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Modeyso dordaviprone 125 mg Capsule, 10-count — NDC 68727-250-01 (Billing 68727-0250-01)

by Jazz Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 10 CAPSULE in 1 BOTTLE

This is a package of 10 capsules of Modeyso dordaviprone 125 mg Capsule from Jazz Pharmaceuticals, Inc., marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 68727-0250-01
🏷️ FDA NDC (as labeled) 68727-250-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 68727-250-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68727 labeler · 250 product · 01 package
Package marketed since
Aug 6, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
10 EA per package
Barcode (UPC-A, from the NDC)
3 6872725001 7
Medicaid fills, this package
35 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68727-250-01
Product NDC 68727-250
11-digit billing NDC 68727025001
NCPDP billing unit EA — each (per item)
RxCUI 2721199, 2721205
UNII 9U35A31JAI
Application # NDA219876
SPL Set ID ad45b43e-fdef-47ad-9c34-055b41bdc576
Established class (EPC) Protease Activator
Mechanism of action Protease Activators
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-06
Route ORAL
Dosage form CAPSULE
Substance DORDAVIPRONE

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

GPI-14 21580015200120
GCN Seq No 088115
GCN 58204
HICL code 050809
Ingredient (HICL) Dordaviprone Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V5
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 2)
HIC3 code V5H
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Activators
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name MODEYSO 125 MG CAPSULE
FDB brand name Modeyso
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088115
  • GCN: 58204
  • GPI-14 (Medi-Span): 21580015200120
  • HICL (First Databank): 050809
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2721199
Why two NDCs? The FDA registers this code as 68727-250-01 — 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 → 68727-0250-01. 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 Protease Activator class.

Pharmacologic class Protease Activator
How it works Protease Activators
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 MODEYSO 125 MG CAPSULE Ingredient Dordaviprone Hcl
📖 What it is MedlinePlus · NLM

Dordaviprone is used to treat certain forms of glioma(a brain tumor that originates in the glial cells, the supportive and protective cells of the brain and spinal cord). Dordaviprone is in a class of medications called protease activators. It works by stopping tumor growth.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $31,937.71 $319,377.10 / 10 capsules
Medicare drug plans payPart D · Q2 2026 $3,244.91 $32,449.06 / 10 capsules
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
68727-0250-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 10 CAPSULE in 1 BOTTLE 2025-08-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Modeyso 125 mgthis 68727-0250-01 Jazz 10 capsules — — 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

🏛️
2025
First FDA approval
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
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 Jan 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 6, 2025 RLD RS ⏳ ~10.3 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 12102639 — method of use (U-4254)
US 10369154 — method of use (U-4254)
US 10172862 — method of use (U-4254)
US 9629842 — method of use (U-4254)
US RE46290 — method of use (U-4254)
US 11976068 — drug product
US 9265765 — drug product
Exclusivity NCE
Exclusivity ODE-547
2025 2027 2029 2031 2033 2035 2037
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 (7)
PatentTypeUse codeExpires
US 12102639 ↗ Method of use U-4254 Jan 30, 2037
US 10369154 ↗ Method of use U-4254 Jan 30, 2037
US 10172862 ↗ Method of use U-4254 Jan 30, 2037
US 9629842 ↗ Method of use U-4254 Apr 30, 2032
US RE46290 ↗ Method of use U-4254 Apr 30, 2032
US 11976068 ↗ Drug product — Mar 1, 2036
US 9265765 ↗ Drug product — Jul 26, 2034
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Aug 6, 2030
ODE-547Orphan Drug Exclusivity (7-year)Aug 6, 2032
Common questions
Is there a generic version of MODEYSO 125 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for MODEYSO 125 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2037 — 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
ShapeCapsule
ImprintCMRX;DDP;125
Size16 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 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 X7XJ6RM9Q2
    A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

3 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

LabelerJazz Pharmaceuticals, Inc.
Application holderCHIMERIX INC
FDA applicationNDA219876 (NDA)
Labeler code68727
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Jazz Pharmaceuticals, Inc. labeler code 68727

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.
🎯 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 157 words ▾

1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Select patients for treatment with MODEYSO based on the presence of an H3 K27M mutation from tumor specimens. ( 2.1 ) • Monitor ECG and electrolytes before starting MODEYSO and periodically during treatment as clinically indicated. ( 2.2 ) • The recommended dose in adult patients is 625 mg orally once weekly.

( 2.3 ) • The recommended dose in pediatric patients weighing ≥10 kg is based on body weight (see Table 1). ( 2.3 ) • Take MODEYSO orally once weekly on an empty stomach, at least 1 hour before or 3 hours after food intake. ( 2.3 ) • Continue MODEYSO until disease progression or unacceptable toxicity.

( 2.3 )

2.1Patient Selection Select patients for treatment with MODEYSO based on the presence of an H3 K27M mutation from tumor specimens [see Clinical Studies ( 14 )] . An FDA-approved test for the detection of this mutation is not currently available.

2.2Recommended Testing Before Starting MODEYSO Monitor electrocardiograms (ECG) and electrolytes before starting MODEYSO and periodically during treatment as clinically indicated [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 )] .

2.3Recommended Dosage and Administration Take MODEYSO on an empty stomach, at least 1 hour before or 3 hours after food intake [see Clinical Pharmacology ( 12.3 )] . Adults The recommended dosage of MODEYSO is 625 mg orally once weekly. Pediatrics The recommended dosage of MODEYSO in pediatric patients aged 1 to <17 years who weigh at least 10 kg is based on body weight (Table 1).

