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DECNUPAZ pivekimab sunirine-pvzy 2 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 00074-0282-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DECNUPAZ pivekimab sunirine-pvzy 2 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 0074-0282-02 (Billing 00074-0282-02)

by AbbVie Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.15 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of DECNUPAZ pivekimab sunirine-pvzy 2 mg/mL Injection, Powder, Lyophilized, For Solution from AbbVie Inc., marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 00074-0282-02
🏷️ FDA NDC (as labeled) 0074-0282-02 billing pads the labeler 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
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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 0074-0282-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0074 labeler · 0282 product · 02 package
Package marketed since
May 27, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 0074028202 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-0282-02
Product NDC 0074-0282
11-digit billing NDC 00074028202
NCPDP billing unit EA — each (per item)
RxCUI 2744303, 2744309
UNII L15LO3W1XX
Application # BLA761460
SPL Set ID 508b6ff8-601d-4901-a7a5-816141134054
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-27
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance PIVEKIMAB SUNIRINE

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

GPI-14 21354950002120
GCN Seq No 089010
GCN 59227
HICL code 051357
Ingredient (HICL) Pivekimab Sunirine-Pvzy
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V39
Therapeutic class — specific (HIC3) Antineoplastic-Cd123-Directed Cytotoxin Conjugate
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DECNUPAZ 2 MG VIAL
FDB brand name Decnupaz
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 089010
  • GCN: 59227
  • GPI-14 (Medi-Span): 21354950002120
  • HICL (First Databank): 051357
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2744303
Why two NDCs? The FDA registers this code as 0074-0282-02 — a 4-4-2 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 labeler segment → 00074-0282-02. 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.

Clinical

Label name DECNUPAZ 2 MG VIAL Ingredient Pivekimab Sunirine-Pvzy

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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
00074-0282-02 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.15 mL in 1 VIAL, SINGLE-DOSE 2026-05-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Decnupaz 2 mg/mLthis 00074-0282-02 AbbVie 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color white
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.

  • 0.45 mg / 1 mL UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • 0.1 mg / 1 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 0.2 mg / 1 mL UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 0.0048 mg / 1 mL UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 1.2 mg / 1 mL UNII AB6MNQ6J6L
    Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
  • 71.7 mg / 1 mL UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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

LabelerAbbVie Inc.
FDA applicationBLA761460 (BLA)
Labeler code00074
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio129 products on file

More NDCs from AbbVie Inc. labeler code 00074

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 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 201 words ▾

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) DECNUPAZ can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome) [see Warnings and Precautions ( 5.1 )] . Closely monitor patients for signs and symptoms of VOD including elevations in liver tests, hepatomegaly (which may be painful), rapid weight gain, and ascites [see Warnings and Precautions ( 5.1 )] . Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ [see Warnings and Precautions ( 5.1 )] .

Delay DECNUPAZ dosage for liver test elevation. Permanently discontinue DECNUPAZ for patients who experience VOD [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) See full prescribing information for complete boxed warning.

VOD, a severe form of hepatotoxicity, has been reported in patients with BPDCN treated with DECNUPAZ, including severe or fatal hepatic VOD. ( 5.1 ) Closely monitor for signs and symptoms of VOD. Monitor liver tests and total bilirubin prior to each dose.

( 5.1 ) Discontinue DECNUPAZ for patients who experience VOD. ( 2.4 , 5.1 )

🎯 Indications and Usage 46 words ▾

1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION For intravenous infusion only. ( 2.6 ) The recommended dose of DECNUPAZ is 0.045 mg/kg once every 3 weeks until disease progression or unacceptable toxicity.

( 2.2 ) Premedicate with a corticosteroid on the day prior to infusion and premedicate with a corticosteroid, antihistamine, and an antipyretic at least 30 to 60 minutes prior to DECNUPAZ infusion. ( 2.3 ) DECNUPAZ requires reconstitution followed by two dilutions prior to administration. See full Prescribing Information for instructions on preparation and administration.

( 2.5 , 2.6 )

2.1Important Administration Instructions DECNUPAZ requires reconstitution followed by two dilutions prior to administration. Read the entire preparation instructions carefully before preparing and administering DECNUPAZ.

2.2Recommended Dosage The recommended dose of DECNUPAZ in adult patients with BPDCN is 0.045 mg/kg intravenously over approximately 15-30 minutes once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Calculate the dose based on the patient’s actual body weight [see Dosage and Administration ( 2.5 ) ] .

