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Vanflyta Quizartinib 26.5 mg Tablet, Film Coated, 14-count — NDC 65597-0511-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vanflyta Quizartinib 26.5 mg Tablet, Film Coated, 14-count — NDC 65597-511-04 (Billing 65597-0511-04)

by Daiichi Sankyo Inc. · 1 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED in 1 BOTTLE

This is a package of 14 tablets of Vanflyta Quizartinib 26.5 mg Tablet, Film Coated from Daiichi Sankyo Inc., marketed since Jul 2023 and currently FDA-listed.

NDC 65597-0511-04
🏷️ FDA NDC (as labeled) 65597-511-04 billing pads the product segment with a zero
This package
Contains14-count Pack sizes2 compare ↓
Also priced by: Part D plans $627.37/unit — full pricing hub ↓
Product page 65597-0511-28 Also comes in: 28 tablets 65597-511-28
Rx only Brand On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65597-511-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65597 labeler · 511 product · 04 package
Package marketed since
Jul 20, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
14 EA per package
Barcode (UPC-A, from the NDC)
3 6559751104 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65597-511-04
Product NDC 65597-511
11-digit billing NDC 65597051104
NCPDP billing unit EA — each (per item)
RxCUI 2643054, 2643060, 2643062, 2643064
UNII WK7Q6ZIZ10
Application # NDA216993
SPL Set ID 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86
Established class (EPC) Kinase Inhibitor
Mechanism of action FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance QUIZARTINIB DIHYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21533047100325
GCN Seq No 085079
GCN 54517
HICL code 049083
Ingredient (HICL) Quizartinib Dihydrochloride
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name VANFLYTA 26.5 MG TABLET
FDB brand name Vanflyta
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085079
  • GCN: 54517
  • GPI-14 (Medi-Span): 21533047100325
  • HICL (First Databank): 049083
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2643054
Why two NDCs? The FDA registers this code as 65597-511-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65597-0511-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VANFLYTA 26.5 MG TABLET Ingredient Quizartinib Dihydrochloride
📖 What it is MedlinePlus · NLM

Quizartinib is used with other chemotherapy drugs to treat a certain type of acute myeloid leukemia (AML; a type of cancer of the white blood cells). Quizartinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

Read the full MedlinePlus article ↗
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $627.37 $8,783.20 / 14 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65597-0511-04 You're viewing this 1 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED in 1 BOTTLE 2023-07-20 — Active
65597-0511-28 65597-511-28 Main listing 1 BOTTLE in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE 2023-07-20 — Active

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 1 bottle in 1 carton / 14 tablet, film coated in 1 bottle.
How does this package differ from NDC 65597-0511-28?
Both are Vanflyta Quizartinib 26.5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 14-count one, while NDC 65597-0511-28 is the 28 tablets package.
What NDC number is used to bill for this package of Vanflyta Quizartinib 26.5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vanflyta 26.5 mgthis 65597-0511-04 Daiichi 14 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
First FDA approval
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 20, 2023 RLD RS ⏳ ~7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9585892 — method of use (U-3661)
US 9585892 — method of use (U-3661)
US 9555040 — method of use (U-3661)
US 9555040 — method of use (U-3661)
US 8836218 — method of use (U-3661)
US 8836218 — method of use (U-3661)
US 8357690 — method of use (U-3661)
US 8357690 — method of use (U-3661)
US 8129374 — method of use (U-3661)
US 8129374 — method of use (U-3661)
US 7968543 — method of use (U-3661)
US 7968543 — method of use (U-3661)
US 8865710 — drug product
US 8865710 — drug product
US 8883783 — drug substance
US 9675549 — drug product
US 8557810 — drug product
US 7820657 — drug substance
US 7820657 — drug substance
US 8883783 — drug substance
US 8557810 — drug product
US 9675549 — drug product
Exclusivity NCE
Exclusivity ODE-437
Exclusivity NCE
Exclusivity ODE-437
2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (22)
PatentTypeUse codeExpires
US 9585892 ↗ Method of use U-3661 Mar 16, 2027
US 9585892 ↗ Method of use U-3661 Mar 16, 2027
US 9555040 ↗ Method of use U-3661 May 14, 2030
US 9555040 ↗ Method of use U-3661 May 14, 2030
US 8836218 ↗ Method of use U-3661 Mar 23, 2030
US 8836218 ↗ Method of use U-3661 Mar 23, 2030
US 8357690 ↗ Method of use U-3661 Feb 26, 2031
US 8357690 ↗ Method of use U-3661 Feb 26, 2031
US 8129374 ↗ Method of use U-3661 Mar 16, 2027
US 8129374 ↗ Method of use U-3661 Mar 16, 2027
US 7968543 ↗ Method of use U-3661 Aug 15, 2029
US 7968543 ↗ Method of use U-3661 Aug 15, 2029
US 8865710 ↗ Drug product — Aug 15, 2029
US 8865710 ↗ Drug product — Aug 15, 2029
US 8883783 ↗ Drug substance — Mar 16, 2027
US 9675549 ↗ Drug product — Sep 30, 2033
US 8557810 ↗ Drug product — Mar 16, 2027
US 7820657 ↗ Drug substance — Sep 26, 2028
US 7820657 ↗ Drug substance — Sep 26, 2028
US 8883783 ↗ Drug substance — Mar 16, 2027
US 8557810 ↗ Drug product — Mar 16, 2027
US 9675549 ↗ Drug product — Sep 30, 2033
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jul 20, 2028
ODE-437Orphan Drug Exclusivity (7-year)Jul 20, 2030
NCENew Chemical Entity (5-year)Jul 20, 2028
ODE-437Orphan Drug Exclusivity (7-year)Jul 20, 2030
Common questions
Is there a generic version of VANFLYTA 26.5 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VANFLYTA 26.5 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White / yellow
ShapeRound
ImprintDSC;512
Size10 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 1I96OHX6EK
    A cyclic carbohydrate derived from plant starch that acts as a solubilizer and stabilizer. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation in the formulation.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDaiichi Sankyo Inc.
Application holderDAIICHI SANKYO INC
FDA applicationNDA216993 (NDA)
Labeler code65597
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio8 products on file

More NDCs from Daiichi Sankyo Inc. labeler code 65597

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST VANFLYTA prolongs the QT interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ] . Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECGs to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ].

Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome [see Contraindications (4) and Warnings and Precautions (5.1) ] . Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia's formula (QTcF) is greater than 450 ms [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] .

Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ] . Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS [see Warnings and Precautions (5.2) ] .

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST See full prescribing information for complete boxed warning. VANFLYTA prolongs the QT interval. ( 12.2 ) Prior to VANFLYTA administration and periodically, perform electrocardiograms (ECGs), monitor for hypokalemia or hypomagnesemia, and correct deficiencies.

( 2.3 , 5.1 ) Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome. ( 4 , 5.1 ) Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia's formula (QTcF) is greater than 450 ms.

( 2.3 , 5.1 ) Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required. ( 2.3 , 5.1 ) Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure. ( 2.4 , 5.1 ) VANFLYTA is available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy (REMS).

( 5.2 )

🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ] . VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

( 1 ) Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. ( 1 ) Limitations of Use VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated [see Clinical Studies (14) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take VANFLYTA tablets orally once daily with or without food at approximately the same time each day. ( 2.2 ) See Full Prescribing Information for recommended VANFLYTA dosage regimen and dosage modifications. ( 2.2 , 2.3 , 2.4 )

2.1Patient Selection Select patients for the treatment of AML with VANFLYTA based on the presence of FLT3-ITD mutation positivity [see Clinical Studies (14) ] . Information on FDA-approved tests for the detection of FLT3-ITD mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

2.2Recommended Dosage A treatment course consists of up to 2 cycles of VANFLYTA in combination with induction cytarabine and anthracycline, up to 4 cycles of VANFLYTA in combination with high-dose cytarabine consolidation, and up to 36 cycles of VANFLYTA as maintenance therapy [see Clinical Studies (14) ] or until disease progression or unacceptable toxicity. VANFLYTA maintenance therapy should be initiated following consolidation chemotherapy upon blood count recovery of absolute neutrophil count >500/mm 3 and platelet count >50,000/mm 3 .

See Table 1 for the recommended dosage of VANFLYTA by phase of therapy . Table 1: VANFLYTA Dosage Regimen VANFLYTA Initiation Induction Patients can receive up to 2 cycles of induction. Consolidation Patients can receive up to 4 cycles of consolidation.

Maintenance Starting on Day 8 (for 7 + 3 regimen) For 5 + 2 regimen as the second induction cycle, VANFLYTA will be given on Days 6 to 19. Starting on Day 6 Starting on Day 1 Dose 35.4 mg orally once daily 35.4 mg orally once daily Administer 26.5 mg orally once daily Days 1 through 14 of the first cycle if QTcF is less than or equal to 450 ms. Increase the dose to 53 mg once daily on Day 15 of the first cycle if QTcF is less than or equal to 450 ms.

Maintain the 26.5 mg once daily dose if QTcF greater than 500 ms was observed during induction or consolidation. Duration (28-day cycles) Two weeks in each cycle (Days 8 to 21) Two weeks in each cycle (Days 6 to 19) Once daily with no break between cycles for up to 36 cycles For patients who proceed to hematopoietic stem cell transplantation (HSCT), VANFLYTA should be stopped 7 days before the start of a conditioning regimen. Administer VANFLYTA orally with or without food at approximately the same time each day.

Swallow tablets whole. Do not cut, crush, or chew the tablets. If a dose of VANFLYTA is vomited, do not administer a replacement dose; wait until the next scheduled dose is due.

If a dose of VANFLYTA is missed or not taken at the usual time, administer the dose as soon as possible on the same day and return to the usual schedule the following day. The patient should not take two doses on the same day.

2.3Monitoring and Dosage Modifications for Adverse Reactions Initiate VANFLYTA only if QTcF is less than or equal to 450 ms [see Warnings and Precautions (5.1) ]. During induction and consolidation, perform ECGs prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated [see Warnings and Precautions (5.1) ]. During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and thereafter as clinically indicated.

Escalate the dose only if QTcF is less than or equal to 450 ms [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ]. Correct electrolyte abnormalities (hypokalemia and hypomagnesemia), and if possible, avoid concomitant administration of drugs that prolong the QT interval [see Warnings and Precautions (5.1) ]. For recommended dosage modifications due to adverse reactions, see Table 2 .

For dosage adjustments due to adverse reactions, see Table 3 . Table 2: Recommended Dosage Modifications for Adverse Reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] Adverse Reaction Recommended Action Grades are in accordance with National Cancer Institute Common Terminology Criteria… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 17.7 mg quizartinib, white, round, film-coated, debossed with "DSC511" 26.5 mg quizartinib, yellow, round, film-coated, debossed with "DSC512" Tablets: 17.7 mg or 26.5 mg of quizartinib. ( 3 )

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS VANFLYTA is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes [see Warnings and Precautions (5.1) ]. Contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes. ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS QT Prolongation, Torsades de Pointes, and Cardiac Arrest: Monitor electrocardiograms and levels of serum electrolytes. Reduce, interrupt, or permanently discontinue VANFLYTA as appropriate. ( 2.3 , 5.1 ) 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 contraception. ( 5.3 , 8.1 , 8.3 )

5.1QT Prolongation, Torsades de Pointes, and Cardiac Arrest VANFLYTA prolongs the QT interval in a dose- and concentration-dependent manner. The mechanism of QTc interval prolongation is via inhibition of the slow delayed rectifier potassium current, I Ks , as compared to all other medications that prolong the QTc interval, which is via the rapid delayed rectifier potassium current, I Kr . Therefore, the level of QTc prolongation with VANFLYTA that predicts the risk of cardiac arrhythmias is unclear.

