gilteritinib
Other Name: Xospata®
- For treating a type of blood cancer called acute myeloid leukemia (AML).
Tell your health care team if you have or had significant medical condition(s), especially if you have / had:
- heart problems (including irregular heartbeat),
- liver problems,
- kidney problems,
- a history of low levels of potassium or magnesium in your blood, or
- any allergies
Remember to:
- Tell your health care team about all of the other medications you are taking.
- Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.
Talk to your health care team about:
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How this medication may affect your sexual health.
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How this medication may affect your ability to have a baby, if this applies to you.
This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.
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If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until at least 6 months after your last dose if you are female, or until at least 4 months after your last dose if you are male. Talk to your health care team about which birth control options are best for you.
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Do not breastfeed while on this medication and for at least 2 months after the last dose.
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This medication is usually taken once a day by mouth. Talk to your health care team about how and when to take your medication.
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Swallow whole with a glass of water, with or without food.
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Do not crush or chew the tablets.
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If you forget to take a dose of your gilteritinib:
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If it has been less than 12 hours from the missed dose, take the dose as usual. Then take your next dose at the normal scheduled time.
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If it has been longer than 12 hours, do not take the dose. Take your next dose at the normal scheduled time. Do not take extra (double up) to make up for the missed dose.
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If you vomit (throw up) after taking the medication, do not take another dose on the same day; take your next dose at the usual time on the next day.
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If you take too much of your medication by accident, or if you think a child or a pet may have swallowed your medication, you must call the Ontario Poison Control Center right away at: 1-800-268-9017.
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Will this medication interact with other medications or natural health products?
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This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment not work as well or cause severe side effects.
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Tell your health care team about all of your:
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prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
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natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
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Check with your health care team before starting or stopping any of them.
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What should I do if I feel unwell, have pain, a headache or a fever?
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Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).
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Fever can be a sign of infection that may need treatment right away.
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If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
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How to check for fever:
Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).
- You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
OR
- 38.0°C (100.4°F) or higher for at least one hour.
- 38.3°C (100.9°F) or higher at any time
If you do have a fever:- Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
- Ask your health care team for the Fever pamphlet for more information.
If you do not have a fever but have mild symptoms such as headache or mild pain:
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Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
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Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
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Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.
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What to DO while on this medication:
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DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
What NOT to DO while on this medication:
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DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.
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DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while taking this drug. They may increase the amount of drug in your blood and increase side effects.
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DO NOT drive, operate machinery or do any tasks that need you to be alert if you feel drowsy or dizzy.
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Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.
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Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
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How to safely touch oral anti-cancer medications
If you are a patient:
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Wash your hands before and after touching your oral anti-cancer medication.
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Swallow each pill whole. Do not crush or chew your pills.
If you are a caregiver:
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Wear nitrile or latex gloves when touching tablets, capsules or liquids.
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Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the oral anti-cancer medication.
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Throw out your gloves after each use. Do not re-use gloves.
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Do not touch oral anti-cancer medications if you are pregnant or breastfeeding.
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What to do if oral anti-cancer medication gets on your skin or in your eyes
If medication gets on your skin:
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Wash your skin with a lot of soap and water.
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If your skin gets red or irritated, talk to your health care team.
If medication gets in your eyes:-
Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.
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The following table lists side effects that you may have when getting gilteritinib. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.
Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on gilteritinib.
Common Side Effects (25 to 49 out of 100 people) | |
Side effects and what to do | When to contact health care team |
Liver problems Your health care team may check your liver function with a blood test. Liver changes do not usually cause any symptoms.
If you have any symptoms of liver problems, get emergency medical help right away.
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Get emergency medical help right away |
Diarrhea What to look for?
What to do? If you have diarrhea:
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Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day) |
Nausea and vomiting (Generally mild) What to look for?
What to do? To help prevent nausea:
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Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe |
Constipation What to look for?
What to do? To help prevent constipation:
To help treat constipation:
Ask your health care team for the Constipation Pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Cough and feeling short of breath What to look for?
What to do?
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Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away |
Fatigue What to look for?
What to do?
Ask your health care team for the Fatigue pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Low neutrophils (white blood cells) in the blood (neutropenia) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for?
You have a fever if your temperature taken in your mouth (oral temperature) is:
What to do? If your health care team has told you that you have low neutrophils:
If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away. |
If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away |
Headache; mild joint, muscle pain or cramps (May be severe) What to look for?
What to do?
Ask your health care team for the Pain pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Eye problems What to look for?
What to do?
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Talk to your health care team as soon as possible |
Less Common Side Effects (10 to 24 out of 100 people) | |
Side effects and what to do | When to contact health care team |
Mild swelling What to look for?
What to do?
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Talk to your health care team if it does not improve or if it is severe |
Dizziness What to look for?
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Talk to your health care team if it does not improve or if it is severe |
Low appetite What to look for?
Ask your health care team for the Loss of Appetite pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Low blood pressure What to look for?
What to do?
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Talk to your health care team if it does not improve or if it is severe |
Pains or cramps in the belly What to look for?
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Talk to your health care team if it does not improve or if it is severe |
Rash; dry, itchy skin What to look for?
What to do? To prevent and treat dry skin:
Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away. |
Talk to your health care team if it does not improve or if it is severe |
Mouth sores What to look for?
To help prevent mouth sores:
Ask your health care team for the Oral Care (Mouth Care) pamphlet for more information. |
Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow |
Taste changes What to look for?
What to do?
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Talk to your health care team if it does not improve or if it is severe |
Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:
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irregular heartbeat, shortness of breath, chest pain or fainting spells
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symptoms of an allergic reaction such as fever, itchiness, rash, swollen lips, face or tongue, chest and throat tightness
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lower back pain, swelling and peeing less than usual
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numbness or tingling of your fingers and toes may happen after starting your treatment
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severe headache, fainting, seizures, confusion and vision loss
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pain in the centre of your belly that may extend to your back
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new swelling neck, groin, or underarm area unusually fast weight gain, bone pain
Who do I contact if I have questions or need help?My cancer health care provider is: ______________________________________________ During the day I should contact:________________________________________________ Evenings, weekends and holidays:______________________________________________
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Other Notes:
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March 2022 New medication information sheet
For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.
The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.
A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.