Molecule
Pivekimab sunirine is a prescription medicine indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). It is available as powder for injection for intravenous use. MedsAcross supplies Pivekimab sunirine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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).
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
2. DOSAGE AND ADMINISTRATION For intravenous infusion only. The recommended dose of DECNUPAZ is 0.045 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. 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. DECNUPAZ requires reconstitution followed by two dilutions prior to administration. See full Prescribing Information for instructions on preparation and administration.
Source: US FDA prescribing information
4. CONTRAINDICATIONS None. None.
Source: US FDA prescribing information
Boxed warning: can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome). Closely monitor patients for signs and symptoms of VOD including elevations in liver tests, 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. Delay DECNUPAZ dosage for liver test elevation. 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. Edema: Monitor for the development of edema and fluid retention.
Source: US FDA prescribing information
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) Infusion-Related Reactions Edema The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. 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.
Source: US FDA prescribing information
7. DRUG INTERACTIONS Strong and M oderate CYP3A Inhibitors: Closely monitor for DECNUPAZ adverse reactions 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. Concomitant use of DECNUPAZ with strong and moderate CYP3A inhibitors may increase unconjugated FGN849 exposure, which may increase the risk of DECNUPAZ adverse reactions.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Pivekimab sunirine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Decnupaz 2 mg/mL powder for injectionIntravenous Cold chain | AbbVie | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 May 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Pivekimab sunirine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Pivekimab sunirine, including Decnupaz.
Yes. The US FDA first approved Pivekimab sunirine on 27 May 2026, according to Drugs@FDA.
At least one listed presentation of Pivekimab sunirine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.