Inhibition of I Ks and I Kr may leave patients with limited reserve leading to a higher risk of QT prolongation and serious cardiac arrhythmias, including fatal outcomes [see Clinical Pharmacology (12.2) ] . Torsades de pointes, ventricular fibrillation, cardiac arrest, and sudden death have occurred in patients treated with VANFLYTA. Of the 1,081 patients with AML treated with VANFLYTA in clinical trials, torsades de pointes occurred in approximately 0.2% of patients, cardiac arrest occurred in 0.6%, including 0.4% with a fatal outcome, and 0.1% of patients experienced ventricular fibrillation [see Adverse Reactions (6.1) ] .

These severe cardiac arrhythmias occurred predominantly during the induction phase. Of the 265 patients with newly diagnosed FLT3-ITD-positive AML treated with VANFLYTA in combination with chemotherapy in the clinical trial, 2.3% were found to have a QTcF greater than 500 ms and 10% of patients had an increase from baseline QTcF greater than 60 ms. The clinical trial excluded patients with a QTcF ≥450 ms or other factors that increased the risk of QT prolongation or arrhythmic events (e.g., NYHA Class III or IV congestive heart failure, hypokalemia, family history of long QT interval syndrome).

Therefore, avoid use in patients who are at significant risk of developing torsades de pointes, including uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, tachyarrhythmias, uncontrolled hypertension, high-degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism. Do not initiate treatment with VANFLYTA if the QTcF interval is greater than 450 ms. Do not use VANFLYTA in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes [see Contraindications (4) ] .

Perform an ECG and correct electrolyte abnormalities prior to initiation of treatment with VANFLYTA. During induction and consolidation, perform an ECG prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated. During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and as clinically indicated thereafter.

Do not escalate the dose if QTcF is greater than 450 ms [see Dosage and Administration (2.3) ] . Perform ECG monitoring of the QT interval more frequently in patients who are at significant risk of developing QT interval prolongation and torsades de pointes, or following dose escalation. Monitor and correct hypokalemia and hypomagnesemia prior to and during treatment with VANFLYTA.

Maintain electrolytes in the normal range. Monitor electrolytes and ECGs more frequently in patients who experience diarrhea or vomiting. Monitor patients more frequently with ECGs if coadministration of VANFLYTA with drugs known to prolong the QT interval is required [see Drug Interactions (7) ] .

R… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation, Torsades de Pointes, and Cardiac Arrest [see Warnings and Precautions (5.1) ] The most common (>20%) adverse reactions, including laboratory abnormalities, are lymphocytes decreased, potassium decreased, albumin decreased, phosphorus decreased, alkaline phosphatase increased, magnesium decreased, febrile neutropenia, diarrhea, mucositis, nausea, calcium decreased, abdominal pain, sepsis, neutropenia, headache, creatine phosphokinase increased, vomiting, and upper respiratory tract infection.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly Diagnosed FLT3-ITD positive AML The safety of VANFLYTA (35.4 mg orally once daily with chemotherapy, 26.5 mg to 53 mg orally once daily as maintenance) in adult patients with newly diagnosed FLT3-ITD positive AML is based on QuANTUM-First, a randomized, double-blind clinical trial of VANFLYTA (n=265) or placebo (n=268) with chemotherapy [see Clinical Studies (14) ] .

Among patients who received VANFLYTA, 38% were exposed for 6 months or longer and 30% were exposed for greater than one year. On the VANFLYTA plus chemotherapy arm, 65% and 44% of patients completed induction and consolidation therapy, respectively, compared to 65% and 34% of patients in the placebo plus chemotherapy arm. 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 arrest. Permanent discontinuation due to an adverse reaction in patients in the VANFLYTA plus chemotherapy arm occurred in 20% of patients. The most frequent (≥2%) adverse reaction which resulted in permanent discontinuation in the VANFLYTA arm was sepsis (5%).

Dosage interruptions of VANFLYTA due to an adverse reaction occurred in 34% of patients. Adverse reactions which required dosage interruption in ≥2% of patients in the VANFLYTA arm included neutropenia (11%), thrombocytopenia (5%), and myelosuppression (3%). Dose reductions of VANFLYTA due to an adverse reaction occurred in 19% of patients.

Adverse reactions which required dosage reductions in ≥2% of patients in the VANFLYTA arm were neutropenia (9%), thrombocytopenia (5%), and electrocardiogram QT prolonged (4%). The most common adverse reactions (≥10% with a difference between arms of ≥2% compared to placebo), including laboratory abnormalities, were lymphocytes decreased, potassium decreased, albumin decreased, phosphorus decreased, alkaline phosphatase increased, magnesium decreased, febrile neutropenia, diarrhea, mucositis, nausea, calcium decreased, abdominal pain, sepsis, neutropenia, headache, creatine phosphokinase increased, vomiting, upper respiratory tract infections, hypertransaminasemia, thrombocytopenia, decreased appetite, fungal infections, epistaxis, potassium increased, herpesvirus infections, insomnia, electrocardiogram QT prolonged, magnesium increased, sodium increased, dyspepsia, anemia, and eye irritation.

