Decnupaz
Pivekimab sunirine-pvzy · Injection, Powder, Lyophilized, For Solution · Intravenous
Uses
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
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 ) 2.1 Important Administration Instructions DECNUPAZ requires reconstitution followed by two dilutions prior to administration. Read the entire preparation instructions carefully before preparing and administering DECNUPAZ. 2.2 Recommended 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 ) ] . 2.3 Premedications 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 2.4 Dosage 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 every 3 weeks Grade 4 (life threatening) Permanently discontinue DECNUPAZ Other Non-hematologic Adverse Reactions [see Adverse Reactions ( 6.1 )] Grade 3 Delay further DECNUPAZ dosing until resolved to ≤ Grade 2 or baseline Grade 4 Permanently discontinue DECNUPAZ ULN=upper limit of normal a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03; Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening. 2.5 Instructions for Preparation Preparation Use aseptic technique to prepare DECNUPAZ. DECNUPAZ is a hazardous drug. Follow applicable special handling and disposal procedures in accordance with local requirements. 1 Determine the dose and the number of DECNUPAZ vials needed. More than one vial may be needed to achieve a full dose. Remove the DECNUPAZ vial(s) from the refrigerator and allow the vial(s) to reach room temperature 15°C to 30°C (59℉ to 86°F) before use. Reconstitution Using a sterile syringe, reconstitute DECNUPAZ by slowly injecting 1.1 mL of Sterile Water for Injection into each vial to obtain a concentration of 2 mg/mL. Each single-dose vial contains 1 mL (2 mg) of withdrawable DECNUPAZ. Gently swirl the vial in a circular motion. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution in each vial should appear clear to slightly opalescent, colorless to slightly yellow and free of visible contaminants, particles and/or particulates. Do not use if discoloration or particulate matter is present. DECNUPAZ contains no preservative. Use reconstituted solution immediately. If not used immediately, store the reconstituted DECNUPAZ vials in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 4 hours from the time of reconstitution. Do not freeze. First Dilution DECNUPAZ must be diluted with 5% Dextrose Injection.
Dosage forms and strengths
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
4. CONTRAINDICATIONS None. None. ( 4 )
Warnings and precautions
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 ) 5.1 Hepatotoxicity , 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 )] . 5.2 Infusion-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 )]. 5.3 Edema 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 edema has returned to Grade 0-1 or baseline. For Grade 3 edema or Grade 2 edema with dose delay for more than 2 weeks, consider resuming at a lower dose. For Grade 4 edema, permanently discontinue. Institute appropriate medical management for edema [see Dosage and Administration ( 2.4 )] . 5.4 Sulfite Allergic Reactions DECNUPAZ 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. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 5.5 Embryo-Fetal Toxicity 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 )] . Advise patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with DECNUPAZ and for 7 months after the last dose. Advise male patients 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 ( 8.1 , 8.3 )] .
Side effects
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 6.1 Clinical 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 0.9 Chills 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 1.7 Cough b 15 0 Skin and subcutaneous tissue disorders Rash c 19 0 Nervous system disorder s Neuropathy peripheral d 18 1.7 Headache b 16 2.6 Dizziness b 10 0.9 Metabolism and nutrition disorders Decreased appetite b 16 0.9 Infections and i nfestations Infections without specified pathogens b 16 6 Viral infections e 13 6 Bacterial infections f 12 5 Pneumonia g 11 9 Psychiatric disorders Insomnia 15 0 Blood and lymphatic system disorders Febrile neutropenia 11 11 § Adverse reactions were graded based on CTCAE Version 4.03 a. Edema includes acute pulmonary edema, face edema, generalized edema, hypervolemia, edema, edema genital, edema peripheral, pericardial effusion, peripheral swelling, pleural effusion, pulmonary edema, swelling face, weight increased, ascites. b. Consists of multiple related terms. c. Rash includes erythema, erythema nodosum, guttate psoriasis, photosensitivity reaction, psoriasis, rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, skin lesion, skin lesion inflammation, stasis dermatitis. d. Neuropathy peripheral includes burning sensation, dysesthesia, facial nerve disorder, hypoesthesia, IIIrd nerve disorder, neuralgia, neuropathy peripheral, paresthesia, sciatica. e. Viral infections includes COVID-19, cytomegalovirus infection, HCoV-229E infection, herpes simplex, herpes zoster, herpes zoster disseminated, influenza, ophthalmic herpes simplex, oral herpes. f. Bacterial infections includes cellulitis, clostridium difficile infection, erysipelas, folliculitis, vulval abscess. g. Pneumonia includes pneumocystis jirovecii pneumonia, pneumonia, pneumonia viral.
Drug interactions
7. DRUG INTERACTIONS Strong and M oderate CYP3A Inhibitors : Closely monitor for DECNUPAZ adverse reactions ( 7.1 ) 7.1 Effect 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
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 ) 8.1 Pregnancy 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. 8.2 Lactation 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. 8.3 Females 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. 8.4 Pediatric Use The safety and effectiveness of DECNUPAZ have not been established in pediatric patients. 8.5 Geriatric 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 )] . 8.6 Renal 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 )] . 8.7 Hepatic 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 >ULN or total bilirubin ≤1.5 times ULN and any AST) [see Clinical Pharmacology ( 12.3 )] .
Pregnancy
8.1 Pregnancy 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
8.4 Pediatric Use The safety and effectiveness of DECNUPAZ have not been established in pediatric patients.
Geriatric use
8.5 Geriatric 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 )] .
Description
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:
Mechanism of action
12.1 Mechanism 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
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 .
Patient information
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
Label text from the FDA structured product label by AbbVie Inc. (revised May 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pivekimab Sunirine in 1 product
Decnupaz NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0074-0282 | Pivekimab Sunirine 2 mg/mL Injection, Powder, Lyophilized, For Solution | AbbVie Inc. | BLA |
Frequently asked questions
What is Decnupaz used for?
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 )
What are the side effects of Decnupaz?
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… See the full label for the complete list.
Who makes Decnupaz?
Decnupaz is listed by 1 labeler in the FDA NDC directory, including AbbVie Inc..