ivosidenib is prescribed for the treatment of a specific type of acute myeloid leukemia (AML) called relapsed or refractory IDH1-mutated AML. AML is a type of cancer that affects the bone marrow and blood cells, where abnormal cells rapidly multiply and interfere with the production of normal blood cells.

The IDH1 mutation is a genetic alteration found in some AML patients, where the isocitrate dehydrogenase 1 enzyme is mutated. Ivosidenib is an isocitrate dehydrogenase 1 (IDH1) inhibitor that works by targeting and inhibiting this mutated enzyme. By doing so, it helps to restore normal blood cell production and slow down the progression of AML.

Ivosidenib is specifically approved for use in patients who have relapsed or refractory AML with the IDH1 mutation. Relapsed AML means that the disease has returned after a period of remission, while refractory AML refers to cases where the disease does not respond to initial treatment.

How should this medicine be used?

Ivosidenib should be used exactly as prescribed by your healthcare provider. It is important to follow the instructions provided on the prescription label and adhere to your doctor’s guidance. Here are some general guidelines on how Ivosidenib is typically used:

• Dosage: The recommended dose of Ivosidenib is usually 500 mg taken orally once daily. Your healthcare provider will determine the appropriate dosage for you based on factors such as your overall health, the specific type of AML, and any other medications you may be taking.
• Timing: Ivosidenib can be taken with or without food. It is generally advised to take it around the same time each day to maintain a consistent level of the medication in your body.
• Duration of treatment: The duration of Ivosidenib treatment will depend on your individual response to the medication and your healthcare provider’s assessment. Treatment may continue as long as you are benefiting from it and tolerating it well.
• Monitoring: During treatment with Ivosidenib, your doctor will closely monitor your progress through regular blood tests and other medical evaluations. This helps assess the effectiveness of the medication and detect any potential side effects or complications.
• Compliance: It is crucial to take Ivosidenib exactly as prescribed and not to alter the dosage or frequency without consulting your healthcare provider. If you miss a dose, 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 resume your regular dosing schedule.

Always consult your doctor or pharmacist for specific instructions on how to use Ivosidenib in your particular case. They will provide you with detailed information and address any concerns or questions you may have regarding its use.

Other uses for this medicine

Ivosidenib is primarily used for the treatment of relapsed or refractory IDH1-mutated acute myeloid leukemia (AML). However, it is important to note that medications are typically prescribed for specific indications approved by regulatory authorities. There were no other approved uses for Ivosidenib beyond IDH1-mutated AML.

What special precautions should I follow?

Regarding special precautions, it is essential to discuss your medical history, current medications, and any underlying conditions with your healthcare provider before starting Ivosidenib. Here are some general precautions associated with Ivosidenib use:

• QT prolongation: Ivosidenib can cause an abnormal heart rhythm called QT prolongation. Inform your doctor if you have a history of heart problems or take medications that may affect heart rhythm. Regular monitoring of your heart’s electrical activity may be conducted during treatment.
• Liver problems: Ivosidenib may cause liver damage. It is important to notify your doctor if you have a history of liver disease or if you experience symptoms such as jaundice (yellowing of the skin or eyes), abdominal pain, or dark urine. Regular liver function tests will be performed during treatment.
• Differentiation syndrome: This potentially life-threatening condition can occur during Ivosidenib treatment. Notify your healthcare provider immediately if you experience symptoms such as fever, cough, difficulty breathing, rapid weight gain, or swelling.
• Interactions with other medications: Inform your doctor about all medications, supplements, or herbal products you are taking as they may interact with Ivosidenib. Certain medications may affect the metabolism of Ivosidenib or increase the risk of side effects.
• Pregnancy and breastfeeding: Ivosidenib may cause harm to unborn babies, so it is important to use effective contraception during treatment if you are of childbearing potential. The use of Ivosidenib during breastfeeding is not recommended.

These are general precautions, and it is crucial to consult your healthcare provider for specific guidance and precautions based on your individual circumstances. They can provide you with personalized information and address any concerns you may have.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Ivosidenib use. However, it is generally recommended to follow a healthy and balanced diet while undergoing treatment for any medical condition. Eating a variety of nutrient-rich foods can support your overall health and well-being.

What should I do if I forget a dose?

If you forget to take a dose of Ivosidenib, follow these general guidelines:

• Timing: Take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. If that is the case, skip the missed dose and resume your regular dosing schedule.
• Do not double dose: Do not take a double dose to make up for the missed one. Taking more than the prescribed dose can increase the risk of side effects.
• Consult your doctor or pharmacist: If you have any concerns or questions about missed doses, it is best to consult your healthcare provider or pharmacist. They can provide you with specific guidance based on your treatment plan.

What side effects can this medication cause?

Ivosidenib, like any medication, can cause side effects. It is important to note that not all individuals will experience these side effects, and their severity can vary. It is essential to discuss potential side effects with your healthcare provider before starting Ivosidenib. Here are some common side effects associated with Ivosidenib:

• Fatigue: Feeling tired or experiencing a lack of energy.
• Joint pain: Discomfort or soreness in the joints.
• Nausea: A feeling of sickness or queasiness in the stomach, sometimes accompanied by the urge to vomit.
• Diarrhea: Loose or watery stools that occur more frequently than usual.
• Increased white blood cell count: Ivosidenib may cause an increase in the number of white blood cells in the blood, which is monitored by regular blood tests.
• Decreased appetite: A reduced desire to eat or loss of interest in food.
• Shortness of breath: Difficulty breathing or a feeling of breathlessness.

It is important to promptly report any side effects or adverse reactions to your healthcare provider. They can provide guidance on managing these side effects or adjust your treatment plan if necessary. Additionally, there may be other less common or rare side effects associated with Ivosidenib that are not listed here, so it’s important to consult with your doctor or pharmacist for comprehensive information specific to your situation.

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

Storage and disposal of Ivosidenib:

• Storage: Ivosidenib should be stored at room temperature, away from moisture and heat. Follow the specific storage instructions provided by your pharmacist or included with the medication.
• Keep out of reach of children: Ensure that Ivosidenib is stored in a safe place where children or pets cannot access it.
• Disposal: It is important to dispose of unused or expired Ivosidenib properly. Follow the disposal instructions provided by your healthcare provider or local regulations. Do not flush medication down the toilet or throw it in the trash unless instructed to do so.

In case of emergency/overdose

In case of emergency or overdose:

• Contact emergency services: If you or someone else experiences severe symptoms, difficulty breathing, or a suspected overdose, immediately call emergency services or your local poison control center.
• Inform healthcare professionals: When seeking emergency assistance, be sure to inform the healthcare professionals about the medication taken and the situation.

What other information should I know?

• Medication interactions: Inform your healthcare provider about all the medications, supplements, or herbal products you are taking, as they may interact with Ivosidenib.
• Regular monitoring: Your healthcare provider will monitor your progress and conduct regular blood tests and medical evaluations to assess the effectiveness of the medication and detect any potential side effects or complications.
• Compliance with appointments: It is important to attend all scheduled appointments with your healthcare provider for follow-up evaluations and to discuss any concerns or changes in your condition.
• Pregnancy and breastfeeding: Ivosidenib may cause harm to unborn babies, so effective contraception should be used during treatment if you are of childbearing potential. Breastfeeding is not recommended while taking Ivosidenib.

Always consult your healthcare provider or pharmacist for specific instructions, guidelines, and any additional information related to the storage, disposal, emergency procedures, or other aspects of Ivosidenib use.