2.3Premedications Administer the premedications in Table 1 the day prior to and the day of the infusion of DECNUPAZ to reduce the risk of infusion-related reactions (IRRs) [see Warnings and Precautions ( 5.2 )] . Table 1. Recommended Premedications Prior to Each DECNUPAZ Infusion Administration Time P rior to DECNUPAZ Infusion Premedication Route of Administration Dose ( or equivalent) Day before DECNUPAZ infusion Corticosteroid Oral or intravenous Dexamethasone 8 mg twice daily 30 to 60 minutes prior to infusion Corticosteroid Intravenous Dexamethasone 8 mg Antihistamine Intravenous Diphenhydramine 25 mg to 50 mg Antipyretic Oral Acetaminophen 325 mg to 650 mg

2.4Dosage Modifications for Adverse Reactions Table 2 provides recommended dosage modifications for DECNUPAZ due to adverse reactions. Table 2. Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity of Adverse Reaction a Dose Modification Guidelines Veno-occlusive disease (VOD) [see Warnings and Precautions ( 5.1 )] Any Grade Permanently discontinue DECNUPAZ Increased aspartate aminotransferase (AST) or alanine aminotransferase (ALT) [see Warnings and Precautions ( 5.1 )] Either AST or ALT is >2.5 x ULN Delay further DECNUPAZ dosing until AST or ALT have returned to ≤2.5 × ULN Increased bilirubin [see Warnings and Precautions ( 5.1 )] Total bilirubin > 1.5 × ULN Delay further DECNUPAZ dosing until total bilirubin has returned to ≤1.5 × ULN Infusion-related reactions [see Warnings and Precautions ( 5.2 )] Grade 2 Interrupt DECNUPAZ infusion and institute appropriate medical management After full resolution of symptoms, resume DECNUPAZ infusion at 50% of the previous rate and if no further symptoms appear, increase rate as appropriate until infusion is completed Grade 3 Stop DECNUPAZ infusion and institute appropriate medical management After full resolution of symptoms, resume the infusion at 50% of the previous rate If symptoms recur, permanently discontinue Grade 4 Permanently discontinue DECNUPAZ Edema [see Warnings and Precautions ( 5.3 )] Grade 1 (5-10% inter-limb discrepancy in volume or circumference, 4 kg weight gain, or 1+ pitting edema (2 mm)) Follow weekly weights Consider administering diuretic therapy Grade 2 (10-30% inter-limb discrepancy in volume or circumference, >4 kg weight gain, or 2+ pitting edema (4 mm)) Administer diuretic therapy Manage hypoalbuminemia as needed Delay further DECNUPAZ dosing until edema has returned to Grade 0-1 or baseline If delayed more than 2 weeks, consider dose reduction before resuming Grade 3 (> 30% inter-limb discrepancy in volume, or 3+/4+ pitting edema (>6 mm)) Consider combination diuretic therapy Manage hypoalbuminemia as needed Delay further DECNUPAZ dosing until edema has returned to Grade 0-1 or baseline Consider resuming DECNUPAZ infusion at 0.015 mg/kg intravenously once e… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 41 words ▾

3. DOSAGE FORMS AND STRENGTHS For injection: 2 mg of pivekimab sunirine-pvzy as a white to off-white, lyophilized cake in a single-dose vial. For injection: 2 mg of pivekimab sunirine-pvzy as a lyophilized cake in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4. CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS I nfusion -related reactions (IRR) : DECNUPAZ can cause serious, life-threatening IRR. Premedicate with a corticosteroid the day before infusion, and premedicate with a corticosteroid, antihistamine, and an antipyretic prior to DECNUPAZ infusion.

Monitor patients for IRR. Interrupt, reduce the rate of infusion, or permanently discontinue DECNUPAZ based on the severity. ( 5.2 ) Edema : Monitor for the development of edema and fluid retention.

Depending on severity, delay, consider resuming at a lower dose, or permanently discontinue DECNUPAZ. ( 5.3 ) Sulfite Allergic Reactions : DECNUPAZ contains sodium metabisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in certain susceptible people. ( 5.4 ) Embryo-fetal toxicity : Can cause fetal harm.

Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.5 )

5.1Hepatotoxicity , Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome) DECNUPAZ can cause hepatotoxicity, including VOD, a severe form of hepatotoxicity. In CADENZA, VOD occurred in 6% (7/116) of adult patients during treatment or following a subsequent hematopoietic stem cell transplantation (HSCT). Of the 7 total patients who developed VOD, 3 patients had treatment-naïve BPDCN and 4 patients had relapsed/refractory BPDCN.

Among all 116 patients treated with DECNUPAZ at 0.045 mg/kg, VOD occurred in 2/116 (2%) during treatment, with onset up to 30 days after the last dose. Among 19 patients with BPDCN who proceeded to HSCT, VOD occurred in 5/19 patients (26%), including two fatal cases. The median time from subsequent HSCT to onset of VOD was 11 days (range: 7 – 25 days).

After receiving DECNUPAZ, patients should be closely monitored for signs and symptoms of VOD including elevations in ALT, AST, total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ. Based on elevations of liver tests, delay DECNUPAZ.

In patients who experience VOD, discontinue DECNUPAZ and treat according to standard medical practice [see Dosage and Administration ( 2.4 )] .

5.2Infusion-Related Reactions DECNUPAZ can cause serious, life-threatening infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. In CADENZA, IRRs occurred in 26% (30/116) of patients during treatment with DECNUPAZ at 0.045 mg/kg once every three weeks, including Grade 1 in 4.3% (5/116), Grade 2 in 16% (19/116), and Grade 3 in 5% (6/116) of patients. IRR occurred in Cycle 1 in 25% (29/116) of patients with decreasing frequency in subsequent cycles.

