Vanflyta Side Effects

Generic name: quizartinib

Medically reviewed by Drugs.com. Last updated on Sep 20, 2023.

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

Applies to quizartinib: oral tablet.

Warning

Oral route (Tablet)

Warning: QT Prolongation, Torsades de Pointes, and Cardiac ArrestQuizartinib prolongs the QT interval in a dose- and concentration-related manner. Prior to quizartinib administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECG to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.Torsades de pointes and cardiac arrest have occurred in patients receiving quizartinib. Do not administer quizartinib to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.Do not initiate treatment with quizartinib or escalate the quizartinib dose if the QT interval corrected by Fridericia's formula (QTcF) is greater than 450 ms.Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.Reduce the quizartinib dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.Because of the risk of QT prolongation, quizartinib is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

Serious side effects of Vanflyta

Along with its needed effects, quizartinib (the active ingredient contained in Vanflyta) 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 quizartinib:

More common

Black, tarry stools
bleeding gums
blood in the urine or stools
body aches or pain
burning or stinging of the skin
chills
confusion
cough
dizziness
ear congestion
fainting
fast heartbeat
fever
headache
lightheadedness
loss of voice
lower back or side pain
painful cold sores or blisters on lips, nose, eyes, or genitals
painful or difficult urination
pale skin
pinpoint red spots on the skin
stuffy or runny nose
trouble breathing
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness

Incidence not known

Chest pain or discomfort
irregular or slow heart rate
no blood pressure
stopping of the heart
unconsciousness

Other side effects of Vanflyta

Some side effects of quizartinib 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

Cracked lips
diarrhea
difficulty in swallowing
eye redness, irritation, or pain
nausea
red, sore eyes
stomach pain
trouble sleeping
vomiting

For Healthcare Professionals

Applies to quizartinib: oral tablet.

General

The most common adverse reactions occurring in greater than 20% of patients included laboratory abnormalities, neutropenia/febrile neutropenia, diarrhea, mucositis, nausea, abdominal pain, sepsis, headache, vomiting, and upper respiratory tract infection.^[Ref]

Cardiovascular

Very common (10% or more): Electrocardiogram QT prolonged (14%), increased baseline QTcF greater than 60 ms (10%)

Common (1% to 10%): Observed QTcF greater than 500 ms

Uncommon (0.1% to 1%): Torsades de pointes, cardiac arrest, ventricular fibrillation

Very rare (less than 0.01%): Fatal ventricular dysfunction, fatal cardiac arrest

Gastrointestinal

Very common (10% or more): Diarrhea, including colitis, enteritis, enterocolitis, gastroenteritis, and neutropenic colitis (42%), mucositis, including anal inflammation, anal ulcer, anorectal discomfort, aphthous ulcer, laryngeal inflammation, laryngeal pain, mucosal inflammation, edema mucosal, esophageal pain, esophageal ulcer, esophagitis, oral blood blister, oral disorder, oral mucosa erosion, oral mucosal blistering, oral mucosal erythema, oral pain, oropharyngeal pain, pharyngeal inflammation, proctalgia, proctitis, stomatitis, tongue ulceration, (38%), nausea (34%), abdominal pain (30%), vomiting (25%), dyspepsia (11%)

Genitourinary

Frequency not reported: Vaginal ulceration due to mucositis

Hematologic

Very common (10% or more): Lymphocytes decreased (60%), albumin decreased (53%), febrile neutropenia, including fatalities (44%), neutropenia (29%), thrombocytopenia (18%), anemia (11%)

Frequency not reported: Myelosuppression

Events reported in other clinical trials: Acute febrile neutrophilic dermatosis (3%)

Additional comments: Notable thrombocytopenia or neutropenia in the absence of active leukemia lasting past cycle day 42 of induction cycle 1 were noted in 8% of patients

Metabolic

Very common (10% or more): Potassium decreased (59%), phosphorus decreased (52%), alkaline phosphatase decreased (51%), magnesium decreased (44%), calcium decreased (33%), creatinine phosphokinase increased (26%), potassium increased (15%), magnesium increased (14%), sodium increased (13%), decreased appetite (17%)

Nervous system

Very common (10% or more): Headache (28%)

Uncommon (0.1% to 1%): Fatal brain edema, fatal cerebral infarction

Ocular

Very common (10% or more): Eye irritation, including dry eye, eye inflammation, eye irritation, eye pain, eye pruritus, foreign body sensation in eyes, keratitis, and ulcerative keratitis (11%)

Oncologic

Events reported in other clinical trials: Differentiation syndrome (5%)

Other

Very common (10% or more): Sepsis (30%), fungal infections (16%), herpes virus infections (14%)

Common (1% to 10%): Fatal adverse reactions from all types (up to 10%)

-Sepsis included: Acinetobacter infection, bacteremia, bacterial sepsis, corynebacterium bacteremia, device related bacteremia, device related sepsis, enterobacter sepsis, enterococcal bacteremia, enterococcal sepsis, escherichia bacteremia, Escherichia sepsis, klebsiella bacteremia, klebsiella sepsis, neutropenic sepsis, pseudomonal bacteremia, pulmonary sepsis, sepsis, septic shock, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, stenotrophomonas sepsis, streptococcal sepsis, and streptococcal bacteremia

-Fungal infections included: Aspergillosis oral, aspergillus infection, bronchopulmonary aspergillosis, candida infection, candida sepsis, fungal infection, fungal sepsis, fungal skin infection, fusarium infection, gastrointestinal candidiasis, hepatic infection fungal, hepatosplenic candidiasis, lower respiratory tract infection fungal, mucormycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, systemic candida, systemic mycosis, tinea cruris, and vulvovaginal candidiasis

-Herpes virus infections included: Disseminated varicella zoster virus infection, genital herpes, herpes simplex, herpesvirus infection, herpes zoster, oral herpes, and varicella zoster virus infection

Psychiatric

Very common (10% or more): Insomnia (14%)

Respiratory

Very common (10% or more): Upper respiratory tract infection (21%), epistaxis (15%)

Very rare (less than 0.01%): Fatal acute respiratory distress syndrome, fatal pulmonary embolism

Hepatic

Very common (10% or more): Hypertransaminasemia, including increased: alanine aminotransferase, aspartate aminotransferase, transaminases, hepatic enzymes (19%)