What is the most important information I should know about tagraxofusp?
Call your doctor right away if you have signs of a serious side effect called capillary leak syndrome: stuffy or runny nose followed by tiredness or dizziness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.
What is tagraxofusp?
Tagraxofusp is used to treat blastic plasmacytoid dendritic cell neoplasm, a rare blood and/or bone marrow cancer.
This medicine is for use in adults and children at least 2 years old.
Tagraxofusp may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving tagraxofusp?
You may need to have a negative pregnancy test 1 week before starting this treatment.
Tagraxofusp may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
How is tagraxofusp given?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using tagraxofusp.
Tagraxofusp is given as an infusion into a vein. A healthcare provider will give you this injection.
You may receive this medicine in a hospital or clinic setting to quickly treat any serious side effects.
You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.
Tagraxofusp is given in a 21-day treatment cycle. You may need to use the medicine only during the first 5 days of each cycle. Your doctor will determine how long to treat you with this medicine.
You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed or permanently discontinued based on the results.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your tagraxofusp injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving tagraxofusp?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of tagraxofusp?
Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; mouth sores; sudden warmth or tingly feeling; difficult breathing; swelling of your face, lips, tongue, or throat.
Capillary leak syndrome is a serious side effect of tagraxofusp. Call your doctor right away if you have a stuffy or runny nose followed by:
- tiredness or dizziness;
- decreased urination;
- trouble breathing; and
- sudden swelling or weight gain.
Common side effects may include:
- capillary leak syndrome;
- swelling in your hands or feet;
- fever; or
- weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect tagraxofusp?
Other drugs may affect tagraxofusp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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