IRR led to discontinuation in one patient. Premedicate with a corticosteroid the day before infusion, and premedicate with a corticosteroid, antihistamine, and antipyretic prior to dosing [ see Dosage and Administration ( 2.3 )] . Premedication the day before infusion and prior to dosing led to reduced frequency and severity of IRRs.

Monitor patients closely for potential IRR during the infusion and for at least four hours, or longer as clinically indicated, after the first infusion and for at least 1 hour after subsequent infusions. Interrupt infusion of DECNUPAZ and institute appropriate medical management if an infusion-related reaction occurs. Depending on the severity of the infusion-related reaction, reduce infusion rate or permanently discontinue [see Dosage and Administration ( 2.4 )].

5.3Edema DECNUPAZ can cause edema and fluid retention, including serious events. In CADENZA, Grade 3-4 edema occurred in 16% (18/116) of patients treated with DECNUPAZ, including Grade 3-4 generalized edema in 2.6% (3/116) of patients [see Adverse Reactions ( 6.1 )]. Monitor patients for new or worsening edema. For Grade 2 or Grade 3 edema, delay further dosing of DECNUPAZ until… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hepatotoxicity, Including Hepatic VOD (also known as Sinusoidal Obstruction Syndrome) [see Warnings and Precautions ( 5.1 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] Edema [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥10%) were neutrophils decreased, platelets decreased, lymphocyte count decreased, white blood cells decreased, hemoglobin decreased, and glucose increased.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical T rials 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 safety of DECNUPAZ was evaluated in CADENZA, a single-arm, open-label study that included 116 adults with newly diagnosed or relapsed/refractory myeloid malignancies, including 84 with BPDCN, treated with DECNUPAZ 0.045 mg/kg once every three weeks.

The median number of cycles administered was 3 (range: 1 to 34) in the overall population, and 3.5 (range: 1 to 34) in patients with BPDCN. Serious adverse reactions occurred in 55% of patients treated with DECNUPAZ. The most common (≥2%) serious adverse reactions were febrile neutropenia, pneumonia, edema, sepsis, hemorrhage, thrombosis, infusion-related reactions, viral infection, pneumonitis, infections without specified pathogens, pyrexia, and musculoskeletal pain.

Fatal adverse reactions occurred in 4.3% of patients who received DECNUPAZ, including cardiac arrest (0.9%), clostridium difficile infection (0.9%), failure to thrive (0.9%), depressed level of consciousness (0.9%), and respiratory failure (0.9%). Permanent discontinuation due to adverse reactions occurred in 10% of patients who received DECNUPAZ. Adverse reactions which resulted in permanent discontinuation of DECNUPAZ in ≥1% of patients included veno-occlusive disease and pneumonitis.

Dosage interruptions of DECNUPAZ due to adverse reactions occurred in 37% of patients. Adverse reactions which resulted in dosage interruptions in ≥2% of patients included edema, pneumonia, infusion-related reaction, bacterial infections, fatigue, hemorrhage, neutropenia, pneumonitis, and pyrexia. Dose reductions of DECNUPAZ due to an adverse reaction occurred in 6% of patients.

Adverse reactions which required dose reductions in ≥2% of patients included edema. The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥10%) were neutrophils decreased, platelets decreased, lymphocyte count decreased, white blood cells decreased, hemoglobin decreased, and glucose increased.

Table 3 summarizes the common adverse reactions (≥10%) in patients treated with DECNUPAZ in CADENZA. Table 3. Adverse Reactions (≥10%) in Patients Who Received DECNUPAZ in CADENZA DECNUPAZ (N=116) Adverse Reaction § All Grades (%) Grade 3 or 4 (%) General disorders and administration site conditions Edema a 52 16 Fatigue b 34 5 Pyrexia b 16

0.9Chills 11 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain b 34 8 Vascular disorders Hemorrhage b 28 6 Thrombosis b 13 5 Injury, poisoning and procedural complications Infusion-related reactions 26 5 Fall 13

1.7 Gastrointestinal disorders Nausea b 24

0.9 Diarrhea b 21

0.9 Constipation 19 0 Abdominal pain b 14

0.9 Respiratory , thoracic and mediastinal disorders Dyspnea b 19

1.7Cough b 15 0 Skin and subcutaneous tissue disorders Rash… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 85 words ▾

7. DRUG INTERACTIONS Strong and M oderate CYP3A Inhibitors : Closely monitor for DECNUPAZ adverse reactions ( 7.1 )

7.1Effect of Other Drugs on DECNUPAZ Strong and moderate CYP3A inhibitors Closely monitor patients for adverse reactions with DECNUPAZ when used concomitantly with strong and moderate CYP3A inhibitors. FGN849 is a substrate of CYP3A [see Clinical Pharmacology ( 12.3 )] . Concomitant use of DECNUPAZ with strong and moderate CYP3A inhibitors may increase unconjugated FGN849 exposure, which may increase the risk of DECNUPAZ adverse reactions.

