(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.
Drug Type: Gilteritinib is a targeted therapy. This medication is classified as a signal transduction inhibitor - a protein-tyrosine kinase inhibitor (for more detail, see "How Gilteritinib Works" below).
What Gilteritinib Is Use For
- Treatment of relapsed or refractory acute myeloid leukemia (AML) in adult patients with a FMS-like tyrosine kinase 3 (FLT3) mutation present in the blood or bone marrow.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Gilteritinib Is Given
- Gilteritinib is a pill taken by mouth once daily
- Gilteritinib can be taken with or without food, but should not be crush or broken
- It is best to take gilteritinib at about the same time each day
- If you miss a dose of gilteritinib, it should be taken as soon as possible on the same day, and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day.
- Do not take extra tablets of gilteritinib to make up the missed dose and do not take more than 2 doses within 12 hours.
- Store the medication in the original bottle at room temperature (68° F to 77° F)
The amount of gilteritinib that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of gilteritinib:
- Most people will not experience all of the gilteritinib side effects listed.
- Gilteritinib side effects are often predictable in terms of their onset, duration, and severity.
- Gilteritinib side effects will improve after therapy is complete
- Gilteritinib side effects may be quite manageable. There are many options to minimize or prevent the side effects of gilteritinib.
The following side effects are common (occurring in greater than 30%) for patients taking Gilteritinib:
These are less common side effects (occurring in 10-29%) for patients receiving Gilteritinib:
These are rare serious side effects for patients receiving gilteritinib:
- Differentiation syndrome: Differentiation syndrome can occur as early as 2 days and during the first 3 months of treatment. Common symptoms include fever, cough, trouble breathing, swelling of the arms and legs, fluid build-up around the heat and lungs, and rapid weight gain. Call your doctor or go to the nearest emergency room if you develop these symptoms. Differentiation syndrome can be life-threatening or fatal if not treated.
Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10 percent of patients - are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
- Altered mental status
- Change in heartbeat
- Dizziness, lightheadedness or fainting
- Severe stomach pain
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
- Abdominal pain that radiates to the back
- Abdominal tenderness or swelling
Always inform your health care provider if you experience any unusual symptoms.
- Before starting gilteritinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
- Gilteritinib may be inadvisable if you have a history of severe allergic reaction to gilteritinib or any of the ingredients of gilteritinib.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking gilteritinib.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking gilteritinib, the medication must be stopped immediately and the woman given appropriate counseling.
- For both men and women: abstinence from sexual intercourse is safe and effective for preventing potential deleterious/toxic effects to a fetus. Use contraceptives, and do not conceive a child (get pregnant) while taking gilteritinib. Barrier methods of contraception, such as condoms, are recommended for at least 6 months after the last dose of gilteritinib.
- Do not breast feed while taking gilteritinib or for 2 months after taking the last dose.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often and after taking each dose of gilteritinib.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports of activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Gilteritinib
You will be checked regularly by your doctor while you are taking gilteritinib to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver). An electrocardiogram (ECG) will also be ordered by your doctor prior to starting treatment with gilteritinib and throughout treatment.
How Gilteritinib Works
Gilteritinib is a targeted therapy. Targeted therapy is the result of many years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, and may be effected by cancer treatments causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists looks for specific differences between the cancer cells and the normal cells. This information is used to help develop a targeted therapy to more directly attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently, but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Gilteritinib is a targeted therapy that targets and binds to multiple enzymes known as tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). FLT3 is a key signaling molecule of lymphocyte development that plays an important role in cell differentiation and survival. By binding to these receptors gilteritinib blocks an important pathway that promotes cell division.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.