A recommended dosage of MODEYSO has not been established in pediatric patients who weigh less than 10 kg. Table 1: Recommended Body Weight-Based Dosage for Pediatric Patients Body Weight (kg) Recommended Dosage 10 kg to <12.5 kg 125 mg Once Weekly 12.5 kg to <27.5 kg 250 mg Once Weekly 27.5 kg to <42.5 kg 375 mg Once Weekly 42.5 kg to <52.5 kg 500 mg Once Weekly ≥52.5 kg 625 mg Once Weekly Continue MODEYSO until disease progression or unacceptable toxicity. Swallow capsules whole.

For patients unable to swallow capsules whole, open each capsule, mix contents with approximately 15 to 30 mL of liquid (sports drink, apple juice, lemonade, or water) before administration, and administer orally as a liquid [see Patient Counseling Information ( 17 )] . Once mixed, administer within 2 hours of preparation, or discard and mix a new dose. Vomiting If vomiting occurs after taking a dose, do not take an additional dose and take the next dose at the regularly scheduled time.

Missed Dose If a dose is missed within 2 days, take the missed dose as soon as possible. If a dose is missed by more than 2 days, skip the missed dose and take the next dose at the scheduled time.

2.4Dosage Modifications for Adverse Reactions The recommended dosage reductions for adverse reactions for MODEYSO are provided in Table 2. Table 2: Recommended Dosage Reductions for Adverse Reactions Patient’s Weight (kg) First Dosage Reduction Second Dosage Reduction Pediatric patients 10 kg to <12.5 kg Permanently discontinue N/A Pediatric patients 12.5 kg to <27.5 kg 125 mg once weekly Permanently discontinue Pediatric patients 27.5 kg to <42.5 kg 250 mg once weekly 125 mg once weekly Pediatric patients 42.5 kg to <52.5 kg 375 mg once weekly 250 mg once weekly Pediatric patients ≥52.5 kg and adult patients 500 mg once weekly 375 mg once weekly The recommended dosage modifications for adverse reactions are provided in Table 3.

Table 3: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity a Dosage Modification b Hypersensitivity [see Warnings and Precautions ( 5.1 )] Any grade If hypersensitivity is suspected based on clinical judgement, interrupt MODEYSO until resolution of the event. Permanently discontinue MODEYSO in patients who develop serious hypersensitivity reactions. QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] QTc absolute value >500 ms or An increase of >60 ms from baseline Interrupt MODEYSO until QTc interval… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 125 mg, white, opaque, hard capsules printed with “DDP” and “125” on the body and “CMRX” on the cap of the capsule. Each capsule contains 125 mg dordaviprone. • Capsules: 125 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity: If clinically significant hypersensitivity or anaphylaxis occur, immediately discontinue MODEYSO and initiate appropriate medical treatment and supportive care. ( 5.1 ) • QTc Interval Prolongation: MODEYSO causes concentration dependent QTc interval prolongation. Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation, and permanently discontinue MODEYSO in patients with signs of life-threatening arrhythmias.

( 5.2 , 12.2 ) • Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 )

5.1Hypersensitivity MODEYSO can cause severe hypersensitivity reactions. In the pooled safety population [see Adverse Reactions ( 6.1 )], Grade 3 hypersensitivity reactions occurred in 0.3% of patients receiving MODEYSO. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

Inform patients about the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical attention if symptoms occur. If clinically significant hypersensitivity or anaphylaxis occur, immediately interrupt MODEYSO and initiate appropriate medical treatment and supportive care. Based on the severity of the adverse reaction, temporarily interrupt or permanently discontinue MODEYSO [see Dosage and Administration ( 2.4 )] .

5.2QTc Interval Prolongation MODEYSO causes a concentration-dependent QTc interval prolongation [see Clinical Pharmacology ( 12.2 )] , which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. In the pooled safety population [see Adverse Reactions ( 6.1 )] , of the 82 patients who underwent at least one post-baseline ECG assessment, 6% experienced an increase in QTc of >60 msec compared to baseline after receiving MODEYSO and 1.2% had an increase in QTc to >500 msec. Monitor ECGs and electrolytes prior to starting MODEYSO and then periodically during treatment as clinically indicated.

Significant prolongation of the QT interval may occur when MODEYSO is taken concomitantly with other products that have a known potential to prolong the QT interval. Avoid concomitant use of MODEYSO with products known to prolong the QT interval. If concomitant use cannot be avoided, separate administration of MODEYSO and the QT-prolonging product [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.2 )] .

Increase the frequency of monitoring when administering MODEYSO to patients taking other products that have a known potential to prolong the QT interval and in patients with congenital long QT syndrome, existing QTc prolongation, a history of ventricular arrhythmias, electrolyte abnormalities, heart failure, or who are taking strong or moderate CYP3A4 inhibitors. Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation, and permanently discontinue MODEYSO in patients with signs of life-threatening arrhythmias [see Dosage and Administration ( 2.4 )] .

5.3Embryo-fetal Toxicity Based on findings from animal studies and its mechanism of action, MODEYSO can cause fetal harm when administered to a pregnant woman. In embryo-fetal development studies, oral administration of dordaviprone to pregnant rats and rabbits during organogenesis caused embryo-fetal mortality, alterations to growth, and structural abnormalities at exposures below the human exposure at the highest recommended dose. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following potential clinically significant adverse reactions are described elsewhere in the labelling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] . • QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] . The most common (≥20%) adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chimerix at toll-free phone # 1-866-662-2679 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. The pooled safety population described in WARNINGS AND PRECAUTIONS and below reflects exposure to MODEYSO at the recommended weight-based dose taken until disease progression or unacceptable toxicity in 376 adult and pediatric patients with glioma across four open-label clinical studies (ONC006, ONC013, ONC014, and ONC018) [see Clinical Studies ( 14 )] .