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed ( 8.2 ) Infer tility : May impair fertility ( 8.3 ) Moderate to Severe Hepatic Impairment : Avoid use of DECNUPAZ ( 8.7 ) Moderate to Severe Renal Impairment : Avoid use of DECNUPAZ ( 8.6 )

8.1Pregnancy Risk Summary Based on its mechanism of action, DECNUPAZ can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . There are no available data on the use of DECNUPAZ in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal reproductive or developmental toxicity studies were not conducted with pivekimab sunirine-pvzy. The cytotoxic component of DECNUPAZ, FGN849, is a DNA-alkylating agent that is toxic to rapidly dividing cells, indicating it has the potential to cause embryofetal lethality and teratogenicity.

8.2Lactation Risk Summary There are no data on the presence of pivekimab sunirine-pvzy or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with DECNUPAZ and for 1 month after the last dose.

8.3Females and Males of Reproductive Potential DECNUPAZ can cause fetal harm when administered to a pregnant patient [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiation of DECNUPAZ. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with DECNUPAZ and for 7 months after the last dose.

Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with DECNUPAZ and for 4 months after the last dose [see Nonclinical Toxicology ( 13.1 )] . Infertility Based on its mechanism of action, DECNUPAZ may impair male and female reproductive function and fertility.

8.4Pediatric Use The safety and effectiveness of DECNUPAZ have not been established in pediatric patients.

8.5Geriatric Use Of the 116 patients who were treated in CADENZA, 70% of patients were ≥65 years of age and 28% were ≥75 years of age. No overall differences in safety or effectiveness of DECNUPAZ have been observed between patients 65 years of age and older and younger adult patients. Age does not have a clinically meaningful effect on the pharmacokinetics of DECNUPAZ [see Clinical Pharmacology ( 12.3 )] .

8.6Renal Impairment Avoid use of DECNUPAZ in patients with moderate to severe renal impairment (CLcr <60 mL/min, estimated by Cockcroft-Gault) or patients with end stage renal disease. A higher incidence of Grade ≥3 adverse events, serious adverse events, and dose delays was observed in patients with moderate renal impairment (CLcr 30 to <60 mL/min). DECNUPAZ has not been studied in patients with severe renal impairment (CLcr <30 mL/min) or end stage renal disease.

No dosage adjustment of DECNUPAZ is recommended for patients with mild renal impairment (CLcr 60 to <90 mL/min, estimated by Cockcroft-Gault) [see Clinical Pharmacology ( 12.3 )] .

8.7Hepatic Impairment Avoid use of DECNUPAZ in patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN with any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). DECNUPAZ has not been studied in patients with severe hepatic impairment.

No dosage adjustment of DECNUPAZ is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 139 words ▾

8.1Pregnancy Risk Summary Based on its mechanism of action, DECNUPAZ can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . There are no available data on the use of DECNUPAZ in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal reproductive or developmental toxicity studies were not conducted with pivekimab sunirine-pvzy. The cytotoxic component of DECNUPAZ, FGN849, is a DNA-alkylating agent that is toxic to rapidly dividing cells, indicating it has the potential to cause embryofetal lethality and teratogenicity.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of DECNUPAZ have not been established in pediatric patients.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Of the 116 patients who were treated in CADENZA, 70% of patients were ≥65 years of age and 28% were ≥75 years of age. No overall differences in safety or effectiveness of DECNUPAZ have been observed between patients 65 years of age and older and younger adult patients. Age does not have a clinically meaningful effect on the pharmacokinetics of DECNUPAZ [see Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pivekimab sunirine-pvzy is a CD123 (alpha-subunit of the interleukin-3 receptor)-directed antibody-drug conjugate (ADC). The antibody is a humanized anti-CD123 IgG1. Pivekimab sunirine-pvzy binds to CD123 expressing cells and upon intracellular processing releases a cell membrane-permeable payload, FGN849, leading to DNA alkylation, single-strand DNA breaks, apoptosis, and cell death.

The payload, FGN849, is a member of the indolinobenzodiazepine pseudodimer (IGN) class of cytotoxic molecules. Pivekimab sunirine-pvzy exhibited antitumor activity in in vitro and in vivo models of BPDCN.

12.2Pharmacodynamics Exposure-Response Relationships Higher FGN849 (cytotoxic component of DECNUPAZ) exposure was associated with increased rates of Grade ≥2 infusion-related reactions. Cardiac Electrophysiology There is insufficient information to characterize the effect of pivekimab sunirine-pvzy on the QTc interval. In 116 patients who received DECNUPAZ 0.045 mg/kg once every 3 weeks in CADENZA, 0.9% of patients had QTcF greater than 500 ms.

12.3Pharmacokinetics Pivekimab sunirine-pvzy and FGN849 pharmacokinetics were observed at Cycle 1 in patients in CADENZA at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. The exposure parameters of pivekimab sunirine-pvzy (ADC) and unconjugated FGN849 are summarized in Table 5. The C max and AUC of the ADC increased more than proportionally over a dose range of 0.045 to 0.18 mg/kg (the approved recommended dose to 4 times the recommended dose).

