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U.S. Department of Health and Human Services

Safety

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Tev-Tropin (somatropin [rDNA origin]) for injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

June 2014

Summary View

PRECAUTIONS

  • In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence.  Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor.
  • Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplams.
  • Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi.

 

July 2011

Summary View

WARNINGS

  • Cases of pancreatitis have been reported rarely in children and adults.....
  • Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,”  (characterized.....

PRECAUTIONS

General
  • Treatment with somatropin may decrease insulin sensitivity....

ADVERSE REACTIONS

  • New-onset type 2 diabetes mellitus has been reported
  • potential immunogenicity of therapeutic proteins