Dinutuximab

Dinutuximab binds to the glycolipid GD2. This glycolipid is expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves.

• Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

• Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab.contraindicated

Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin [see Clinical Studies (14) ] . Administer required premedication and hydration prior to initiation of each Unituxin infusion [see Dosage and Administration (2.2) ] . 17.5 mg/m 2 /day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. ( 2.1 , 2.4 ) 2.1 Recommended Dose The recommended dose of Unituxin is 17.5 mg/m 2 /day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles (Table 1 and Table 2) [see Dosage and Administration (2.4) and Clinical Studies (14) ] . Initiate at an infusion rate of 0.875 mg/m 2 /hour for 30 minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75 mg/m 2 /hour. Follow dose modification instructions for adverse reactions [see Dosage and Administration (2.3) ] . Table 1: Schedule of Unituxin Administration for Cycles 1, 3, and 5 Cycle Day 1 through 3 4 5 6 7 8 through 24 Cycles 1, 3, and 5 are 24 days in duration. Unituxin X X X X Table 2: Schedule of Unituxin Administration for Cycles 2 and 4 Cycle Day 1 through 7 8 9 10 11 12 through 32 Cycles 2 and 4 are 32 days in duration. Unituxin X X X X 2.2 Required Pre-treatment Guidelines Intravenous Hydration Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over 1 hour just prior to initiating each Unituxin infusion.

Neurological Disorders of the Eye: Interrupt Unituxin for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue Unituxin for recurrent eye disorders or loss of vision. ( 5.2 ) Prolonged Urinary Retention and Transverse Myelitis: Permanently discontinue Unituxin and institute supportive care. ( 5.2 ) Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS. ( 5.2 ) Capillary Leak Syndrome and Hypotension: Administer required prehydration and monitor patients closely during treatment. Depending upon severity, manage by interruption, infusion rate reduction, or permanent discontinuation. ( 5.3 , 5.4 ) Infection: Interrupt until resolution of systemic infection. ( 5.5 ) Bone Marrow Suppression: Monitor peripheral blood counts during Unituxin therapy. ( 5.6 ) Electrolyte Abnormalities: Monitor serum electrolytes closely. ( 5.7 ) Atypical Hemolytic Uremic Syndrome: Permanently discontinue Unituxin and institute supportive management. ( 5.8 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1) ] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2) ] Capillary Leak Syndrome [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Infection [see Warnings and Precautions (5.5) ] Bone Marrow Suppression [see Warnings and Precautions (5.6) ] Electrolyte Abnormalities [see Warnings and Precautions (5.7) ] Atypical Hemolytic Uremic Syndrome [see Warnings and Precautions (5.8) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.9) ] The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. ( 5 , 6.1 ) The most common serious adverse reactions (≥5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. ( 5 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. 8.2 Lactation Risk Summary There is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, human IgG is present in human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment with Unituxin. 8.3 Females and Males of Reproductive Potential Contraception Females Unituxin may cause fetal harm [see Use in Specific Populations (8.1) ] .

Metabolism

The pharmacokinetics of dinutuximab was evaluated by a population pharmacokinetic analysis in a clinical study of Unituxin in combination with GM-CSF, IL-2, and RA. In this study, 27 children with high-risk neuroblastoma (age: 3.9±1.9 years) received up to 5 cycles of Unituxin at 17.5 mg/m 2 /day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days.

• Mar 10, 2015BLABLA125516United Therap

1. 1Pyrexia16721%
2. 2Off Label Use11014%
3. 3Pain8511%
4. 4Neuroblastoma Recurrent8310%
5. 5Abdominal Pain769.4%
6. 6Aspartate Aminotransferase Increased637.8%
7. 7Alanine Aminotransferase Increased617.6%
8. 8Vomiting607.5%
9. 9Anaemia567.0%
10. 10Hypotension567.0%
11. 11Hypoalbuminaemia546.7%
12. 12Neuroblastoma526.5%
13. 13Diarrhoea506.2%
14. 14Hypoxia486.0%
15. 15Pain In Extremity475.8%

The 10 most recently updated of 51 ClinicalTrials.gov registrations naming Dinutuximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
  Recruiting · Phase 2 · Interventional · 62 enrolled · New Approaches to Neuroblastoma Therapy Consortium
  NCT06450041updated 2026-06-10
• Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
  Recruiting · Phase 2 · Interventional · 27 enrolled · Tianjin Medical University Cancer Institute and Hospital
  NCT07318831updated 2026-06-04
• Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
  Completed · Phase 2 · Interventional · 42 enrolled · National Cancer Institute (NCI)
  NCT03786783updated 2026-06-02
• Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
  Recruiting · Phase 1 · Interventional · 40 enrolled · National Cancer Institute (NCI)
  NCT06995872updated 2026-05-22
• Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
  Completed · Phase 2 · Interventional · 225 enrolled · University of Birmingham
  NCT02308527updated 2026-05-12
• Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
  Recruiting · Phase 2 · Interventional · 500 enrolled · Giselle Sholler
  NCT02559778updated 2026-04-28
• Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma
  Active not recruiting · Phase 1 · Interventional · 44 enrolled · University Hospital Southampton NHS Foundation Trust
  NCT02914405updated 2026-04-28
• Therapy for Children With Advanced Stage Neuroblastoma
  Completed · Phase 2 · Interventional · 153 enrolled · St. Jude Children's Research Hospital
  NCT01857934updated 2026-04-16
• Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 76 enrolled · National Cancer Institute (NCI)
  NCT07437963updated 2026-04-15

Frequently asked questions

How does Dinutuximab work?

Dinutuximab binds to the glycolipid GD2. This glycolipid is expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves.

What is Dinutuximab used for?

According to FDA labeling, Dinutuximab carries indications including: Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dinutuximab?

Dinutuximab is classified as Glycolipid Disialoganglioside-directed Antibody, Glycolipid Disialoganglioside-directed Antibody Interactions, Immunologic Factor Interactions, Increased Cellular Death, Increased Immunologic Activity.

What are the brand names for Dinutuximab?

Dinutuximab is marketed under brand names including Unituxin.

What are the contraindications for Dinutuximab?

Dinutuximab labeling lists contraindications including: Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab.. Always consult the full prescribing information and a clinician.