ADC time to maximum concentrations (T max ) occurred approximately at the end of the infusion, while FGN849 T max occurred approximately 2 hours after the end of infusion. There was no accumulation of the ADC or FGN849 in Cycle 3. Table 5.

Cycle 1 Exposure parameters of pivekimab sunirine-pvzy and unconjugated FGN849 at DECNUPAZ 0.045 mg/kg Every 3 Weeks P ivekimab sunirine - pvzy Geometric mean (%CV) Unconjugated FGN849 Geometric mean (%CV) C max 442 (169) ng/mL 58.8 (110) pg/mL AUC last 892 (101) ng•h/mL 171 (128) pg•h/mL C max =maximum concentration, AUC last =area under the concentration from time zero to the last quantifiable concentration Distribution Pivekimab sunirine-pvzy volume of distribution is

5.4L (39). FGN849 plasma protein binding is 99.6% in vitro . Elimination Pivekimab sunirine-pvzy elimination half-life is approximately 1.5 hours at the 0.045 mg/kg every 3 weeks dosage. Pivekimab sunirine-pvzy clearance is

1.8L/hour (76). Metabolism Pivekimab sunirine-pvzy is expected to be catabolized into small peptides and amino acids. FGN849 is primarily metabolized by CYP3A.

Specific Populations No clinically significant differences in the pharmacokinetics of pivekimab sunirine-pvzy or FGN849 were observed for age (19 to 91 years), body weight (45 to 160 kg), mild hepatic impairment (total bilirubin >ULN to 1.5 times ULN and any AST), or CLcr 60 to <90 mL/min (estimated by Cockcroft-Gault). Higher pivekimab sunirine-pvzy exposure and lower FGN849 exposure were observed in female patients compared to those in male patients. The pharmacokinetics of pivekimab sunirine-pvzy in patients with moderate to severe hepatic impairment (total bilirubin >1.5 times ULN with any AST) or CLcr <60 mL/min is unknown.

Drug Interaction Studies No dedicated clinical studies evaluating the drug-drug interaction potential of pivekimab sunirine-pvzy have been conducted. In Vitro Studies Cytochrome P450 (CYP) Enzymes : FGN849 is primarily a CYP3A substrate but is not a significant substrate of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6. FGN849 is an inhibitor of CYP3A and CYP2C8 but is not an inhibitor of CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.

Transporter system s : FGN849 is a substrate of P-gp and BCRP but is not a substrate of MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, or OCT2. FGN849 is not an inhibitor of P-gp, BCRP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 81 words ▾

12.1Mechanism of Action Pivekimab sunirine-pvzy is a CD123 (alpha-subunit of the interleukin-3 receptor)-directed antibody-drug conjugate (ADC). The antibody is a humanized anti-CD123 IgG1. Pivekimab sunirine-pvzy binds to CD123 expressing cells and upon intracellular processing releases a cell membrane-permeable payload, FGN849, leading to DNA alkylation, single-strand DNA breaks, apoptosis, and cell death.

The payload, FGN849, is a member of the indolinobenzodiazepine pseudodimer (IGN) class of cytotoxic molecules. Pivekimab sunirine-pvzy exhibited antitumor activity in in vitro and in vivo models of BPDCN.

📦 How Supplied / Storage and Handling 96 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING How Supplied DECNUPAZ (pivekimab sunirine-pvzy) for injection is a sterile, preservative-free, white to off-white lyophilized cake, supplied in a single-dose glass vial. The DECNUPAZ vial stoppers are not made with natural rubber latex.

2 mg single-dose vial with dark grey flip-top (NDC 0074-0282-02) Storage and Handling Store DECNUPAZ vials upright in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of preparation in the original carton to protect from light. Do not freeze or shake. DECNUPAZ is a hazardous product.

Follow applicable special handling and disposal procedures 1 .

📋 Description 191 words ▾

11. DESCRIPTION Pivekimab sunirine-pvzy is a CD123-directed antibody and alkylating agent conjugate created by conjugating the IgG1 monoclonal antibody G4723A to the DGN549C linker-payload. The antibody-drug conjugate (ADC) contains approximately two DGN549C molecules sulfonated prior to conjugation and bound to the heavy chains (HC) of the G4723A antibody.

Pivekimab sunirine-pvzy has an approximate molecular weight of 148 kDa. Pivekimab sunirine-pvzy is produced by site directed chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis.

Pivekimab sunirine-pvzy has the following structure: DECNUPAZ (pivekimab sunirine-pvzy) for injection is a sterile, lyophilized cake in a single-dose vial for reconstitution and dilution. DECNUPAZ is supplied as 2 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL) to obtain a concentration of 2 mg/mL. Following reconstitution, each mL delivers 2 mg of pivekimab sunirine-pvzy, methionine (0.45 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.2 mg), sodium metabisulfite (0.0048 mg), succinic acid (1.2 mg), trehalose (71.7 mg), and Sterile Water for Injection.