Tables 5 and 6 summarize adverse reactions and laboratory abnormalities observed in patients receiving VANFLYTA in the clinical trial. Table 5: Adverse Reactions (≥10%) in Patients with Newly Diagnosed FLT3-ITD positive AML Who Received VANFLYTA (with a Difference Betwee… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 7: Effect of Other Drugs on VANFLYTA Strong CYP3A Inhibitors Clinical Impact VANFLYTA is a CYP3A substrate. Concomitant use of VANFLYTA with a strong CYP3A inhibitor increases quizartinib systemic exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of VANFLYTA adverse reactions. Prevention or Management Reduce the dosage of VANFLYTA [see Dosage and Administration (2.4) ].

Strong or Moderate CYP3A Inducers Clinical Impact Concomitant use of VANFLYTA with strong or moderate CYP3A inducers decreases quizartinib systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce VANFLYTA efficacy. Prevention or Management Avoid concomitant use of VANFLYTA with strong or moderate CYP3A inducers [see Clinical Pharmacology (12.3) ] . QT Interval Prolonging Drugs Clinical Impact VANFLYTA prolongs the QT/QTc interval.

Coadministration of VANFLYTA with other drugs that prolong the QT interval may further increase the incidence of QT prolongation [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ] . Prevention or Management Monitor patients more frequently with ECG if co-administration of VANFLYTA with drugs known to prolong the QT interval is required. Examples of QT prolonging drugs include but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus.

Breast Cancer Resistant Protein (BCRP) Substrates Clinical Impact Concomitant use of VANFLYTA with BCRP substrates may increase the risk of BCRP substrate-associated adverse reactions [see Clinical Pharmacology (12.3) ] . Prevention or Management Avoid concomitant use of VANFLYTA with drugs that are BCRP substrates where possible. If concomitant use is unavoidable, monitor patients more frequently for BCRP substrate-associated adverse reactions and decrease the BCRP substrates dosage(s) in accordance with the respective Prescribing Information.

Strong CYP3A Inhibitors: Reduce the VANFLYTA dose. ( 2.4 , 7 ) Strong or Moderate CYP3A Inducers: Avoid concomitant use. ( 7 , 12.3 ) Breast Cancer Resistant Protein (BCRP) substrates: Avoid concomitant use.

( 7 , 12.3 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, VANFLYTA can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on VANFLYTA use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral administration of quizartinib to pregnant rats during organogenesis resulted in adverse developmental outcomes including structural abnormalities and alterations to growth at maternal exposures approximately 3 times those in patients at the maximum recommended human dose (MRHD) of 53 mg/day ( see Data ).

Advise pregnant women of the potential risk to a fetus. The background risk in the U.S. general population of major birth defects is 2-4%, and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received oral doses of quizartinib of 0, 0.6, 2, or 6 mg/kg/day during the period of organogenesis.

Administration of quizartinib at the dose of 6 mg/kg/day was associated with adverse developmental outcomes including structural abnormalities (anasarca and edema) and alterations to growth (lower fetal weights and effects on skeletal ossification). At this dose, the maternal systemic exposures (AUC) were approximately 3 times the human exposure at the MRHD of 53 mg/day.

8.2Lactation Risk Summary There are no data on the presence of quizartinib or its metabolites in human milk, or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with VANFLYTA and for one month after the last dose.

8.3Females and Males of Reproductive Potential VANFLYTA can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential within seven days before starting treatment with VANFLYTA. Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with VANFLYTA and for 7 months after the last dose.

Males Based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment with VANFLYTA and for 4 months after the last dose [see Nonclinical Toxicology (13.1) ] . Infertility Females Based on findings from animal studies, VANFLYTA may impair female fertility. These effects on fertility were reversible [see Nonclinical Toxicology (13.1) ] .

Males Based on findings from animal studies, VANFLYTA may impair male fertility. These effects on fertility were reversible [see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use Safety and effectiveness of VANFLYTA have not been established in pediatric patients.

8.5Geriatric Use There were 533 patients with newly diagnosed AML in the clinical study; of the total number of VANFLYTA-treated patients, 69 (26%) were 65 years of age and older, while 1 (0.4%) was 75 years of age [see Clinical Studies (14) ] . No overall differences in safety or efficacy were observed between patients 65 years of age and older and younger adult patients.

8.6Renal Impairment No dosage adjustment is recommended in patients with mild to moderate renal impairment (i.e., estimated creatinine clearance [CLcr] by Cockcroft-Gault equation: CLcr 30 to 89 mL/min). VANFLYTA has not been studied in patients with severe renal impairment (CLcr <30 mL/min) [see Clinical Pharmacology (12.3) ] .

8.7Hepatic Impairment No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Class A or total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1 to 1.5 times ULN and any value for AST) or moderate hepatic im… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 213 words ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, VANFLYTA can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on VANFLYTA use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral administration of quizartinib to pregnant rats during organogenesis resulted in adverse developmental outcomes including structural abnormalities and alterations to growth at maternal exposures approximately 3 times those in patients at the maximum recommended human dose (MRHD) of 53 mg/day ( see Data ).

Advise pregnant women of the potential risk to a fetus. The background risk in the U.S. general population of major birth defects is 2-4%, and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received oral doses of quizartinib of 0, 0.6, 2, or 6 mg/kg/day during the period of organogenesis.

Administration of quizartinib at the dose of 6 mg/kg/day was associated with adverse developmental outcomes including structural abnormalities (anasarca and edema) and alterations to growth (lower fetal weights and effects on skeletal ossification). At this dose, the maternal systemic exposures (AUC) were approximately 3 times the human exposure at the MRHD of 53 mg/day.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of VANFLYTA have not been established in pediatric patients.

