Decnupaz

Decnupaz is used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults. BPDCN is a rare, aggressive blood cancer that blends features of leukemia and lymphoma. It typically presents with skin lesions and tends to spread quickly to the bone marrow, lymph nodes, and central nervous system. Decnupaz is given as an intravenous (IV) infusion, once every three weeks.

Decnupaz (pivekimab sunirine-pvzy) is an antibody-drug conjugate that targets CD123-expressing cancer cells, delivering a potent cancer cell death–inducing agent (called a toxic payload) that damages DNA and triggers cell death in BPDCN.

Decnupaz (pivekimab sunirine-pvzy) gained FDA approval on May 27, 2026. There is no generic available. FDA approval was based on the Phase 1/2 CADENZA trial (NCT03386513):

• Newly diagnosed patients (n=33): Nearly 70% achieved a response, with almost 40% going on to receive a stem cell transplant
• Relapsed/refractory patients (n=51): Around 16% achieved a response, with approximately 12% going on to receive a stem cell transplant.

Decnupaz carries a Boxed Warning for liver toxicity, including hepatic veno-occlusive disease (VOD).

Serious Liver Problems

Decnupaz can cause serious liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver) that can be severe, life-threatening, or may lead to death.

Your healthcare provider will do blood tests before each dose and during treatment to check for liver problems. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including:

• Yellowing of the skin or eyes
• Pain in your stomach (abdomen)
• Fast weight gain
• Swelling of your stomach
• Dark urine.

Your healthcare provider may delay or stop treatment with Decnupaz if you have severe liver problems.

Contains Sulfites

Decnupaz contains sodium metabisulfite, a sulfite that may cause severe, life-threatening allergic reactions in some people, especially those with asthma. Get medical help right away if you develop hives, itching, rash, swelling of the eyes, tongue, or lips, chest pain, or trouble breathing or swallowing.

Do not use Decnupaz if you are allergic to pivekimab sunirine-pvzy, to sulfites, or to any of the ingredients in Decnupaz.

Before receiving Decnupaz, tell your healthcare provider about all of your medical conditions, including if you:

• Have liver problems
• Are allergic to sulfites
• Have asthma
• Have kidney problems
• Are pregnant or plan to become pregnant. Decnupaz can harm your unborn baby. Females who can become pregnant: Your healthcare provider will check for pregnancy before you start treatment. Use effective birth control during treatment and for 7 months after your last dose. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment.

Males with female partners who can become pregnant:

• Use effective birth control during treatment and for 4 months after your last dose.
• Are breastfeeding or plan to breastfeed. It is not known if Decnupaz passes into breast milk. Do not breastfeed during treatment and for 1 month after the last dose.

It is not known if Decnupaz is safe and effective in children.

If you have moderate to severe liver or kidney disease, do not use Decnupaz.

• Reduced liver function may impair drug metabolism and increase the risk of toxicity.
• Reduced kidney function may affect drug clearance and raise the risk of harmful side effects.

Possible Serious Side Effects

Decnupaz can sometimes cause serious side effects, including:

• Liver problems (hepatotoxicity), including veno-occlusive disease. See Important Information above.
• Infusion-related reactions (IRR). Decnupaz can cause serious, life-threatening infusion-related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion to help reduce these reactions, and will monitor you during and after each infusion. Tell your healthcare provider right away if you develop: Shortness of breath Nausea or vomiting Flushing or chills Chest pain Fever Feeling faint or lightheaded
• Fluid retention (edema). Decnupaz can cause your body to hold too much fluid. Your healthcare provider may prescribe a diuretic (water pill) if you develop edema. Tell your healthcare provider if you notice: Swelling of your ankles or legs Shortness of breath or difficulty breathing Unusual weight gain
• Sulfite allergic reactions. Decnupaz contains sodium metabisulfite, which may cause severe allergic reactions, particularly in people with asthma. Get medical help right away if you develop hives, itching, rash, swelling of the eyes, tongue, or lips, chest pain, or trouble breathing.

Common Side Effects

The most common side effects of Decnupaz are:

• Fluid retention (edema)
• Bleeding
• Feeling tired (fatigue)
• Infusion-related reactions
• Muscle, bone, and joint pain
• Nausea
• Diarrhea

Common Severe Abnormal Laboratory Results

The most common severe abnormal laboratory test results with Decnupaz include:

• Decreased white blood cell counts
• Decreased platelet counts
• Decreased red blood cell counts
• Increased blood sugar level

Decnupaz may also cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Decnupaz. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to AbbVie Inc. at 1-800-633-9110.

Your healthcare provider will give you Decnupaz into your vein through an intravenous (IV) line.

• Decnupaz is given once every three weeks (21-day treatment cycle).
• Your first infusion will be given over 30 minutes. If you do not have problems with your first infusion, subsequent infusions may be given over 15 minutes.
• Your healthcare provider will decide how many treatment cycles you will receive.
• You will receive premedication the day before and on the day of your infusion to help reduce infusion-related reactions. This may include: a corticosteroid (eg, dexamethasone) on the day before the infusion; and a corticosteroid, an antihistamine (eg, diphenhydramine), and an antipyretic (eg, acetaminophen) at least 30 to 60 minutes before the infusion.
• Your healthcare provider may slow down or permanently stop your infusion if you have an infusion-related reaction.
• Your healthcare provider may decrease your dose, delay your infusion, or permanently stop treatment if you have side effects.

Because Decnupaz is given by a healthcare provider in a clinical setting, a missed dose will typically be rescheduled by your healthcare team. If you miss or need to reschedule your infusion appointment, contact your healthcare provider as soon as possible.

Because Decnupaz is administered by a healthcare provider, an overdose is unlikely. However, if you have any concerns about your dose or experience unusual symptoms during or after your infusion, tell your healthcare provider right away or go to the nearest hospital emergency room.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect Decnupaz and increase your risk of side effects.

If a patient is taking a strong or moderate CYP3A inhibitor alongside Decnupaz, watch closely for increased side effects. These drugs can slow the breakdown of Decnupaz in the body, potentially raising drug levels and the risk of toxicity.

• Examples of strong CYP3A inhibitors include: Ketoconazole, itraconazole (antifungals) Clarithromycin (antibiotic) Ritonavir, cobicistat (HIV medications)
• Examples of moderate CYP3A inhibitors: Fluconazole (antifungal) Diltiazem, verapamil (heart medications) Erythromycin (antibiotic).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Decnupaz is prepared and stored by your healthcare provider or pharmacist in a clinical setting. You will not need to store it at home. Ask your healthcare provider or pharmacist if you have questions about how Decnupaz is stored or handled.

Keep all medicines out of the reach of children.

Active ingredient: pivekimab sunirine-pvzy

Inactive ingredients: methionine, polysorbate 20, sodium hydroxide, sodium metabisulfite, succinic acid, trehalose, and sterile water for injection

Supplied as 2 mg of pivekimab sunirine-pvzy as a lyophilized cake in a single-dose vial.

Decnupaz is manufactured and marketed by AbbVie Inc., North Chicago, IL 60064, USA. U.S. License Number: 1889.