Unituxin Approved for Neuroblastoma
March 13, 2015 - The U.S. Food and Drug Administration (FDA) approved Unituxin, manufactured by United Therapeutics. Unituxin is an initial therapy along with other cancer drugs, radiation and surgery for children who have high-risk neuroblastoma. Neuroblastoma is a rare cancer usually diagnosed before a child turn five years old. A monoclonal antibody, Unituxin sticks to neuroblastoma cells, attracting immune cells and causing the cancer cells to disintegrate.
Candidates for Unituxin are children who have at least partially responded to previous drug therapy. Dosing is based on body surface area and is administered by intravenous (IV) infusion for four consecutive days. Treatment can be repeated up to five times. Side effects can be serious and can including severe pain, which is managed with IV opioid pain relievers given before, during and after Unituxin infusions. Patients receiving Unituxin need to be monitored for infusion reactions, such as low blood pressure and swollen airways.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.