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use There were 533 patients with newly diagnosed AML in the clinical study; of the total number of VANFLYTA-treated patients, 69 (26%) were 65 years of age and older, while 1 (0.4%) was 75 years of age [see Clinical Studies (14) ] . No overall differences in safety or efficacy were observed between patients 65 years of age and older and younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Quizartinib is a small molecule inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation.

Quizartinib showed antitumor activity in a mouse model of FLT3-ITD-dependent leukemia.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of quizartinib have not been fully characterized. Cardiac Electrophysiology In vitro studies have shown that quizartinib is a predominant inhibitor of the slow delayed rectifier potassium current, I Ks . The exposure-response analysis predicted a concentration-dependent QTcF interval median prolongation of 18 and 24 ms [upper bound of 2-sided 90% confidence interval (CI): 21 and 27 ms] at the median steady-state C max of quizartinib at the 26.5 mg and 53 mg dose level during maintenance therapy [see Warnings and Precautions (5.1) and Drug Interactions (7) ] .

12.3Pharmacokinetics The pharmacokinetics of quizartinib and its major circulating active metabolite (AC886) were characterized in healthy subjects and in patients with cancer and are presented as geometric mean (percent coefficient of variation [%CV]) unless otherwise specified. Steady state quizartinib concentrations were achieved at Day 15 following once daily dosage in patients with AML. Quizartinib exposure (AUC and C max ) increased proportionally in the dose range of 26.5 mg (0.75 times the recommended 35.4 mg induction dose) to 79.5 mg (2.25 times the recommended 35.4 mg induction dose) in healthy subjects and 17.7 mg (0.5 times the recommended 35.4 mg induction dose) to 53 mg (1.5 times the recommended 35.4 mg induction dose) in patients with AML.

Table 8: Pharmacokinetic Properties of Quizartinib and AC886 Quizartinib AC886 General Information Steady state exposure following 35.4 mg VANFLYTA once daily during induction therapy in patients with newly diagnosed AML C max 140 ng/mL (71%) 163 ng/mL (52%) AUC 0-24h 2,680 ng∙h/mL (85%) 3,590 ng∙h/mL (51%) Steady state exposure following 35.4 mg VANFLYTA once daily during consolidation therapy in patients with newly diagnosed AML C max 204 ng/mL (64%) 172 ng/mL (47%) AUC 0-24h 3,930 ng∙h/mL (78%) 3,800 ng∙h/mL (46%) Steady state exposure following 53 mg VANFLYTA once daily during maintenance therapy in patients with newly diagnosed AML C max 529 ng/mL (60%) 262 ng/mL (48%) AUC 0-24h 10,200 ng∙h/mL (75%) 5,790 ng∙h/mL (46%) Accumulation ratio Mean (±SD) (AUC 0-24h ) 5.4 (4.4) 8.7 (6.8) Absorption The mean (SD) absolute bioavailability of quizartinib from the tablet formulation was 71% (±7%) in healthy subjects.

After oral administration under fasted conditions, time to peak concentration (median T max ) of quizartinib and AC886 measured post dose was approximately 4 hours (range 2 to 8 hours) and 5 to 6 hours (range 4 to 120 hours), respectively, in healthy subjects. No clinically significant differences in the pharmacokinetics of quizartinib were observed when administered with a high-fat, high-calorie meal. Distribution Volume of distribution at steady state in healthy subjects was estimated to be 275 L (17%).

In vitro plasma protein binding of quizartinib and AC886 is 99% or greater. In vitro blood-to-plasma ratio for quizartinib and AC886 ranges from 0.79-1.30 and 1.36-3.19, respectively. Elimination Total body clearance of quizartinib in healthy subjects was estimated to be

2.23L/hour (29%). The mean (SD) effective half-lives (t 1/2 ) in patients with newly diagnosed AML for quizartinib and AC886 during maintenance therapy are 81… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 86 words ▾

12.1Mechanism of Action Quizartinib is a small molecule inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation.

Quizartinib showed antitumor activity in a mouse model of FLT3-ITD-dependent leukemia.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VANFLYTA (quizartinib) is supplied as round, film-coated tablets, packaged in bottles with a child-resistant closure. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Tablet Strength Tablet Description Package Configuration NDC 17.7 mg White, round, film-coated, debossed with "DSC511" , 28-count bottle 65597-504-28 14-count bottle 65597-504-04 26.5 mg Yellow, round, film-coated, debossed with "DSC512" 28-count bottle 65597-511-28 14-count bottle 65597-511-04

📦 Storage and Handling 58 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Tablet Strength Tablet Description Package Configuration NDC 17.7 mg White, round, film-coated, debossed with "DSC511" , 28-count bottle 65597-504-28 14-count bottle 65597-504-04 26.5 mg Yellow, round, film-coated, debossed with "DSC512" 28-count bottle 65597-511-28 14-count bottle 65597-511-04

📋 Description 176 words ▾

11 DESCRIPTION VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is N -(5- tert -butyl-isoxazol-3-yl)- N '-{4-[7-(2-(morpholin-4-ylethoxy)imidazo[2,1- b ][1,3]benzothiazol-2-yl]phenyl}urea dihydrochloride. Quizartinib dihydrochloride is a white to off-white solid with a molecular formula of C 29 H 32 N 6 O 4 S∙2 HCl and a molecular weight of 633.6 for the salt and 560.7 for the free base.

The aqueous solubility of quizartinib dihydrochloride (pKa 4.75 and 3.16) decreases with increasing pH. It is very slightly soluble in aqueous media at pH 1 and practically insoluble or insoluble at pH 2 and higher. Quizartinib dihydrochloride is very slightly soluble in ethanol.

The chemical structure of quizartinib dihydrochloride is: VANFLYTA is supplied as film-coated tablets containing 20 mg and 30 mg quizartinib dihydrochloride equivalent to 17.7 mg or 26.5 mg of quizartinib, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, talc, titanium dioxide, and triacetin.

