One day. One outpatient
infusion. Once every
21 days.^1,2

Dosing

One outpatient infusion
of DECNUPAZ every 21 days^1,2

Continue until disease progression
or unacceptable toxicity¹

Premedications required

Administer premedications the day prior to and on the day* of the infusion of DECNUPAZ to reduce the risk of infusion-related reactions¹

Weight-based dosing

The recommended dose of DECNUPAZ is 0.045 mg/kg based on the patient’s actual body weight¹

Rapid administration

Administered over ~15–30 minutes^† as an IV infusion¹

Infusion monitoring and management

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

Outpatient infusion from the start²

^*30–60 minutes prior to each DECNUPAZ infusion.¹

^†This does not include administration of premedications or monitoring.

Premedications

Administer premedications the day prior to and on the day of the infusion of DECNUPAZ to reduce the risk of infusion-related reactions.¹

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Recommended Premedications Prior to Each DECNUPAZ Infusion¹
ADMINISTRATION TIME PRIOR TO DECNUPAZ INFUSION	PREMEDICATION	ROUTE OF ADMINISTRATION	DOSE (OR EQUIVALENT)
Day before DECNUPAZ infusion	Corticosteroid	Oral or IV	Dexamethasone 8 mg twice daily
30–60 minutes prior to infusion	Corticosteroid	IV	Dexamethasone 8 mg
	Antihistamine	IV	Diphenhydramine 25 mg to 50 mg
	Antipyretic	Oral	Acetaminophen 325 mg to 650 mg

Considerations for specific patient populations

Pregnancy/those with reproductive potential: DECNUPAZ can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after last dose¹
Lactation: Advise women not to breastfeed during treatment with DECNUPAZ and for 1 month after the last dose¹
Pediatric use: Safety and effectiveness of DECNUPAZ have not been established in pediatric patients¹
For patients with renal impairment: No dosage adjustment of DECNUPAZ is recommended for patients with mild renal impairment (CLcr 60 to <90 mL/min, estimated by Cockcroft‍-‍Gault)¹
- Moderate to severe 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 disease¹
For patients with 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)¹
- Moderate to severe hepatic impairment: Avoid use of DECNUPAZ in patients with moderate to severe hepatic impairment (total bilirubin >1.5 × ULN with any AST)¹

AST=aspartate aminotransferase; BPDCN=blastic plasmacytoid dendritic cell neoplasm; CLcr=creatinine clearance; IV=intravenous; ULN=upper limit of normal

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Preparation & Administration

Instructions for preparation

Important preparation instructions

DECNUPAZ requires reconstitution followed by two dilutions prior to administration. Read the entire Instructions for Preparation section carefully before preparing and administering DECNUPAZ¹

Use aseptic technique to prepare DECNUPAZ¹
DECNUPAZ is a hazardous drug. Follow applicable special handling and disposal procedures in accordance with local requirements¹
Determine the dose and the number of DECNUPAZ vials needed. More than one vial may be needed to achieve a full dose¹
Remove the DECNUPAZ vial(s) from the refrigerator and allow the vial(s) to reach room temperature 15°C to 30°C (59°F to 86°F) before use¹

View full details for reconstitution, dilution, administration, and storage by clicking each topic.

BPDCN=blastic plasmacytoid dendritic cell neoplasm; IV=intravenous

Treatment
Modifications

Recommended dosage modifications for adverse reactions

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Recommended Dosage Modifications for Adverse Reactions¹
ADVERSE REACTION	SEVERITY^a	DOSE MODIFICATION GUIDELINES
Veno-occlusive disease	Any Grade	Permanently discontinue DECNUPAZ
Increased AST or ALT	Either AST or ALT is >2.5 × the ULN	Delay further DECNUPAZ dosing until AST or ALT have returned to ≤2.5 × the ULN
Increased bilirubin	Total bilirubin >1.5 × the ULN	Delay further DECNUPAZ dosing until total bilirubin has returned to ≤1.5 × the ULN
Infusion-related reactions	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	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 IV once every 3 weeks
	Grade 4 (life-threatening)	Permanently discontinue DECNUPAZ
Other non-hematologic adverse reactions	Grade 3	Delay further DECNUPAZ dosing until resolved to ≤ Grade 2 or baseline
Other non-hematologic adverse reactions	Grade 4	Permanently discontinue DECNUPAZ

^aNational Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03; Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life‑threatening.¹

ALT=alanine aminotransferase; AST=aspartate aminotransferase; BPDCN=blastic plasmacytoid dendritic cell neoplasm; IV=intravenous; ULN=upper limit of normal

How to order DECNUPAZ

DECNUPAZ can be purchased from Specialty Distributors or Pharmacies. You can find contact details for specialty distributors and pharmacies for easy ordering.

See Ordering Info

Safety

Mechanism of Action