DECNUPAZ Powder for solution for injection Ref.[116689] Active ingredients: Pivekimab sunirine

Source: FDA, National Drug Code (US) Revision Year: 2026

1. Indications and Usage

DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

2. Dosage and Administration

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 Prior 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.
Add 4.8 mL of 5% Dextrose Injection to the reconstituted solution in the vial. Mix the diluted solution by gentle inversion. Do not shake.
The resulting diluted solution concentration is 0.4 mg/mL.
Calculate the required administration volume needed from the first dilution of vial(s). Volume needed from vial(s) after first dilution (mL) = Dose (mg) / 0.4 mg/mL.
DECNUPAZ requires a second dilution prior to administration.

Second Dilution:

Withdraw the calculated volume from the first dilution of vial(s) using an appropriately sized syringe.
Withdraw an equal volume of 5% Dextrose Injection in an appropriately sized second syringe.
Attach a connector to the two syringes and transfer DECNUPAZ into the syringe containing 5% Dextrose Injection.
Disconnect the syringes. Draw air into the syringe containing the DECNUPAZ diluted solution and close.
Gently invert the syringe to mix the solution. Do not shake.
Remove air bubbles from the syringe before administration.
The final concentration is 0.2 mg/mL.
Discard any unused drug remaining in the vial(s).
Do not use an in-line filter due to increased drug loss. If an in-line filter is required, a 1.2 micron polyethersulfone (PES) filter can be used.

Storage of Diluted Solution

Immediately use diluted DECNUPAZ solution.
The total storage time from the start of dose preparation to completion of administration should not exceed 24 hours. Store the diluted solution of DECNUPAZ under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, including up to 8 hours at room temperature at 9°C to 25°C (48°F to 77°F), from the time of reconstitution to completion of the intravenous infusion.
Discard diluted infusion solution if storage time exceeds these limits.
If refrigerated, allow approximately 30 minutes for the diluted solution to come to room temperature prior to administration. Do not shake.
Do not freeze the diluted infusion solution.
Protect from light during storage.
Do not shake.

2.6 Administration

After preparing the dose for infusion, visually inspect the syringe content for particulates and discard if present.
Do not mix DECNUPAZ with any other drugs or any intravenous fluids other than 5% Dextrose Injection.
Protect the intravenous syringe from light using a light-blocking cover during infusion. The infusion line does not need to be protected from light.
Administer DECNUPAZ as an intravenous infusion only. Do not administer as an intravenous push or bolus.
- The first infusion of DECNUPAZ should be administered at a rate of 0.8 mL/min (0.165 mg/min) for the first 30 minutes.
- If well tolerated, the infusion rate can be increased after 30 minutes to 1.7 mL/min (0.33 mg/min), if necessary.
- Subsequent infusions may be delivered at the highest tolerated rate.
Following the infusion, flush the intravenous line with sufficient volume of 5% Dextrose Injection to ensure delivery of the full dose. Do not use any other intravenous fluids for flushing.

16.2. 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 procedures¹.

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