WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME)1 See full prescribing information for complete boxed warning. 1
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Decnupaz®
Pivekimab sunirine-pvzy, a CD123-directed antibody-drug conjugate (ADC), is an antineoplastic agent.1
Pivekimab sunirine-pvzy has the following uses:
Pivekimab sunirine-pvzy is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).1
Pivekimab sunirine-pvzy is available in the following dosage form(s) and strength(s):
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For IV infusion only. 1
None.1
Pivekimab sunirine-pvzy can cause hepatotoxicity, including hepatic veno-occlusive disease (VOD), a severe form of hepatotoxicity.1 In the CADENZA study, VOD occurred in 6% (7/116) of adult patients during treatment or following a subsequent hematopoietic stem cell transplantation (HSCT).1 Of the 7 total patients who developed VOD, 3 patients had treatment-naïve BPDCN and 4 patients had relapsed/refractory BPDCN.1 Among all 116 patients treated with pivekimab sunirine-pvzy at 0.045 mg/kg, VOD occurred in 2/116 (2%) during treatment, with onset up to 30 days after the last dose.1 Among 19 patients with BPDCN who proceeded to HSCT, VOD occurred in 5/19 patients (26%), including two fatal cases.1 The median time from subsequent HSCT to onset of VOD was 11 days (range: 7 - 25 days).1
After receiving pivekimab sunirine-pvzy, 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.1 Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of pivekimab sunirine-pvzy.1 Based on elevations of liver tests, delay pivekimab sunirine-pvzy.1 In patients who experience VOD, discontinue pivekimab sunirine-pvzy and treat according to standard medical practice.1
Pivekimab sunirine-pvzy 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.1 In the CADENZA study, IRRs occurred in 26% (30/116) of patients during treatment with pivekimab sunirine-pvzy 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.1 IRR occurred in Cycle 1 in 25% (29/116) of patients with decreasing frequency in subsequent cycles.1 IRR led to discontinuation in one patient. 1
Premedicate with a corticosteroid the day before infusion, and premedicate with a corticosteroid, antihistamine, and antipyretic prior to dosing.1 Premedication the day before infusion and prior to dosing led to reduced frequency and severity of IRRs.1
Monitor patients closely for potential IRR during the infusion and for at least 4 hours, or longer as clinically indicated, after the first infusion and for at least 1 hour after subsequent infusions.1
Interrupt infusion of pivekimab sunirine-pvzy and institute appropriate medical management if an infusion-related reaction occurs.1 Depending on the severity of the infusion-related reaction, reduce infusion rate or permanently discontinue.1
Pivekimab sunirine-pvzy can cause edema and fluid retention, including serious events.1 In the CADENZA study, Grade 3-4 edema occurred in 16% (18/116) of patients treated with pivekimab sunirine-pvzy, including Grade 3-4 generalized edema in 2.6% (3/116) of patients. 1
Monitor patients for new or worsening edema.1 For Grade 2 or Grade 3 edema, delay further dosing of pivekimab sunirine-pvzy until edema has returned to Grade 0-1 or baseline.1 For Grade 3 edema or Grade 2 edema with dose delay for more than 2 weeks, consider resuming at a lower dose.1 For Grade 4 edema, permanently discontinue.1 Institute appropriate medical management for edema.1
Pivekimab sunirine-pvzy contains sodium metabisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.1 The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.1 Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.1
Based on its mechanism of action, pivekimab sunirine-pvzy can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells). 1
Advise patients of the potential risk to the fetus.1 Advise females of reproductive potential to use effective contraception during treatment with pivekimab sunirine-pvzy and for 7 months after the last dose.1 Advise male patients with female partners of reproductive potential to use effective contraception during treatment with pivekimab sunirine-pvzy, and for 4 months after the last dose.1
Based on its mechanism of action, pivekimab sunirine-pvzy can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells.1 There are no available data on the use of pivekimab sunirine-pvzy in pregnant women to inform a drug-associated risk.1 Advise patients of the potential risks to a fetus. 1
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.1
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.1 Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with pivekimab sunirine-pvzy and for 1 month after the last dose.1
Females and Males of Reproductive Potential
Pivekimab sunirine-pvzy can cause fetal harm when administered to a pregnant patient.1
Verify pregnancy status in females of reproductive potential prior to initiation of pivekimab sunirine-pvzy.1
Advise females of reproductive potential to use effective contraception during treatment with pivekimab sunirine-pvzy and for 7 months after the last dose. 1
Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with pivekimab sunirine-pvzy and for 4 months after the last dose.1
Based on its mechanism of action, pivekimab sunirine-pvzy may impair male and female reproductive function and fertility.1
The safety and effectiveness of pivekimab sunirine-pvzy have not been established in pediatric patients.1
Of the 116 patients who were treated in the CADENZA study, 70% of patients were ≥65 years of age and 28% were ≥75 years of age.1 No overall differences in safety or effectiveness of pivekimab sunirine-pvzy have been observed between patients 65 years of age and older and younger adult patients.1
Age does not have a clinically meaningful effect on the pharmacokinetics of pivekimab sunirine-pvzy.1
Avoid use of pivekimab sunirine-pvzy in patients with moderate to severe renal impairment (CLcr <60 mL/min, estimated by Cockcroft-Gault) or patients with end stage renal disease.1 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).1 Pivekimab sunirine-pvzy has not been studied in patients with severe renal impairment (CLcr <30 mL/min) or end stage renal disease. 1
No dosage adjustment of pivekimab sunirine-pvzy is recommended for patients with mild renal impairment (CLcr 60 to <90 mL/min, estimated by Cockcroft-Gault).1
Avoid use of pivekimab sunirine-pvzy in patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN with any AST).1 Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST).1 Pivekimab sunirine-pvzy has not been studied in patients with severe hepatic impairment.1
No dosage adjustment of pivekimab sunirine-pvzy is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin ≤1.5 times ULN and any AST).1
The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea.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.1
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Strong and Moderate CYP3A Inhibitors: Closely monitor for pivekimab sunirine-pvzy adverse reactions.1
Pivekimab sunirine-pvzy is a CD123 (alpha-subunit of the interleukin-3 receptor)-directed antibody-drug conjugate (ADC).1 The antibody is a humanized anti-CD123 IgG1.1 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.1 The payload, FGN849, is a member of the indolinobenzodiazepine pseudodimer (IGN) class of cytotoxic molecules.1 Pivekimab sunirine-pvzy exhibited antitumor activity in in vitro and in vivo models of BPDCN.1
Additional Information
AHFS first Release™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IV infusion | 2 mg | Decnupaz® | AbbVie |
AHFS® Drug Information. © Copyright, 1959-2026, Selected Revisions July 10, 2026. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. AbbVie Inc. DECNUPAZ® (pivekimab sunirine-pvzy) INTRAVENOUS prescribing information. 2026 May. [Web]