Applies to avapritinib: oral tablet.
Serious side effects of Avapritinib
Along with its needed effects, avapritinib 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 avapritinib:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest tightness
- defects in intelligence, short-term memory, learning ability, and attention
- dizziness
- ear congestion
- headache
- loss of voice
- lower back or side pain
- mood or mental changes
- nervousness
- pale skin
- pounding in the ears
- runny or stuffy nose
- slow or fast heartbeat
- sneezing
- sore throat
- trouble sleeping
- trouble with breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Agitation
- black, tarry stools
- bloody stools
- chest pain
- chills
- confusion
- constipation
- cough
- decreased awareness or responsiveness
- decreased urine output
- depressed mood
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry skin and hair
- dilated neck veins
- fainting
- feeling cold
- fever
- frequent urge to urinate
- gaseous stomach pain
- hair loss
- hoarseness or husky voice
- hostility
- increased sensitivity of the skin to sunlight
- irritability
- lightheadedness
- loss of consciousness
- muscle cramps, stiffness, and twitching
- nausea
- pounding in the ears
- rapid weight gain
- rapid, shallow breathing
- redness or other discoloration of the skin
- seizures
- sensitivity to heat
- severe sleepiness
- severe sunburn
- skin rash
- sneezing
- sore throat
- stomach pain and bloating
- sweating
- swelling of the face, ankles, or hands
- swelling of the finger, feet, or lower legs
- unusual drowsiness, dullness, or feeling of sluggishness
- vomiting of blood or material that looks like coffee grounds
- weight gain or loss
- yellow eyes or skin
Other side effects of Avapritinib
Some side effects of avapritinib 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
- Bad unusual or unpleasant (after)taste
- belching
- change in taste
- decreased appetite
- diarrhea
- difficulty in moving
- feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
- hair color changes
- heartburn
- increased tearing
- indigestion
- muscle pain or stiffness
- pain in the joints
- skin rash
- stomach discomfort, upset, or pain
- swelling of the eye, eyelid, or inner lining of the eyelid
- vomiting
Less common
- Redness or pain of the skin
- scaling of the skin on the hands and feet
- tingling of the hands and feet
- ulceration of the skin
For Healthcare Professionals
Applies to avapritinib: oral tablet.
Hematologic
Very common (10% or more): Hemoglobin decreased (81%), leukocytes decreased (62%), neutrophils decreased (43%), platelets decreased (27%), international normalized ratio (INR) increased (24%), activated partial thromboplastin time increased (13%)[Ref]
Ocular
Very common (10% or more): Increased lacrimation (33%)[Ref]
Metabolic
Very common (10% or more): Anorexia (38%), phosphate decreased (49%), potassium decreased (34%), albumin decreased (31%), magnesium decreased (29%), sodium decreased (28%), weight loss (13%)[Ref]
Psychiatric
Very common (10% or more): Cognitive impairment (48%), sleep disorders (e.g., insomnia, somnolence, sleep disorder) (15%), mood disorders (e.g., agitation, anxiety, depression, depressed mood, dysphoria, irritability, mood altered,
nervousness, personality change, suicidal ideation) (13%)
Common (1% to 10%): Speech disorders, hallucinations[Ref]
Hepatic
Very common (10% or more): Bilirubin increased (69%), aspartate aminotransferase increased (51%), alkaline phosphatase increased (14%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (17%), pleural effusion (12%)[Ref]
Other
Very common (10% or more): Edema (e.g., face swelling, conjunctival edema, eye edema, eyelid edema, orbital edema, periorbital edema, face edema, mouth edema, pharyngeal edema, peripheral edema, edema, generalized edema, localized edema, peripheral swelling, testicular edema) (72%), fatigue/asthenia (61%), pyrexia (14%)[Ref]
General
The most common adverse reactions (20% or greater) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness.[Ref]
Nervous system
Very common (10% or more): Dizziness (22%), headache (17%), taste effects (e.g., dysgeusia, ageusia) (15%)[Ref]
Renal
Very common (10% or more): Creatinine increased (29%)[Ref]
Cardiovascular
Common (1% to 10%): Intracranial hemorrhage (e.g., subdural hematoma, intracranial hemorrhage, cerebral hemorrhage)[Ref]
Dermatologic
Very common (10% or more): Rash (e.g., rash, rash maculopapular, rash erythematous, rash macular, rash generalized, rash papular) (23%), hair color changes (21%), alopecia (13%)
Common (1% to 10%): Palmar-plantar erythrodysesthesia[Ref]
Endocrine
Common (1% to 10%): Thyroid disorders (e.g., hyperthyroid, hypothyroid)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (64%), vomiting (38%), diarrhea (37%), abdominal pain (e.g., abdominal pain, upper abdominal pain, abdominal discomfort, lower abdominal pain, abdominal tenderness, epigastric discomfort) (31%), constipation (23%), dyspepsia (16%)[Ref]
