Gilteritinib (Xospata®)
Pronounce: GIL te RI ti nib
Classification: Kinase inhibitor
About Gilteritinib (Xospata®)
A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a particular enzyme from working, this medication can slow the growth of cancer cells. Gilteritinib works in certain leukemias with a mutation in the FLT3 gene. Your oncology team will test you for this mutation, which must be present to receive the medication.
How to Take Gilteritinib
Gilteritinib is given in 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. If you miss a dose and it has been less than 12 hours since your regular dose time, take it as soon as you remember. If it has been more than 12 hours, skip the dose. Do not take 2 doses at once to make up for a missed dose.
It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.
The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include carbamazepine, dexamethasone, phenytoin, rifampin, phenobarbital, and St.John’s Wort, among others. Be sure to tell your healthcare provider about all medications and supplements you take.
Storage and Handling
Store your medication in the original container with the label. If you want to use a pillbox, talk to your pharmacist. Keep it in a dry place at room temperature unless your provider or pharmacist tells you otherwise. Keep containers out of reach of children and pets.
If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing people should not prepare the dose for you. Ask your provider where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.
Where Do I Get This Medication?
Some cancer medications are only available through specialty pharmacies. Your provider or pharmacist will start this process. Your insurance plan may also affect where you can get your medication. Call your prescription plan provider to find out which specialty pharmacies are in-network.
Insurance Information
This medication may be covered by your prescription plan. If you qualify, you may be able to get financial help through patient assistance programs (PAP). Co-pay cards may also be available to lower your out-of-pocket cost if you have commercial (not Medicare/Medicaid/Tricare) insurance. Your pharmacist, social worker, or navigator can help find resources for financial support.
Possible Side Effects
These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.
Differentiation Syndrome
Differentiation syndrome is when there is a large, fast release of certain proteins from your immune system. These proteins, called cytokines, are released into your bloodstream. This can cause symptoms such as:
- A fever. Call for a temperature over 100.4°F or 38°C or as directed by your provider.
- Sudden weight gain.
- Bone or joint pain.
- Fluid build-up around your heart, lungs, and/or chest, causing shortness of breath.
You may be given medications to help treat this syndrome. Your provider will watch closely for these signs and symptoms, which often start within 2 weeks of starting treatment, but can happen as long as 6 months after treatment. Tell your provider right away if you have any of these symptoms
Muscle or Joint Pain/Aches and Headache
You may have joint or muscle pain/aches and headaches while taking this medication. Your provider can recommend medications and other ways to help relieve your pain.
Liver Toxicity
This medication can cause liver toxicity, or liver problems, which your provider may monitor for with blood tests called liver function tests. Symptoms may be:
- Yellowing of your skin or eyes.
- Dark or brown urine.
- Pain in your abdomen (belly).
Tell your provider if you have any of these symptoms.
Lung Problems and Pneumonia
This medication can cause various types of pneumonia and/or interstitial lung disease. Symptoms include cough, shortness of breath, and fatigue. Report these symptoms to your oncology care team.
Peripheral Edema
Peripheral edema is swelling in your hands, arms, legs, ankles, and feet. It is caused by retention (buildup) of fluid. To help get rid of the fluid, you can elevate (lift up) the affected body part and rest it on a pillow. You may need medications to help your body get rid of the extra fluid, and you may be told to follow a low salt diet. Tell your providers if you have any new or worsening swelling.
Diarrhea
Diarrhea is when you pass three or more stools in a day. Your providers can suggest medications to relieve diarrhea. Do not take any medications to manage your diarrhea without talking to your provider first, as your stool may need to be tested. To manage it, try eating foods that are low in fiber and bland, like white rice and boiled or baked chicken. Try not to eat raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is a type of fiber found in some foods that helps absorb (soak up) fluid. Foods high in soluble fiber are applesauce, bananas (ripe), canned fruit, oranges, boiled potatoes, white rice, foods made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Stay hydrated by drinking 8 to 10 glasses of non-alcoholic, non-caffeinated fluid each day.
Constipation
Constipation is when you have less bowel movements than usual or are having trouble passing stool. To relieve constipation, you can include fiber in your diet (fruits like prunes, apples, peaches, and pear nectars/juices), drink 8 to 10 glasses of non-alcoholic fluids a day, and stay active. Taking a stool softener once or twice a day can prevent constipation. If you do not have a bowel movement for 2 to 3 days, call your provider.
Nausea and/or Vomiting
Talk to your providers if you have nausea and/or vomiting. They can prescribe medications to help you. Making changes to your diet can also help. Avoid things that make your symptoms worse, like heavy or greasy/fatty foods and spicy or acidic foods, like tomatoes, lemons, and oranges. Try saltines or ginger ale to help your symptoms.
Call your providers if you cannot keep fluids down for more than 12 hours or if you feel lightheaded or dizzy.
Mouth Ulcers (Mucositis)
This medication can cause sores or soreness in your mouth and/or throat, called mucositis. Tell your providers if your mouth, tongue, inside of your cheek, or throat becomes white, has ulcers, or is painful. Medications can be used to manage pain. Regular mouth care can help prevent or manage mouth sores. Some things you can do are:
- Brush with a soft-bristle toothbrush or cotton swab twice a day.
- Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight-ounce glass of warm water) can be used a few times each day.
- If your mouth gets dry, eat moist foods, drink plenty of fluids (6 to 8 glasses), and suck on sugarless hard candy.
- Avoid smoking and chewing tobacco, and drinking alcoholic beverages and citrus juices.
Low Blood Pressure
This medication can cause low blood pressure (hypotension). Patients should have their blood pressure checked regularly during therapy. Report any headaches, vision changes, or dizziness to your oncology care team.
Laboratory Changes
This medication can change many laboratory values. Your healthcare team will monitor your lab values throughout treatment and replace/treat as necessary.
Fatigue
Fatigue can cause exhaustion, feeling worn out and that your body is "heavy" and hard to move, or being unable to focus. It is common when you have cancer, and it is not the same as feeling tired. You may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save your energy for more important activities. Exercise can help lessen fatigue. Talk to your providers about ways to deal with this side effect.
Reproductive Concerns
There is a higher risk of health problems for your baby if you are pregnant, become pregnant, or get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy. Talk with your provider about what kind of birth control is safest for you and your partner.
If you can become pregnant, you will need to use effective birth control for 6 months after the last dose of this medication, even if your menstrual cycle has stopped or changed.
If you can get someone pregnant, you will need to use effective birth control for 4 months after the last dose of this medication, even if you believe you are not producing sperm.
You should not breastfeed during treatment and for 2 months after the last dose of this medication.
Important but Less Common Side Effects
Posterior Reversible Encephalopathy Syndrome (PRES)
This medication can cause a neurological (brain) disorder called posterior reversible encephalopathy syndrome (PRES or reversible posterior leukoencephalopathy (RPLS). Symptoms of PRES/RPLS are:
- Headache.
- Seizure.
- Lethargy (feeling tired, drowsy, sluggish).
- Confusion.
- Blindness and other vision changes.
- Neurological problems.
Tell your provider about any of these symptoms right away.
QT Prolongation
QT prolongation is when your heart is not working how it should, and it can cause slow or abnormal heartbeats or an abnormal heart rhythm. Tell your provider right away if you feel abnormal heartbeats or if you feel dizzy or faint.