Full Answer
How much does xospata® (gilteritinib) cost?
The Astellas Patient Assistance Program a provides XOSPATA ® (gilteritinib) at no cost to patients who meet the program eligibility requirements.
What is gilteritinib used to treat?
Gilteritinib is used to treat acute myeloid leukemia (AML) in adults with an abnormal FLT3 gene. Your doctor will test you for this gene. Gilteritinib is given after other cancer treatments did not work or have stopped working.
What happens if you have an allergic reaction to gilteritinib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Gilteritinib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated.
How should I take gilteritinib?
What is gilteritinib used for?
What other drugs will affect gilteritinib?
How long does it take for Gilteritinib to kill you?
How to report side effects of Gilteritinib?
How long does it take for differentiation syndrome to show up on gilteritinib?
Can you take gilteritinib if you are allergic to it?
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About this website
Gilteritinib Side Effects: Common, Severe, Long Term - Drugs.com
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 1 Sep 2022), Cerner Multum™ (updated 5 Sep 2022), ASHP (updated 12 Sep 2022 ...
Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated ...
Original Article from The New England Journal of Medicine — Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML
Gilteritinib - Wikipedia
Gilteritinib; Clinical data; Trade names: Xospata: AHFS/Drugs.com: Monograph: MedlinePlus: a619003: 6-Ethyl-3-[3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl ...
Gilteritinib (Xospata) - Drug Information | Chemocare
(GIL te RI ti nib) Trade Name(s): Xospata® Gilteritinib is the generic name for the trade name drug Xospata®. In some cases, health care professionals may use the trade name Xospata® when referring to the generic drug name gilteritinib.
Gilteritinib (Xospata®) | Macmillan Cancer Support
Gilteritinib (Xospata ®) is used to treat acute myeloid leukaemia (AML).It is used if tests show that the leukaemia cells have a gene change called an FLT3 mutation. It is best to read this information with our general information about AML.. Gilteritinib is a type of targeted therapy drug called a cancer growth inhibitor.. Your doctor will talk to you about this treatment and its possible ...
FDA approves gilteritinib for relapsed or refractory acute myeloid ...
On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid ...
Astellas Patient Assistance Program
The Astellas Patient Assistance Program a (PAP) provides XOSPATA ® (gilteritinib) at no cost to patients who meet the program eligibility requirements.
Eligibility Requirements
XOSPATA Support Solutions ® will evaluate a patient's eligibility for the Astellas PAP. For more information, contact us at 1-844-632-9272 . We are available Monday–Friday, 8:30 am–8:00 pm ET.
Application Process
Complete the PAP application, including all signatures, and either upload it through the Prescriber Portal or fax it to 1‑844‑730‑8816. If the patient is eligible for the Astellas PAP, we will notify you and the patient, and the XOSPATA prescription will be shipped directly to the patient's home.
XOSPATA May Help People Live Longer
XOSPATA was studied in people with FLT3m+ AML when the disease had come back or had not improved after previous treatment. The study compared overall survival in people who had taken XOSPATA vs those who received chemotherapy. In the study, the median overall survival for people who took XOSPATA was 9 months vs 6 months with chemotherapy.
XOSPATA Support Solutions SM Is Here to Help
XOSPATA Support Solutions can help provide you or your loved one with information about financial assistance programs.
XOSPATA Patient Savings Program
The XOSPATA Patient Savings Program* is for eligible patients who have commercial prescription insurance. The Program parameters are as follows:
ENROLLING IN THE XOSPATA PATIENT SAVINGS PROGRAM
Healthcare provider offices can begin the Program enrollment process on behalf of patients by applying here and selecting the "healthcare provider office" option. The patient will then receive notification by email as to how to complete the Program application process initiated by their healthcare provider office.
How to Take Gilteritinib
Gilteritinib is given in a tablet form to be taken by mouth, typically once a day. You should take this medication with a full glass of water. It can be taken without food. Do not crush, break or chew the tablets. Try to take your dose at the same time each day.