Of the 376 patients who received MODEYSO, 35% were exposed for 6 months, and 17% were exposed for 1 year. The median age was 23 years (range: 3 to 80): 30% were 2 to 11 years old, 11% were 12 to 17 years old, 55% were 18 to 64 years old, and 3.7% were 65 years or older. Fifty-two percent (52%) were female; 74% White, 10% unknown race or race not reported, 9% Black or African American, 4% Asian, 2.9% other or multiple races; and 13% were of Hispanic or Latino ethnicity.

Karnofsky/Lansky Performance Status (KPS/LPS) score was 80 to 100 in 66% of patients, 60 to 70 in 27%, and <60 in 7%. Relevant disease characteristics included primary tumor locations in the midline (91%) and non‑midline regions (9%); 33% had diffuse intrinsic pontine glioma (DIPG); 30% had multifocal disease; 79% had an H3 K27M mutation; 75% had recurrent disease. Serious adverse reactions occurred in 33% of patients who received MODEYSO.

Serious adverse reactions in >2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%), and muscular weakness (2.1%). Fatal adverse reactions occurred in 1% of patients who received MODEYSO, including cardiac arrest (0.5%), intracranial hemorrhage (0.3%), and encephalopathy (0.3%). Permanent discontinuation of MODEYSO due to an adverse reaction occurred in 2.1% of patients.

Adverse reactions which resulted in permanent discontinuation of MODEYSO in >1 patient included confusional state. Dosage interruptions of MODEYSO due to an adverse reaction occurred in 6% of patients. Adverse reactions which required dosage interruption in >1 patient included increased alanine aminotransferase, increased aspartate aminotransferase, decreased lymphocyte count, muscular weakness, and aspiration pneumonia.

Dose reductions of MODEYSO due to an adverse reaction occurred in 2.7% of patients. Adverse reactions which required dose reductions in >1 patient included decreased neutrophil count and increased alanine aminotransferase. The most common adverse reactions (≥20%) were fatigue, headache, vomiting, nausea, and musculoskeletal pain.

The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased calcium, and increased alanine aminotransferase. Adverse reactions that occurred in at least 10% of patients treated with MODEYSO are presented in Table 4. Table 4: Adverse Reactions (≥10%) in Patients with Glioma Who Received MODEYSO in ONC006, ONC013, ONC014, and ONC018 Adverse Reaction MODEYSO (N=376) All Grades (%) Grade 3 or 4 (%) General Disorders Fatigue a 34

3.2 Gait disturbance 16

3.7 Nervous System Disorders Headache b 32

4.3 Cranial nerve disorders c 16

1.3 Hemiparesis 15

4.5Dysarthria… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • CYP3A4 Inhibitors: Avoid concomitant use of strong and moderate CYP3A4 inhibitors with MODEYSO. If concomitant use cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the dose of MODEYSO as recommended. ( 2.5 , 7.1 ) • CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO.

( 7.1 ) • Drugs Known to Prolong QTc Interval: Avoid concomitant use of MODEYSO with products known to prolong the QTc interval. If concomitant use cannot be avoided, separate administration of MODEYSO and the QT-prolonging product. ( 5.2 , 7.2 , 12.2 )

7.1Effect of Other Drugs on MODEYSO Table 6 describes drug interactions where concomitant use of another drug affects MODEYSO. Table 6: Effect of Other Drugs on MODEYSO Strong and Moderate CYP3A4 Inhibitors Prevention or Management • Avoid concomitant use of strong and moderate CYP3A4 inhibitors with MODEYSO. • If concomitant use cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the MODEYSO dose as recommended [see Dosage and Administration ( 2.5 )] . Mechanism and Clinical Effects • Dordaviprone is a CYP3A4 substrate. • Strong and moderate CYP3A4 inhibitors increase dordaviprone exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of MODEYSO‑related adverse reactions [see Warnings and Precautions ( 5.2 )] .

Strong or Moderate CYP3A4 Inducers Prevention or Management • Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO . Mechanism and Clinical Effects • Dordaviprone is a CYP3A4 substrate. • Strong and moderate CYP3A4 inducers decrease dordaviprone exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce the anti-tumor activity of MODEYSO.

7.2Drugs Known to Prolong QTc Interval Table 7 describes drug interactions associated with QTc interval prolongation when used concomitantly with MODEYSO. Table 7: Products that Prolong QTc Interval Products that Prolong QTc Interval Prevention or Management • Avoid concomitant use of MODEYSO with products known to prolong the QTc interval. • If concomitant use cannot be avoided, separate administration of MODEYSO and the QT-prolonging product [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.2 )] .

Clinical Impact • MODEYSO causes concentration dependent QTc interval prolongation [see Clinical Pharmacology ( 12.2 )] . • Concomitant use of MODEYSO with other QT-prolonging products may increase the risk of QTc-associated arrhythmias [see Warnings and Precautions ( 5.2 )] .

👥 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 [see Clinical Pharmacology ( 12.1 )] , MODEYSO can cause fetal harm when administered to a pregnant woman. There are no available data on MODEYSO use in pregnant women to inform a drug‑associated risk. In animal embryo-fetal development studies, oral administration of dordaviprone to pregnant rats and rabbits during the period of organogenesis caused embryofetal mortality, alterations to growth, and structural abnormalities at exposures below the human exposure at the highest recommended dose (see Data ).

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, dordaviprone was administered orally to pregnant rats during the period of organogenesis from gestation day 7 to 17 at doses of 25, 62.5, and 125 mg/kg/day.

