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Ayvakit Side Effects

Generic Name: avapritinib

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

For the Consumer

Applies to avapritinib: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Not able to focus.
  • Memory problems or loss.
  • Trouble speaking.
  • Swelling.
  • Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
  • Feeling sleepy.
  • Shortness of breath.
  • Call your doctor right away if you have signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of suicide, seizures, or very bad headaches.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
  • Change in color of hair.
  • Hair loss.
  • Feeling tired or weak.
  • More tears.
  • Headache.
  • Change in taste.
  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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]

References

1. "Product Information. Ayvakit (avapritinib)." Blueprint Medicines Corporation, Cambridge, MA.

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.