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Request A RepWell-characterized safety in the CADENZA clinical trial
Low discontinuation rate
10% of all patients treated with DECNUPAZ discontinued treatment due to adverse reactions1*
*Adverse reactions which resulted in permanent discontinuation of DECNUPAZ in ≥1% of patients included veno-occlusive disease and pneumonitis.1
CADENZA included 116 patients with newly diagnosed or relapsed/refractory myeloid malignancies, including 84 with BPDCN1
| Adverse Reactions (≥10%) in Patients Who Received DECNUPAZ in CADENZA1 | ||
|---|---|---|
| ADVERSE REACTIONa | DECNUPAZ (N=116) | |
| ALL GRADES (%) | GRADE 3 OR 4 (%) | |
| General disorders and administration site conditions | ||
| Edemab | 52 | 16 |
| Fatiguec | 34 | 5 |
| Pyrexiac | 16 | 0.9 |
| Chills | 11 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painc | 34 | 8 |
| Vascular disorders | ||
| Hemorrhagec | 28 | 6 |
| Thrombosisc | 13 | 5 |
| Injury, poisoning, and procedural complications | ||
| Infusion-related reactions | 26 | 5 |
| Fall | 13 | 1.7 |
| Gastrointestinal disorders | ||
| Nauseac | 24 | 0.9 |
| Diarrheac | 21 | 0.9 |
| Constipation | 19 | 0 |
| Abdominal painc | 14 | 0.9 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Dyspneac | 19 | 1.7 |
| Coughc | 15 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Rashd | 19 | 0 |
| Nervous system disorders | ||
| Neuropathy peripherale | 18 | 1.7 |
| Headachec | 16 | 2.6 |
| Dizzinessc | 10 | 0.9 |
| Metabolism and nutrition disorders | ||
| Decreased appetitec | 16 | 0.9 |
| Infections and infestations | ||
| Infections without specified pathogensc | 16 | 6 |
| Viral infectionsf | 13 | 6 |
| Bacterial infectionsg | 12 | 5 |
| Pneumoniah | 11 | 9 |
| Psychiatric disorders | ||
| Insomnia | 15 | 0 |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 11 | 11 |
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.1
aAdverse reactions were graded based on CTCAE Version 4.03.1
bEdema 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 increase, ascites.1
cConsists of multiple related terms.1
dRash 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.1
eNeuropathy peripheral includes burning sensation, dysesthesia, facial nerve disorder, hypoesthesia, IIIrd nerve disorder, neuralgia, neuropathy peripheral, paresthesia, sciatica.1
fViral infections include COVID-19, cytomegalovirus infection, HCoV-229E infection, herpes simplex, herpes zoster, herpes zoster disseminated, influenza, ophthalmic herpes simplex, oral herpes.1
gBacterial infections include cellulitis, Clostridium difficile infection, erysipelas, folliculitis, vulval abscess.1
hPneumonia includes Pneumocystis jirovecii pneumonia, pneumonia, pneumonia viral.1
BPDCN=blastic plasmacytoid dendritic cell neoplasm; COVID-19=Coronavirus Disease of 2019; CTCAE=Common Terminology Criteria for Adverse Events; HCoV-229E=Human Coronavirus 229E
Incidence of veno-occlusive disease, infusion-related reactions, and edema
Hepatotoxicity, including hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome)
In CADENZA, VOD was reported in 6% (n/N=7/116) of adult patients during treatment or following a subsequent HSCT.1
On-treatment VOD
Occurred in
2 of 116
patients during treatment with DECNUPAZ, with onset up to 30 days after the last dose1*
Both events resolved but led to treatment discontinuation2
Post-HSCT VOD
Nineteen patients with BPDCN received subsequent HSCT after completing treatment with DECNUPAZ.1
VOD occurred in
5 of 19 patients1†
- Of those 5 patients with VOD, 2 events were fatal1
- The median time from subsequent HSCT to onset of VOD was 11 days (range: 7–25 days)1
†Out of the 5 patients, 4 had relapsed/refractory disease and 1 patient was treatment naïve.3
Monitoring considerations
- Patients should be closely monitored for signs and symptoms of VOD, including elevations in ALT, AST, and 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 DECNUPAZ1
- Based on elevations of liver tests, delay DECNUPAZ. In patients who experience VOD, discontinue DECNUPAZ and treat according to standard medical practice1
Infusion-related reactions
Occurred in
26%
(n/N=30/116)
of patients during treatment with DECNUPAZ
in the CADENZA trial1*
Infusion-related reactions occurred in Cycle 1 in 25% (n/N=29/116) of patients, with decreasing frequency in subsequent cycles1
Mostly mild to moderate
- Grade 1: 4.3% (n/N=5/116)1
- Grade 2: 16% (n/N=19/116)1