Storage and Handling
Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.
Where do I get this medication?
Depending on your prescription coverage, this medication may be available at your local retail pharmacy or through a specialty pharmacy. Your oncology team will work with your prescription drug plan to identify the appropriate supplier for this medication.
Insurance Information
This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available.
Possible Side Effects of Gliteritinib
There are a number of things you can do to manage the side effects of gilteritinib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:
Differentiation Syndrome
This results from the changes gilteritinib causes to blood cell production in patients with leukemia. Symptoms of differentiation syndrome include fever (temperature >100.4°F or 38°C), sudden weight gain, bone or joint pain, and fluid build-up around the heart, lungs, and/or chest, causing shortness of breath or difficulty breathing.
What is Xospata used for?
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
How to contact Xospata support?
If eligible, XOSPATA Support Solutions SM will ship directly to your patient. For more information on the XOSPATA QUICK START+ Program, call 1-844-632-9272 or visit.
Does Astellas provide Xospata?
The Astellas Patient Assistance Program provides XOSPATA at no cost to patients who meet the program eligibility requirements. †
How should I take gilteritinib?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
What is gilteritinib used for?
Gilteritinib is used to treat acute myeloid leukemia (AML) in adults with an abnormal FLT3 gene. Your doctor will test you for this gene. Gilteritinib is given after other cancer treatments did not work or have stopped working. Gilteritinib may also be used for purposes not listed in this medication guide.
What other drugs will affect gilteritinib?
Other drugs may affect gilteritinib, 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.
How long does it take for Gilteritinib to kill you?
This condition may occur within 2 days to 3 months after you start taking gilteritinib.
How to report side effects of Gilteritinib?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Gilteritinib side effects (more detail)
How long does it take for differentiation syndrome to show up on gilteritinib?
This condition may occur within 2 days to 3 months after you start taking gilteritinib. Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing; bone pain; rapid weight gain; or. swelling in your arms, legs, underarms, groin, or neck.
Can you take gilteritinib if you are allergic to it?
Before taking this medicine. You should not use gilteritinib if you are allergic to it. an electrolyte imbalance (such as low levels of potassium or magnesium in your blood). Before you take gilteritinib, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
How should I take gilteritinib?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
What is gilteritinib used for?
Gilteritinib is used to treat acute myeloid leukemia (AML) in adults with an abnormal FLT3 gene. Your doctor will test you for this gene. Gilteritinib is given after other cancer treatments did not work or have stopped working. Gilteritinib may also be used for purposes not listed in this medication guide.
What other drugs will affect gilteritinib?
Other drugs may affect gilteritinib, 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.
How long does it take for Gilteritinib to kill you?
This condition may occur within 2 days to 3 months after you start taking gilteritinib.
How to report side effects of Gilteritinib?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Gilteritinib side effects (more detail)
How long does it take for differentiation syndrome to show up on gilteritinib?
This condition may occur within 2 days to 3 months after you start taking gilteritinib. Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing; bone pain; rapid weight gain; or. swelling in your arms, legs, underarms, groin, or neck.
Can you take gilteritinib if you are allergic to it?
Before taking this medicine. You should not use gilteritinib if you are allergic to it. an electrolyte imbalance (such as low levels of potassium or magnesium in your blood). Before you take gilteritinib, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Contraindications
Warnings and Precautions
- Differentiation Syndrome (See BOXED WARNING)3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated wit…
Adverse Reactions
- Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These were cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%). 7% discon…
Drug Interactions
- Combined P-gp and Strong CYP3A InducersConcomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers. Strong CYP3A inhibitorsConcomitant use of XOSPATA with a strong CYP3A inhibitor increases …
Specific Populations
- LactationAdvise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose. Please see Full Prescribing Informationincluding BOXED WARNING for additional safety information.