Overview | Schedule | Side Effects | Monitoring | Tips | Patient Assistance | Emotional Wellness | Drugs | References
Treatment Name: Gilteritinib (Xospata®)
How does gilteritinib work?
A mutated FLT3 protein, (pronounced “flit three”), is sometimes found in myeloid white blood cells and can cause these cells to divide more rapidly and survive longer, leading to leukemia. Gilteritinib is designed to bind to mutated FLT3 (FLT3 stands for Fms-Like Tyrosine kinase 3) on the surface of myeloid leukemia cells. By blocking the function of the abnormally active FLT3 protein, gilteritinib slows the production of new leukemia cells and causes some of the leukemia cells to die. Patients without a known FLT3 mutation may not benefit from gilteritinib (Xospata®).
Goals of therapy:
Gilteritinib is taken to help patients achieve remission and possibly receive a bone marrow transplant. If a bone marrow transplant can be done, gilteritinib is commonly given with the goal of cure; however, if a bone marrow transplant cannot be done, gilteritinib is given to help patients live longer, but is not given with the goal of cure.
How is gilteritinib therapy for AML taken?
- Usual starting dose: 120 mg (three 40 mg tablets) by mouth once daily, every day
Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.
Gilteritinib is usually taken at home. It is taken until the therapy no longer works, unacceptable side effects occur, or when a bone marrow transplant can be done. Therapy is typically given for at least six months to see if it works.
What are the most common side effects from gilteritinib for AML?
In clinical studies, the most commonly reported side effects of gilteritinib (Xospata®) are shown here:
- Neutropenic fever (47%)
- Low red blood cells [Anemia] (47%)
- Fever (43%)
- Liver injury (42%)
- Diarrhea (33%)
- Constipation (31%)
- Low blood potassium (29%)
- Fatigue (29%)
- Cough (29%)
- Low platelets [Thrombocytopenia] (26%)
- Headache (26%)
- Swelling in arms or legs (24%)
- Shortness of breath (24%)
- Vomiting (22%)
On average, 11% of patients discontinue treatment due to unacceptable side effects.
Importantly, not all people who experience a side effect from gilteritinib will experience it in the same way. It may be mild in some or severe in others, depending upon the individual. Everybody is different. Additionally, side effects may vary over time. For some, side effects may be a reason to delay or switch treatment, reduce the dose, or avoid treatment with a certain medication altogether.
Side effects may be treatable when they occur or preventable by taking certain medications before they happen. When medications are taken to prevent a problem, this is known as prophylaxis, or "prophy" for short.
After starting treatment with gilteritinib, be sure to come back and watch all of the side effect videos shown below. Each of these videos contain valuable information about side effect management that will hopefully help you to both feel better and stay out of the hospital.
Watch videos on common gilteritinib therapy side effects below
How often is monitoring needed?
Labs (blood tests) may be checked before treatment, once weekly for the first month, then every other week for the second month. It may then be checked once monthly thereafter, if stable. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), creatine phosphokinase, plus any others your doctor may order. An EKG may be checked before treatment, then once weekly for two weeks, then monthly thereafter.
How often is imaging needed?
Imaging may be checked if there are concerns for an infection or to check for certain side effects. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue gilteritinib as planned, reduce the dose, delay treatment until the side effect goes away, or switch to an alternative therapy.
Questions to Ask Your...
A better understanding of your treatments will allow you to ask more questions of your healthcare team. We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it's not always easy to know what questions to ask, we've tried to make it easy for you!
Choose any healthcare provider below to see common questions that you may want to ask of this person. Then, either print each list to bring to your clinic visits, or copy the questions and send them as a message to your healthcare team through your electronic medical record.
What are the most important things to know about gilteritinib while receiving therapy?
- Differentiation syndrome may occur anytime during the first two months of treatment with gilteritinib. It is characterized by fever, shortness of breath, weight gain, or heart, liver, or kidney problems. It may be life threatening. It is best treated with a potent steroid known as dexamethasone if it develops
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for AML. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Gilteritinib (Xospata®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Gilteritinib (Xospata®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Gilteritinib (Xospata®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Gilteritinib (Xospata®)