Dordaviprone caused maternal mortality, pre-implantation loss, and embryo-fetal toxicity of absent eye and small renal papillae at the 125 mg/kg/day dose (≥2 times the human recommended doses based on body surface area). In an embryo-fetal development study, dordaviprone was administered orally to pregnant rabbits during the period of organogenesis from gestation days 7 to 19 at doses of 10, 25, 62.5, and 100 mg/kg/day. Dordaviprone caused maternal mortality, embryo‑fetal mortality, lower fetal weights, and structural malformations of the face, limbs, vessels, brain, and heart at doses of ≥10 mg/kg/day (≥0.4 times the human exposure at the highest recommended dose based on C max ).

8.2Lactation Risk Summary There are no data on the presence of dordaviprone or its metabolites in human milk, their effects on a breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children from MODEYSO, advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential MODEYSO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating MODEYSO [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose [see Use in Specific Populations ( 8.1 )] .

Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Infertility Based on the mechanism of action of dordaviprone (dopamine D2 receptor inhibition and alterations to mitochondrial function), treatment with MODEYSO may adversely impact fertility in males and females.

8.4Pediatric Use The safety and effectiveness of MODEYSO has been established in pediatric patients aged 1 year and older for the treatment of diffuse midline glioma harboring an H3 K27M mutation [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The efficacy of MODEYSO was evaluated in 4 pediatric patients aged 9 to 17 years with diffuse midline glioma harboring an H3 K27M mutation. Safety was evaluated in 154 pediatric patients with glioma aged 3 to 17 years who received MODEYSO at the recommended dose across four open‑label clinical studies (ONC006, ONC013, ONC014, and ONC018).

Of these 154 patients, 73% were 3 to 11 years of age and 27% were 12 to 17 years of age. No additional safety signals were observed in pediatric patients [see Adverse Reactions ( 6.1 )] . The exposure of dordaviprone in pediatric patients weighing 10 kg and higher is predicted to be within the range of exposures predicte… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , MODEYSO can cause fetal harm when administered to a pregnant woman. There are no available data on MODEYSO use in pregnant women to inform a drug‑associated risk. In animal embryo-fetal development studies, oral administration of dordaviprone to pregnant rats and rabbits during the period of organogenesis caused embryofetal mortality, alterations to growth, and structural abnormalities at exposures below the human exposure at the highest recommended dose (see Data ).

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, dordaviprone was administered orally to pregnant rats during the period of organogenesis from gestation day 7 to 17 at doses of 25, 62.5, and 125 mg/kg/day.

Dordaviprone caused maternal mortality, pre-implantation loss, and embryo-fetal toxicity of absent eye and small renal papillae at the 125 mg/kg/day dose (≥2 times the human recommended doses based on body surface area). In an embryo-fetal development study, dordaviprone was administered orally to pregnant rabbits during the period of organogenesis from gestation days 7 to 19 at doses of 10, 25, 62.5, and 100 mg/kg/day. Dordaviprone caused maternal mortality, embryo‑fetal mortality, lower fetal weights, and structural malformations of the face, limbs, vessels, brain, and heart at doses of ≥10 mg/kg/day (≥0.4 times the human exposure at the highest recommended dose based on C max ).

🧒 Pediatric Use 191 words ▾

8.4Pediatric Use The safety and effectiveness of MODEYSO has been established in pediatric patients aged 1 year and older for the treatment of diffuse midline glioma harboring an H3 K27M mutation [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The efficacy of MODEYSO was evaluated in 4 pediatric patients aged 9 to 17 years with diffuse midline glioma harboring an H3 K27M mutation. Safety was evaluated in 154 pediatric patients with glioma aged 3 to 17 years who received MODEYSO at the recommended dose across four open‑label clinical studies (ONC006, ONC013, ONC014, and ONC018).

Of these 154 patients, 73% were 3 to 11 years of age and 27% were 12 to 17 years of age. No additional safety signals were observed in pediatric patients [see Adverse Reactions ( 6.1 )] . The exposure of dordaviprone in pediatric patients weighing 10 kg and higher is predicted to be within the range of exposures predicted in adults at the recommended dosage [see Clinical Pharmacology ( 12.3 )] .

The safety and effectiveness of MODEYSO have not been established in pediatric patients less than 1 year of age.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Of the 376 patients with glioma who received MODEYSO at the recommended dose across four open-label clinical studies (ONC006, ONC013, ONC014, and ONC018), 3.7% of patients were ≥65 years of age and 0.5% were ≥75 years of age. Clinical studies of MODEYSO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P (ClpP). Dordaviprone also inhibits the dopamine D2 receptor. Diffuse midline gliomas harboring an H3 K27M mutation are associated with the loss of H3 K27 trimethylation.

In-vitro, dordaviprone activated the integrated stress response, induced apoptosis, and altered mitochondrial metabolism leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma models. Dordaviprone exhibited antitumor activity in cell-based assays and in vivo models of H3 K27M-mutant diffuse glioma.

12.2Pharmacodynamics Cardiac Electrophysiology At 1.2 times the maximum recommended dose, the estimated mean QTcF change was 11.8 msec (90% CI: 9.8, 13.7) [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 )] . Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dordaviprone have not been fully characterized.

12.3Pharmacokinetics Dordaviprone pharmacokinetics were predicted following a single dose in patients at the approved recommended dosage and are presented as mean (CV%) unless otherwise specified. Dordaviprone maximum concentration (C max ) is 2.8 mcg/mL (42%), and total systemic exposure (AUC) is 23 hr·mcg/mL (48%). Dordaviprone C max and AUC increased in a dose proportional manner over the dose range of 125 to 625 mg.

