Unituxin Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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)].


There is currently no drug history available for this drug.

Other Information

Unituxin (dinutuximab) is a chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Unituxin binds to the glycolipid disialoganglioside (GD2). Dinutuximab is produced in the murine myeloma cell line, SP2/0.

Unituxin is a sterile, preservative-free, clear/colorless to slightly opalescent solution for intravenous infusion. Unituxin is supplied in single-use vials of 17.5 mg/5mL. Each vial contains 3.5 mg/mL of dinutuximab, histidine (20mM), polysorbate 20 (0.05%), sodium chloride (150 mM), and water for injection; hydrochloric acid is added to adjust pH to 6.8.

Unituxin Manufacturers

  • United Therapeutics Corp.
    Unituxin (Dinutuximab) Injection [United Therapeutics Corp.]

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