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.
Serious side effects of Gilteritinib
Along with its needed effects, gilteritinib 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 or tightness
- 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
- trouble 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
- 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
Other side effects of Gilteritinib
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]