No accumulation is observed following once weekly dosing. Absorption Dordaviprone median (min, max) time to maximum plasma concentration (T max ) is 1.4 hours (0.5, 5.6 hours). Food Effect Dordaviprone C max decreased by 40% with no change on AUC following administration with a high-fat meal (800 to 1,000 calories, 50% fat).

Distribution Dordaviprone apparent (oral) volume of distribution is 450 L (40%). Dordaviprone plasma protein binding is 95% to 97% and independent of concentrations in vitro. The median blood-to-plasma ratio is 0.67 in vitro.

Metabolism Dordaviprone is primarily metabolized by CYP3A4 with minor contribution from CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP3A5. Excretion Dordaviprone mean terminal half-life is 11 hours (30%), and the apparent clearance is approximately 27 L/hr (48%). Following a single dose of radiolabeled dordaviprone, 70% of the dose was recovered in urine and 20% in feces with no notable unchanged dordaviprone in urine or feces.

Specific Populations No clinically significant differences in the pharmacokinetics of dordaviprone were observed based on age (3 to 90 years), sex, race (74% White, 9% Black or African American, or 5% Asian) or mild hepatic impairment (total bilirubin ≤ULN with AST >ULN or total bilirubin >1 to 1.5 times ULN with any AST). The effect of severe hepatic impairment (total bilirubin >3 times ULN with any AST) on dordaviprone pharmacokinetics is unknown. Pediatric Patients The exposure of dordaviprone in pediatrics weighing 10 kg and higher is predicted to be within the range of exposures predicted in adults at the recommended dosage.

Renal Impairment Following a single oral dose of 375 mg (0.6 times the maximum approved recommended dose), dordaviprone AUC increased by 1.5-fold and C max by 1.1-fold in subjects with severe renal impairment (CLcr <30 mL/min, estimated by the Cockcroft-Gault equation). Hepatic Impairment Following a single oral dose of 125 mg (0.2 times the maximum approved recommended dose) dordaviprone AUC increased by 1.5-fold and C max by 1.2-fold in subjects with moderate hepatic impairment (Child Pugh class B). Drug Interaction Studies Clinical Studies and Model-Informed Approaches CYP3A4 Inhibitors: Dordaviprone C max increased by 2-fold and AUC increased by 4-fold following concomitant administration of itraconazole (strong CYP3A4 inhibitor) 200 mg once daily for 8 days.

Dordaviprone C max is predicted to increase by ~1.5-fold and AUC by 2.5-fold following concomitant administration of fluconazole or erythromycin (mo… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P (ClpP). Dordaviprone also inhibits the dopamine D2 receptor. Diffuse midline gliomas harboring an H3 K27M mutation are associated with the loss of H3 K27 trimethylation.

In-vitro, dordaviprone activated the integrated stress response, induced apoptosis, and altered mitochondrial metabolism leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma models. Dordaviprone exhibited antitumor activity in cell-based assays and in vivo models of H3 K27M-mutant diffuse glioma.

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Strength Description Package Configuration NDC Number 125 mg White, opaque, hard capsules printed with “DDP” and “125” on the body and “CMRX” on the cap of the capsule. Each bottle contains 10 capsules and desiccant with a child‑resistant closure. 68727-250-01 Storage 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].

📋 Description 163 words ▾

11 DESCRIPTION Dordaviprone is a protease activator. Dordaviprone is present as dordaviprone hydrochloride with the molecular formula C 24 H 26 N 4 O•2HCl. The molecular weight is 459.41.

The full chemical name for dordaviprone hydrochloride is 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo[1,2- a ]pyrido[3,4-e]pyrimidin-5(4 H )-one dihydrochloride. Dordaviprone hydrochloride has the following chemical structure: Dordaviprone hydrochloride is a white to off-white solid that is freely soluble in water. The 1% solution of dordaviprone hydrochloride is measured as pH 3.3.

MODEYSO (dordaviprone) capsules are supplied as 125 mg strength capsules in an immediate‑release oral formulation. Each MODEYSO capsule contains 125 mg of dordaviprone (equivalent to 148.8 mg of dordaviprone hydrochloride). The inactive ingredients in the capsule include magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

The capsule shell consists of hypromellose and titanium dioxide. The black printing ink contains alcohol, D&C yellow #10, FD&C blue #1, FD&C blue #2, FD&C red #40, ferrosoferric oxide, methyl alcohol, N‑ butyl alcohol, propylene glycol, and shellac glaze (20% esterified). chem structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and caregiver to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Hypersensitivity Advise patients that MODEYSO can cause hypersensitivity. Inform patients about the signs and symptoms of hypersensitivity reactions and instruct patients or caregivers to seek immediate medical attention if symptoms occur [see Warnings and Precautions ( 5.1 )] .

QTc Interval Prolongation Advise patients that MODEYSO can cause QTc interval prolongation. Inform patients of the signs and symptoms of QTc prolongation and instruct patients or caregivers to seek immediate medical attention if symptoms occur [see Warnings and Precautions ( 5.2 )] . Drug Interactions Inform patients that MODEYSO may interact with some drugs.

Advise patients to inform their healthcare provider about all medications they are taking, including prescription and over-the-counter drugs, vitamins, and herbal products. Additionally, patients should consult their healthcare provider before starting or stopping any prescription drug, nonprescription drug, or supplement [see Drug Interactions ( 7 )] . Administration Instruct patients and caregivers to read the Instructions for Use before taking MODEYSO, and each time the patient gets a refill as there may be new information they need to know.

Patients should take MODEYSO orally once weekly on an empty stomach, at least 1 hour before or 3 hours after food intake. Take the prescribed dose at the same time on the same day of the week [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] . Instruct patients to swallow capsules whole.

