Frequently Asked Questions about Xospata® (gilteritinib)

Understand the administration, side effects and answers to frequently asked questions about Xospata®

Generic Name: gilteritinib

Trade Name: Xospata®

For which conditions is Xospata approved for? Xospata is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and/or life-threatening side effects of differentiation syndrome which affects your blood cells.

What is the mechanism of action? Xospata is kinase inhibitor. A kinase is a type of protein in the body that helps control cell division. Cancer cells grow in an uncontrolled fashion, and Xospata works by interfering with the kinase to stop cancer cells from dividing and growing.

How is Xospata typically given (administered)? Xospata is taken orally, once per day at the same time each day. Xospata should be swallowed whole (do not chew or split) with or without food. If you miss a dose or vomit immediately after you have taken Xospata, take the dose of Xospata as soon as possible on the same day and take your next dose the next day at your regularly scheduled time; do not take two doses within 12 hours. However, do not take two doses at the same time to make up for a missed dose.

How are patients typically monitored? During treatment with Xospata, at a minimum your healthcare provider will do blood tests to check your blood counts and echochardiograms. Xospata may harm an unborn baby. Do not breastfeed during treatment with Xospata and for at least 1 month after the last dose of Xospata.

What are the common (occur in 20% or more of patients) side effects of treatment with Xospata?

  • Changes in liver function tests
  • Joint or muscle pain
  • Fatigue
  • Fever
  • Mouth sores
  • Swelling of arms or legs
  • Rash
  • Diarrhea
  • Shortness of breath
  • Nausea
  • Cough
  • Constipation
  • Eye problems
  • Headache
  • Dizziness
  • Low blood pressure
  • Vomiting
  • Decreased urination

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xospata and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Are there any special precautions patients should be aware of before starting treatment?

Tell your doctor about all of your medical conditions including heart problems, experience abnormal electrolytes or if you or your partner are pregnant or are planning on becoming pregnant and if you are breastfeeding. Xospata may cause serious side effects including posterior reversible encephalopathy syndrome (PRES). Do not take Xospata if you are allergic to gilteritinib or any of the ingredients in Xospata.

When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your doctor right away if you experience any of the following that worsen quickly: a seizure or headache, change in alertness, confusion or changes in eyesight.

XOSPATA may cause severe or life-threatening side effects from differentiation syndrome and it is important that you call your healthcare provider or seek care from the nearest emergency room right away if you experience any of the following symptoms:

· Fever

· Cough

· Shortness of breath

· Swelling of arms and legs

· Rash

· Decreased urination

· Swelling around neck, grown or underarm area

· Fast weight gain (more than 10 pounds in a week)

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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