What is the most important information I should know about XOSPATA?
Here you will find answers to some of the most commonly asked questions about FLT3m+ AML and XOSPATA (Zoh spah' tah). Clicking on a question will reveal the answer. If you have other questions, reach out to your doctor.
Throughout this section, you'll notice that some words are magenta and bold. These words are defined in a glossary of terms at the bottom of the page.
Acute myeloid leukemia, or AML, is a type of blood cancer that starts in the bone marrow, where blood cells are made. In FLT3m+ AML, mutations in the FLT3 gene cause abnormal (leukemia) cells to grow and multiply, leaving less room for healthy blood cells to develop.
Mutations in the FLT3 gene are the most common types of mutations in AML. About 1 in 3 people diagnosed with AML may have a FLT3 mutation.
Relapse is when AML comes back after a period of improvement with treatment. Refractory means AML has not improved after previous treatment(s).
A targeted therapy, like XOSPATA, works by targeting specific parts of cancer cells in order to lower the number of these cells in the body.
XOSPATA is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a FLT3 mutation when the disease has come back or has not improved after previous treatment(s). Your healthcare provider will perform a test to make sure that XOSPATA is right for you. It is not known if XOSPATA is safe and effective in children.
XOSPATA is a targeted therapy and works differently than traditional chemotherapy. Traditional chemotherapy works by killing fast-growing cells, which can include cancer cells and other types of cells. Targeted therapies are designed to target certain features of cancer cells, like mutations. Other cells in the body may still be affected during treatment, but this type of therapy is designed with a specific target in mind.
In FLT3m+ AML, the number of leukemia cells increases in the bone marrow, leaving less room for healthy cells to grow. XOSPATA targets the FLT3 mutation, which may cause leukemia cells to stop growing in the bone marrow.* With fewer leukemia cells, the bone marrow may have more room for healthy blood cells.
*This is how XOSPATA was shown to work in laboratory studies.
Your doctor may use different measures to know if you are responding to treatment. One way is to check your blood counts to measure the number of leukemia cells in your body. When there are no signs of leukemia cells found in the blood or bone marrow, and blood counts have returned to normal, it is called complete remission. This does not mean that the cancer has been cured.
It may take time to see a response with XOSPATA. Your doctor may treat you with XOSPATA for a minimum of 6 months, as long as your disease is not getting worse and there are no serious side effects.
The most common side effects of XOSPATA include:
Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking XOSPATA if you develop certain side effects during treatment with XOSPATA.
These are not all of the possible side effects of XOSPATA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before taking XOSPATA, tell your healthcare provider about all of your medical conditions, including if you:
Take XOSPATA exactly as your healthcare provider tells you to. Do not change your dose or stop taking XOSPATA without talking to your healthcare provider. Take XOSPATA 1 time a day at about the same time each day. Swallow XOSPATA tablets whole. Do not break, crush, or chew the tablet. XOSPATA can be taken with or without food.
If you miss a dose of XOSPATA, or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose. Return to your normal schedule the following day. Do not take 2 doses of XOSPATA within 12 hours.
If you have further questions about your XOSPATA dose, reach out to your doctor.
XOSPATA comes in a child-resistant package. Store XOSPATA at room temperature between 68°F to 77°F (20°C to 25°C). Keep XOSPATA in the original container to protect it from light, moisture, and humidity.
Keep XOSPATA and all medicines out of the reach of children.
XOSPATA is a specialty drug, so it cannot be filled at your local pharmacy. After your doctor writes you a prescription for XOSPATA, they can send the prescription to a specialty pharmacy or to XOSPATA Support SolutionsSM.
Next, XOSPATA Support SolutionsSM or the specialty pharmacy will call you to confirm details about your address and insurance coverage.
After your XOSPATA prescription is approved by your insurance company, it will be dispensed and shipped by a XOSPATA network specialty pharmacy right to your home. You will then receive a call from the specialty pharmacy to arrange refills of your prescription.
Your doctor may also be able to provide XOSPATA in their office. Ask your doctor if this is an option for you.
If XOSPATA is not covered by your insurance, XOSPATA Support SolutionsSM may be able to help. XOSPATA Support SolutionsSM helps people who have been prescribed XOSPATA access their medication as quickly as possible.
When you call XOSPATA Support SolutionsSM, a case manager will work with you to understand your healthcare coverage and identify financial assistance information that may be available to help.
To speak with a case manager, call XOSPATA Support SolutionsSM at 1-844-632-9272, Monday through Friday, 8:30 am to 8:00 pm ET.
If you have commercial prescription insurance, you may be eligible* for the XOSPATA Copay Card Program. With the copay card, you pay as little as $0 per prescription, up to a maximum savings of $25,000 per calendar year, and are enrolled in the program for a 12-month period. You have a maximum copay assistance limit of $7000 per calendar year. There are no income requirements. Talk to your doctor or pharmacist about enrolling in the XOSPATA Copay Card Program.
*By enrolling in the XOSPATA Patient Savings Program ("Program"), the patient acknowledges that they currently meet the eligibility criteria and will comply with the following terms and conditions: The Program is for eligible patients with commercial prescription insurance coverage for XOSPATA® (gilteritinib) and is good for use only with a valid prescription for XOSPATA. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Patients who move from commercial insurance to federal or state health insurance will no longer be eligible, and agree to notify the Program of any such change. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received by the patient through the Program. This offer is not conditioned on any past, present, or future purchase of XOSPATA. This offer is not transferrable and cannot be combined with any other offer, free trial, prescription savings card, or discount. The full value of the Program benefits is intended to pass entirely to the eligible patient. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, Puerto Rico, Guam and Virgin Islands. This offer is not valid for cash paying patients. This Program is void where prohibited by law. No membership fees. It is illegal to sell, purchase, trade, counterfeit, duplicate, or reproduce, or offer to sell, purchase, trade, counterfeit, duplicate or reproduce the card. This offer will be accepted only at participating pharmacies. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice. The Program has a maximum copay assistance limit of $7,000 per calendar year. After the annual maximum on copay assistance is reached, patient will be responsible for the remaining out-of-pocket costs for XOSPATA. Astellas may reduce or discontinue the copay assistance available under the Program if it determines an enrolled patient is subject to a program offered by a third-party payer or pharmacy benefit manager, or an agent of either, that adjusts patients’ out-of-pocket cost-sharing obligations based on the copay assistance provided by this Program, or excludes the copay assistance provided under this Program from counting towards an enrolled patient’s out-of-pocket cost-sharing obligations (“maximizer” or “accumulator” program). The Program uses advanced logic to identify whether a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program. Unless prohibited by law, Astellas may reduce the cost-sharing assistance available under the Program to a per claim maximum of $25 if it determines a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program.
When symptoms or signs start fast and quickly worsen.
The part of the body where blood cells are made.
Piece of deoxyribonucleic acid (DNA) that determines traits, passed on through families.
A type of cancer that starts in blood-forming tissue, such as bone marrow.
A small, ring-shaped cell that helps to form clots in the blood in order to slow or stop bleeding and to help wounds heal.
Cancer that has not improved after previous treatment(s).
When cancer has come back after a period of improvement.
Treatment that works by targeting specific parts of cancer cells in order to lower the number of these cells in the body.