For patients unable to swallow capsules whole, instruct patients to open capsules and mix contents with approximately 15 to 30 mL of liquid (sports drink, apple juice, lemonade, or water). Instruct patients to drink the mixture. After drinking the mixture, instruct patients to add another 15 to 30 mL of the liquid to the container, swirl to dissolve any remaining medication, and then drink the remaining contents [see Dosage and Administration ( 2.3 ) and Instructions for Use] .

Embryo-fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.1 , 8.3 )] . Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose [see Use in Specific Populations ( 8.3 )] .

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose [see Use in Specific Populations ( 8.2 )] . Distributed by: Jazz Pharmaceuticals, Inc.

Palo Alto, CA 94306

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Dordaviprone pharmacokinetics were predicted following a single dose in patients at the approved recommended dosage and are presented as mean (CV%) unless otherwise specified. Dordaviprone maximum concentration (C max ) is 2.8 mcg/mL (42%), and total systemic exposure (AUC) is 23 hr·mcg/mL (48%). Dordaviprone C max and AUC increased in a dose proportional manner over the dose range of 125 to 625 mg.

No accumulation is observed following once weekly dosing. Absorption Dordaviprone median (min, max) time to maximum plasma concentration (T max ) is 1.4 hours (0.5, 5.6 hours). Food Effect Dordaviprone C max decreased by 40% with no change on AUC following administration with a high-fat meal (800 to 1,000 calories, 50% fat).

Distribution Dordaviprone apparent (oral) volume of distribution is 450 L (40%). Dordaviprone plasma protein binding is 95% to 97% and independent of concentrations in vitro. The median blood-to-plasma ratio is 0.67 in vitro.

Metabolism Dordaviprone is primarily metabolized by CYP3A4 with minor contribution from CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP3A5. Excretion Dordaviprone mean terminal half-life is 11 hours (30%), and the apparent clearance is approximately 27 L/hr (48%). Following a single dose of radiolabeled dordaviprone, 70% of the dose was recovered in urine and 20% in feces with no notable unchanged dordaviprone in urine or feces.

Specific Populations No clinically significant differences in the pharmacokinetics of dordaviprone were observed based on age (3 to 90 years), sex, race (74% White, 9% Black or African American, or 5% Asian) or mild hepatic impairment (total bilirubin ≤ULN with AST >ULN or total bilirubin >1 to 1.5 times ULN with any AST). The effect of severe hepatic impairment (total bilirubin >3 times ULN with any AST) on dordaviprone pharmacokinetics is unknown. Pediatric Patients The exposure of dordaviprone in pediatrics weighing 10 kg and higher is predicted to be within the range of exposures predicted in adults at the recommended dosage.

Renal Impairment Following a single oral dose of 375 mg (0.6 times the maximum approved recommended dose), dordaviprone AUC increased by 1.5-fold and C max by 1.1-fold in subjects with severe renal impairment (CLcr <30 mL/min, estimated by the Cockcroft-Gault equation). Hepatic Impairment Following a single oral dose of 125 mg (0.2 times the maximum approved recommended dose) dordaviprone AUC increased by 1.5-fold and C max by 1.2-fold in subjects with moderate hepatic impairment (Child Pugh class B). Drug Interaction Studies Clinical Studies and Model-Informed Approaches CYP3A4 Inhibitors: Dordaviprone C max increased by 2-fold and AUC increased by 4-fold following concomitant administration of itraconazole (strong CYP3A4 inhibitor) 200 mg once daily for 8 days.

Dordaviprone C max is predicted to increase by ~1.5-fold and AUC by 2.5-fold following concomitant administration of fluconazole or erythromycin (moderate CYP3A4 inhibitor). CYP3A4 Inducers : Dordaviprone C max is predicted to decrease by 68% and AUC by 83% following concomitant administration of rifampin (strong CYP3A4 inducer) and dordaviprone C max is predicted to decrease by 44% and AUC by 65% following concomitant administration of efavirenz (moderate CYP3A4 inducer). Other Drugs : No clinically significant difference in dordaviprone pharmacokinetics is predicted when used concomitantly with cimetidine (weak CYP3A4 inhibitor).

No clinically significant difference in dordaviprone pharmacokinetics is observed with multiple doses of a rabeprazole (proton-pump inhibitor). No clinically significant differences in the pharmacokinetics of the following drugs are predicted following concomitant use with MODEYSO: dabigatran etixelate (P-gp substrate), rosuvastatin (BCRP substrate), midazolam (CYP3A substrate), desipramine (CYP2D6 substrate) and repaglinide (CYP2C8 substrate). In Vitro Studies CYP Enzymes : Dordaviprone inhibits CYP1A2, CYP2B6, and CYP2C19 and induces CYP… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 59 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At 1.2 times the maximum recommended dose, the estimated mean QTcF change was 11.8 msec (90% CI: 9.8, 13.7) [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 )] . Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dordaviprone have not been fully characterized.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of MODEYSO was evaluated in adult and pediatric patients with glioma across five open‑label, non-randomized clinical studies conducted in the U.S. (ONC006 [NCT02525692], ONC013 [NCT03295396], ONC014 [NCT03416530], ONC016 [NCT05392374], and ONC018 [NCT03134131]). Pre-specified criteria were defined to establish an integrated efficacy population; eligible patients were required to have received single-agent MODEYSO, have diffuse midline glioma harboring an H3 K27M mutation with progressive and measurable disease per Response Assessment in Neuro-Oncology-High Grade Glioma (RANO-HGG) criteria, be ≥90 days post‑radiation therapy, have adequate washout from prior anticancer therapies, have a Karnofsky Performance Status/Lansky Performance Status (KPS/LPS) score ≥60, and have stable or decreasing corticosteroid use.