The pH is 4.2. Pivekimab sunirine-pvzy has the following structure:

💬 Information for Patients ~2 min read ▾

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Veno-occlusive Disease (VOD) Advise patients that DECNUPAZ can cause VOD.

Advise patients to immediately contact their healthcare provider if they experience symptoms of VOD, which may include jaundice, rapid weight gain, dark urine, and abdominal pain or distention. Inform patients that liver problems may require dosing interruption or permanent discontinuation of DECNUPAZ [see Warnings and Precautions ( 5.1 )] . Infusion-Related Reactions Advise patients that DECNUPAZ can cause infusion-related reactions.

Advise patients to immediately contact their healthcare provider for any signs or symptoms of infusion-related reactions, which may include chills, tachycardia, hypotension, fever, tachypnea, and dyspnea [see Warnings and Precautions ( 5.2 )] . Edema Advise patients that DECNUPAZ can cause edema. Advise patients to contact their healthcare provider if they experience swelling, weight gain, shortness of breath or difficulty breathing, or fluid retention [see Warnings and Precautions ( 5.3 )] .

Sulfite Allergic Reactions Advise patients about potential for sulfite sensitivity. Inform patients that DECNUPAZ contains sodium metabisulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, and to seek immediate medical care if they experience these signs or symptoms [see Warnings and Precautions ( 5.4 )]. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus.

Advise female patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with DECNUPAZ [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with DECNUPAZ and for 7 months after the last dose [see Use in Specific Populations ( 8.3 )] . Advise males with female partners of reproductive potential to use effective contraception during treatment with DECNUPAZ and for 4 months after the last dose [see Use in Specific Populations ( 8.3 )] .

Infertility Advise females and males of reproductive potential that DECNUPAZ may impair reproductive function and fertility [see Use in Specific Populations ( 8.3 ) ] . Lactation Advise women not to breastfeed during treatment and for 1 month after the last dose of DECNUPAZ [see Use in Specific Populations ( 8.2 )] . Manufactured by: AbbVie Inc.

North Chicago, IL 60064, U.S.A. U.S. License No.

1889 © 2026 AbbVie. All rights reserved. DECNUPAZ and its design are trademarks of ImmunoGen, Inc., an AbbVie company.

20098137

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE DECNUPAZ (DEK-nuh-paz) (pivekimab sunirine-pvzy) for injection, for intravenous use What is the most important information I should know about DECNUPAZ? DECNUPAZ can cause serious side effects, including: Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver) that can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems.

Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including: ○ yellowing of the skin or eyes ○ pain in your stomach (abdomen) ○ fast weight gain ○ swelling of your stomach ○ dark urine Your healthcare provider will check you for liver problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also delay or stop treatment with DECNUPAZ if you have severe liver problems. See “What are the possible side effects of DECNUPAZ?” for more information about side effects.

What is DECNUPAZ? DECNUPAZ is a prescription medicine used to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). It is not known if DECNUPAZ is safe and effective in children.

Before receiving DECNUPAZ, tell your healthcare provider about all of your medical conditions, including if you: have liver problems are allergic to sulfites have asthma have kidney problems are pregnant or plan to become pregnant. DECNUPAZ can harm your unborn baby. Females who are able to become pregnant: ○ Your healthcare provider will check for pregnancy before you start treatment with DECNUPAZ. ○ Use effective birth control (contraception) during treatment with DECNUPAZ and for 7 months after your last dose. ○ Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with DECNUPAZ.

Males who have female partners who are able to become pregnant: ○ Use an effective birth control during treatment with DECNUPAZ and for 4 months after your last dose DECNUPAZ. are breastfeeding or plan to breastfeed. It is not known if DECNUPAZ passes into your breast milk. Do not breastfeed during treatment with DECNUPAZ and for 1 month after the last dose.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect DECNUPAZ and increase your risk of side effects. How will I receive DECNUPAZ?

Your healthcare provider will give you DECNUPAZ into your vein through an intravenous (IV) line over about 15 to 30 minutes. DECNUPAZ is given 1 time every three weeks (21-day treatment cycle). You will receive your first infusion over 30 minutes.

If you do not have problems with your first infusion, you may receive your next infusions over 15 minutes. Your healthcare provider will decide how many treatments of DECNUPAZ you will receive. Your healthcare provider will give you medicines the day before and on the day of your infusion to help reduce infusion-related reactions.

See “What are the possible side effects of DECNUPAZ?” Your healthcare provider may slow down your infusion of DECNUPAZ or permanently stop treatment with DECNUPAZ if you have an infusion-related reaction. What are the possible side effects of DECNUPAZ? DECNUPAZ can cause serious side effects, including: See “What is the most important information I should know about DECNUPAZ?” Infusion-related reactions (IRR).

