WARNING

A dangerous or potentially fatal collection of symptoms known as differentiation syndrome may be brought on by gilteritinib. To determine whether you are exhibiting this syndrome, your doctor will closely monitor you. Make a quick call to your doctor if you encounter any of the following signs: Fever, cough, rash, abrupt weight gain, decreased urination, disorientation, arm or leg swelling, shortness of breath, breathing difficulties, chest pain, or bone pain. Up to 3 months after beginning gilteritinib therapy, these effects are possible. When differentiation syndrome first appears, your doctor will prescribe drugs to treat it. He or she may also advise you to temporarily cease taking gilteritinib.

When you start gilteritinib therapy and each time you get a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist.

Why is this medication prescribed?

Gilteritinib is a medication that is primarily prescribed for the treatment of adult patients with acute myeloid leukemia (AML) that has a mutation in the FLT3 gene. AML is a type of cancer that affects the blood and bone marrow, and the FLT3 mutation is found in approximately 30% of AML patients. Gilteritinib is specifically designed to target and inhibit the FLT3 mutation, which can help in controlling the progression of the disease.

Gilteritinib is usually prescribed by a healthcare professional, such as an oncologist, and it is available in oral form as tablets. The specific dosage and treatment regimen may vary depending on individual factors, including the patient’s overall health, the stage of the disease, and other medications they may be taking. It is important to follow the instructions provided by the healthcare professional and the information on the prescription label.

How should this medicine be used?

Typically, Gilteritinib is taken once daily with or without food. The tablets should be swallowed whole and not crushed, chewed, or broken. If a dose is missed, it should be taken as soon as remembered, unless it is close to the time for the next scheduled dose. It is important to avoid doubling the dose to make up for a missed one.

It is crucial to consult with a healthcare professional for personalized guidance on the appropriate dosage, usage, and any potential side effects or drug interactions associated with Gilteritinib.

Other uses for this medicine

It is always best to consult with a healthcare professional or refer to the latest prescribing information and clinical guidelines for the most accurate and up-to-date information on the uses of Gilteritinib.

What special precautions should I follow?

Regarding special precautions or guidelines to follow while using Gilteritinib, it is crucial to adhere to the recommendations provided by the prescribing healthcare professional. Here are some general points to consider:

• Medical supervision: Gilteritinib is typically prescribed and monitored by an oncologist or a healthcare professional experienced in treating AML. Regular follow-up visits and laboratory tests may be necessary to monitor the response to treatment and manage any potential side effects.
• Dosage and administration: Follow the prescribed dosage and administration instructions provided by the healthcare professional. Take the medication exactly as directed and do not adjust the dosage without consulting the healthcare professional.
• Interactions with other medications: Inform the prescribing doctor about all the medications, supplements, and herbal products you are taking, as some drugs may interact with Gilteritinib and affect its effectiveness or increase the risk of side effects. This includes prescription medications, over-the-counter drugs, and any other substances.
• Side effects: Gilteritinib may cause side effects, which can vary from person to person. Common side effects may include fatigue, nausea, vomiting, diarrhea, fever, abnormal liver function tests, and muscle pain. However, it is important to promptly report any unusual or severe side effects to the healthcare professional.
• Pregnancy and breastfeeding: Gilteritinib may harm an unborn baby, so it is important to discuss the risks and benefits of the medication if you are pregnant or planning to become pregnant. Similarly, it is not recommended to breastfeed while taking Gilteritinib, as it may pass into breast milk and harm the nursing infant.

What special dietary instructions should I follow?

There are no specific dietary instructions for Gilteritinib. Generally, it can be taken with or without food. However, it’s always a good idea to follow a healthy and balanced diet while undergoing cancer treatment. Eating a variety of nutritious foods and staying well-hydrated can support your overall well-being and help maintain strength and energy levels. If you have any specific dietary concerns or restrictions, it’s advisable to consult with a healthcare professional or a registered dietitian who can provide personalized dietary recommendations.

What should I do if I forget a dose?

If you forget to take a dose of Gilteritinib, you should take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, you should skip the missed dose and continue with your regular dosing schedule. It’s important not to double up on doses to make up for a missed one, as this can increase the risk of side effects or overdose. If you have any concerns about missed doses or how to manage them, it’s best to consult with your healthcare professional for specific guidance based on your treatment plan.

What side effects can this medication cause?

Gilteritinib, like any medication, can cause side effects. Not all individuals will experience these side effects, and their severity can vary from person to person. It is important to note that the following list includes commonly reported side effects, but it may not be exhaustive. If you are taking Gilteritinib and experience any concerning or persistent side effects, it is crucial to contact your healthcare professional for guidance. Here are some potential side effects associated with Gilteritinib:

• Fatigue or weakness
• Nausea
• Vomiting
• Diarrhea
• Fever
• Abnormal liver function tests
• Musculoskeletal pain or muscle spasms
• Edema (swelling due to fluid retention)
• Dizziness
• Headache
• Cough
• Shortness of breath or difficulty breathing
• Irregular heartbeat or palpitations
• Skin rash or itching
• Changes in taste perception
• Eye problems such as blurred vision or dry eyes
• Decreased appetite or weight loss

It is important to promptly report any side effects to your healthcare professional, as they can provide appropriate guidance and make any necessary adjustments to your treatment plan. They can also provide additional information on managing or alleviating these side effects.

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

• Storage: Gilteritinib should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C). It is important to keep it in its original container and protect it from light and moisture. Avoid storing it in the bathroom or any area with excessive humidity or temperature fluctuations.
• Disposal: It is recommended to follow local regulations and guidelines for the proper disposal of unused or expired medications. Do not dispose of Gilteritinib in household trash or flush it down the toilet unless instructed to do so by authorized disposal methods. Contact your healthcare professional, pharmacist, or local waste management authorities for guidance on safe disposal options.

In case of emergency/overdose

If you suspect an overdose or experience any severe symptoms after taking Gilteritinib, such as severe dizziness, fainting, difficulty breathing, or irregular heartbeat, it is important to seek immediate medical attention or contact your local emergency services. You can also call the Poison Control Center at 1-800-222-1222 (in the United States) for further guidance.

What other information should I know?

Other important information to know:

• Regular appointments: Make sure to attend all scheduled appointments with your healthcare professional for monitoring and follow-up during your Gilteritinib treatment.
• Drug interactions: Inform your healthcare professional about all the medications, supplements, and herbal products you are taking to avoid potential interactions that can affect the effectiveness or safety of Gilteritinib.
• Blood cell count monitoring: Gilteritinib can affect your blood cell counts, so your healthcare professional may perform regular blood tests to monitor your blood cell levels and overall health.
• Pregnancy and breastfeeding: Discuss with your healthcare professional the risks and benefits of using Gilteritinib if you are pregnant, planning to become pregnant, or breastfeeding. Gilteritinib may have harmful effects on unborn babies or nursing infants.
• Follow instructions: Follow your healthcare professional’s instructions regarding the dosage, timing, and duration of Gilteritinib treatment. Do not modify the dosage or stop taking the medication without consulting your healthcare professional.
• Keep a list: Maintain a list of all your medications, including Gilteritinib, and share it with your healthcare professional during appointments or in case of emergencies.

Please note that the information provided here is for general knowledge and should not replace the specific instructions and advice given by your healthcare provider.