Patients with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, atypical histologies, or cerebrospinal fluid dissemination were excluded. Patients received weight-based dosing of MODEYSO until disease progression or unacceptable toxicity. The integrated efficacy population included 50 patients who met these criteria.

The major efficacy outcome measure was overall response rate (ORR) assessed by blinded independent central review (BICR) according to RANO 2.0 criteria. Additional efficacy outcome measures were BICR-assessed ORR according to RANO-HGG criteria and Response Assessment in Neuro-Oncology-Low Grade Glioma (RANO-LGG) criteria, duration of response, and time to response. Baseline demographics were: median age 31 years (range: 9 to 70) with 6% younger than 17 years of age; 46% female; 80% White, 6% Black or African American, 2% Asian, 10% other races, and 2% race unknown; 8% were of Hispanic or Latino ethnicity; 72% had KPS/LPS 80 to 100.

Relevant disease characteristics included 72% treated at first recurrence, 28% had 2 or more recurrences; primary tumor location was thalamic in 52% and non-thalamic midline region in 48%; 88% received prior temozolomide; 62% were receiving corticosteroids at baseline; median time from end of prior radiation was 7.4 months (range: 3.0 to 102.1). Efficacy results are shown in Table 8. Table 8: Efficacy Results for Patients with Diffuse Midline Glioma Harboring an H3 K27M Mutation in Studies ONC006, ONC013, ONC014, ONC016, and ONC018 per RANO

2.0Efficacy Parameter MODEYSO N=50 Overall Response Rate (95% CI) a 22% (12, 36) Partial response (PR) 16% Minor response (MR) 6% Duration of Response N=11 Median (95% CI) b , months 10.3 (7.3, 15.2) % with observed DOR ≥6 months c 73% % with observed DOR ≥12 months c 27% Abbreviations: BICR=blinded independent central review; CI=confidence interval; RANO=Response Assessment in Neuro-Oncology. a. Confirmed overall response rate assessed by BICR; CI based on Clopper-Pearson method. b. Based on Kaplan-Meier estimate. c.

Based on observed time. Among responders, the median time to response was 3.6 months (range 1.6, 15.6). Using BICR-assessed RANO 2.0 criteria, there was one additional responder based on the integrated response assessment, which takes into account corticosteroid use and performance status.

Based on BICR-assessed RANO-HGG criteria (n=50), the ORR was 20% (95% CI: 10, 34), with 1 complete and 9 partial responses. Based on BICR-assessed RANO-LGG criteria (n=50), the ORR was 20% (95% CI: 10, 34), with 5 partial and 5 minor responses.

🧪 Nonclinical Toxicology 162 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with dordaviprone were not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitro (Ames and micronucleus assay) and in vivo (mouse micronucleus) assays. Impairment of Fertility Dedicated fertility studies were not conducted with dordaviprone.

13.2Animal Toxicology and/or Pharmacology The nonclinical safety profile of dordaviprone reflects the on-target pharmacology and dopamine receptor inhibition. In repeat-dose toxicology studies of up to 13 weeks in duration, weekly oral administration of dordaviprone to dogs caused central nervous system-related toxicities including whole body tremors, cranial tremors, seizures, excessive salivation, lateral recumbency, rigidity, paddling of limbs, overall rigid body, salivation, abnormal gait/stance, and twitching at doses resulting in less than or equal to 0.7 times the human exposure at the highest recommended dose based on AUC.

In a 13-week repeat-dose toxicology study in rats, mammary gland hyperplasia occurred at doses resulting in 0.11 times the human exposure at the highest recommended dose based on AUC.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 43 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with dordaviprone were not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitro (Ames and micronucleus assay) and in vivo (mouse micronucleus) assays. Impairment of Fertility Dedicated fertility studies were not conducted with dordaviprone.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION MODEYSO (moh-DAY-soh) (dordaviprone) capsules, for oral use What is MODEYSO? MODEYSO is a prescription medicine used to treat adults and children 1 year of age and older with a certain type of brain tumor called diffuse midline glioma that has a specific “H3 K27M” gene mutation and has worsened after other treatments. It is not known if MODEYSO is safe and effective in children less than 1 year of age.

Before taking MODEYSO, tell your healthcare provider about all your medical conditions, including if you: • have heart failure or heart rhythm problems, including QT prolongation and long QT syndrome. • are pregnant or plan to become pregnant. MODEYSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MODEYSO. o Your healthcare provider should check to see if you are pregnant before you begin treatment with MODEYSO. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with MODEYSO and for 1 month after your last dose. o Males with partners who are able to become pregnant should use effective contraception during treatment with MODEYSO and for 1 month after your last dose. • are breastfeeding or plan to breastfeed.

It is not known if MODEYSO passes into breast milk. Do not breastfeed during treatment with MODEYSO and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MODEYSO and other medicines may affect the way each other work and may cause serious side effects. You can ask your healthcare provider or pharmacist for a list of medications that interact with MODEYSO.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start or stop taking any new medicines without first talking to your healthcare provider.

How should I take MODEYSO? • Take MODEYSO exactly as your healthcare provider tells you. • Do not change your dose or stop taking MODEYSO without talking to your healthcare provider. • Your healthcare provider may change your dose, temporarily stop, or completely stop treatment with MODEYSO if you develop certain side effects. • Take MODEYSO 1 time each week on the same day of the week. Take all of the capsules prescribed for your dose at the same time. • Take MODEYSO on an empty stomach, at least 1 hour before or 3 hours after eating food. • Swallow MODEYSO capsules whole.

