August 23, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

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Advise patients:

  • To take premedications, including thyroid-blocking agents as prescribed [see WARNINGS AND PRECAUTIONS].
  • To contact a healthcare professional if they experience signs and symptoms of allergic reactions [see WARNINGS AND PRECAUTIONS].
  • To report to a health care professional any signs of cytopenias (bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue, or symptoms of infection such as fever) [see WARNINGS AND PRECAUTIONS].
  • Of the need for frequent monitoring for up to 3 months after treatment, and the potential for persistent cytopenias beyond 3 months.
  • Concerning the risk of radiation exposure to household contacts, pregnant women and small children from radioactive materials remaining in the patient's body following the BEXXAR therapeutic regimen. Provide patient-specific advice orally and in writing [see WARNINGS AND PRECAUTIONS].
  • Of the need for life-long monitoring for hypothyroidism [see WARNINGS AND PRECAUTIONS].
  • Who are pregnant that the BEXXAR therapeutic regimen can cause hypothyroidism in the infant [see WARNINGS AND PRECAUTIONS, Use in Special Populations].
  • To check with their physicians before receiving live virus vaccinations [see WARNINGS AND PRECAUTIONS].
  • Who are of reproductive potential to use effective contraceptive methods during treatment and for a minimum of 12 months following the BEXXAR therapeutic regimen [see Use in Special Populations].
  • To discontinue nursing during and after the BEXXAR therapeutic regimen [see Use in Special Populations].

Last reviewed on RxList: 9/27/2012
This monograph has been modified to include the generic and brand name in many instances.

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