European Commission Grants Marketing Authorisation for Unituxin™ (dinutuximab) for the Treatment of Paediatric High-Risk Neuroblastoma - Seite 4

It is recommended that vasopressor therapy is also administered if necessary to restore an adequate perfusion pressure.

• Neurological Disorders of the Eye
  • Eye disorders may occur, especially with repeated courses. These changes usually resolve over time.  Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes.

• Hepatic Dysfunction
  • Regular monitoring of liver function is recommended during dinutuximab immunotherapy.

• Systemic Infections
  • Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection. 
  • Patients should have no evidence of systemic infection and any identified infection should be under control before beginning therapy.

• Laboratory Test Abnormalities
  • Electrolyte abnormalities occurring in at least 25% of patients who received Unituxin included hyponatraemia and hypokalaemia. 

• Atypical Haemolytic Uraemic Syndrome
  • Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.  Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.

For the Summary of Product Characteristics, and detailed information on this medicinal product, please visit www.ema.europa.eu.

About United Therapeutics

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions.

Forward-looking Statements

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, among others, statements relating to the safety and benefits of Unituxin to children.  These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results.  Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.  We are providing this information as of August 17, 2015, and we assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.  [uthr-g]

UNITUXIN is a trademark of United Therapeutics Corporation.