DECNUPAZ can cause serious, life-threatening infusion-related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion of DECNUPAZ to help reduce infusion-related reactions. Your healthcare provider will check you for symptoms of infusion-related reactions during your infusion and for at least four hours or longer if needed, after your first infusion, and for at least one hour after each of… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pivekimab sunirine-pvzy and FGN849 pharmacokinetics were observed at Cycle 1 in patients in CADENZA at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. The exposure parameters of pivekimab sunirine-pvzy (ADC) and unconjugated FGN849 are summarized in Table 5. The C max and AUC of the ADC increased more than proportionally over a dose range of 0.045 to 0.18 mg/kg (the approved recommended dose to 4 times the recommended dose).

ADC time to maximum concentrations (T max ) occurred approximately at the end of the infusion, while FGN849 T max occurred approximately 2 hours after the end of infusion. There was no accumulation of the ADC or FGN849 in Cycle 3. Table 5.

Cycle 1 Exposure parameters of pivekimab sunirine-pvzy and unconjugated FGN849 at DECNUPAZ 0.045 mg/kg Every 3 Weeks P ivekimab sunirine - pvzy Geometric mean (%CV) Unconjugated FGN849 Geometric mean (%CV) C max 442 (169) ng/mL 58.8 (110) pg/mL AUC last 892 (101) ng•h/mL 171 (128) pg•h/mL C max =maximum concentration, AUC last =area under the concentration from time zero to the last quantifiable concentration Distribution Pivekimab sunirine-pvzy volume of distribution is

5.4L (39). FGN849 plasma protein binding is 99.6% in vitro . Elimination Pivekimab sunirine-pvzy elimination half-life is approximately 1.5 hours at the 0.045 mg/kg every 3 weeks dosage. Pivekimab sunirine-pvzy clearance is

1.8L/hour (76). Metabolism Pivekimab sunirine-pvzy is expected to be catabolized into small peptides and amino acids. FGN849 is primarily metabolized by CYP3A.

Specific Populations No clinically significant differences in the pharmacokinetics of pivekimab sunirine-pvzy or FGN849 were observed for age (19 to 91 years), body weight (45 to 160 kg), mild hepatic impairment (total bilirubin >ULN to 1.5 times ULN and any AST), or CLcr 60 to <90 mL/min (estimated by Cockcroft-Gault). Higher pivekimab sunirine-pvzy exposure and lower FGN849 exposure were observed in female patients compared to those in male patients. The pharmacokinetics of pivekimab sunirine-pvzy in patients with moderate to severe hepatic impairment (total bilirubin >1.5 times ULN with any AST) or CLcr <60 mL/min is unknown.

Drug Interaction Studies No dedicated clinical studies evaluating the drug-drug interaction potential of pivekimab sunirine-pvzy have been conducted. In Vitro Studies Cytochrome P450 (CYP) Enzymes : FGN849 is primarily a CYP3A substrate but is not a significant substrate of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6. FGN849 is an inhibitor of CYP3A and CYP2C8 but is not an inhibitor of CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.

Transporter system s : FGN849 is a substrate of P-gp and BCRP but is not a substrate of MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, or OCT2. FGN849 is not an inhibitor of P-gp, BCRP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, or OCT2.

🧬 Pharmacodynamics 61 words ▾

12.2Pharmacodynamics Exposure-Response Relationships Higher FGN849 (cytotoxic component of DECNUPAZ) exposure was associated with increased rates of Grade ≥2 infusion-related reactions. Cardiac Electrophysiology There is insufficient information to characterize the effect of pivekimab sunirine-pvzy on the QTc interval. In 116 patients who received DECNUPAZ 0.045 mg/kg once every 3 weeks in CADENZA, 0.9% of patients had QTcF greater than 500 ms.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES

14.1Treatment-naïve Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) CADENZA (NCT03386513) was a multicenter, open-label, single-arm, clinical trial that included 33 adult patients with treatment-naїve BPDCN with no central nervous system (CNS) involvement. Treatment consisted of DECNUPAZ 0.045 mg/kg intravenously once every three weeks. Patient baseline characteristics are presented in Table 6.

Table 6. Baseline Demographics of Patients with Treatment-naїve BPDCN Parameter N= 33 Gender, N (%) Male 27 (82) Female 6 (18) Race, N (%) White 27 (82) Black or African American 1 (3) Not Reported 5 (15) Ethnicity, N (%) Hispanic or Latino 4 (12) Non-Hispanic or Latino 28 (85) Unknown 1 (3) Age (years) Median (Range) 73 (48, 84) ECOG, N (%) 0 12 (36) 1 21 (64) BPDCN at Baseline, N (%) Skin 31 (94) Bone Marrow 16 (48) Peripheral Blood 3 (9) Lymph Nodes 12 (36) Viscera 0 Disease subgroup, N (%) BPDCN de novo 22 (67) BPDCN with PCHM a 11 (33) a PCHM is defined as any previously diagnosed or concurrently present hematologic malignancy at the time of BPDCN diagnosis The efficacy of DECNUPAZ in patients with treatment-naїve BPDCN was based on the rate of complete remission or clinical complete remission (CR/CRc).

Key efficacy measures are presented in Table 7. The median follow-up was 21.5 months (range: 4.2, 27). The median time to CR/CRc was 1.8 months (range: <0.5 to 4).

