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Xospata Side Effects

Generic Name: gilteritinib

Medically reviewed by Drugs.com. Last updated on Aug 5, 2020.

Note: This document contains side effect information about gilteritinib. Some of the dosage forms listed on this page may not apply to the brand name Xospata.

For the Consumer

Applies to gilteritinib: oral tablet

Warning

Oral route (Tablet)

Warning: Differentiation SyndromePatients treated with gilteritinib have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

Side effects requiring immediate medical attention

Along with its needed effects, gilteritinib (the active ingredient contained in Xospata) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking gilteritinib:

More common

  • Bloody urine
  • blurred vision
  • chest pain
  • chills
  • confusion
  • cough
  • decreased frequency or amount of urine
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast or irregular heartbeat
  • fever
  • headache
  • increased thirst
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • nausea
  • nervousness
  • pounding in the ears
  • rapid, shallow breathing
  • recurrent fainting
  • slow heartbeat
  • sneezing
  • sore throat
  • stomach pain
  • sweating
  • swelling of the face, fingers, or lower legs
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Less common

  • Anxiety
  • blue or pale skin
  • chest discomfort
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • difficulty swallowing
  • dilated neck veins
  • extreme tiredness or weakness
  • hives, itching, skin rash
  • irregular breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • unusual drowsiness
  • vision problems

Side effects not requiring immediate medical attention

Some side effects of gilteritinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Change in taste
  • constipation
  • decreased appetite
  • diarrhea
  • loss of taste
  • muscle or joint pain
  • swelling or inflammation of the mouth
  • trouble sleeping

For Healthcare Professionals

Applies to gilteritinib: oral tablet

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction[Ref]

Immunologic

Very common (10% or more): Pneumonia (15%), sepsis (15%)[Ref]

Musculoskeletal

Very common (10% or more): Myalgia/arthralgia (e.g., arthralgia, back pain, bone pain, myalgia, musculoskeletal pain, neck pain, non-cardiac chest pain, pain in extremity) (42%)[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (86%), hypocalcemia (61%), edema (34%), hyponatremia (32%), decreased appetite (15%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (14%)[Ref]

Hepatic

Very common (10% or more): Increased transaminases (aspartate aminotransferase increased, alanine aminotransferase increased, transaminases increased, liver function test increased, hepatic failure, hepatocellular injury, hepatotoxicity) (41%), bilirubin increased (11%)[Ref]

Respiratory

Very common (10% or more): Dyspnea (34%), pneumonia (30%), cough (25%)[Ref]

Other

Very common (10% or more): Fatigue/malaise (40%), fever (35%)

Common (1% to 10%): Differentiation syndrome[Ref]

Nervous system

Very common (10% or more): Headache (21%), dizziness (20%), dysgeusia (11%)

Common (1% to 10%): Posterior reversible encephalopathy syndrome (PRES)[Ref]

Renal

Very common (10% or more): Renal impairment (e.g., acute kidney injury, blood creatinine increased, chronic kidney disease, oliguria, renal disorder, renal

failure, renal impairment, renal injury, renal tubular necrosis) (19%)[Ref]

Cardiovascular

Very common (10% or more): Hypotension (30%), hypertension (10%)

Common (1% to 10%): Prolonged QT interval, cardiac failure (e.g., cardiac failure, cardiac failure congestive, cardiomyopathy, cardiomegaly, chronic left ventricular failure, ejection fraction decreased), pericardial effusion, pericarditis[Ref]

Dermatologic

Very common (10% or more): Rash (30%)[Ref]

Gastrointestinal

Very common (10% or more): Noninfectious diarrhea (34%), nausea (27%), stomatitis (26%), vomiting (20%), abdominal pain (e.g., abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, epigastric discomfort, GI pain) (17%)[Ref]

References

1. "Product Information. Xospata (gilteritinib)." Astellas Pharma US, Inc, Deerfield, IL.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.