WARNING

Idhifa (enasidenib) is a medication used to treat a specific type of acute myeloid leukemia (AML) known as relapsed or refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation. While Idhifa can be effective in managing this condition, it is important to be aware of potential risks and side effects associated with its use. Here are some key points:

• Differentiated adverse reactions: Idhifa may cause various side effects, ranging from mild to severe. Common side effects include nausea, vomiting, diarrhea, decreased appetite, fatigue, fever, cough, and joint pain.
• Differentiation syndrome: This is a potentially life-threatening complication associated with Idhifa treatment. It occurs when the leukemia cells release certain substances that cause swelling and organ damage. Symptoms may include fever, difficulty breathing, fluid retention, chest pain, and rapid weight gain. If any of these symptoms occur, immediate medical attention is necessary.
• Liver problems: Idhifa can cause liver damage or abnormal liver function, leading to symptoms such as jaundice (yellowing of the skin or eyes), dark urine, abdominal pain, or persistent nausea and vomiting. Regular liver function tests are typically performed during treatment.
• Electrolyte imbalances: Idhifa may disrupt the balance of electrolytes in the body, such as potassium or magnesium. This can lead to muscle weakness, irregular heartbeat, or other symptoms related to electrolyte disturbances.
• Increased risk of bleeding: Idhifa can affect blood clotting, making it easier to bruise or bleed. It is important to monitor for signs of excessive bleeding, such as unusual bruising, bleeding gums, or nosebleeds.
• Other risks: There may be other, less common risks associated with Idhifa that are specific to an individual’s medical history or condition. It’s essential to discuss any pre-existing medical conditions, medications, or allergies with the healthcare provider before starting treatment.

It’s crucial to remember that the above information provides only a brief overview of potential risks, and each individual’s situation may vary. It is essential to consult with a healthcare professional who can provide personalized information, guidance, and monitoring throughout the treatment process.

Why is this medication prescribed?

Idhifa (enasidenib) is prescribed for the treatment of a specific type of acute myeloid leukemia (AML) known as relapsed or refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation. AML is a type of cancer that affects the bone marrow and blood cells.

The IDH2 mutation leads to the production of an abnormal enzyme that disrupts normal cell function and contributes to the development of leukemia. Idhifa works by inhibiting this abnormal enzyme, helping to restore normal cell development and reducing the growth of cancer cells.

How should this medicine be used?

Here are some key points on how Idhifa should be used:

• Prescription and dosage: Idhifa is available only with a prescription from a healthcare professional. The dosage and treatment duration will be determined by the healthcare provider based on individual factors such as overall health, specific mutation status, and response to treatment.
• Oral medication: Idhifa comes in the form of oral tablets. It is taken by mouth with water, usually once daily. The tablets should be swallowed whole and should not be crushed, chewed, or split.
• Food intake: Idhifa can be taken with or without food. However, it is recommended to take it at the same time each day to establish a routine.
• Follow healthcare provider’s instructions: It is important to strictly follow the instructions provided by the healthcare provider. The dosage should not be changed or stopped without consulting them, as it may affect the effectiveness of the treatment.
• Regular monitoring: During Idhifa treatment, regular check-ups and blood tests are typically conducted to monitor the response to the medication, assess any side effects, and adjust the dosage if necessary.
• Other medications and supplements: Inform the healthcare provider about any other medications, supplements, or herbal products being taken, as they may interact with Idhifa and affect its efficacy or increase the risk of side effects.

It is crucial to have open communication with the healthcare provider throughout the treatment process to address any concerns, report any changes in health or side effects, and receive appropriate guidance for optimal use of Idhifa.

Other uses for this medicine

Idhifa (enasidenib) is primarily used for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. This specific mutation must be present for Idhifa to be effective. Currently, there are no other approved uses for Idhifa beyond this indication.

What special precautions should I follow?