The 26.5 mg tablet coating also contains ferric oxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). QT Prolongation, Torsades de Pointes, and Cardiac Arrest Inform patients of symptoms that may be associated with significant QTc interval prolongation including dizziness, lightheadedness, and fainting. Advise patients to report these symptoms and the use of all medications to their healthcare provider [see Warnings and Precautions (5.1) ].

VANFLYTA REMS VANFLYTA is available only through a restricted program called the VANFLYTA REMS. Inform patients that they will be given a VANFLYTA Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms related to QT prolongation/cardiac arrhythmia which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.2) ] .

Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins, and herbal products. Advise patients to avoid concomitant use of St. John's wort as it is a strong CYP3A inducer [see Drug Interactions (7) ].

Embryo-Fetal Toxicity and Use of Contraceptives Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with VANFLYTA and for 7 months after the last dose. Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during VANFLYTA treatment.

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VANFLYTA and for 4 months after the last dose [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ]. Infertility Advise females and males of reproductive potential that VANFLYTA may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ] . Lactation Advise women not to breastfeed during treatment with VANFLYTA and for one month after the last dose [see Use in Specific Populations (8.2) ].

Dosing and Storage Instructions Advise patients that VANFLYTA should be taken once daily at approximately the same time each day and may be taken with or without food. Advise patients to swallow tablets whole. Advise patients not to cut, crush, or chew the tablets [see Dosage and Administration (2.2) ].

Instruct patients that if a dose of VANFLYTA is vomited, not to take an additional dose that day, and to wait until the next scheduled dose on the following day. If a dose of VANFLYTA is missed or not taken at the usual time, instruct patients to take the dose as soon as possible on the same day and return to the usual dosing schedule the following day. Store VANFLYTA at room temperature from 20°C to 25°C (68°F to 77°F).

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE VANFLYTA (van-FLITT-ah) (quizartinib) tablets This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 7/2023 What is the most important information I should know about VANFLYTA?

VANFLYTA may cause serious side effects, including: Changes in the electrical activity of your heart called QT prolongation, torsades de pointes, and your heart stopping (cardiac arrest). QT prolongation can cause irregular heartbeats that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with VANFLYTA.

Tell your healthcare provider right away if you have an irregular heartbeat or feel dizzy, lightheaded, or faint, or have diarrhea or vomiting. VANFLYTA is available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy (REMS) due to the risk of QT prolongation, torsades de pointes, and cardiac arrest. You will receive a VANFLYTA Patient Wallet Card from your healthcare provider.

Carry the VANFLYTA Patient Wallet Card with you at all times and show it to all of your healthcare providers. The VANFLYTA Patient Wallet Card lists signs and symptoms of QT prolongation and torsades de pointes. Get medical help right away if you develop any of the signs and symptoms listed on the VANFLYTA Patient Wallet Card.

You may need to be treated in a hospital. See " What are the possible side effects of VANFLYTA? " for more information about side effects. What is VANFLYTA?

VANFLYTA is a prescription medicine used in combination with certain chemotherapy medicines and alone as maintenance therapy to treat adults with newly diagnosed acute myeloid leukemia (AML) with a FLT3-ITD mutation. Your healthcare provider will perform a test to make sure that VANFLYTA is right for you. VANFLYTA is not for use alone as maintenance therapy after a hematopoietic stem cell transplant.

It is not known if VANFLYTA is safe and effective in children. Do not take VANFLYTA if you have very low potassium, very low magnesium, long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes. Before you take VANFLYTA, tell your healthcare provider about all of your medical conditions, including if you: have any heart problems. have low blood levels of potassium or magnesium. are pregnant or plan to become pregnant.

VANFLYTA can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VANFLYTA. If you are able to become pregnant, your healthcare provider will perform a pregnancy test within 7 days before you start treatment with VANFLYTA.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with VANFLYTA and for 7 months after the last dose of VANFLYTA. Males who have female partners who are able to become pregnant should use effective birth control during treatment with VANFLYTA and for 4 months after the last dose of VANFLYTA. Talk to your healthcare provider about birth control methods you can use during this time. are breastfeeding or plan to breastfeed.

It is not known if VANFLYTA passes into your breast milk. Do not breastfeed during treatment with VANFLYTA and for 1 month after the last dose of VANFLYTA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VANFLYTA and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take St. John's wort.

You should not take St. John's wort during treatment with VANFLYTA. How should I take VANFLYTA?

Take VANFLYTA exactly as your healthcare provider tells you to. Do not change your dose or stop taking VANFLYTA unless your healthcare provider tells you t… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of quizartinib and its major circulating active metabolite (AC886) were characterized in healthy subjects and in patients with cancer and are presented as geometric mean (percent coefficient of variation [%CV]) unless otherwise specified. Steady state quizartinib concentrations were achieved at Day 15 following once daily dosage in patients with AML. Quizartinib exposure (AUC and C max ) increased proportionally in the dose range of 26.5 mg (0.75 times the recommended 35.4 mg induction dose) to 79.5 mg (2.25 times the recommended 35.4 mg induction dose) in healthy subjects and 17.7 mg (0.5 times the recommended 35.4 mg induction dose) to 53 mg (1.5 times the recommended 35.4 mg induction dose) in patients with AML.

