Label Changes for:

Norditropin Cartridges (somatropin [rDNA origin] injection)

September 2014

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

September 2014

WARNINGS AND PRECAUTIONS

5.3 Neoplasms
  • 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 [see Contraindications (4.3)]. 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 neoplasms.
  • Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi.

 

May 2011

WARNINGS AND PRECAUTIONS

Impaired Glucose Tolerance and Diabetes Mellitus
  • ...New-onset Type 2 diabetes mellitus has been reported.

Pancreatitis
  • Cases of have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain.


ADVERSE REACTIONS

Postmarketing Experience
  • New-onset Type 2 diabetes mellitus has been reported

 

Hide
(web1)