Regarding special precautions, here are some important points to consider:

• Pregnancy and breastfeeding: Idhifa may cause harm to an unborn baby, so it is important to inform the healthcare provider if you are pregnant or planning to become pregnant. Similarly, it is not recommended to breastfeed while receiving Idhifa treatment due to the potential risk to the infant.
• Liver function: Idhifa can cause liver problems or abnormal liver function. Regular monitoring of liver function through blood tests is necessary during treatment. It is important to report any symptoms of liver damage, such as jaundice, dark urine, or abdominal pain, to the healthcare provider.
• Differentiation syndrome: Idhifa treatment may lead to differentiation syndrome, a potentially life-threatening condition characterized by swelling and organ damage. Early symptoms may include fever, difficulty breathing, fluid retention, chest pain, or rapid weight gain. It is important to seek immediate medical attention if any of these symptoms occur.
• Bleeding risk: Idhifa can increase the risk of bleeding. It is important to promptly report any signs of excessive bleeding, such as unusual bruising, bleeding gums, nosebleeds, or blood in the urine or stool, to the healthcare provider.
• Drug interactions: Idhifa can interact with other medications, including prescription drugs, over-the-counter medications, and herbal supplements. Inform the healthcare provider about all medications being taken to avoid potential interactions.
• Allergies and sensitivities: It is important to inform the healthcare provider about any known allergies or sensitivities to medications or other substances, as Idhifa may contain inactive ingredients that could cause allergic reactions.

These are not all the precautions associated with Idhifa, and it is important to discuss individual circumstances, medical history, and any specific concerns with the healthcare provider before starting Idhifa treatment. They will be able to provide personalized guidance and monitor the treatment effectively.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Idhifa (enasidenib) use. However, it is generally recommended to follow a healthy and balanced diet while undergoing cancer treatment. It’s important to discuss any specific dietary concerns or restrictions with your healthcare provider or a registered dietitian who can provide personalized guidance based on your individual needs.

What should I do if I forget a dose?

If you forget to take a dose of Idhifa, here’s what you should do:

• Timing: Take the missed dose 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.
• Double-dosing: Do not take a double dose to make up for the missed dose. Taking more than the prescribed amount can increase the risk of side effects without providing any additional benefit.
• Consult healthcare provider: If you are unsure about what to do or have any concerns, it is best to contact your healthcare provider for guidance. They can advise you on the appropriate course of action based on your specific situation.

What side effects can this medication cause?

Idhifa (enasidenib) may cause several side effects. It’s important to note that not all individuals will experience these side effects, and their severity can vary. Here are some common side effects associated with Idhifa:

• Nausea and vomiting
• Diarrhea
• Decreased appetite
• Fatigue
• Fever
• Cough
• Joint pain
• Increased levels of bilirubin (a substance produced by the liver)
• Electrolyte imbalances (such as low potassium or magnesium levels)
• Shortness of breath
• Swelling in the hands, feet, or ankles
• Headache
• Rash
• Muscle pain
• Dizziness
• Abdominal pain

It’s important to promptly report any side effects to your healthcare provider. They can provide guidance on managing these side effects or adjust the dosage if necessary. Additionally, there may be other less common or more serious side effects associated with Idhifa, so it’s important to discuss any concerns with your healthcare provider. They will be able to provide detailed information and support throughout your treatment.

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

Storage and disposal:

• Store Idhifa tablets at room temperature, away from excessive heat, moisture, and direct light.
• Keep Idhifa out of reach of children and pets.
• Do not use Idhifa beyond the expiration date mentioned on the packaging.

Disposal of unused or expired medication:

• Follow your local regulations and guidelines for the proper disposal of medications.
• Do not flush Idhifa tablets down the toilet or pour them into a drain unless specifically instructed to do so.
• Consult a pharmacist or healthcare provider for guidance on the safe disposal of Idhifa.

In case of emergency/overdose

• In the case of a suspected overdose or a medical emergency, immediately call emergency services or go to the nearest emergency room.
• Contact a poison control center or seek immediate medical attention even if there are no symptoms. Provide them with all relevant information, including the name of the medication, dosage, and time of ingestion.

What other information should I know?

• Regular monitoring: You will likely undergo regular check-ups, blood tests, and other medical evaluations during your Idhifa treatment to monitor its effectiveness and detect any potential side effects.
• Compliance: It is important to take Idhifa exactly as prescribed by your healthcare provider. Do not adjust the dosage or stop taking the medication without their guidance.
• Interactions: Inform your healthcare provider about all other medications, supplements, and herbal products you are taking, as they may interact with Idhifa and affect its efficacy or increase the risk of side effects.
• Follow-up appointments: Keep all scheduled appointments with your healthcare provider to discuss your progress, address any concerns, and receive any necessary adjustments to your treatment plan.
• Supportive care: Your healthcare provider may recommend additional supportive care measures, such as anti-nausea medications, to manage side effects and optimize your well-being during treatment.

Remember to consult your healthcare provider or pharmacist for specific instructions and guidance regarding the storage, disposal, emergencies, and any other information related to your individual situation and treatment with Idhifa.