If the capsules cannot be swallowed whole, see the detailed Instructions for Use for how to prepare and take or give MODEYSO as a liquid. • If vomiting happens after taking a dose of MODEYSO, do not take another dose. Take the next dose of MODEYSO on the next regularly scheduled weekly day of the week. • If you miss a weekly dose of MODEYSO by: o 2 days or less, take the missed dose as soon as you remember. Take the next dose of MODEYSO on the next regularly scheduled day of the week. o More than 2 days, skip the missed dose and take the next dose of MODEYSO on the next regularly scheduled day of the week.

What are the possible side effects of MODEYSO? MODEYSO may cause serious side effects, including: • Allergic reactions. Allergic reactions may happen during treatment with MODEYSO and can be severe.

Stop taking MODEYSO and get immediate emergency medical help right away if you get any signs or symptoms of allergic reactions, including: o rash o hives o fever o feeling faint or dizzy o wheezing or trouble breathing o swelling of the face or throat • Heart rhythm problems (QTc interval prolongation). MODEYSO can cause changes in the electrical activity of your heart and can increase your chance of getting a type of abnormal heart rhythm that can lead to sudden death called torsades de pointes. Before you sta… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE MODEYSO [moh-DAY-soh] (dordaviprone) capsules, for oral use This Instructions for Use contains information on how to prepare and take or give MODEYSO capsules as a liquid. Read this Instructions for Use carefully before you prepare and take or give a dose of MODEYSO for the first time and each time you or your child gets a prescription refill. There may be new information.

This information does not take the place of talking with your healthcare provider about your or your child’s medical condition or treatment. Important Information You Need to Know Before Preparing and Taking or Giving MODEYSO Capsules as a Liquid. • For oral use only (take by mouth). • Take or give MODEYSO exactly as your healthcare provider tells you. Do not change the dose or stop taking MODEYSO without talking to your healthcare provider. • Take or give MODEYSO 1 time each week on the same day of the week.

Take or give all of the capsules prescribed for your dose at the same time. • Take or give MODEYSO on an empty stomach, at least 1 hour before or 3 hours after eating food. • If you or your child cannot swallow the capsules whole, the capsules can be dissolved in sports drink, apple juice, lemonade, or water and taken as a liquid. • Check the expiration date on the MODEYSO bottle. Do not take or give MODEYSO if the expiration date has passed. Contact your pharmacist if the medicine is expired. • Do not take or give MODEYSO if the bottle or the capsules are broken or damaged.

Contact your healthcare provider or pharmacist for a replacement. Supplies needed to prepare and dissolve MODEYSO capsules to take or give as a liquid. Section A: Preparing and dissolving MODEYSO capsules to take or give as a liquid Preparing to dissolve the capsules Step 1: Wash and dry your hands.

Place the MODEYSO bottle on a clean, flat surface. Gather the rest of the supplies you will need so they are ready to use. Step 2: Check the prescribed dose.

Count out the number of MODEYSO capsules needed for the dose. Opening the capsules Step 3: Hold the capsule over a clean, empty cup. Carefully open the capsule by gently pulling and twisting both ends.

Slowly empty the contents (powder) into the cup. If any powder remains inside the capsule shell, gently tap the shell over the cup to remove any remaining powder. Step 4: Repeat Step 3 for each additional capsule needed for the prescribed dose.

Dissolving the capsules in liquid Step 5: Use a tablespoon (15 mL) to measure the liquid. Add 1 to 2 tablespoons (about 15 mL to 30 mL) of your chosen liquid (sports drink, apple juice, lemonade, or water) to the cup. Step 6: Gently swirl the liquid around the cup before taking or giving the mixture until no large chunks of powder remain.

The mixture may look cloudy. This is normal and okay. Section B: Taking or giving a dose of MODEYSO as a liquid Step 7: Take or give all of the mixture as soon as possible.

Always take or give the mixture within 2 hours of preparing it. An oral dosing syringe may be used to take or give the mixture by mouth. Refer to Section D for detailed instructions.

The mixture may be taken or given through a feeding tube. Refer to Section E for detailed instructions. Throw away the mixture if it is not taken within 2 hours of preparing it and go back to Section A to prepare a new dose.

If vomiting happens after taking or giving the dose, or not all of the liquid is swallowed, do not take or give another dose. Take the next dose of MODEYSO on the next regularly scheduled day of the week. Step 8: After taking or giving the dose, add 1 to 2 more tablespoons (about 15 mL to 30 mL) of your chosen liquid to the cup.

Step 9: Swirl the liquid around the cup to make sure any remaining medicine is mixed with the liquid. This helps make sure that no medicine is left behind. Step 10: Repeat Step 7 .

Section C: Disposing of (throwing away) empty MODEYSO capsule shells and cleaning the cup Step 11: After taking or giving the dose, throw empty capsule shells in the… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 28 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL RX ONLY MODEYSO™ (dordaviprone) 125 mg 10 CAPSULES FOR ORAL USE See Full Prescribing Information For MODEYSO Inside carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bottle

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q4 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
35
Units reimbursed last 4 qtrs
56
Gross reimbursed last 4 qtrs
$1.79M
Avg / prescription
$51,100.34
Avg / unit
$31,937.71
Latest quarter Q4 2025
35Rx
Fee-for-service vs managed care ⓘ
66% FFS 34% MCO
Fee-for-service · 23 Rx Managed care · 12 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 38 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 18 units · 0.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 0.1 /100k
2 Texas 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Modeyso — 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 Modeyso. 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
$2.8M
Claims incl. refills
49
Beneficiaries
20
Spend / beneficiary
$139,797.06
Spend / claim
$57,060.02
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.

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 — Not published for this NDC No photo available yet for this listing.
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) ✓ Available
“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 Jazz Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jazz Pharmaceuticals, 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.
← 68727-0150-01 · Jazz 68727-0712-01 · Jazz →
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.