Table 8: Pharmacokinetic Properties of Quizartinib and AC886 Quizartinib AC886 General Information Steady state exposure following 35.4 mg VANFLYTA once daily during induction therapy in patients with newly diagnosed AML C max 140 ng/mL (71%) 163 ng/mL (52%) AUC 0-24h 2,680 ng∙h/mL (85%) 3,590 ng∙h/mL (51%) Steady state exposure following 35.4 mg VANFLYTA once daily during consolidation therapy in patients with newly diagnosed AML C max 204 ng/mL (64%) 172 ng/mL (47%) AUC 0-24h 3,930 ng∙h/mL (78%) 3,800 ng∙h/mL (46%) Steady state exposure following 53 mg VANFLYTA once daily during maintenance therapy in patients with newly diagnosed AML C max 529 ng/mL (60%) 262 ng/mL (48%) AUC 0-24h 10,200 ng∙h/mL (75%) 5,790 ng∙h/mL (46%) Accumulation ratio Mean (±SD) (AUC 0-24h ) 5.4 (4.4) 8.7 (6.8) Absorption The mean (SD) absolute bioavailability of quizartinib from the tablet formulation was 71% (±7%) in healthy subjects.

After oral administration under fasted conditions, time to peak concentration (median T max ) of quizartinib and AC886 measured post dose was approximately 4 hours (range 2 to 8 hours) and 5 to 6 hours (range 4 to 120 hours), respectively, in healthy subjects. No clinically significant differences in the pharmacokinetics of quizartinib were observed when administered with a high-fat, high-calorie meal. Distribution Volume of distribution at steady state in healthy subjects was estimated to be 275 L (17%).

In vitro plasma protein binding of quizartinib and AC886 is 99% or greater. In vitro blood-to-plasma ratio for quizartinib and AC886 ranges from 0.79-1.30 and 1.36-3.19, respectively. Elimination Total body clearance of quizartinib in healthy subjects was estimated to be

2.23L/hour (29%). The mean (SD) effective half-lives (t 1/2 ) in patients with newly diagnosed AML for quizartinib and AC886 during maintenance therapy are 81 hours (±73) and 136 hours (±113), respectively. Metabolism In vitro quizartinib is primarily metabolized via oxidation by CYP3A4/5 and AC886 is formed and metabolized by CYP3A4/5.

Excretion Following a single radiolabeled dose of quizartinib 53 mg to healthy subjects, 76.3% of the total radioactivity was recovered in feces (4% unchanged) and 1.64% in urine. Specific Populations There were no clinically significant differences in the exposure of quizartinib and AC886 based on age (range 18 to 91 years), sex, race (White 65%, Asian 18%, Black 9%), or body weight (range 37 to 153 kg). Patients with Renal Impairment Mild or moderate renal impairment (i.e., estimated creatinine clearance [CLcr] by Cockcroft-Gault equation: 30 to 89 mL/min) were not associated with clinically significant differences in the exposure of quizartinib and AC886.

The impact of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of quizartinib and AC886 is unknown [see Use in Specific Populations (8.6) ] . Patients with Hepatic Impairment Mild (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN or total bilirubin >1 to 1.5 times ULN and any value for AST) or moderate (total bilirubin >1.5 to 3 times ULN and any value for AST) hepatic impairment were not associated with clinically significant differences in the exposure of… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 104 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of quizartinib have not been fully characterized. Cardiac Electrophysiology In vitro studies have shown that quizartinib is a predominant inhibitor of the slow delayed rectifier potassium current, I Ks . The exposure-response analysis predicted a concentration-dependent QTcF interval median prolongation of 18 and 24 ms [upper bound of 2-sided 90% confidence interval (CI): 21 and 27 ms] at the median steady-state C max of quizartinib at the 26.5 mg and 53 mg dose level during maintenance therapy [see Warnings and Precautions (5.1) and Drug Interactions (7) ] .

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of VANFLYTA in combination with chemotherapy was evaluated in QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled study of 539 patients with newly diagnosed FLT3-ITD positive AML. FLT3-ITD status was determined prospectively with a clinical trial assay and verified retrospectively using the companion diagnostic LeukoStrat ® CDx FLT3 Mutation Assay, which is an FDA-approved test for selection of patients with AML for VANFLYTA treatment. Patients were stratified by age (<60 versus ≥60 years), white blood cell count at diagnosis (<40×10 9 /L versus ≥40×10 9 /L), and region (North America, Europe versus Asia, other regions).

Patients were randomized (1:1) to receive VANFLYTA (n=268) or placebo (n=271) in combination with induction and consolidation therapy and as maintenance monotherapy according to the initial assignment, as follows: a) Induction : 35.4 mg orally once daily on Days 8-21 of 7 + 3 (cytarabine [100 or 200 mg/m 2 /day] on Days 1 to 7 plus daunorubicin [60 mg/m 2 /day] or idarubicin [12 mg/m 2 /day] on Days 1 to 3) and on Days 8-21 or 6-19 of an optional second induction (7 + 3 or 5 + 2 [5 days cytarabine plus 2 days daunorubicin or idarubicin], respectively), b) Consolidation : 35.4 mg orally once daily on Days 6-19 of high-dose cytarabine (1.5 to 3 g/m 2 every 12 hours on Days 1, 3 and 5) for up to 4 cycles, and c) Maintenance : 26.5 mg orally once daily on Days 1 to 14 and 53 mg once daily thereafter for up to thirty-six 28-day cycles.

There was no re-randomization at the start of post consolidation therapy. Patients who proceeded to hematopoietic stem cell transplantation (HSCT) initiated maintenance therapy after recovery from the HSCT. The two treatment groups were generally balanced with respect to baseline demographics and disease characteristics.

Of the 539 randomized patients, the median age was 56 years (range 20-75 years); 46% were male; 60% were White, 29% were Asian, 1% were Black, and 10% were other races. Eighty-four percent had an Eastern Cooperative Oncology Group (ECOG) baseline performance status of 0 or 1. The majority of the patients (72%) had intermediate risk cytogenetics at baseline.

