VANFLYTA showed a manageable safety profile

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation1

  • VANFLYTA has serious Warnings and Precautions. The following safety profile is a partial presentation of the risks associated with VANFLYTA. Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide2
  • Contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes2
  • QT Prolongation, Torsades de Pointes, and Cardiac Arrest: Monitor electrocardiograms and levels of serum electrolytes. Reduce, interrupt, or permanently discontinue VANFLYTA as appropriate2
  • Embryo-Fetal Toxicity: VANFLYTA can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception2
Common adverse
reactions

Adverse Reactions (≥10%) in Patients Receiving VANFLYTA (with a Difference Between Arms of ≥2% Compared to Placebo) IN THE CLINICAL TRIAL2

Chart outlining the common adverse reactions in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy Swipe to the left
Chart outlining the common adverse reactions in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy

*Including fatalities.2

Includes other related terms.2

Diarrhea includes colitis, diarrhea, enteritis, enterocolitis, gastroenteritis, and neutropenic colitis.2

§Mucositis includes 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 mucosal erosion, oral mucosal blistering, oral mucosal erythema, oral pain, oropharyngeal pain, pharyngeal inflammation, proctalgia, proctitis, stomatitis, tongue ulceration, and vaginal ulceration.2

||Sepsis includes 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.2

Fungal infection includes 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.2

#Herpesvirus infection (including fatal events) include disseminated varicella zoster virus infection, genital herpes, herpes simplex, herpesvirus infection, herpes zoster, oral herpes, and varicella zoster virus infection.2

**Hypertransaminasemia includes alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hepatic enzymes increased, and hypertransaminasemia.2

††Eye irritation includes dry eye, eye inflammation, eye irritation, eye pain, eye pruritus, foreign body sensation in eyes, keratitis, and ulcerative keratitis.2

Laboratory
Abnormalities

Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients (with a Difference Between Arms of ≥2% Compared to Placebo) IN THE CLINICAL TRIAL1

Chart outlining laboratory abnormalities in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy Swipe to the left
Chart outlining laboratory abnormalities in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy

*The denominator used to calculate the rate varied from 199 to 260 in VANFLYTA + chemotherapy and from 187 to 267 in placebo + chemotherapy based on the number of patients with a baseline value and at least one post-treatment value.2

  • Serious adverse reactions in ≥5% of patients who received VANFLYTA plus chemotherapy were: febrile neutropenia (11%). Fatal adverse reactions occurred in 10% of patients who received VANFLYTA plus chemotherapy, including sepsis (5%), fungal infections (0.8%), brain edema (0.8%), and one case each of febrile neutropenia, pneumonia, cerebral infarction, acute respiratory distress syndrome, pulmonary embolism, ventricular dysfunction, and cardiac arrest2
  • With VANFLYTA, 34% of patients experienced a dose interruption due to ARs, 19% had a dose reduction, and 20% discontinued2
    • Adverse reactions which required dosage interruption in ≥2% of patients in the VANFLYTA arm included neutropenia (11%), thrombocytopenia (5%), and myelosuppression (3%)2
    • Adverse reactions which required dosage reductions in ≥2% of patients in the VANFLYTA arm were neutropenia (9%), thrombocytopenia (5%), and electrocardiogram QT prolonged (4%)2
    • The most frequent (≥2%) adverse reaction which resulted in permanent discontinuation in the VANFLYTA arm was sepsis (5%)2

AR=adverse reaction.

The VANFLYTA REMS
VANFLYTA is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS because of the serious risk of QT prolongation, torsades de pointes, and cardiac arrest.2
Further information is available at www.VANFLYTAREMS.com or by calling 1-855-212-6670.
References:

1. Daver N, Schlenk RF, Russell NH, Levis MJ. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019;33:299-312. doi:10.1038/s41375-018-0357-9 2. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023.