- Grade 3: 5% (n/N=6/116)1
Reduce risk with premedications
- Administer a prophylactic corticosteroid the day before infusion. Administer a corticosteroid, an antihistamine, and an antipyretic 30–60 minutes prior to infusion1
- Premedication the day before infusion and prior to dosing led to reduced frequency and severity of infusion-related reactions1
Discontinuation
- One patient discontinued treatment due to infusion-related reactions1
Monitoring considerations
- Monitor patients closely for potential infusion-related reactions 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 infusions1
- 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 discontinue1
*Recommended dose of DECNUPAZ in adult patients with BPDCN is 0.045 mg/kg IV once every 3 weeks.1
Edema*
Grade 3–4 edema occurred in
16%
(n/N=18/116)
of patients during treatment with DECNUPAZ in the CADENZA trial1
- All Grades: 52% (n/N=60/116)1
- Grade 3–4 generalized edema: 2.6% (n/N=3/116)1
45% (n/N=52/116) of patients in CADENZA experienced peripheral edema4
PERIPHERAL EDEMA IN ALL PATIENTS PER CYCLE IN CADENZA (N=116)1,5
Incidence of Peripheral Edema
DECNUPAZ can cause edema and fluid retention, including serious events1
Monitoring considerations
- Monitor patients for new or worsening edema1
- For Grade 2 or 3 edema, delay further dosing until edema has returned to Grade 0–1 or baseline1
- 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 discontinue1
*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 increase, ascites.1
Incidence of capillary leak syndrome
Occurred in
9%
(n/N=10/116)
of patients during treatment with DECNUPAZ1,3
CLS Grades: Placeholder copy3
In the CADENZA clinical trial, events occurring with DECNUPAZ most commonly had a subacute presentation.
Capillary leak syndrome includes the occurrence of at least 2 of the following new-onset signs and symptoms within 7 days of each other:
- Hypoalbuminemia (including albumin <3.0 g/dL)1
- Edema (including weight increase of >5 kg)1
- Hypotension (including systolic blood pressure <90 mmHg)1
ALT=alanine aminotransferase; AST=aspartate aminotransferase; BPDCN=blastic plasmacytoid dendritic cell neoplasm; HSCT=hematopoietic stem cell transplantation; IV=intravenous; VOD=veno-occlusive disease
Laboratory abnormalities observed in the CADENZA trial1
| Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received DECNUPAZ in CADENZA1 | ||
|---|---|---|
| LABORATORY ABNORMALITYa | DECNUPAZb | |
| ALL GRADES (%) | GRADE 3 OR 4 (%) | |
| Chemistry | ||
| Creatinine increased | 76 | 0 |
| Glucose increased | 53 | 10 |
| Albumin decreased | 50 | 1.8 |
| Phosphate decreased | 39 | 8 |
| Calcium decreased | 34 | 1.8 |
| Alanine aminotransferase increased | 32 | 4.4 |
| Aspartate aminotransferase increased | 29 | 0.9 |
| Sodium decreased | 28 | 1.8 |
| Potassium decreased | 26 | 3.5 |
| Alkaline phosphatase increased | 20 | 0.9 |
| Magnesium decreased | 18 | 0 |
| Bilirubin increased | 16 | 0.9 |
| Hematology | ||
| Platelets decreased | 64 | 40 |
| Neutrophils decreased | 63 | 45 |
| Lymphocyte count decreased | 62 | 39 |
| White blood cells decreased | 55 | 34 |
| Hemoglobin decreased | 40 | 20 |
- Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ. Based on elevations of liver tests, delay DECNUPAZ1
- Avoid use of DECNUPAZ in patients with moderate to severe hepatic impairment (total bilirubin >1.5 × ULN with any AST).1
- 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 disease1
aLaboratory abnormalities were graded based on CTCAE Version 4.03.1
bThe denominator used to calculate the rate varied from 78 to 114 based on the number of patients with at least one post-baseline value.1
ALT=alanine aminotransferase; AST=aspartate aminotransferase; BPDCN=blastic plasmacytoid dendritic cell neoplasm; CLcr=creatinine clearance; CTCAE=Common Terminology Criteria for Adverse Events; ULN=upper limit of normal
Additional safety information
Dose interruptions and dose reductions
Interruptions
- Dosage interruptions of DECNUPAZ due to adverse reactions occurred in 37% of patients1
- Adverse reactions which resulted in dosage interruptions in ≥2% of patients included edema, pneumonia, infusion-related reaction, bacterial infections, fatigue, hemorrhage, neutropenia, pneumonitis, and pyrexia1
Dose reductions
- Dose reductions of DECNUPAZ due to an adverse reaction occurred in 6% of patients1
- Adverse reactions which required dose reductions in ≥2% of patients included edema1