FLT3-ITD variant allelic frequency (VAF) was 3-25% in 36% of patients, >25-50% in 52% of patients, and >50% in 12% of patients. NPM1 mutations were identified in 52% of patients. A second course of induction was administered to 20% of the patients, 65% initiated at least one cycle of consolidation, and 39% initiated maintenance.

Among the patients who entered maintenance, 64% completed at least 12 cycles, 36% completed at least 24 cycles, and 16% completed all 36 planned cycles of maintenance. Twenty-nine percent (157/539) of the patients underwent HSCT in first complete remission (CR). The overall rate of HSCT (including the following settings: first CR, induction failure, or salvage after relapse) was 54% (144/268) in the VANFLYTA plus standard chemotherapy arm versus 47% (128/271) in the placebo plus standard chemotherapy arm.

All patients were followed for survival. Efficacy was established on the basis of overall survival (OS), measured from the date of randomization until death by any cause. The primary analysis was conducted after a minimum follow-up of 24 months after the randomization of the last patient.

The study demonstrated a statistically significant improvement in OS for the VANFLYTA arm [hazard ratio (HR) 0.78; 95% CI: 0.62, 0.98; 2-sided p=0.0324] (see Figure 1 ). Figure 1: Kaplan-Meier Curve for Overall Survival in QuANTUM-First In an exploratory subgroup analysis of the 89/208 (43%) of patients who received maintenance therapy with VANFLYTA or placebo following consolidation chemotherapy, the OS HR was 0.40 (95% CI: 0.19, 0.84). Of 119/208 (57%) of patients who received maintenance therapy with VANFLYTA or placebo following HSCT, the OS HR was 1.62 (95% CI: 0.62, 4.22).

The CR rate in the VANFLYTA arm was 55% (95% CI: 48.7, 60.9) with a me… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 181 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with quizartinib. Quizartinib was mutagenic in a bacterial reverse mutation (Ames) assay and not mutagenic in an in vivo transgenic rat mutation assay. Quizartinib was not genotoxic in vitro in mouse lymphoma thymidine kinase mutation and human lymphocyte chromosome aberration assays, or in an in vivo rat bone marrow micronucleus assay.

Fertility studies in animals have not been conducted with quizartinib. However, adverse findings in male and female reproductive systems were observed in repeat-dose toxicity studies in rats and monkeys. Findings in female animals (rats or monkeys) included ovarian cysts, vaginal mucosal modifications, and atrophy of the uterus, ovary, and vagina, starting at exposures (AUC) approximately 0.2 times the MRHD of 53 mg/day.

In male animals (rats and monkeys), findings included testicular seminiferous tubular degeneration, failure of sperm release, germ cell depletion in the testes, and oligospermia/aspermia, starting at exposures approximately 0.4 times the MRHD. After approximately one month of recovery period, all these findings except the vaginal mucosal modifications in the female rats were reversible.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 178 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with quizartinib. Quizartinib was mutagenic in a bacterial reverse mutation (Ames) assay and not mutagenic in an in vivo transgenic rat mutation assay. Quizartinib was not genotoxic in vitro in mouse lymphoma thymidine kinase mutation and human lymphocyte chromosome aberration assays, or in an in vivo rat bone marrow micronucleus assay.

Fertility studies in animals have not been conducted with quizartinib. However, adverse findings in male and female reproductive systems were observed in repeat-dose toxicity studies in rats and monkeys. Findings in female animals (rats or monkeys) included ovarian cysts, vaginal mucosal modifications, and atrophy of the uterus, ovary, and vagina, starting at exposures (AUC) approximately 0.2 times the MRHD of 53 mg/day.

In male animals (rats and monkeys), findings included testicular seminiferous tubular degeneration, failure of sperm release, germ cell depletion in the testes, and oligospermia/aspermia, starting at exposures approximately 0.4 times the MRHD. After approximately one month of recovery period, all these findings except the vaginal mucosal modifications in the female rats were reversible.

📄 Package Label / Principal Display Panel 98 words ▾

PRINCIPAL DISPLAY PANEL - 17.7 mg Tablet Bottle Carton NDC 65597-504-04 14 tablets VANFLYTA ® (quizartinib) tablets 17.7 mg Rx only Swallow tablets whole. Do not cut, crush, or chew the tablets. Dispense accompanying Medication Guide to each patient. Daiichi-Sankyo PRINCIPAL DISPLAY PANEL - 17.7 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 26.5 mg Tablet Bottle Carton NDC 65597-511-04 14 tablets VANFLYTA ® (quizartinib) tablets 26.5 mg Rx only Swallow tablets whole. Do not cut, crush, or chew the tablets. Dispense accompanying Medication Guide to each patient. Daiichi-Sankyo PRINCIPAL DISPLAY PANEL - 26.5 mg Tablet Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
28 tablets65597-0511-28 41 Rx · $1,167,629
14 tablets this page65597-0511-04 No Medicaid data
Drug total (last 4 qtrs): 41 Rx · 1,946 units · $1,167,629 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vanflyta — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vanflyta. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.02M
Claims incl. refills
185
Beneficiaries
83
Spend / beneficiary
$48,467.37
Spend / claim
$21,744.82
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS — VANFLYTA REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VANFLYTA (this brand).

Top reported reactions

Death51
Nausea43
Platelet Count Decreased42
Pyrexia39
Infection34
Electrocardiogram Qt Prolonged33
Fatigue33

Age at onset

Adolescent1
Adult43
Elderly18

Reporter sex

634 reports
Male · 47%
Female · 53%

Serious outcomes

Hospitalization217
Death100
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 237 6
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Daiichi Sankyo Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 tablets (65597-0511-28). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Daiichi Sankyo Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65597-0504-04 · Daiichi 65597-0801-01 · Daiichi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.