Among the 33 patients with treatment-naїve BPDCN, 13 (39.4%) patients were able to receive post-study treatment HSCT. Table 7. Efficacy Results in Patients with Treatment-naїve BPDCN Endpoint N = 33 CR/CRc a Rate, N (%) b ,c 23 (69.7) (95% CI) (51.3, 84.4) CR, N (%) 16 (48.5) (95% CI) (30.8, 66.5) CRc, N (%) 7 (21.2) (95% CI) (9.0, 38.9) Duration of CR/CRc (months) d , e , f Median 9.7 95% CI (2.9, NE) CI = confidence interval; NE = not estimable a CRc is defined as complete remission with residual skin abnormality not indicative of active disease. b CR/CRc rate was 77.3% (95% CI: 54.6, 92.2) in patients with de novo BPDCN (N=22). c CR/CRc rate was 54.5% (95% CI: 23.4, 83.3) in patients with PCHM (N=11). d Kaplan-Meier estimate. e Median duration of CR/CRc was 9.8 months (range: 0.9, 23.9+) in 17 patients with de novo BPDCN who achieved CR/CRc. f Median duration of CR/CRc was 6.3 months (range: 2.4, 23.2+) in 6 patients with BPDCN with PCHM who achieved CR/CRc.

14.2Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) CADENZA (NCT03386513) was a multicenter, open-label, single-arm, clinical trial that included 51 adult patients with relapsed or refractory BPDCN without evidence of active CNS disease treated with DECNUPAZ 0.045 mg/kg intravenously once every three weeks. Patient baseline characteristics are presented in Table 8. Table 8.

Baseline Demographics of Patients with Relapsed or Refractory BPDCN Parameter N=51 Gender, N (%) Male 42 (82) Female 9 (18) Race, N (%) White 42 (82) Black or African American 2 (4) Asian 1 (2) Not Reported 6 (12) Ethnicity, N (%) Hispanic or Latino 8 (16) Non-Hispanic or Latino 38 (75) Unknown 5 (10) Age (years) Median (Range) 69 (19, 85) ECOG, N (%) 0 18 (35) 1 30 (59) 2 2 (4) 3 1 (2) BPDCN at Baseline, N (%) Skin 34 (67) Bone Marrow 24 (47) Peripheral Blood 10 (20) Lymph Nodes 18 (35) Viscera 3 (6) Number of prior lines of therapy, median (Range) 1 (1, 4) Prior stem cell transplantation, N (%) 16 (31) The efficacy of DECNUPAZ in patients with relapsed/refractory BPDCN was based on the rate of CR/CRc.

Key efficacy measures are presented in Table 9. The median follow-up was 24.1 months (range: 0.2 to 30.4). The median time to CR/CRc was 1.7 months (range: 1 to 6).

Among the 51 patients with relapsed/refractory BPDCN, 6 (11.8%) patients were able to receive post-study treatment HSCT. Table 9. Efficacy Results in Patients with Relapsed or Refractory BPDCN Endpoint N = 51 CR/CRc a Rate, N (%) 8 (15.7) (95% CI) (7.0, 28.6) CR, N (%) 7 (13.7) (95% CI) (5.7, 26.3) CRc, N (%) 1 (2.0) (95% CI) (0.… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 86 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted with pivekimab sunirine-pvzy or the small molecule FGN849. Mutagenesis FGN849 was mutagenic in the bacterial reverse mutation (Ames) assay and clastogenic in the in vitro and in vivo (rat) micronucleus assays. These results are consistent with the pharmacological mechanism of action of DNA alkylation that induces G2-M phase arrest of dividing cells resulting in cell death.

Impairment of Fertility Fertility studies have not been conducted with pivekimab sunirine-pvzy or FGN849.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 83 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted with pivekimab sunirine-pvzy or the small molecule FGN849. Mutagenesis FGN849 was mutagenic in the bacterial reverse mutation (Ames) assay and clastogenic in the in vitro and in vivo (rat) micronucleus assays. These results are consistent with the pharmacological mechanism of action of DNA alkylation that induces G2-M phase arrest of dividing cells resulting in cell death.

Impairment of Fertility Fertility studies have not been conducted with pivekimab sunirine-pvzy or FGN849.

📚 References 8 words ▾

15. REFERENCES 1 “OSHA Hazardous Drugs.” OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Package Label / Principal Display Panel 85 words ▾

PRINCIPAL DISPLAY PANEL NDC 0074-0282-02 Decnupaz TM pivekimab sunirine-pvzy for injection 2 mg per vial WARNING: Hazardous Drug For intravenous infusion after reconstitution and two dilutions 1 Single-dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie PRINCIPAL DISPLAY PANEL NDC 0074-0282-02 DecnupazTM pivekimab sunirine-pvzy for injection 2 mg per vial WARNING: Hazardous Drug For intravenous infusion after reconstitution and two dilutions 1 Single-dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie

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

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← 00074-0243-02 · AbbVie 00074-0501-01 · AbbVie →
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